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Sample records for risperidone long-acting injectable

  1. Treatment-completion rates with olanzapine long-acting injection versus risperidone long-acting injection in a 12-month, open-label treatment of schizophrenia: indirect, exploratory comparisons

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    Ascher-Svanum H

    2012-05-01

    Full Text Available Haya Ascher-Svanum1, William S Montgomery2, David P McDonnell3, Kristina A Coleman4, Peter D Feldman11Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA; 2Eli Lilly Australia Pty Ltd, West Ryde, New South Wales, Australia; 3Eli Lilly and Company, Cork, Ireland; 4OptumInsight, Lilyfield, New South Wales, AustraliaBackground: Little is known about the comparative effectiveness of atypical antipsychotics in long-acting injection formulation. Due to the absence of head-to-head studies comparing olanzapine long-acting injection and risperidone long-acting injection, this study was intended to make exploratory, indirect, cross-study comparisons between the long-acting formulations of these two atypical antipsychotics in their effectiveness in treating patients with schizophrenia.Methods: Indirect, cross-study comparisons between olanzapine long-acting injection and risperidone long-acting injection used 12-month treatment-completion rates, because discontinuation of an antipsychotic for any cause is a recognized proxy measure of the medication's effectiveness in treating schizophrenia. Following a systematic review of the literature, two indirect comparisons were conducted using open-label, single-cohort studies in which subjects were stabilized on an antipsychotic medication before depot initiation. The first analysis compared olanzapine long-acting injection (one study with pooled data from nine identified risperidone long-acting injection studies. The second analysis was a “sensitivity analysis,” using only the most similar studies, one for olanzapine long-acting injection and one for risperidone long-acting injection, which shared near-identical study designs and involved study cohorts with near-identical patient characteristics. Pearson Chi-square tests assessed group differences on treatment-completion rates.Results: Comparison of olanzapine long-acting injection data (931 patients with the pooled data from the nine

  2. Cost effectiveness of long-acting risperidone injection versus alternative antipsychotic agents in patients with schizophrenia in the USA.

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    Edwards, Natalie C; Locklear, Julie C; Rupnow, Marcia F T; Diamond, Ronald J

    2005-01-01

    The availability of long-acting risperidone injection may increase adherence and lead to improved clinical and economic outcomes for individuals with schizophrenia. The objective of this study was to assess the cost effectiveness of long-acting risperidone, oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot in patients with schizophrenia over 1 year from a healthcare system perspective. Published medical literature, unpublished data from clinical trials and a consumer health database, and a clinical expert panel were utilized to populate a decision analytical model comparing the seven treatment alternatives. The model captured rates of patient compliance, the rates, frequency and duration of relapse, incidence of adverse events, and healthcare resource utilization and associated costs. Primary outcomes were expressed in terms of percentage of patients relapsing per year, number of relapse days per year (number and duration of relapses per patient per year), and total direct 2003 medical cost per patient per year. On the basis of model projections, the proportions of patients experiencing a relapse requiring hospitalization in 1 year were 66% for haloperidol depot, 41% for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 26% for long-acting risperidone, whereas the proportions of patients with an exacerbation not requiring hospitalization were 60% for haloperidol depot, 37% for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 24% for long-acting risperidone. The mean number of days of relapse requiring hospitalization per patient per year were 28 for haloperidol depot, 18 for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 11 for long-acting risperidone, whereas the mean number of days of exacerbation not requiring hospitalization were eight for haloperidol depot, five for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole

  3. Risperidone long-acting injection: a review of its long term safety and efficacy

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    Michael K Rainer

    2008-08-01

    Full Text Available Michael K RainerMemory-Clinic and Psychiatric Department, Donauspital, Vienna, AustriaAbstract: A long-acting form of the second-generation antipsychotic drug risperidone is now broadly available for the treatment of schizophrenia and closely related psychiatric conditions. It combines the advantage of previously available depot formulations for first-generation drugs with the favorable characteristics of the modern “atypical” antipsychotics, namely higher efficacy in the treatment of the negative symptoms of schizophrenia and reduced motor disturbances. Published clinical studies show an objective clinical efficacy (as per psychiatric symptom scores and relapse data that exceeds that of oral atypical antipsychotics when patients are switched to the long-acting injectable form, a low incidence of treatment-emergent extrapyramidal side effects, and very good acceptance by patients. Available data for maintenance treatment of bipolar disorder show equivalence with the oral form instead of superiority, but are still limited. As it seems likely that efficacy benefits are mostly due to the fact that the injectable form reduces the demand for patient compliance to one physician visit every 2 weeks instead of self-administration on a daily or twice-daily basis, additional potential could exist in other psychiatric disorders where atypical antipsychotic drugs are of benefit but where patient adherence to treatment schedules is typically low.Keywords: risperidone, schizophrenia, psychotic disorders, patient compliance; delayed-action preparations, injections, intramuscular

  4. Combination treatment with risperidone long-acting injection and psychoeducational approaches for preventing relapse in schizophrenia

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    Zhao Y

    2013-10-01

    Full Text Available Yueren Zhao,1–3 Taro Kishi,1 Nakao Iwata,1 Manabu Ikeda3,4 1Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, Japan; 2Department of Psychiatry, Okehazama Hospital Fujita Kokoro Care Center, Toyoake, Aichi, Japan; 3Department of Neuropsychiatry, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Kumamoto, Japan; 4Department of Neuropsychiatry, Faculty of Life Sciences, Kumamoto University, Kumamoto, Kumamoto, Japan Abstract: A recent meta-analysis showed that long-acting injectable (LAI antipsychotics were not superior to oral antipsychotics for preventing relapse in patients with schizophrenia. We therefore designed a treatment strategy combining risperidone LAI and COMPASS (COMprehensive Psycho-educational Approach and Scheme Set, an original psychoeducational program supporting treatment with risperidone LAI and evaluating subjective treatment satisfaction, transition of symptoms, and effectiveness in preventing symptomatic relapse. The aim of this study was to examine whether addition of COMPASS to risperidone LAI was more effective in preventing relapse in schizophrenia patients than risperidone LAI alone, with the latter group consisting of patients enrolled in a Phase III trial of risperidone LAI in Japan. Patients were followed up for 6 months, with COMPASS continuously implemented from the transition to the observation phase. The primary efficacy measurements were relapse rate (rates of rehospitalization and discontinuation due to inefficacy. Secondary efficacy measurements were the Brief Psychiatric Rating Scale (BPRS and Global Assessment of Functioning (GAF scores. Of the 96 patients originally enrolled, 19 (19.8% were discontinued from all causes. During the 6-month study period, ten of the 96 patients (10.4% relapsed, compared with a 12.2% relapse rate in patients enrolled in a Phase III trial of risperidone LAI in Japan. Patients showed significant improvements in BPRS total

  5. Worsening of myasthenia gravis after administration of injectable long-acting risperidone for treatment of schizophrenia; first case report and a call for caution.

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    Al-Hashel, Jasem Y; Ismail, Ismail Ibrahim; John, John K; Ibrahim, Mohammed; Ali, Mahmoud

    2016-01-01

    Myasthenia gravis is an autoimmune disease characterized by muscle weakness due to autoantibodies affecting the neuromuscular junction. Co-occurrence of myasthenia gravis and schizophrenia is very rare and raises a challenge in management of both diseases. Antipsychotic drugs exhibit anticholinergic side effects and have the potentials of worsening myasthenia. Long-acting risperidone is an injectable atypical antipsychotic drug that has not been previously reported to worsen myasthenia gravis in literature. We report the first case report of worsening of myasthenia after receiving long-acting risperidone injection for schizophrenia in a 29-year-old female with both diseases. She started to have worsening 2 weeks following the first injection and her symptoms persisted despite receiving plasma exchange. This could be explained by the pharmacokinetics of the drug. We recommend that long-acting risperidone should be used with caution in patients with myasthenia gravis, and clinicians must be aware of the potential risks of this therapy. Copyright © 2016 Elsevier B.V. All rights reserved.

  6. Cost-effectiveness model of long-acting risperidone in schizophrenia in the US.

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    Edwards, Natalie C; Rupnow, Marcia F T; Pashos, Chris L; Botteman, Marc F; Diamond, Ronald J

    2005-01-01

    Schizophrenia is a devastating and costly illness that affects 1% of the population in the US. Effective pharmacological therapies are available but suboptimal patient adherence to either acute or long-term therapeutic regimens reduces their effectiveness. The availability of a long-acting injection (LAI) formulation of risperidone may increase adherence and improve clinical and economic outcomes for people with schizophrenia. To assess the cost effectiveness of risperidone LAI compared with oral risperidone, oral olanzapine and haloperidol decanoate LAI over a 1-year time period in outpatients with schizophrenia who had previously suffered a relapse requiring hospitalisation. US healthcare system. Published medical literature, unpublished data from clinical trials and a consumer health database, and a clinical expert panel were used to populate a decision-analysis model comparing the four treatment alternatives. The model captured: rates of patient compliance; rates, frequency and duration of relapse; incidence of adverse events (bodyweight gain and extrapyramidal effects); and healthcare resource utilisation and associated costs. Primary outcomes were: the proportion of patients with relapse; the frequency of relapse per patient; the number of relapse days per patient; and total direct medical cost per patient per year. Costs are in year 2002 US dollars. Based on model projections, the proportions of patients experiencing a relapse requiring hospitalisation after 1 year of treatment were 66% for haloperidol decanoate LAI, 41% for oral risperidone and oral olanzapine and 26% for risperidone LAI, while the proportion of patients with a relapse not requiring hospitalisation were 60%, 37%, 37% and 24%, respectively. The mean number of days of relapse requiring hospitalisation per patient per year was 28 for haloperidol decanoate LAI, 18 for oral risperidone and oral olanzapine and 11 for risperidone LAI, while the mean number of days of relapse not requiring

  7. Risperidone long-acting injection in the treatment of schizophrenia: 24-month results from the electronic Schizophrenia Treatment Adherence Registry in Canada

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    Williams R

    2014-02-01

    Full Text Available Richard Williams,1 Ranjith Chandrasena,2 Linda Beauclair,3 Doanh Luong,4 Annette Lam4 On behalf of the e-STAR study group 1Vancouver Island Health Authority, Victoria, BC, Canada; 2Chatham-Kent Health Alliance, Chatham, ON, Canada; 3Allan Memorial Institute, Montreal, QC, Canada; 4Janssen Inc., Toronto, ON, Canada Objective: To assess outcomes over 24 months in Canadian patients with schizophrenia initiated on risperidone long-acting injection (RLAI and participating in the electronic Schizophrenia Treatment Adherence Registry (e-STAR. Materials and methods: Patients with schizophrenia or schizoaffective disorder were enrolled from 24 sites after an independent decision to initiate RLAI. Subsequent patient management was based on usual clinical practice at each site and was not protocol-driven. Relevant data were collected retrospectively by chart review for 12 months prior to RLAI and prospectively for 24 months following RLAI initiation. Results: Patients (n=188 had a mean age of 39.2 years, were 66.3% male, and 27.7% were inpatients at baseline. Twenty-four months after initiating therapy (initial dose =28.7 mg, 34.1% (95% confidence interval 27.2%–42.2% of patients had discontinued RLAI with a mean time to discontinuation of 273.4±196 days. Over the treatment period, there were significant (P<0.001 changes from baseline in Clinical Global Impression-Severity (CGI-S; 3.48 versus [vs] 4.31 at baseline, Global Assessment of Functioning (GAF; 56.1 vs 48.1, and Personal and Social Performance (PSP; 59.1 vs 46.9 scale scores. In addition, after 12 months, there were significant (P<0.001 decreases in the percentage of patients hospitalized (23.9% vs 58.5% pre-RLAI, mean length of stay (11.4 vs 30.4 days, and number of hospitalizations (0.32 vs 0.87 compared to the 12-month pre-RLAI period. Reductions in hospitalization continued into the second 12 months of therapy, when only 9% of patients were hospitalized and mean length of stay was 2.0 days

  8. Long-term outcomes in patients with schizophrenia treated with risperidone long-acting injection or oral antipsychotics in Spain: results from the electronic Schizophrenia Treatment Adherence Registry (e-STAR).

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    Olivares, J M; Rodriguez-Morales, A; Diels, J; Povey, M; Jacobs, A; Zhao, Z; Lam, A; Villalobos Vega, J C; Cuéllar, J Alonso; de Castro, F J Alberca; Quintero, C Morillo-Velarde; Martíin, J F Román; Domínguez, P Tabares; Ojeda, J L Prados; Cortés, S Sanz; Cala, F I Mata; Marín, C Gutiérrez; Castro, L Moyano; Duaso, M A Haza; Albarracín, J Requena; Vergara, G Narbona; Benítez, A Fernández; Cleries, F Mayoral; Pérez-Brian, J M García-Herrera; Aragón, A Bordallo; Navarro, J C Rodríguez; Biedma, J A Algarra; de Pedro, R Bravo; González, J F Delgado; López, M E Jaén; Moreno, H Díaz; López, J A Soto; Rodríguez, E Ojeda; de Hoyos, C Martínez; Sacristán, M Pardilla; Martín, M D Molina; Ballesteros, E Martín; Rodríguez, P A Sopelana; Menéndez, L Fernández; Rivas, R Santos; del Pino Cuadrado, P; Lauffer, J Correas; Solano, J J Rodríguez; Martínez, J M Fernández; Solano, F García; Rodríguez, P García-Lamberde; Rodríguez, J A Romero; Cano, T Rodríguez; Fortacin, M Ducaju; Lobeiras, J M Blanco; Sampedro, J M Piñeiro; Bravo, A Pérez; Pellicer, A Fernández; López, M D Alonso; Liste, J Fraga; Fernández, M Riobo; Losada, A Casas; Mendez, R Vazquez-Noguerol; Romero, S Agra; Blanco, J J Blanco; Bonaselt, I Tortajada; Mahia, M C García; del Valle, E Ferrer Gómez; Yañez, P Quiroga; Camarasa, M Gelabert; Alonso, J A Barbado; Mendez, G Florez; Feliz, F Doce; Lamela, M A López; Piñero, M Vega; Alvarado, P Fuentes; Gómez, I López; Martín, P Fadon; Gómez, J L Santos; López, A García; Jiménez, A Rodríguez; Nafs, A Escudero; Barquero, N Casas; Ortiz, R Fernández-Villamor; Noguera, J L Velez; Carrasco, P Ruiz; Muñoz, J Martín; Palma, M Masegoza; Hortelano, C Marín; Bonome, L Sánchez; Sevilla, J Sánchez; Juan, J M Mongil San; Ramos, J M García; Muñoz, J L Vallejo; Guisasola, J Elorza; Vazquez, L Santamaria; Guerras, F Campo; Nebot, F J Arrufat; Fernández, F J Baron; Nicolau, A L Palomo; Subirats, R Catala; Kidias, M Messays; Navarro, V Fabregat; García, B Frades; del Rosal, F Mejias; de Vicente Muñoz, T; Ballester, J Año; Lieb, P Malabia; Martel, A Delgado; Bea, E Roca; Joaquim, I Grau; Enjuanes, F Boatas; Piñol, M Bañuelos; Carbonell, E Fontova I; Muñoz, R Martín; Giribets, C Argila; Sans, L Albages; Blanco, A Serrano; Felipe, M Arcega; Muñoz, P González; Villanueva, A Pons; Arroyo, M Bernardo; Borri, R Coronas; Fallada, S Miret; Merola, M Celma; Rodon, E Parellada; Palmes, J R Pigem; Martínez, E Pérez; Catala, J Matarredona; Coca, A Sandoval; Ferrandiz, F Pascual; Paya, E Ferrandiz; Caballero, G Iturri; Bonet, A Franco; Figueras, J Fluvia; Pagador, P Moreno; Garibo, M Medina; Camo, V Pérez; Carrillo, C Sanz; Valero, C Pelegrin; Rebollo, F J Caro; García Campayo, J; Sala Ayma, J M Sala; Roig, M Martínez; de Uña Mateos, M A; Bertolin, R García; García, A Martín; Mazo, F Jiménez; Velasco, J L Galvez; Pérez, L Santa Maria; Casado, C Jiménez; Barba, J J Mancheño; Diaz, M Conde; Rubio, J P Alcon; Mandoli, A Soler; Herrero, A Uson; Martínez, A Rodríguez; Serrano, P Salgado; Rodríguez, E Nieto; Montesinos, J Segui; Macia, J Ferragud; Mateos Marcos, A Mateos; Soto, J V Pérez-Fuster; Dumont, M Verdaguer; Pagan, J Parra; Martínez, V Balanza; Santiuste de Pablos, M; Delgado, C Espinosa; Quiles, M D Martínez; López, F J Manzanera; Navarro, P Pozo; Torres, A Micol; Ingles, F J Martínez; Arias-Camison, J M Salmeron; Manzano, J C López; Peña, R Villanueva; Guitarte, G Petersen; Fontecilla, H Blasco; Romero, J Barjau; Gil, R Sanz; Lozano, J Marín; Adanez, L Donaire; Zarranz Herrera-Oria, I; Jiménez, J Pérez; Vaz, F Carrato; García, O Sanz; Anton, C Contreras; Casula, R Reixach; Hernandez, M C Natividad; Escabias, F Teba; Torresano, J Rodríguez; Pérez-Villamil, A Huidobro; Estevez, L; Figuero, M Aragües; Muñoz de Morales, A; Calvin, J L Rodríguez; Criado, M Delgado; Rodríguez, V Molina; Ambrosolio, E Balbo; Madera, P M Holgado; Alfaro, G Ponce; Vidal, M M Rojas; Valtuille, A García; Ruiz, O; Cabornero, G Lucas; Echevarria Martínez de Bujo, M; Mallen, M J Maicas; Puigros, J Santandreu; Martorell, A Liñana; Forteza, A Clar; Arrebola, E Rodríguez; Rodríguez de la Torre, M; Saiz, C G Anton; Bardolet I Casas, C; Linde, E Rodríguez; De Arce Cordon, R; Molina, E M Padial; Carazo, F J Ruiz; Romero, J J Muro; Cano, D Vico; Dorado, M Soria; Velazquez, S Campos; Sánchez, A J Rodríguez; Leon, S Ocio; Sánchez, K Pachas; Benitez, M Henry; Zugarramurai, A Intxausti; Contreras, M A; De la Varga González, M; Marín, P Barreiro; Robina, F Gómez; García, M Sánchez; Pérez, F J Otero; Bros, P Cubero; Gómez, A Carrillo; de Dios Molina Martín, J; Perera, J L Carrasco; Averbach, M C; Perera, J L Carrasco; Palancares, E Goenaga; Gallego de Dios, M T; Rojo, C Fernández; Iglesias, S Sánchez; Merino, M I Rubio; Mestre, N Prieto; Urdaniz, A Pérez; Sánchez, J M Martínez; Seco, R Gordo; Muñoz, J Franco; Agut, M Mateos; Lozano, M L Blanco; Herguedas, F Martín; Pena, A Torcal; García, J Vicente; Martínez, A Varona; Sanz Granado, O Sanz; Fernández, M A Medina; Canseco, J M Moran; López, P A Megia; Martín, M A Franco; Barrio, J A Espina; Ubago, J Giner; Bennassar, M Roca; Díez, J M Olivares; Fleta, J L Hernandez; Fortes, F Porras; López, C Arango; Medina, O; Alvarez, D Figuera; Roca, J M Peña; Valladolid, G Rubio; Tavera, J A Furquet; García-Castrillon Sales, J A; Llordes, I Batalla; Melgarejo, C Anchuistegui; Cañas de la Paz, F; Callol, V Vallés; García, M Bousoño; García, J Bobes; Leal, F J Vaz; Corrales, E Cáceres; Iglesias, E Sánchez; Gómez, M A Carreiras; Serrano, G García; Chillarón, E G Román; Aguado, F J Samino; Castillo, J J Molina; González, A González; Vázquez, J Gallardo; Peralvarez, M Bolivar; Diaz, M Rios; Mesa, M Ybarzabal; Artiles, F J Acosta; Chao, M Ajoy; Mesa, M Ybarzabal; del Rosario Santana, P; Escudero, M A García; Berenguer, M Molla; Llacer, J M Bonete; Berna, J A Juan; Ortiz, J Barragán; Pardell, L Tost; Hernández-Alvarez de Sotomayor, C; Méndez, M R Cejas; Garate, R Cabrera; Múgica, B Díaz; González, M Caballero; Domingo, J Pujol; Navarro, C Sáez; Vera, G Selva; Cuquerella, M A; Monzo, J Lonjedo; Boada, P Cervera; Pérez, M F Martín; Parrado, E Carrasco; Sánchez, J J Yañez; Fernández, J Calvo

    2009-06-01

    The electronic Schizophrenia Treatment Adherence Registry (e-STAR) is a prospective, observational study of patients with schizophrenia designed to evaluate long-term treatment outcomes in routine clinical practice. Parameters were assessed at baseline and at 3 month intervals for 2 years in patients initiated on risperidone long-acting injection (RLAI) (n=1345) or a new oral antipsychotic (AP) (n=277; 35.7% and 36.5% on risperidone and olanzapine, respectively) in Spain. Hospitalization prior to therapy was assessed by a retrospective chart review. At 24 months, treatment retention (81.8% for RLAI versus 63.4% for oral APs, p<0.0001) and reduction in Clinical Global Impression Severity scores (-1.14 for RLAI versus -0.94 for APs, p=0.0165) were significantly higher with RLAI. Compared to the pre-switch period, RLAI patients had greater reductions in the number (reduction of 0.37 stays per patient versus 0.2, p<0.05) and days (18.74 versus 13.02, p<0.01) of hospitalizations at 24 months than oral AP patients. This 2 year, prospective, observational study showed that, compared to oral antipsychotics, RLAI was associated with better treatment retention, greater improvement in clinical symptoms and functioning, and greater reduction in hospital stays and days in hospital in patients with schizophrenia. Improved treatment adherence, increased efficacy and reduced hospitalization with RLAI offer the opportunity of substantial therapeutic improvement in schizophrenia.

  9. Long-acting injectable antipsychotics: focus on olanzapine pamoate

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    JP Lindenmayer

    2010-05-01

    Full Text Available JP LindenmayerDepartment of Psychiatry, New York University School of Medicine, New York NY, USAAbstract: Medication non-adherence in patients with schizophrenia continues to be a significant problem and threatens successful treatment outcomes. Medication non-adherence is often associated with negative consequences, including symptom exacerbation, more frequent emergency room visits, re-hospitalizations and relapse. Long-acting injectable (LAI forms of antipsychotics allow for rapid identification of non-adherence, obviate the need for the patient to take the medication on a daily basis and increase adherence to some significant degree. Eli Lilly has developed a long-acting depot formulation of olanzapine, olanzapine pamoate, which has recently been approved by the FDA for the US market, and which will be reviewed here. Olanzapine LAI appears to be an effective antipsychotic at dosages of 210 mg every 2 weeks, 300 mg every 2 weeks and 405 mg every 4 weeks in patients with acute schizophrenia, and at 150 mg every 2 weeks, 300 mg every 2 weeks and at 405 mg every 4 weeks for the maintenance treatment of stable patients. Oral supplementation appears not to be needed, particularly not at the onset of treatment with the LAI as is necessary with risperidone LAI. Its efficacy is in general comparable to the efficacy seen with oral olanzapine at a corresponding dose. The side effect profile is also comparable to the side effects observed with oral olanzapine, including lower rates of extrapyramidal symptoms, prolactin elevation and cardiovascular side effects, but significant metabolic effects. The latter include significant weight gain, lipid abnormalities and glucose dysregulation. While the injection site adverse events are overall mild, the most significant serious adverse event is the post-injection delirium sedation syndrome (PDSS. While rare, this syndrome results from inadvertent intravascular injection of olanzapine LAI and can cause a range of

  10. [Cost-effectiveness analysis of schizophrenic patient care settings: impact of an atypical antipsychotic under long-acting injection formulation].

    Science.gov (United States)

    Llorca, P M; Miadi-Fargier, H; Lançon, C; Jasso Mosqueda, G; Casadebaig, F; Philippe, A; Guillon, P; Mehnert, A; Omnès, L F; Chicoye, A; Durand-Zaleski, I

    2005-01-01

    pharmaceutical formulation of antipsychotics. Hospitalization and relapse risks are lower in compliant than in non-compliant patients. The main objective of this pharmacoeconomic analysis is to evaluate the impact in terms of medical benefits and costs of the following strategies: 1. Risperidone long-acting injection: first long-acting injectable atypical antipsychotic; 2. Haloperidol depot: long-acting injectable conventional neuroleptic; 3. Olanzapine: atypical antipsychotic available commercially in oral formulation. The target population defined for the study are young schizophrenic patients treated for at least 1 year and whose disorder has not been diagnosed for longer than 5 years. The time horizon is 2 years. A cost-effectiveness analysis is performed. The perspective adopted is the French Health System. The main hypothesis of the model is that an increase in compliance linked to the use of long-acting injectable formulation could lead to an increased efficacy and a modification of the cost-effectiveness ratio. A decision tree was built. Six periods of follow-up are identified with a duration of 4-months per period. The tree contains 3 principal arms, each one corresponding to a specific treatment: risperidone LA injection, haloperidol decanoate and olanzapine. For each arm, at the chance node, two health states are identified: either the patient responds favourably to the treatment or does not respond favourably and requires a switch to another drug treatment. After a period of response, the patient can either remain in the same state or experiences a clinical deterioration. If the patient presents a clinical deterioration, he can either go back to a positive response state after a period of intensive follow-up or remain in an insufficient response state; in this case, a change of antipsychotic treatment is necessary. In the model, a patient should receive four different treatments before a long-term hospitalization takes put in place. According to the market

  11. Risperidone Injection

    Science.gov (United States)

    ... release (long-acting) injection is used to treat schizophrenia (a mental illness that causes disturbed or unusual ... may help control your symptoms but will not cure your condition. Continue to keep appointments to receive ...

  12. Six-month open-label follow-up of risperidone long-acting injection use in pediatric bipolar disorder.

    Science.gov (United States)

    Boarati, Miguel A; Wang, Yuan-Pang; Ferreira-Maia, Ana Paula; Cavalcanti, Ana Rosa S; Fu-I, Lee

    2013-01-01

    Recent studies suggest that risperidone long-acting injection (RLAI) may be considered for controlling mood episodes in bipolar disorder patients who have relapsed due to medication nonadherence or failure to respond to standard therapies. Currently, no study has reported the usefulness of RLAI in youths with bipolar disorder. The aim of this study was to evaluate short-term effects of RLAI in the naturalistic treatment of early-onset bipolar disorder and its role in symptomatic remission and adherence to treatment. Nineteen early-onset bipolar disorder outpatients receiving RLAI were observed in a 6-month naturalistic study at the outpatient clinic of the Child and Adolescent Affective Disorders Program at the Institute of Psychiatry of the University of São Paulo, São Paulo, Brazil. All patients met DSM-IV criteria for bipolar disorder. Clinical response to RLAI was evaluated using the Children's Global Assessment Scale (CGAS) and Clinical Global Impressions scale (CGI) across 3 time periods: index time (T0), 8 weeks after (T1), and 24 weeks after (T2). These subjects were recruited from May 2008 to December 2009. Patients receiving RLAI presented considerable improvement in global functioning (CGAS: T0 = 20.6; T1 = 42.9; and T2 = 49.2) and clinical severity (CGI: T0 = 5.9; T1 = 3.9; and T2 = 3.4). Global CGI mean scores of clinical improvement were 2.2 at T1 and 2.4 at T2. There were no significant changes in laboratory measurements and weight throughout follow-up. RLAI was shown to be an alternative treatment for youths with bipolar disorder failing to respond to prior medication trials or with adherence problems. Further blind, randomized controlled studies are necessary to confirm these initial findings. Sistema Nacional de Informaçōes Sobre Ética em Pesquisa Envolvendo Seres Humanos-Commisão Nacional de Ética em Pesquisa identifier: CAAE 0709.0.015.000-06.

  13. Second-generation long-acting injectable antipsychotics in schizophrenia: patient functioning and quality of life

    Directory of Open Access Journals (Sweden)

    Montemagni C

    2016-04-01

    Full Text Available Cristiana Montemagni,1,2 Tiziana Frieri,1,2 Paola Rocca1,2 1Department of Neuroscience, Unit of Psychiatry, University of Turin, 2Department of Mental Health, Azienda Sanitaria Locale (ASL Torino 1 (TO1, Azienda Ospedaliero-Universitaria (AOU Città della Salute e della Scienza di Torino, Turin, Italy Abstract: Long-acting injectable antipsychotics (LAIs were developed to make treatment easier, improve adherence, and/or signal the clinician when nonadherence occurs. Second-generation antipsychotic LAIs (SGA-LAIs combine the advantages of SGA with a long-acting formulation. The purpose of this review is to evaluate the available literature concerning the impact of SGA-LAIs on patient functioning and quality of life (QOL. Although several studies regarding schizophrenia patients’ functioning and QOL have been performed, the quantity of available data still varies greatly depending on the SGA-LAI under investigation. After reviewing the literature, it seems that SGA-LAIs are effective in ameliorating patient functioning and/or QOL of patients with schizophrenia, as compared with placebo. However, while methodological design controversy exists regarding the superiority of risperidone LAI versus oral antipsychotics, the significant amount of evidence in recently published research demonstrates the beneficial influence of risperidone LAI on patient functioning and QOL in stable patients and no benefit over oral treatment in unstable patients. However, the status of the research on SGA-LAIs is lacking in several aspects that may help physicians in choosing the correct drug therapy. Meaningful differences have been observed between SGA-LAIs in the onset of their clinical efficacy and in the relationships between symptoms and functioning scores. Moreover, head-to-head studies comparing the effects of SGA-LAIs on classical measures of psychopathology and functioning are available mainly on risperidone LAI, while those comparing olanzapine LAI with other

  14. Medication adherence in patients with psychotic disorders: an observational survey involving patients before they switch to long-acting injectable risperidone

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    Baylé FJ

    2015-09-01

    Full Text Available Franck Jean Baylé,1 Arnaud Tessier,2,3 Sophie Bouju,4 David Misdrahi2,3 1Sainte-Anne Hospital (SHU, Paris V-Descartes University, Paris, 2Hôpital Charles Perrens, Pôle de Psychiatrie Adulte, 3CNRS UMR 5287-INCIA, Bordeaux University, Bordeaux, 4Janssen-Cilag France, Issy Les Moulineaux, Paris, France Background: Maintaining antipsychotic therapy in psychosis is important in preventing relapse. Long-acting depot preparations can prevent covert non-adherence and thus potentially contribute to better patient outcomes. In this observational survey the main objective is to evaluate medication adherence and its determinants for oral treatment in a large sample of patients with psychosis.Methods: In this cross-sectional survey medication adherence for oral treatment was assessed by patients using the patient-rated Medication Adherence Questionnaire (MAQ. Data were collected by physicians on patients with a recent acute psychotic episode before switching to long-acting injectable risperidone. Other evaluations included disease severity (Clinical Global Impression – Severity, patients’ insight (Positive and Negative Syndrome Scale item G12, treatment acceptance (clinician-rated Compliance Rating Scale, and therapeutic alliance (patient-rated 4-Point ordinal Alliance Scale.Results: A total of 399 psychiatrists enrolled 1,887 patients (mean age 36.8±11.9 years; 61.6% had schizophrenia. Adherence to oral medication was “low” in 53.2% of patients, “medium” in 29.5%, and “high” in 17.3%. Of patients with psychiatrist-rated active acceptance of treatment, 70% had “medium” or “high” MAQ scores (P<0.0001. Medication adherence was significantly associated with therapeutic alliance (4-Point ordinal Alliance Scale score; P<0.0001. Patient age was significantly associated with adherence: mean age increased with greater adherence (35.6, 36.7, and 38.6 years for patients with “low”, “medium”, and “high” levels of adherence

  15. Cognitive and psychomotor effects of risperidone in schizophrenia and schizoaffective disorder.

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    Houthoofd, Sofie A M K; Morrens, Manuel; Sabbe, Bernard G C

    2008-09-01

    The aim of this review was to discuss data from double-blind, randomized controlled trials (RCTs) that have investigated the effects of oral and long-acting injectable risperidone on cognitive and psychomotor functioning in patients with schizophrenia or schizoaffective disorder. PubMed/MEDLINE and the Institute of Scientific Information Web of Science database were searched for relevant English-language double-blind RCTs published between March 2000 and July 2008, using the terms schizophrenia, schizoaffective disorder, cognition, risperidone, psychomotor, processing speed, attention, vigilance, working memory, verbal learning, visual learning, reasoning, problem solving, social cognition, MATRICS, and long-acting. Relevant studies included patients with schizophrenia or schizoaffective disorder. Cognitive domains were delineated at the Consensus Conferences of the National Institute of Mental Health-Measurement And Treatment Research to Improve Cognition in Schizophrenia (NIMH-MATRICS). The tests employed to assess each domain and psychomotor functioning, and the within-group and between-group comparisons of risperidone with haloperidol and other atypical antipsychotics, are presented. The results of individual tests were included when they were individually presented and interpretable for either drug; outcomes that were presented as cluster scores or factor structures were excluded. A total of 12 articles were included in this review. Results suggested that the use of oral risperidone appeared to be associated with within-group improvements on the cognitive domains of processing speed, attention/vigilance, verbal and visual learning and memory, and reasoning and problem solving in patients with schizophrenia or schizoaffective disorder. Risperidone and haloperidol seemed to generate similar beneficial effects (on the domains of processing speed, attention/vigilance, [verbal and nonverbal] working memory, and visual learning and memory, as well as psychomotor

  16. The cost effectiveness of long-acting/extended-release antipsychotics for the treatment of schizophrenia: a systematic review of economic evaluations.

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    Achilla, Evanthia; McCrone, Paul

    2013-04-01

    Antipsychotic medication is the mainstay of treatment in schizophrenia. Long-acting medication has potential advantages over daily medication in improving compliance and thus reducing hospitalization and relapse rates. The high acquisition and administration costs of such formulations raise the need for pharmacoeconomic evaluation. The aim of this article is to provide a comprehensive review of the available evidence on the cost effectiveness of long-acting/extended-release antipsychotic medication and critically appraise the strength of evidence reported in the studies from a methodological viewpoint. Relevant studies were identified by searching five electronic databases: PsycINFO, MEDLINE, EMBASE, the NHS Economic Evaluation Database and the Health Technology Assessment database (HTA). Search terms included, but were not limited to, 'long-acting injection', 'economic evaluation', 'cost-effectiveness' and 'cost-utility'. No limits were applied for publication dates and language. Full economic evaluations on long-acting/extended-release antipsychotics were eligible for inclusion. Observational studies and clinical trials were also checked for cost-effectiveness information. Conference abstracts and poster presentations on the cost effectiveness of long-acting antipsychotics were excluded. Thirty-two percent of identified studies met the selection criteria. Pertinent abstracts were reviewed independently by two reviewers. Relevant studies underwent data extraction by one reviewer and were checked by a second, with any discrepancies being clarified during consensus meetings. Eligible studies were assessed for methodological quality using the quality checklist for economic studies recommended by the NICE guideline on interventions in the treatment and management of schizophrenia. After applying the selection criteria, the final sample consisted of 28 studies. The majority of studies demonstrated that risperidone long-acting injection, relative to oral or other long-acting

  17. Cabotegravir long acting injection protects macaques against intravenous challenge with SIVmac251.

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    Andrews, Chasity D; Bernard, Leslie St; Poon, Amanda Yee; Mohri, Hiroshi; Gettie, Natanya; Spreen, William R; Gettie, Agegnehu; Russell-Lodrigue, Kasi; Blanchard, James; Hong, Zhi; Ho, David D; Markowitz, Martin

    2017-02-20

    We evaluated the effectiveness of cabotegravir (CAB; GSK1265744 or GSK744) long acting as preexposure prophylaxis (PrEP) against intravenous simian immunodeficiency virus (SIV) challenge in a model that mimics blood transfusions based on the per-act probability of infection. CAB long acting is an integrase strand transfer inhibitor formulated as a 200 mg/ml injectable nanoparticle suspension that is an effective PrEP agent against rectal and vaginal simian/human immunodeficiency virus transmission in macaques. Three groups of rhesus macaques (n = 8 per group) were injected intramuscularly with CAB long acting and challenged intravenously with 17 animal infectious dose 50% SIVmac251 on week 2. Group 1 was injected with 50 mg/kg on week 0 and 4 to evaluate the protective efficacy of the CAB long-acting dose used in macaque studies mimicking sexual transmission. Group 2 was injected with 50 mg/kg on week 0 to evaluate the necessity of the second injection of CAB long acting for protection against intravenous challenge. Group 3 was injected with 25 mg/kg on week 0 and 50 mg/kg on week 4 to correlate CAB plasma concentrations at the time of challenge with protection. Five additional macaques remained untreated as controls. CAB long acting was highly protective with 21 of the 24 CAB long-acting-treated macaques remaining aviremic, resulting in 88% protection. The plasma CAB concentration at the time of virus challenge appeared to be more important for protection than sustaining therapeutic plasma concentrations with the second CAB long acting injection. These results support the clinical investigation of CAB long acting as PrEP in people who inject drugs.

  18. Use of Aripiprazole Long Acting Injection in Negative Symptoms of Schizophrenia

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    Suneeta James

    2016-01-01

    Full Text Available Background. Evidence for the efficacious use of second-generation antipsychotics for the treatment of negative symptoms in schizophrenia is scant. Case Presentation. We report the case of a 34-year-old female of Afro-Caribbean origin, who presented with prominent negative symptoms of schizophrenia and was successfully treated with aripiprazole long acting injection. Within a period of six to nine months, the patient returned to her premorbid level of functioning. Conclusion. Aripiprazole long acting injection promises benefits in the treatment of negative symptoms of schizophrenia. Further research needs to be conducted on the use of this drug.

  19. A Retrospective Study of Long Acting Risperidone Use to Support Treatment Adherence in Youth with Conduct Disorder.

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    Demirkaya, Sevcan Karakoç; Aksu, Hatice; Özgür, Börte Gürbüz

    2017-11-30

    Risperidone has been widely used to control aggression and conduct disorder (CD) in youth; however, treatment compliance is a major problem in CD. Our aim is to evaluate the effectiveness and tolerability of long-acting risperidone (LAR) in treating nonadherent cases. The medical records of children and adolescents who had CD and were nonadherent to conventional drugs and psychosocial interventions (and therefore taking LAR) were reviewed. Informed consent on offlabel use of LAR was obtained from the parents. Clinical Global Impression (CGI) Severity (CGI-S) and CGI-Improvement scales were used and baseline and end points were compared. The study comprised 14 children and adolescents (5 girls, 9 boys). All had comorbid disorders: substance use disorder (n=8), attention deficit hyperactivity disorder (n=6), and major depression (n=2). Mean duration of LAR use was 3.1 months (1.5-8 months). We observed significant improvements in the baseline and endpoint CGI-S scores for CD in all but one patient (Z=-3.198; p <0.001). Only mild adverse effects were observed: weight gain (n=2), sedation (n=1), leg cramps (n=1), and increased appetite with no weight gain (n=1). LAR is effective and tolerable for patients with CD who can't be medicated with oral preparations due to nonadherence to treatment. Even short-term LAR use is effective to get compliance. As CD predicts numerous problems in adulthood, appropriate treatment is crucial. To our knowledge, this is the first study on LAR use in youth with CD. The use of LAR deserves careful consideration and further controlled studies are needed to confirm our findings.

  20. Once-monthly paliperidone injection for the treatment of schizophrenia

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    Delia Bishara

    2010-09-01

    Full Text Available Delia BisharaPharmacy Department, South London and Maudsley NHS Foundation Trust, London, United KingdomAbstract: Paliperidone palmitate is a new long-acting antipsychotic injection for the treatment of acute and maintenance therapy in schizophrenia. Paliperidone (9-hydroxyrisperidone is the major active metabolite of risperidone and acts at dopamine D2 and serotonin 5HT2A receptors. As with other atypical antipsychotics, it exhibits a high 5HT2A:D2 affinity ratio. It also has binding activity as an antagonist at α1- and α2 adrenergic receptors and H1 histaminergic receptors, but has virtually no affinity for cholinergic receptors. Paliperidone palmitate has been shown to be effective in reducing Positive and Negative Syndrome Scale total scores in four short-term trials in acute schizophrenia. It was also effective as maintenance therapy in a long-term trial in which time to recurrence of symptoms was significantly longer in paliperidone-treated patients compared with placebo. In addition, paliperidone was shown to be noninferior to risperidone long-acting injection in one study, but this noninferiority was not established in another longer study comparing the two drugs. Treatment should be initiated with 234 mg on day 1 and 156 mg on day 8, followed by a recommended monthly maintenance dose of 39–234 mg based on efficacy and tolerability. Paliperidone palmitate is generally well tolerated, although it can cause weight gain and a rise in prolactin levels, which is generally greater in women than in men. Overall, paliperidone palmitate may have advantages over other currently available long-acting injections, and therefore may be a useful alternative for the treatment of schizophrenia, although further long-term trials comparing it with active treatments are warranted.Keywords: paliperidone palmitate, injection, schizophrenia, long-acting

  1. Long acting risperidone in Australian patients with chronic schizophrenia: 24-month data from the e-STAR database

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    Lambert Tim

    2012-03-01

    Full Text Available Abstract Background This observational study was designed to collect treatment outcomes data in patients using the electronic Schizophrenia Treatment Adherence Registry (e-STAR. Methods Patients with schizophrenia or schizoaffective disorder in Australia who were prescribed risperidone long-acting injection (RLAI between 2003 and 2007 were assessed 12-months retrospectively, at baseline and 24-months prospectively at 3-monthly intervals. The intent-to-treat population, defined as all patients who received at least one dose of RLAI at baseline, was used for the efficacy and safety analyses. Results At total of 784 patients (74% with schizophrenia, 69.8% male with a mean age of 37.1 ± 12.5 years and 10.6 ± 9.5 years since diagnosis were included in this Australian cohort. A significant improvement in mean Clinical Global Impression - severity score was observed at 24-months (4.52 ± 1.04 at baseline, 3.56 ± 1.10 at 24-months. Most of this improvement was seen by 3-months and was also reflected in mean Global Assessment of Functioning score, which improved significantly at 24-months (42.9 ± 14.5 at baseline, 59 ± 15.4 at 24-months. For patients still receiving RLAI at 24-months there was an increase from a mean baseline RLAI dose of 26.4 ± 5 mg to 43.4 ± 15.7 mg. Sixty-six percent of patients discontinued RLAI before the 24-month period--this decreased to 46% once patients lost to follow-up were excluded. Conclusion Over the 24-month period, initiation of RLAI was associated with improved patient functioning and illness severity in patients with schizophrenia or schizoaffective disorder. Improved outcomes were observed early and sustained throughout the study. Trial Registration Clinical Trials Registration Number, NCT00283517.

  2. Pharmacogenomics and Efficacy of Risperidone Long-Term Treatment in Thai Autistic Children and Adolescents

    NARCIS (Netherlands)

    Nuntamool, Nopphadol; Ngamsamut, Nattawat; Vanwong, Natchaya; Puangpetch, Apichaya; Chamnanphon, Monpat; Hongkaew, Yaowaluck; Limsila, Penkhae; Suthisisang, Chuthamanee; Wilffert, Bob; Sukasem, Chonlaphat

    2017-01-01

    The purpose of this study was to evaluate the association of pharmacogenomic factors and clinical outcome in autistic children and adolescents who were treated with risperidone for long periods. Eighty-two autistic subjects diagnosed with DSM-IV and who were treated with risperidone for more than

  3. Effects of short- and long-term risperidone treatment on prolactin levels in children with autism.

    Science.gov (United States)

    Anderson, George M; Scahill, Lawrence; McCracken, James T; McDougle, Christopher J; Aman, Michael G; Tierney, Elaine; Arnold, L Eugene; Martin, Andrés; Katsovich, Liliya; Posey, David J; Shah, Bhavik; Vitiello, Benedetto

    2007-02-15

    The effects of short- and long-term risperidone treatment on serum prolactin were assessed in children and adolescents with autism. Patients with autism (N = 101, 5-17 years of age) were randomized to an 8-week trial of risperidone or placebo and 63 then took part in a 4-month open-label follow-up phase. Serum samples were obtained at Baseline and Week-8 (N = 78), and at 6-month (N = 43) and 22-month (N = 30) follow-up. Serum prolactin was determined by immunoradiometric assay; dopamine type-2 receptor (DRD2) polymorphisms were genotyped. Baseline prolactin levels were similar in the risperidone (N = 42) and placebo (N = 36) groups (9.3 +/- 7.5 and 9.3 +/- 7.6 ng/ml, respectively). After 8 weeks of risperidone, prolactin increased to 39.0 +/- 19.2 ng/ml, compared with 10.1 +/- 8.8 ng/ml for placebo (p autism. Although risperidone-induced increases tended to diminish with time, further research on the consequences of long-term prolactin elevations in children and adolescents is needed.

  4. Treatment of anorexia nervosa with long-term risperidone in an outpatient setting: case study.

    Science.gov (United States)

    Kracke, Elsa J; Tosh, Aneesh K

    2014-01-01

    There are currently few studies focusing on the efficacy of long-term atypical antipsychotics to treat anorexia nervosa in the pediatric population. This case report follows the treatment of a 17 year-old female with anorexia nervosa over her four-year undergraduate career. After two years of multidisciplinary treatment, low-dose risperidone was initiated due to persistence of her disease. She expressed decreased rigidity around meal times, her weight improved and she had resumption of menses. She was compliant with treatment through graduation and maintained her weight gain. Atypical antipsychotics are a treatment option in the management of anorexia nervosa. Risperidone has not been studied as frequently as olanzapine for eating disorders. Risperidone was chosen for its more favorable side effect profile and decreased cost to the patient. Previous studies on anorexia nervosa treatment have occurred during inpatient treatment and have limited follow-up due to patients' refusal to initiate or maintain medication compliance. This case presents 17 months of outpatient data. The efficacy of risperidone therapy was evaluated with frequent weight checks, subjective decrease in rigidity, serial complete metabolic panels, and restoration of menses. In this case report, an adolescent female treated with low-dose risperidone had decreased rigid thinking, weight gain and resolution of secondary amenorrhea without medication side effects. Therefore, the atypical antipsychotic risperidone may be an effective long-term outpatient treatment option for patients with anorexia nervosa.

  5. Pharmacogenomics and Efficacy of Risperidone Long-Term Treatment in Thai Autistic Children and Adolescents.

    Science.gov (United States)

    Nuntamool, Nopphadol; Ngamsamut, Nattawat; Vanwong, Natchaya; Puangpetch, Apichaya; Chamnanphon, Monpat; Hongkaew, Yaowaluck; Limsila, Penkhae; Suthisisang, Chuthamanee; Wilffert, Bob; Sukasem, Chonlaphat

    2017-10-01

    The purpose of this study was to evaluate the association of pharmacogenomic factors and clinical outcome in autistic children and adolescents who were treated with risperidone for long periods. Eighty-two autistic subjects diagnosed with DSM-IV and who were treated with risperidone for more than 1 year were recruited. Pharmacogenomics and clinical outcome (CGI-I, aggressive, overactivity and repetitive score) were evaluated. Almost all patients showed stable symptoms on aggressive behaviour (89.02%), overactivity (71.95%), repetitive (70.89%) behaviour and all clinical symptoms (81.71%). Only 4.48% of patients showed minimally worse CGI-I score. Patients in the non-stable symptom group had DRD2 Taq1A non-wild-type (TT and CT) frequencies higher than the clinically stable group (p = 0.04), whereas other gene polymorphisms showed no significant association. Haplotype ACCTCAT (rs6311, rs1045642, rs1128503, rs1800497, rs4436578, rs1799978, rs6280) showed a significant association with non-stable clinical outcome (χ 2  = 6.642, p = 0.010). Risperidone levels showed no association with any clinical outcome. On the other hand, risperidone dose, 9-OH risperidone levels and prolactin levels were significantly higher in the non-stable compared to the stable symptom group (p = 0.013, p = 0.044, p = 0.030). Increased appetite was the most common adverse drug reaction and associated with higher body-weight, whereas it was not significantly associated with genetic variations and non-genetic information. In conclusion, risperidone showed efficacy to control autism, especially aggressive symptoms in long-term treatment. However, Taq1A T - carrier of dopamine 2 receptor gene - is associated with non-stable response in risperidone-treated patients. This study supports pharmacogenomics testing for personalized therapy with risperidone in autistic children and adolescents. © 2017 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  6. Early-life risperidone enhances locomotor responses to amphetamine during adulthood.

    Science.gov (United States)

    Lee Stubbeman, Bobbie; Brown, Clifford J; Yates, Justin R; Bardgett, Mark E

    2017-10-05

    Antipsychotic drug prescriptions for pediatric populations have increased over the past 20 years, particularly the use of atypical antipsychotic drugs such as risperidone. Most antipsychotic drugs target forebrain dopamine systems, and early-life antipsychotic drug exposure could conceivably reset forebrain neurotransmitter function in a permanent manner that persists into adulthood. This study determined whether chronic risperidone administration during development modified locomotor responses to the dopamine/norepinephrine agonist, D-amphetamine, in adult rats. Thirty-five male Long-Evans rats received an injection of one of four doses of risperidone (vehicle, .3, 1.0, 3.0mg/kg) each day from postnatal day 14 through 42. Locomotor activity was measured for 1h on postnatal days 46 and 47, and then for 24h once a week over the next two weeks. Beginning on postnatal day 75, rats received one of four doses of amphetamine (saline, .3, 1.0, 3.0mg/kg) once a week for four weeks. Locomotor activity was measured for 27h after amphetamine injection. Rats administered risperidone early in life demonstrated increased activity during the 1 and 24h test sessions conducted prior to postnatal day 75. Taking into account baseline group differences, these same rats exhibited significantly more locomotor activity in response to the moderate dose of amphetamine relative to controls. These results suggest that early-life treatment with atypical antipsychotic drugs, like risperidone, permanently alters forebrain catecholamine function and increases sensitivity to drugs that target such function. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases

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    Stefaniak Victoria J

    2010-06-01

    Full Text Available Abstract Background An advance in the treatment of schizophrenia is the development of long-acting intramuscular formulations of antipsychotics, such as olanzapine long-acting injection (LAI. During clinical trials, a post-injection syndrome characterized by signs of delirium and/or excessive sedation was identified in a small percentage of patients following injection with olanzapine LAI. Methods Safety data from all completed and ongoing trials of olanzapine LAI were reviewed for possible cases of this post-injection syndrome. Descriptive analyses were conducted to characterize incidence, clinical presentation, and outcome. Regression analyses were conducted to assess possible risk factors. Results Based on approximately 45,000 olanzapine LAI injections given to 2054 patients in clinical trials through 14 October 2008, post-injection delirium/sedation syndrome occurred in approximately 0.07% of injections or 1.4% of patients (30 cases in 29 patients. Symptomatology was consistent with olanzapine overdose (e.g., sedation, confusion, slurred speech, altered gait, or unconsciousness. However, no clinically significant decreases in vital signs were observed. Symptom onset ranged from immediate to 3 to 5 hours post injection, with a median onset time of 25 minutes post injection. All patients recovered within 1.5 to 72 hours, and the majority continued to receive further olanzapine LAI injections following the event. No clear risk factors were identified. Conclusions Post-injection delirium/sedation syndrome can be readily identified based on symptom presentation, progression, and temporal relationship to the injection, and is consistent with olanzapine overdose following probable accidental intravascular injection of a portion of the olanzapine LAI dose. Although there is no specific antidote for olanzapine overdose, patients can be treated symptomatically as needed. Special precautions include use of proper injection technique and a post-injection

  8. Treatment of pneumonia in pigs with long-acting injectable tylosin.

    Science.gov (United States)

    Couper, A; Cromie, L; Neeve, S; Pommier, P; Keïta, A; Pagot, E

    2006-12-09

    A blinded, randomised clinical trial was carried out in Brittany, France on three commercial pig farms with a history of pneumonia. Pigs with clinical signs of respiratory disease were randomly allocated to one of two treatment groups; 100 pigs received a single intramuscular injection of a long-acting formulation of tylosin at a dose rate of 20 mg tylosin/kg bodyweight, and 101 pigs received three consecutive daily intramuscular injections of 10 mg tylosin/kg bodyweight. The pigs' rectal temperatures and other clinical variables were recorded at intervals and a scoring system was used to evaluate the results of the treatments. Relapses were recorded for up to nine days after the treatment. There were no statistically significant differences between the two treatments in terms of clinical scores, rectal temperatures, or cure or relapse rates.

  9. Making the leap from daily oral dosing to long-acting injectables: lessons from the antipsychotics.

    Science.gov (United States)

    Remenar, Julius F

    2014-06-02

    There are now long-acting versions of six antipsychotic drugs on the U.S. market, and with them, five unique combinations of molecular form and delivery strategy long-acting-injectable-antipsychotics (LAIAs) show evidence of reduced relapses of schizophrenia, but their introduction has been slow, taking at least nine years after the approval of each oral drug. Oily solutions of lipophilic prodrugs were the first to enter the LAIA market, but they relied on esterification of a hydroxyl handle that was lost with the emergence of the atypical antipsychotics. A review of the literature and patents shows that companies tested many different approaches before reaching the currently marketed versions, including aqueous suspensions of poorly soluble salts, polymeric microspheres, and new approaches to making prodrugs. Yet, very little has been published to support faster development of safe long-acting injectables (LAIs). This review introduces some of the critical considerations in creating an LAI; then it analyzes the existing products and discusses areas where further research is needed. The available literature suggests that lipophilic prodrugs may be inherently safer than poorly soluble salts as LAIs. Other areas needing additional study include (1) the range of physical properties acceptable for LAIs and the effect of prodrug tail length in achieving them, and (2) the role of physiological responses at the injection site in the release of drug from a depot.

  10. Preparation of a reproducible long-acting formulation of risperidone-loaded PLGA microspheres using microfluidic method.

    Science.gov (United States)

    Jafarifar, Elham; Hajialyani, Marziyeh; Akbari, Mona; Rahimi, Masoud; Shokoohinia, Yalda; Fattahi, Ali

    2017-09-01

    The aim of the present study is to prepare risperidone-loaded poly lactic-co-glycolic acid (PLGA) microspheres within microfluidic system and to achieve a formulation with uniform size and monotonic and reproducible release profile. In comparison to batch method, T-junction and serpentine chips were utilized and optimizing study was carried out at different processing parameters (e.g. PLGA and surfactant concentration and flow rates ratio of outer to inner phase). The computational fluid dynamic (CFD) modeling was performed, and loading and release study were carried out. CFD simulation indicates that increasing the flow rate of aqueous phase cause to decrease the droplet size, while the change in size of microspheres did not follow a specific pattern in the experimental results. The most uniform microspheres and narrowest standard deviation (66.79 μm ± 3.32) were achieved using T-junction chip, 1% polyvinylalcohol, 1% PLGA and flow rates ratio of 20. The microfluidic-assisted microspheres were more uniform with narrower size distribution. The release of risperidone from microspheres produced by the microfluidic method was more reproducible and closer to zero-order kinetic model. The release profile of formulation with 2:1 drug-to-polymer ratio was the most favorable release, in which 41.85% release could be achieved during 24 days.

  11. The Pharmacokinetics of Second-Generation Long-Acting Injectable Antipsychotics: Limitations of Monograph Values.

    Science.gov (United States)

    Lee, Lik Hang N; Choi, Charles; Collier, Abby C; Barr, Alasdair M; Honer, William G; Procyshyn, Ric M

    2015-12-01

    Product monographs (also known by terms such as Summary of Product Characteristics and Highlights of Prescribing Information, depending on the jurisdiction) provide essential information to ensure the safe and effective use of a drug. Medical practitioners often rely on these monographs for guidance on matters related to pharmacokinetics as well as indications, contraindications, clinical pharmacology, and adverse reactions. The clinical and scientific information found within these documents, forming the basis for decision making, are presumed to be derived from well-designed studies. The objective of this review is to examine the source and validity of the pharmacokinetic data used in establishing the half-lives and times to steady-state reported in the product monographs of second-generation long-acting injectable antipsychotics. Thus, we have critically evaluated the clinical trials from which the pharmacokinetic parameters listed in the product monographs were determined. In many cases, the pharmacokinetic information presented in product monographs is of limited use to clinicians wishing to optimize the effectiveness and tolerability of second-generation long-acting injectable antipsychotics. Under such circumstances, off-label prescribing practices may actually produce better clinical outcomes than if decisions were made based on the product monographs alone.

  12. A critical appraisal of paliperidone long-acting injection in the treatment of schizoaffective disorder

    Directory of Open Access Journals (Sweden)

    Chue P

    2016-01-01

    Full Text Available Pierre Chue,1 James Chue2 1Department of Psychiatry, University of Alberta, 2Clinical Trials and Research Program, Edmonton, AB, Canada Abstract: Schizoaffective disorder (SCA is a chronic and disabling mental illness that presents with mixed symptoms of schizophrenia and affective disorders. SCA is recognized as a discrete disorder, but with greater heterogeneity and symptom overlap, leading to difficulty and delay in diagnosis. Although the overall prognosis is intermediate between schizophrenia and mood disorders, SCA is associated with higher rates of suicide and hospitalization than schizophrenia. No treatment guidelines exist for SCA, and treatment is frequently complex, involving off-label use and polypharmacy (typically combinations of antipsychotics, mood stabilizers, and antidepressants. Oral paliperidone extended-release was the first agent to be approved for the treatment of SCA. As in schizophrenia and bipolar disorder, adherence to oral medications is poor, further contributing to suboptimal outcomes. The use of an antipsychotic in a long-acting injection (LAI addresses adherence issues, thus potentially reducing relapse. Paliperidone palmitate represents the LAI formulation of paliperidone. In a long-term, double-blind, randomized, controlled trial of adult patients (n=334; intent-to-treat [ITT] with SCA, paliperidone long-acting injection (PLAI significantly delayed risk of relapse compared to placebo (hazard ratio 2.49, 95% confidence interval, 1.55–3.99; P<0.001. This study demonstrated the efficacy and safety of PLAI when used as either monotherapy or adjunctive therapy for the maintenance treatment of SCA. The results are consistent with a similarly designed study conducted in patients with schizophrenia, which suggests a benefit in the long-term control of not only psychotic but also affective symptoms. No new safety signals were observed. When used in monotherapy, PLAI simplifies treatment by reducing complex

  13. Preparation and in-vitro characterization of Risperidone-cyclodextrin inclusion complexes as a potential injectable product

    Directory of Open Access Journals (Sweden)

    D Shukla

    2009-12-01

    Full Text Available "n  "n Background and the purpose of the study: This investigation deals with risperidone cyclodextrin (CD complexation for parenteral administration to improve its aqueous solubility which would be beneficial over immediate and sustained release formulations available in market especially for agitated and non-cooperative psychotic patients. "nMethods: The phase solubility study of the drug with β-CD, hydroxypropyl (HP-β-CD and γ-CD was conducted and CDs with higher stability constants were selected for complexation. The complexes of Risperidone with β-CD and HP-β-CD were prepared by precipitation and vacuum drying methods, respectively. Fourier transform-infrared, X-ray diffraction and differential scanning calorimetry techniques were used for characterization of complexes. Drug precipitation study of complex's solution in water for injection and 100 ml of 0.1 M pH 7.4 phosphate buffer saline and stability study in accelerated condition were also carried out. "nResults: The stability constants of the CD were in the following order: β-CD (341.953±11.87 M-1 > HP-β-CD (170.817± 5.93 M-1 > γ-CD (93.716 ± 3.25 M-1. CDs with high stability constants were selected to prepare the drug CD complex. The complexation efficiencies of β-CD and HP-β-CD were 95.23 ± 2.27% and 97.59 ±1.97%, respectively. Both types of CDs exhibited complexation at 1:2 molar stoichiometric ratio. The drug precipitation study indicated complete solubility (100% drug dissolution without a trace of precipitate within 5 mins. The complexes were found to be stable for a period of 3 months under accelerated stability conditions. Major conclusion:Stable complexes of risperidone were successfully formulated using both β-CD and HP-β-CD by simple and highly efficient methods of complexation for parenteral administration.

  14. Decision-making Capacity for Treatment of Psychotic Patients on Long Acting Injectable Antipsychotic Treatment.

    Science.gov (United States)

    Nystazaki, Maria; Pikouli, Katerina; Tsapakis, Eva-Maria; Karanikola, Maria; Ploumpidis, Dimitrios; Alevizopoulos, Giorgos

    2018-04-01

    Providing informed, consent requires patients' Decision-Making Capacity for treatment. We evaluated the Decision Making Capacity of outpatients diagnosed with schizophrenia and schizoaffective disorder on treatment with Long Acting Injectable Antipsychotic medication. This is a retrospective, cross-sectional, correlational study conducted at two Depot Clinics in Athens, Greece. Participants included 65 outpatients diagnosed with schizophrenia and schizoaffective disorder on treatment with Long Acting Injectable Antipsychotics. Over half of the participants showed poor understanding of the information given regarding their disease and treatment (Understanding subscale), however >70% seemed to comprehend the relevance of this information to their medical condition (Appreciation subscale). Moreover, half of the participants reported adequate reasoning ability (Reasoning subscale), whilst patients who gained >7% of their body weight scored statistically significantly higher in the subscales of Understanding and Appreciation. Our results suggest that there is a proportion of patients with significantly diminished Decision Making Capacity, hence a full assessment is recommended in order to track them down. Further research is needed to better interpret the association between antipsychotic induced weight gain and Decision Making Capacity in patients suffering from schizophrenia or schizoaffective disorder. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Cost Effectiveness of Paliperidone Long-Acting Injectable Versus Other Antipsychotics for the Maintenance Treatment of Schizophrenia in France.

    Science.gov (United States)

    Druais, Sylvain; Doutriaux, Agathe; Cognet, Magali; Godet, Annabelle; Lançon, Christophe; Levy, Pierre; Samalin, Ludovic; Guillon, Pascal

    2016-04-01

    French clinical recommendations suggest prescribing long-acting injectable (LAI) antipsychotics to patients with a maintenance treatment indication in schizophrenia. Despite this, and due to their relatively high acquisition and administration costs, LAIs are still underused in clinical practice in France, thus highlighting the need for pharmacoeconomic evaluations. Our objective was to estimate the cost effectiveness of paliperidone LAI (or paliperidone palmitate), a once-monthly second-generation LAI antipsychotic, compared with the most common antipsychotic medications for the maintenance treatment of schizophrenia in France. A Markov model was developed to simulate the progression of a cohort of schizophrenic patients through four health states (stable treated, stable non-treated, relapse and death) and to consider up to three lines of treatment to account for changes in treatment management. Paliperidone LAI was compared with risperidone LAI, aripiprazole LAI, olanzapine LAI, haloperidol LAI (or haloperidol decanoate) and oral olanzapine. Costs, quality-adjusted life-years (QALYs) and number of relapses were assessed over 5 years based on 3-month cycles with a discount rate of 4% and from a French health insurance perspective. Patients were considered to be stabilised after a schizophrenic episode and would enter the model at an initiation phase, followed by a prevention of relapse phase if successful. Data (e.g. relapse or discontinuation rates) for the initiation phase came from randomised clinical trials, whereas relapse rates in the prevention phase were derived from hospitalisation risks based on real-life French data to capture adherence effects. Safety and utility data were derived from international publications. Additionally, costs were retrieved from French health insurance databases and publications. Finally, expert opinion was used for validation purposes or in case of gaps in data. The robustness of results was assessed through deterministic and

  16. Hospitalizations and economic analysis in psychotic patients with paliperidone palmitate long-acting injection.

    Science.gov (United States)

    Mesones-Peral, Jesús E; Gurillo-Muñoz, Pedro; Sánchez-Sicilia, Mari Paz; Miller, Adam; Griñant-Fernández, Alejandra

    Prevent hospitalizations in psychotic disorders is an important aim, so long-acting antipsychotic is a good option that can control better the correct adherence. Moreover, in the current economic context pharmacoeconomic studies are necessary. We estimate the effect in prevention of paliperidone palmitate long-acting injection (PP-LAI) and calculate the economic cost in the 12 months preceding the start of treatment with PP-LAI and 12 months later. Mirror image study of 71 outpatients diagnosed with psychotic disorders and treated with PP-LAI. In a first analysis, we measured along one year: number of hospitalizations/year, number of hospitalization in days, number of emergency assists/year and if there is antipsychotics associated to long-acting treatment. After this phase, we applied Fees Act of Valencia for economic analysis and estimate of the cost per hospitalization (€ 5,640.41) and hospital emergency (€ 187.61). After one year of treatment with PP-LAI (mean dose=130.65mg/month), we obtained greater numbers in assistance variables: total hospitalizations decrease, 78.8% (P=.009); shortening in hospitalization days, 89.4% (P=.009); abridgement of number of emergency assists, 79.1% (P=.002); decrease of rate of antipsychotics associated to long-acting treatment, 21% (P<.0001); increase in monotherapy, 53.8% (P<.0001). Therefore, after 12 months of treatment with PP-LAI we obtained a reduction in inpatient spending (savings of € 175,766.54) and increased spending on antipsychotics 32% (equivalent to € 151,126.92). PP-LAI can be an effective therapy for the treatment of patients with severe psychotic disorders: improves symptomatic stability and can prevent hospitalizations with cost-effective symptom control. Copyright © 2016 SEP y SEPB. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. Risperidone versus typical antipsychotic medication for schizophrenia.

    Science.gov (United States)

    Hunter, R H; Joy, C B; Kennedy, E; Gilbody, S M; Song, F

    2003-01-01

    found in long-term studies (n=859, 2RCTs RR not 20% improved 0.51 CI 0.38 to 0.67 NNT 4;n=675 1RCT, RR not improved 40% 0.75 CI 0.66 to 0.84 NNT 5; n=675, 1 RCT, RR not 60% improved 0.90 CI 0.84 to 0.96, NNT 11). Risperidone was also more likely to reduce relapse at one year follow up, compared with haloperidol (n=367, 1 RCT, RR 0.64 CI 0.41 to 0.99, NNT 7). Less people allocated risperidone left studies before completion, both for short-term (n=3066, 16 RCTs, RR 0.76 CI 0.63 to 0.92, NNT 6) and long-term trials (n=1270, 4RCTs, RR 0.55 CI 0.42 to 0.73 NNT 4). For general movement disorders results favoured risperidone. People given risperidone had significantly fewer general movement disorders (including extrapyramidal side effects) than those receiving older typical antipsychotics (n=2702, 10 RCTs, RR 0.63 CI 0.56 to 0.71, NNT 3). Significantly fewer people given risperidone used antiparkinsonian drugs (n=2524, 11 RCTs, RR 0.66 CI 0.58 to 0.74, NNT 4). As regards body weight, however, four studies (n=1708) found people were more likely to gain weight if allocated risperidone compared to typical antipsychotics (RR 1.55 CI 1.25 to 1.93, NNH 3). Risperidone was no more or less likely than haloperidol to cause sexual problems such as erectile dysfunction (n=106, 2 RCTs, RR 1.55 CI 0.58 to 4.20). Finally, some results found risperidone was more likely to cause rhinitis than conventional antipsychotics (n=656, 3 RCTs, RR1.99 CI 1.24 to 3.19, NNH 3). Risperidone may be more acceptable to those with schizophrenia than older antipsychotics and have marginal benefits in terms of limited clinical improvement. Its adverse effect profile may be better than haloperidol. With the addition of more studies to this review, the publication bias evident in previous versions is no longer a significant issue. Any marginal benefits this drug may have have to be balanced against its greater cost and increased tendency to cause side effects such as weight gain. Recent important longer term

  18. Long-acting reversible hormonal contraception | Dahan-Farkas ...

    African Journals Online (AJOL)

    Long-acting reversible hormonal contraceptives are effective methods of birth control that provide contraception for an extended period without requiring user action. Long-acting reversible hormonal contraceptives include progesterone only injectables, subdermal implants and the levonorgestrel intrauterine system.

  19. An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia

    Directory of Open Access Journals (Sweden)

    Pandina Gahan

    2012-06-01

    Full Text Available Abstract Background Data on the long-term efficacy, safety, and tolerability of risperidone in adolescents with schizophrenia are limited. The objective of this study was to evaluate the efficacy and safety of maintenance risperidone treatment in adolescents with schizophrenia. Methods This open-label study of adolescents aged 13 to 17 years with schizophrenia was a single extension study of two short-term double-blind risperidone studies and also enrolled subjects directly in open-label risperidone treatment. The risperidone dose was flexible and ranged from 2 to 6 mg/day. Most subjects enrolled for 6 months; a subset enrolled for 12 months. Assessment tools included the Positive and Negative Syndrome Scale total and factor scores, Clinical Global Impressions, Children’s Global Assessment Scale, adverse event (AE monitoring, vital signs, laboratory testing, and extrapyramidal symptom rating scales. Results A total of 390 subjects were enrolled; 48 subjects had received placebo in a previous double-blind study; 292 subjects had received risperidone as part of their participation in one of two previous controlled studies; and 50 subjects were enrolled directly for this study. A total of 279 subjects enrolled for 6 months of treatment, and 111 subjects enrolled for 12 months of treatment. Overall, 264 (67.7% subjects completed this study: 209 of the 279 subjects (75% in the 6-month group and 55 of the 111 subjects (50% in the 12-month group. The median mode dose was 3.8 mg/day. At 6 months, all three groups experienced improvement from open-label baseline in symptoms of schizophrenia as well as general assessments of global functioning. Improvements were generally maintained for the duration of treatment. The most common AEs (≥10% of subjects were somnolence, headache, weight increase, hypertonia, insomnia, tremor, and psychosis. Potentially prolactin-related AEs (PPAEs were reported by 36 (9% subjects. The AE profile in this study was

  20. Development of a long-acting injectable formulation with nanoparticles of rilpivirine (TMC278) for HIV treatment.

    Science.gov (United States)

    Baert, Lieven; van 't Klooster, Gerben; Dries, Willy; François, Marc; Wouters, Alfons; Basstanie, Esther; Iterbeke, Koen; Stappers, Fred; Stevens, Paul; Schueller, Laurent; Van Remoortere, Pieter; Kraus, Guenter; Wigerinck, Piet; Rosier, Jan

    2009-08-01

    Long-acting parenteral formulations of antiretrovirals could facilitate maintenance and prophylactic treatment in HIV. Using the poorly water- and oil-soluble non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) as base or hydrochloride (HCl), nanosuspensions were prepared by wet milling (Elan NanoCrystal technology) in an aqueous carrier. Laser diffraction showed that the average particles size were (1) close to the targeted size proportionality (200-400-800 nm), with increasing distributions the larger the average particle size, and (2) were stable over 6 months. Following single-dose administration, the plasma concentration profiles showed sustained release of TMC278 over 3 months in dogs and 3 weeks in mice. On comparison of intramuscular and subcutaneous injection of 5mg/kg (200 nm) in dogs, the subcutaneous route resulted in the most stable plasma levels (constant at 25 ng/mL for 20 days, after which levels declined slowly to 1-3 ng/mL at 3 months); 200 nm nanosuspensions achieved higher and less variable plasma concentration profiles than 400 and 800 nm nanosuspensions. In mice, the pharmacokinetic profiles after a single 20mg/kg dose (200 nm) were similar with two different surfactants used (poloxamer 338, or d-alpha-tocopheryl polyethylene glycol 1000 succinate). In conclusion, this study provides proof-of-concept that 200-nm sized TMC278 nanosuspensions may act as long-acting injectable.

  1. Risperidone-induced reversible neutropenia.

    Science.gov (United States)

    Kattalai Kailasam, Vasanth; Chima, Victoria; Nnamdi, Uchechukwu; Sharma, Kavita; Shah, Kairav

    2017-01-01

    This case report presents a 44-year-old man with a history of schizophrenia who developed neutropenia on risperidone therapy. The patient's laboratory reports showed a gradual decline of leukocytes and neutrophils after resolution and rechallenging. This was reversed with the discontinuation of risperidone and by switching to olanzapine. In this case report, we also discuss the updated evidence base for management of risperidone-induced neutropenia.

  2. A critical appraisal of paliperidone long-acting injection in the treatment of schizoaffective disorder.

    Science.gov (United States)

    Chue, Pierre; Chue, James

    2016-01-01

    Schizoaffective disorder (SCA) is a chronic and disabling mental illness that presents with mixed symptoms of schizophrenia and affective disorders. SCA is recognized as a discrete disorder, but with greater heterogeneity and symptom overlap, leading to difficulty and delay in diagnosis. Although the overall prognosis is intermediate between schizophrenia and mood disorders, SCA is associated with higher rates of suicide and hospitalization than schizophrenia. No treatment guidelines exist for SCA, and treatment is frequently complex, involving off-label use and polypharmacy (typically combinations of antipsychotics, mood stabilizers, and antidepressants). Oral paliperidone extended-release was the first agent to be approved for the treatment of SCA. As in schizophrenia and bipolar disorder, adherence to oral medications is poor, further contributing to suboptimal outcomes. The use of an antipsychotic in a long-acting injection (LAI) addresses adherence issues, thus potentially reducing relapse. Paliperidone palmitate represents the LAI formulation of paliperidone. In a long-term, double-blind, randomized, controlled trial of adult patients (n=334; intent-to-treat [ITT]) with SCA, paliperidone long-acting injection (PLAI) significantly delayed risk of relapse compared to placebo (hazard ratio 2.49, 95% confidence interval, 1.55-3.99; P<0.001). This study demonstrated the efficacy and safety of PLAI when used as either monotherapy or adjunctive therapy for the maintenance treatment of SCA. The results are consistent with a similarly designed study conducted in patients with schizophrenia, which suggests a benefit in the long-term control of not only psychotic but also affective symptoms. No new safety signals were observed. When used in monotherapy, PLAI simplifies treatment by reducing complex pharmacotherapy and obviating the necessity for daily oral medications. PLAI is the second agent, and the first LAI, to be approved for the treatment of SCA; as an LAI

  3. Formulation, in vitro and in vivo evaluation of transdermal patches containing risperidone.

    Science.gov (United States)

    Aggarwal, Geeta; Dhawan, Sanju; Hari Kumar, S L

    2013-01-01

    The efficacy of oral risperidone treatment in prevention of schizophrenia is well known. However, oral side effects and patient compliance is always a problem for schizophrenics. In this study, risperidone was formulated into matrix transdermal patches to overcome these problems. The formulation factors for such patches, including eudragit RL 100 and eudragit RS 100 as matrix forming polymers, olive oil, groundnut oil and jojoba oil in different concentrations as enhancers and amount of drug loaded were investigated. The transdermal patches containing risperidone were prepared by solvent casting method and characterized for physicochemical and in vitro permeation studies through excised rat skin. Among the tested preparations, formulations with 20% risperidone, 3:2 ERL 100 and ERS 100 as polymers, mixture of olive oil and jojoba oil as enhancer, exhibited greatest cumulative amount of drug permeated (1.87 ± 0.09 mg/cm(2)) in 72 h, so batch ROJ was concluded as optimized formulation and assessed for pharmacokinetic, pharmacodynamic and skin irritation potential. The pharmacokinetic characteristics of the optimized risperidone patch were determined using rabbits, while orally administered risperidone in solution was used for comparison. The calculated relative bioavailability of risperidone transdermal patch was 115.20% with prolonged release of drug. Neuroleptic efficacy of transdermal formulation was assessed by rota-rod and grip test in comparison with control and marketed oral formulations with no skin irritation. This suggests the transdermal application of risperidone holds promise for improved bioavailability and better management of schizophrenia in long-term basis.

  4. Long-term functional improvements in the 2-year treatment of schizophrenia outpatients with olanzapine long-acting injection

    Directory of Open Access Journals (Sweden)

    Ascher-Svanum H

    2014-06-01

    Full Text Available Haya Ascher-Svanum,1 Diego Novick,2,3 Josep Maria Haro,4 Jordan Bertsch,4 David McDonnell,1 Holland Detke11Eli Lilly and Company, Indianapolis, IN, USA; 2Eli Lilly and Company, Windlesham, Surrey, UK; 3Departament de Psiquiatria, Universitat Autonoma de Barcelona, Spain; 4Parc Sanitari Sant Joan de Déu, Centro de Investigación Biomédica en Red en el Área de Salud Mental, Universitat de Barcelona, Barcelona, SpainBackground: Little is known about the long-term changes in the functioning of schizophrenia patients receiving maintenance therapy with olanzapine long-acting injection (LAI, and whether observed changes differ from those seen with oral olanzapine.Methods: This study describes changes in the levels of functioning among outpatients with schizophrenia treated with olanzapine-LAI compared with oral olanzapine over 2 years. This was a secondary analysis of data from a multicenter, randomized, open-label, 2-year study comparing the long-term treatment effectiveness of monthly olanzapine-LAI (405 mg/4 weeks; n=264 with daily oral olanzapine (10 mg/day; n=260. Levels of functioning were assessed with the Heinrichs–Carpenter Quality of Life Scale. Functional status was also classified as “good”, “moderate”, or “poor”, using a previous data-driven approach. Changes in functional levels were assessed with McNemar’s test and comparisons between olanzapine-LAI and oral olanzapine employed the Student’s t-test. Results: Over the 2-year study, the patients treated with olanzapine-LAI improved their level of functioning (per Quality of Life total score from 64.0–70.8 (P<0.001. Patients on oral ­olanzapine also increased their level of functioning from 62.1–70.1 (P<0.001. At baseline, 19.2% of the olanzapine-LAI-treated patients had a “good” level of functioning, which increased to 27.5% (P<0.05. The figures for oral olanzapine were 14.2% and 24.5%, respectively (P<0.001. Results did not significantly differ between

  5. Physician and patient benefit–risk preferences from two randomized long-acting injectable antipsychotic trials

    Directory of Open Access Journals (Sweden)

    Katz EG

    2016-10-01

    Full Text Available Eva G Katz,1 Brett Hauber,2 Srihari Gopal,3 Angie Fairchild,2 Amy Pugh,4 Rachel B Weinstein,3 Bennett S Levitan3 1Janssen Research & Development, LLC, Raritan, NJ, 2RTI Health Solutions, Research Triangle Park, NC, 3Janssen Research & Development, LLC, Titusville, NJ, 4The University of California, San Francisco (UCSF, CA, USA Purpose: To quantify clinical trial participants’ and investigators’ judgments with respect to the relative importance of efficacy and safety attributes of antipsychotic treatments for schizophrenia, and to assess the impact of formulation and adherence.Methods: Discrete-choice experiment surveys were completed by patients with schizophrenia and physician investigators participating in two phase-3 clinical trials of paliperidone palmitate 3-month long-acting injectable (LAI antipsychotic. Respondents were asked to choose between hypothetical antipsychotic profiles defined by efficacy, safety, and mode of administration. Data were analyzed using random-parameters logit and probit models.Results: Patients (N=214 and physicians (N=438 preferred complete improvement in positive symptoms (severe to none as the most important attribute, compared with improvement in any other attribute studied. Both respondents preferred 3-month and 1-month injectables to oral formulation (P<0.05, irrespective of prior adherence to oral antipsychotic treatment, with physicians showing greater preference for a 3-month over a 1-month LAI for nonadherent patients. Physicians were willing to accept treatments with reduced efficacy for patients with prior poor adherence. The maximum decrease in efficacy (95% confidence interval [CI] that physicians would accept for switching a patient from daily oral to 3-month injectable was as follows: adherent: 9.8% (95% CI: 7.2–12.4, 20% nonadherent: 25.4% (95% CI: 21.0–29.9, and 50% nonadherent: >30%. For patients, adherent: 10.1% (95% CI: 6.1–14.1, nonadherent: the change in efficacy studied was

  6. Different MK-801 administration schedules induce mild to severe learning impairments in an operant conditioning task: role of buspirone and risperidone in ameliorating these cognitive deficits.

    Science.gov (United States)

    Rapanelli, Maximiliano; Frick, Luciana Romina; Bernardez-Vidal, Micaela; Zanutto, Bonifacio Silvano

    2013-11-15

    Blockade of N-methyl-d-aspartate receptor (NMDA) by the noncompetitive NMDA receptor (NMDAR) antagonist MK-801 produces behavioral abnormalities and alterations in prefrontal cortex (PFC) functioning. Due to the critical role of the PFC in operant conditioning task learning, we evaluated the effects of acute, repeated postnatal injections of MK-801 (0.1mg/kg) on learning performance. We injected Long-Evans rats i.p. with MK-801 (0.1mg/kg) using three different administration schedules: injection 40 min before beginning the task (during) (n=12); injection twice daily for six consecutive days prior to beginning the experimental procedures (prior) (n=12); or twice daily subcutaneous injections from postnatal day 7 to 11 (postnatal) (n=12). Next, we orally administered risperidone (serotonin receptor 2A and dopamine receptor 2 antagonist, 1mg/kg) or buspirone (serotonin receptor 1A partial agonist, 10mg/kg) to animals treated with the MK-801 schedule described above. The postnatal and prior administration schedules produced severe learning deficits, whereas injection of MK-801 just before training sessions had only mild effects on acquisition of an operant conditioning. Risperidone was able to reverse the detrimental effect of MK-801 in the animals that were treated with MK-801 during and prior training sessions. In contrast, buspirone was only effective at mitigating the cognitive deficits induced by MK-801 when administered during the training procedures. The data demonstrates that NMDA antagonism disrupts basic mechanisms of learning in a simple PFC-mediated operant conditioning task, and that buspirone and risperidone failed to attenuate the learning deficits when NMDA neurotransmission was blocked in the early stages of the postnatal period. Copyright © 2013 Elsevier B.V. All rights reserved.

  7. Effects of Environmental Manipulations and Treatment with Bupropion and Risperidone on Choice between Methamphetamine and Food in Rhesus Monkeys.

    Science.gov (United States)

    Banks, Matthew L; Blough, Bruce E

    2015-08-01

    Preclinical and human laboratory choice procedures have been invaluable in improving our knowledge of the neurobiological mechanisms of drug reinforcement and in the drug development process for candidate medications to treat drug addiction. However, little is known about the neuropharmacological mechanisms of methamphetamine vs food choice. The aims of this study were to develop a methamphetamine vs food choice procedure and determine treatment effects with two clinically relevant compounds: the monoamine uptake inhibitor bupropion and the dopamine antagonist risperidone. Rhesus monkeys (n=6) responded under a concurrent schedule of food delivery (1-g pellets, fixed-ratio (FR) 100 schedule) and intravenous methamphetamine injections (0-0.32 mg/kg/injection, FR10 schedule) during 7-day bupropion (0.32-1.8 mg/kg/h) and risperidone (0.001-0.0056 mg/kg/h) treatment periods. For comparison, effects of removing food pellets or methamphetamine injections and FR response requirement manipulations were also examined. Under saline treatment conditions, food was preferred over no methamphetamine or small unit methamphetamine doses (0.01-0.032 mg/kg/injection). Larger methamphetamine doses resulted in greater methamphetamine preference and 0.32 mg/kg/injection methamphetamine maintained near exclusive preference. Removing food availability increased methamphetamine choice, whereas removing methamphetamine availability decreased methamphetamine choice. Methamphetamine choice was not significantly altered when the FR response requirements for food and drug were the same (FR100:FR100 or FR10:FR10). Risperidone treatment increased methamphetamine choice, whereas bupropion treatment did not alter methamphetamine choice up to doses that decreased rates of operant behavior. Overall, these negative results with bupropion and risperidone are concordant with previous human laboratory and clinical trials and support the potential validity of this preclinical methamphetamine vs food

  8. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism

    Directory of Open Access Journals (Sweden)

    Stickelmeyer Mary

    2010-06-01

    Full Text Available Abstract Background Olanzapine long-acting injection (LAI is a salt-based depot antipsychotic combining olanzapine and pamoic acid. The slow intramuscular dissolution of this practically insoluble salt produces an extended release of olanzapine lasting up to 4 weeks. However, in a small number of injections ( Methods Healthcare providers involved in the PDSS cases were queried for clinical information around the events. Plasma samples from patients experiencing PDSS were collected when possible (12/30 cases and olanzapine concentrations compared with the known pharmacokinetic profile for olanzapine LAI. Product batches and used vials from the PDSS cases were evaluated for compliance with established manufacturing standards and/or possible user error. Because this depot formulation depends upon slow dissolution at the intramuscular injection site, in-vitro experiments were conducted to assess solubility of olanzapine pamoate in various media. Results Injection administrators reported no unusual occurrences during the injection. No anomalies were found with the product batches or the remaining suspension in the used vials. Olanzapine concentrations during PDSS events were higher than the expected 5-73 ng/mL range, with concentrations exceeding 100 ng/mL and in some cases reaching >600 ng/mL during the first hours after injection but then returning to the expected therapeutic range within 24 to 72 hours. Solubility and dissolution rate of olanzapine pamoate were also found to be substantially greater in plasma than in other media such as those approximating the environment in muscle tissue. Conclusions Manufacturing irregularities, improper drug reconstitution, and inappropriate dosing were ruled out as possible causes of PDSS. In-vitro solubility and in-vivo pharmacokinetic investigations suggest that PDSS is related to exposure of the injected product to a substantial volume of blood. This exposure is most likely the result of unintended partial

  9. Switching to olanzapine long-acting injection from either oral olanzapine or any other antipsychotic: comparative post hoc analyses

    Directory of Open Access Journals (Sweden)

    Ciudad A

    2013-11-01

    Full Text Available Antonio Ciudad,1 Ernie Anand,2 Lovisa Berggren,3 Marta Casillas,4 Alexander Schacht,3 Elena Perrin5 1Department of Clinical Research and Development, Eli Lilly & Co, Madrid, Spain; 2Neuroscience Medical Affairs – EU, Lilly Research Centre, Windlesham, Surrey, UK; 3Global Statistical Sciences, Eli Lilly & Co, Bad Homburg, Germany; 4European Scientific Communications, Eli Lilly & Co, Madrid, Spain; 5Medical Department, Eli Lilly & Co, Suresnes, Paris, France Background: A considerable proportion of patients suffering from schizophrenia show suboptimal responses to oral antipsychotics due to inadequate adherence. Hence, they are likely to benefit from switching to a long-acting injectable formulation. These post hoc analyses assessed the clinical effects of switching to olanzapine long-acting injection (OLAI from either oral olanzapine (OLZ or other antipsychotics (non-OLZ. Methods: Post hoc analyses were done based on two randomized studies (one short-term, one long-term conducted in patients suffering from schizophrenia and treated with OLAI. The short-term study was an 8-week placebo-controlled, double-blind trial in acute patients, and the long-term study was a 2-year, oral olanzapine-controlled, open-label, follow-up of stabilized outpatients. Results: These analyses used data from 62 OLAI-treated patients (12 switched from OLZ, 50 from non-OLZ from the short-term study and 190 OLAI-treated patients (56 switched from OLZ, 134 from non-OLZ from the long-term study. Kaplan–Meier survival analyses of time to all-cause discontinuation of OLAI treatment did not differ significantly between OLZ and non-OLZ patients in the short-term study (P=0.209 or long-term study (P=0.448. Similarly, the proportions of OLZ and non-OLZ patients that discontinued OLAI were not statistically different in the short-term (16.7% versus 36.0%, respectively; P=0.198 or long-term (57.1% versus 47.8% respectively; P=0.238 studies. In the short-term study, no

  10. Suicide Prevention in Schizophrenia: Do Long-Acting Injectable Antipsychotics (LAIs) have a Role?

    Science.gov (United States)

    Pompili, Maurizio; Orsolini, Laura; Lamis, Dorian A; Goldsmith, David R; Nardella, Adele; Falcone, Giulia; Corigliano, Valentina; Luciano, Mario; Fiorillo, Andrea

    2017-01-01

    Suicide risk is a major cause of death among patients with schizophrenia. Death by suicide has been reported in approximately 5% of schizophrenia patients although this figure appears to be an underestimate of the problem. A number of risk factors are routinely reported as associated with suicide risk among these patients, some of which are modifiable by targeted therapeutic strategies. Clozapine is the only compound that gathered evidence as an effective treatment for reducing suicide risk in schizophrenia. Long-Acting Injectable Antipsychotics (LAIs) have a range of advantages in terms of efficacy, safety and tolerability in the treatment of schizophrenia, and one area of interest is whether LAI-treatment may decrease suicidality by indirectly acting on a range of risk factors for suicide specific to schizophrenia patients. This background encouraged the present review of research pertaining to LAIs in relation to modifiable risk factors for suicide in schizophrenia. We viewed our task as gathering, speculating and critically appraising the available research relevant to the topic, with the aim of formulating a hypothesis to be tested with further research. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  11. Long acting injectable hormonal contraceptives.

    Science.gov (United States)

    Fraser, I S

    1982-03-01

    Injectable hormonal preparations can be highly effective and satisfactory contraceptives. The two main preparations available today are depot medroxy progesterone acetate (DMPA) and norethisterone oenanthate (NET-OEN), but several other approaches are currently under clinical trial. Injectable contraceptives have some unique advantages which give them justifiably wide appeal amongst many groups of women. However, they do have a number of disadvantages including invariable menstrual disturbance and a delay in the return of fertility. One formulation of DMPA, Depo-Provera, is probably the most extensively investigated single hormonal contraceptive ever made. These studies indicate that it is remarkably safe and does not face any more unresolved issues than the combined pill, intrauterine device or tubal sterilization. However, for a number of disparate emotional and political reasons it has attracted the attention of several consumer and feminist groups, who have waged a prolonged and quite unjustified campaign against it. It is to be hoped that future debate will be conducted on a more informed, rational and less emotional basis. Injectable contraceptives should have an important place in the family planning armamentarium of all countries, and current developments should lead to a decrease in concerns about presently available agents. This should further increase the widespread acceptability of this approach to contraception.

  12. Pharmacology and clinical experience with risperidone.

    Science.gov (United States)

    Love, R C; Nelson, M W

    2000-12-01

    Risperidone (Risperdal, Janssen Pharmaceutica) is a second generation antipsychotic (SGA) for the treatment of schizophrenia and other psychotic disorders. It is a potent antagonist of serotonin-2 (5-HT2) and dopamine-2 (D2) receptors in the brain. In comparison to conventional antipsychotics, risperidone demonstrates superior efficacy against the positive and negative symptoms of schizophrenia and a decreased occurrence of extrapyramidal side effects (EPS). Risperidone causes less weight gain than other marketed SGAs, but can increase prolactin levels and cause EPS in a dose-related manner. In a variety of pharmacoeconomic analyses, it has proven to be a cost-effective addition to the antipsychotic armamentarium. As the first SGA available for front line use, risperidone has established a new standard of care for the treatment of individuals with psychotic disorders.

  13. Risperidone as a treatment for childhood habitual behavior

    Science.gov (United States)

    Omranifard, Victoria; Najafi, Mostafa; Sharbafchi, Mohammad Reza; Emami, Parisa; Maracy, Mohammad

    2013-01-01

    Objective: The aim of this study was to investigate the effect of adding risperidone to the general behavioral treatment of masturbation in children 3-7 years old. Methods: A 4 week randomized clinical controlled trial was designed in year 2009. Samples have been chosen from children who have been referred to the Child and Adolescence Psychiatric Clinic of Isfahan University of Medical Sciences. Ninety children were recruited at the study and randomly allocated into the risperidone and control groups (44 and 46 respectively). The risperidone group was medicated simultaneously by behavioral treatments and 0.25-1 mg of risperidone daily while the controls only received the behavioral treatments. Findings: The mean ± SD age of the risperidone and control groups was 5.3 ± 1.1 and 4.9 ± 1.1 years, respectively. The mean ± SD of the period of suffering from masturbation was 3.4 ± 1.2 and 3.8 ± 1.7 months in the risperidone and the control groups, respectively. At the beginning of the study, the mean frequency of masturbation in control and the risperidone groups was 2.6 ± 0.9 and 2.7 ± 0.9 times/day, whereas after the 4th week, it decreased to 1.4 ± 0.6 and 1.1 ± 0.5 times/day, respectively. The results showed a more reduction in the mean frequency of masturbation in the risperidone group significantly. Conclusion: In comparison to the general behavioral treatment, risperidone in addition to the behavioral treatment will probably reduce the frequency of masturbation in children more effectively. PMID:24991601

  14. Treatment patterns in Medicaid patients with schizophrenia initiated on a first- or second-generation long-acting injectable versus oral antipsychotic

    Directory of Open Access Journals (Sweden)

    Pilon D

    2017-03-01

    Full Text Available Dominic Pilon,1 Kruti Joshi,2 Neeta Tandon,2 Marie-Hélène Lafeuille,1 Rhiannon L Kamstra,1 Bruno Emond,1 Patrick Lefebvre2 1Groupe d’analyse, Ltée, Montréal, QC, Canada; 2Janssen Scientific Affairs, LLC, Titusville, NJ, USA Background: Poor antipsychotic (AP adherence is a key issue in patients with schizophrenia. First-generation antipsychotic (FGA and second-generation antipsychotic (SGA long-acting injectable therapies (LAI may improve adherence compared to oral antipsychotics (OAP. The objective of the study was to compare treatment adherence and persistence in Medicaid patients with schizophrenia initiated on first-generation long-acting injectable therapies (FGA-LAI or second-generation long-acting injectable therapies (SGA-LAI versus OAP.Methods: Adults with schizophrenia initiated on FGA-LAI, SGA-LAI, or OAP on or after January 2010 were identified using a six-state Medicaid database (January 2009– March 2015. Outcomes were assessed during the 12 months following treatment initiation. Index medication adherence was assessed using the proportion of days covered ≥80%, while persistence was assessed as no gap of ≥30, ≥60, or ≥90 days between days of supply. Outcomes were compared between FGA/SGA-LAI and OAP cohorts using chi-squared tests and adjusted odds ratios (OR.Results: During follow-up, AP polypharmacy was more common in FGA-LAI patients (N=1,089; 36%; P=0.029 and less common in SGA-LAI patients (N=2,209; 27%; P<0.001 versus OAP patients (N=20,478; 33%. After adjustment, SGA-LAI patients had 24% higher odds of adherence at 12 months (OR: 1.24; P<0.001, in contrast to FGA-LAI patients who had 48% lower odds of adherence (OR: 0.52; P<0.001 relative to OAP patients. SGA-LAI patients were more likely to be persistent (no gap ≥60 days at 12 months than OAP patients (37% vs 30%; P<0.001, but not FGA-LAI patients (31% vs 30%; P=0.776. In comparison to OAP patients, SGA-LAI patients had 46% higher adjusted odds of

  15. Differential Long-Term Effects of Haloperidol and Risperidone on the Acquisition and Performance of Tasks of Spatial Working and Short-Term Memory and Sustained Attention in Rats

    Science.gov (United States)

    Hutchings, Elizabeth J.; Waller, Jennifer L.

    2013-01-01

    A common feature of the neuropsychiatric disorders for which antipsychotic drugs are prescribed is cognitive dysfunction, yet the effects of long-term antipsychotic treatment on cognition are largely unknown. In the current study, we evaluated the effects of long-term oral treatment with the first-generation antipsychotic haloperidol (1.0 and 2.0 mg/kg daily) and the second-generation antipsychotic risperidone (1.25 and 2.5 mg/kg daily) on the acquisition and performance of two radial-arm maze (RAM) tasks and a five-choice serial reaction-time task (5C-SRTT) in rats during days 15–60 and 84–320 days of treatment, respectively. In the RAM, neither antipsychotic significantly affected the acquisition or performance of a spatial win shift or a delayed non–match-to-position task. Conversely, in the rats administered 5C-SRTT, haloperidol was associated with profound deficits in performance, and the subjects were not able to progress through all stages of task acquisition. Depending on the dose, risperidone was associated with a greater number of trials to meet specific performance criteria during task acquisition compared with vehicle-treated controls; however, most subjects were eventually able to achieve all levels of task acquisition. Both haloperidol and risperidone also increased the number of perseverative and time-out responses during certain stages of task acquisition, and the response and reward latencies were slightly higher than controls during several stages of the study. These results in rats suggest that while long-term treatment with haloperidol or risperidone may not significantly affect spatial working or short-term memory, both antipsychotics can (depending on dose) impair sustained attention, decrease psychomotor speed, increase compulsive-type behaviors, and impair cognitive flexibility. PMID:24042161

  16. Differential long-term effects of haloperidol and risperidone on the acquisition and performance of tasks of spatial working and short-term memory and sustained attention in rats.

    Science.gov (United States)

    Hutchings, Elizabeth J; Waller, Jennifer L; Terry, Alvin V

    2013-12-01

    A common feature of the neuropsychiatric disorders for which antipsychotic drugs are prescribed is cognitive dysfunction, yet the effects of long-term antipsychotic treatment on cognition are largely unknown. In the current study, we evaluated the effects of long-term oral treatment with the first-generation antipsychotic haloperidol (1.0 and 2.0 mg/kg daily) and the second-generation antipsychotic risperidone (1.25 and 2.5 mg/kg daily) on the acquisition and performance of two radial-arm maze (RAM) tasks and a five-choice serial reaction-time task (5C-SRTT) in rats during days 15-60 and 84-320 days of treatment, respectively. In the RAM, neither antipsychotic significantly affected the acquisition or performance of a spatial win shift or a delayed non-match-to-position task. Conversely, in the rats administered 5C-SRTT, haloperidol was associated with profound deficits in performance, and the subjects were not able to progress through all stages of task acquisition. Depending on the dose, risperidone was associated with a greater number of trials to meet specific performance criteria during task acquisition compared with vehicle-treated controls; however, most subjects were eventually able to achieve all levels of task acquisition. Both haloperidol and risperidone also increased the number of perseverative and time-out responses during certain stages of task acquisition, and the response and reward latencies were slightly higher than controls during several stages of the study. These results in rats suggest that while long-term treatment with haloperidol or risperidone may not significantly affect spatial working or short-term memory, both antipsychotics can (depending on dose) impair sustained attention, decrease psychomotor speed, increase compulsive-type behaviors, and impair cognitive flexibility.

  17. Risperidone-related reversal of primary enuresis: an unusual case report.

    Science.gov (United States)

    Mendhekar, D N; Andrade, C

    2010-03-01

    Occasional reports have documented treatment-emergent enuresis with medication regimens that include risperidone. In contrast to these reports, we present a 12-year-old girl with mild mental retardation and primary nocturnal enuresis who received risperidone (0.5 mg/day) for the isolated symptom of inappropriate smiling. Surprisingly, in addition to reduction in inappropriate smiling, risperidone also substantially decreased the frequency of enuresis. These benefits with risperidone were confirmed in an on-off-on treatment sequence. To our knowledge, this is the first case in literature of primary enuresis responding to low-dose risperidone. Low-dose risperidone may merit study in children with enuresis. Clinical implications and possible mechanisms are discussed.

  18. Postmortem Femoral Blood Concentrations of Risperidone

    DEFF Research Database (Denmark)

    Linnet, Kristian; Johansen, Sys Stybe

    2014-01-01

    Postmortem femoral blood concentrations of the antipsychotic drug risperidone and the active metabolite 9-hydroxyrisperidone were determined by an achiral LC-MS/MS method in 38 cases. The cause of death was classified as unrelated to risperidone in 30 cases, in which the sum of the concentration ...

  19. Risperidone-induced enuresis in two children with autistic disorder.

    Science.gov (United States)

    Hergüner, Sabri; Mukaddes, Nahit Motavalli

    2007-08-01

    Risperidone appears to be effective in treating behavioral problems in children with autistic disorder. Although increased appetite, weight gain, and sedation are among the most common side effects, risperidone-induced enuresis is rarely reported. We will present two cases with risperidone-induced enuresis, and discuss our findings in the context of current literature. Two children aged 11 and 10 years, diagnosed with autism and mental retardation, have developed new-onset diurnal and nocturnal enuresis respectively on their first and second weeks of risperidone monotherapy (1.5 and 1 mg/day). They did not experience sedation, and their medical history and workup were unremarkable. As enuresis did not resolve spontaneously, we decided to substitute risperidone with olanzapine. Enuresis ceased rapidly after discontinuation of risperidone with no emergence when patients were treated with olanzapine 5 mg/day for a period of 6 months and 1 year, respectively. Although the pathophysiology of antipsychotic-induced enuresis remains unclear, a number of mechanisms including alpha(1)-adrenergic blockade, dopamine blockade, and antimuscarinic effects has been proposed. Olanzapine has lower alpha(1)-adrenergic and dopaminergic blockade properties, thus changing risperidone to olanzapine may be an alternative modality in risperidone-induced enuresis when antipsychotic treatment is crucial. Clinicians should be more vigilant about screening for this side effect, especially in younger population with developmental disabilities.

  20. GSK1265744 pharmacokinetics in plasma and tissue after single-dose long-acting injectable administration in healthy subjects.

    Science.gov (United States)

    Spreen, William; Ford, Susan L; Chen, Shuguang; Wilfret, David; Margolis, David; Gould, Elizabeth; Piscitelli, Stephen

    2014-12-15

    GSK1265744 (744) is an HIV-1 integrase inhibitor in clinical development as a long-acting (LA) injectable formulation. This study evaluated plasma and tissue pharmacokinetics after single-dose administration of 744 LA administered by intramuscular (IM) or subcutaneous injections. This was a phase I, open-label, 9-cohort, parallel study of 744 in healthy subjects. 744 was administered as a 200 mg/mL nanosuspension at doses of 100-800 mg IM and 100-400 mg subcutaneous. Eight (6 active and 2 placebo) male and female subjects participated in each of the first 7 cohorts. All 8 subjects, 4 males and 4 females, received active 744 LA in cohorts 8 and 9 and underwent rectal and cervicovaginal tissue sampling, respectively. Plasma pharmacokinetic sampling was performed for a minimum of 12 weeks or until 744 concentrations were ≤0.1 μg/mL. Rectal and cervicovaginal tissue biopsies were performed at weeks 2 and 8 (cohort 8) and weeks 4 and 12 (cohort 9). 744 LA was generally safe and well tolerated after single injections. A majority of subjects reported injection site reactions, all graded as mild in intensity. Plasma concentration-time profiles were prolonged with measureable concentrations up to 52 weeks after dosing. 744 LA 800 mg IM achieved mean concentrations above protein adjusted-IC90 for approximately 16 weeks. Rectal and cervicovaginal tissue concentrations ranged from injection has potential application as a monthly or less frequent HIV treatment or prevention agent.

  1. Adjunctive treatment with aripiprazole for risperidone-induced hyperprolactinemia

    Directory of Open Access Journals (Sweden)

    Ranjbar F

    2015-03-01

    Full Text Available Fatemeh Ranjbar,1 Homayoun Sadeghi-Bazargani,2,3 Parisa Niari Khams,1 Asghar Arfaie,1 Azim Salari,4 Mostafa Farahbakhsh1 1Clinical Psychiatry Research Center, Tabriz University of Medical Sciences, Tabriz, East Azerbaijan, Iran; 2Road Traffic Injury Research Center, Department of Statistics & Epidemiology, Tabriz University of Medical Sciences, Tabriz, Iran; 3World Health Organization Collaborating Center on Community Safety Promotion, Karolinska Institute, Stockholm, Sweden; 4Emam Khomeini Hospital, Naghadeh, West Azerbaijan, Iran Background: Antipsychotics have been used for more than 50 years in the treatment of schizophrenia and many other psychiatric disorders. Prolactin levels usually increase in patients treated with risperidone. Aripiprazole, which has a unique effect as an antipsychotic, is a D2 receptor partial agonist. It is an atypical antipsychotic with limited extrapyramidal symptoms. Since it acts as an antagonist in hyperdopaminergic conditions and as an agonist in hypodopaminergic conditions, it does not have adverse effects on serum prolactin levels. The present study aimed to investigate the effect of aripiprazole on risperidone-induced hyperprolactinemia. Methods: This before-and-after clinical trial was performed in 30 patients. Baseline prolactin levels were measured in all patients who were candidates for treatment with risperidone. In subjects with elevated serum prolactin, aripiprazole was added to their treatment. Serum prolactin levels were measured during the first week, second week, and monthly thereafter for at least 3 months or until prolactin levels became normal. The data were analyzed using Stata version 11 software. Survival analysis and McNemar’s test were also performed. Results: The mean age of the participants was 30.8 years. Prolactin levels normalized in 23 (77% participants during the study, and menstrual disturbances normalized in 25 (83.3%. Prolactin levels normalized in most patients between days 50

  2. [Atypical antipsychotics and sexual dysfunction: five case-reports associated with risperidone].

    Science.gov (United States)

    Haefliger, T; Bonsack, C

    2006-01-01

    Sexual and reproductive function side effects of atypical antipsychotics are frequent, often underestimated and badly tolerated. They contribute to the 50% rate of non-compliance reported for treated patients. Prevalence of sexual dysfunction associated with atypical antipsychotic treatment is high, varying from 18 to 96%. Atypical antipsychotics aren't, as a group, much better than typical antipsychotics, and among them, risperidone seems to induce more and quetiapine less sexual dysfunction. Most atypicals are non-selective, and have actions on multiple central and peripheral receptors. Among these, dopaminergic blockade could have a direct - altering motivation (desire) and reward (orgasm) - and an indirect negative influence on sexuality. Actually, the secondary hyperprolactinemia induced by some antipsychotics (typical antipsychotics, risperidone and amisulpiride), is dose-dependent, more pronounced for female patients, and may have a detrimental effect on sexual function. It also may result in hypogonadism, particularly for female patients. The long-term consequences of this secondary hypogonadism are subject to debate but potentially severe. Furthermore, the blocking and/or modulating actions of atypical antipsychotics on adrenaline, serotonine, histamine or acetyl-choline receptors all have the potential to contribute to secondary sexual problems. The pharmacological profile of risperidone, characterized by a strong affinity for D2 and alpha1 receptors, correlates with his tendency to significantly elevate prolactin levels and to produce ejaculatory disturbances. FIVE CASE-REPORTS: We describe five case-reports of sexual or hormonal disturbances associated with risperidone treatment: two cases of ejaculatory disturbance, one case of galactorrhea and two cases of amenorrhea. Alberto and David are two young male schizophrenic patients, treated with risperidone, and complaining of a total absence of ejaculation despite a preserved orgasm. Many recent case

  3. Triiodothyronine accelerates and enhances the antipsychotic effect of risperidone in acute schizophrenia.

    Science.gov (United States)

    Steibliene, Vesta; Bunevicius, Adomas; Savickas, Arunas; Prange, Arthur J; Nemeroff, Charles B; Bunevicius, Robertas

    2016-02-01

    In acute psychotic schizophrenia patients we investigated if the combination of triiodothyronine (T3) plus risperidone was more effective when compared to risperidone monotherapy. Thirty-two in-patients meeting the DSM-IV-TR diagnostic criteria for schizophrenia and without thyroid disease received risperidone (flexibly adjusted dose for tolerability) and were randomized to additionally receive either T3 (25 μg daily; risperidone plus T3 group) or placebo (risperidone plus placebo group). Treatment lasted until meeting the response to treatment criteria defined as score of ≤ 3 on the Clinical Global Impression Severity and Improvement scales. Acute psychotic episode symptom severity was evaluated using the Brief Psychiatric Rating Scale (BPRS) at treatment initiation and at the final study assessment. Fourteen patients were randomized to receive risperidone plus T3 and eighteen to receive risperidone plus placebo. The time until treatment response was shorter in the risperidone plus T3 group relative to the risperidone plus placebo group (25.5 ± 4.4 days vs 32.2 ± 8.2 days, respectively; p = 0.001). Moreover, there was a greater reduction of BPRS-total score (p = 0.01) in the risperidone plus T3 group relative to the risperidone plus placebo group. Treatment with T3 was associated with shorter time to treatment response (β = -0.440, p = 0.022) and with greater improvement in BPRS score (β = 0.240, p = 0.053), independent of patients' gender, age, baseline BPRS score and mean risperidone dose. The study confirms that addition of T3 to risperidone was associated with accelerated and enhanced treatment response in acutely psychotic schizophrenic patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Preparation and Biological Evaluation of Radioiodinated Risperidone and Lamotrigine as Models for Brain Imaging

    International Nuclear Information System (INIS)

    Saddar, E.; El-Tawoosy, M.; Motaleb, H.A.

    2014-01-01

    Brain imaging technology is becoming an important tool in both research and clinical care. Due to the sensitivity of brain imaging technology, neuroscientists are able to visualize brain structure and function from the level of individual molecules to the whole brain, recognize and diagnose neurological disorders, develop new strategies for treatment and determine how therapies work. The study aimed to take advantages from drugs that are able to cross the brain barrier for the development of potential radiopharmaceuticals for non-invasive brain imaging. Risperidone and lamotrigine were successfully labeled with 125 I via direct electrophilic substitution reaction at 80 degree C. The reaction parameters affecting the preparation process were studied. 125 I-risperidone and 125 I-lamotrigine gave maximum labeling yield of 89 % ± 3.75 and 97.5 % ± 1.0 %, respectively and their stability were up to 6 and 24 h, respectively. Biodistribution studies showed that maximum uptake of 125 I-risperidone and 125 I-lamotrigine in the brain of mice were 4.27 % ± 0.38 and 2.45 % ± 0.18 of the injected activity/g tissue organ, at 10

  5. Comparison of Risperidone and Olanzapine in Bipolar and Schizoaffective Disorders

    Science.gov (United States)

    Masand, Prakash S.; Wang, Xiaohong; Gupta, Sanjay; Schwartz, Thomas L.; Virk, Subhdeep; Hameed, Ahmad

    2002-01-01

    Objective: To compare risperidone and olanzapine for efficacy, tolerability, need for concomitant mood stabilizers, and cost of treatment in bipolar and schizoaffective disorders. Method: We conducted a retrospective chart review of 36 consecutive outpatients with DSM-IV bipolar or schizoaffective disorder seen in 3 settings who received risperidone or olanzapine for at least 1 month between May and August 1997. Results: The mean ± SD doses were 3.7 ± 3.5 mg/day of risperidone and 12.0 ± 5.4 mg/day of olanzapine. Between-treatment differences in patient characteristics, psychiatric history, Clinical Global Impressions scale ratings, and duration of treatment were not significant. Similar proportions of patients in the 2 groups reported side effects, including extrapyramidal symptoms, akathisia, tardive dyskinesia, and precipitation of mania by the respective drug. Patients in the olanzapine group received a significantly higher dose of concomitant lithium than those receiving risperidone (mean daily lithium doses: risperidone group, 750 ± 150 mg; olanzapine group, 1211 ± 186 mg; p = .006). The total daily acquisition cost per patient was $11.84 for olanzapine versus $5.81 for risperidone. Conclusion: Olanzapine and risperidone were equally efficacious and safe in the treatment of patients with bipolar or schizoaffective disorder, but treatment costs and dose of concomitant lithium were lower in risperidone-treated patients. PMID:15014747

  6. Risperidone treatment increases CB1 receptor binding in rat brain

    DEFF Research Database (Denmark)

    Secher, Anna; Husum, Henriette; Holst, Birgitte

    2010-01-01

    , the ghrelin receptor, neuropeptide Y, adiponectin and proopiomelanocortin. We investigated whether the expression of these factors was affected in rats chronically treated with the antipsychotic risperidone. METHODS: Male Sprague-Dawley rats were treated with risperidone (1.0 mg/kg/day) or vehicle (20...... showed that risperidone treatment altered CB(1) receptor binding in the rat brain. Risperidone-induced adiposity and metabolic dysfunction in the clinic may be explained by increased CB(1) receptor density in brain regions involved in appetite and regulation of metabolic function....

  7. P-glycoprotein interaction with risperidone and 9-OH-risperidone studied in vitro, in knock-out mice and in drug-drug interaction experiments

    DEFF Research Database (Denmark)

    Ejsing, Thomas B.; Pedersen, Anne D.; Linnet, Kristian

    2005-01-01

    P-glycoprotein, risperidone, nortriptyline, cyclosporine A, drug-drug interaction, blood-brain barrier, knock-out mice......P-glycoprotein, risperidone, nortriptyline, cyclosporine A, drug-drug interaction, blood-brain barrier, knock-out mice...

  8. Increased use of antipsychotic long-acting injections with community treatment orders.

    Science.gov (United States)

    Patel, Maxine X; Matonhodze, Jane; Baig, Mirza K; Gilleen, James; Boydell, Jane; Holloway, Frank; Taylor, David; Szmukler, George; Lambert, Tim; David, Anthony S

    2011-04-01

    Community treatment orders (CTOs) are increasingly being used, despite a weak evidence base, and problems continue regarding Second Opinion Appointed Doctor (SOAD) certification of medication. The aim of the current study was to describe current CTO usage regarding patient characteristics, prescribed medication and CTO conditions. A 1-year prospective cohort study with consecutive sampling was conducted for all patients whose CTO was registered in a large mental health trust. Only the first CTO for each patient was included. Measures included sociodemographic variables, psychiatric diagnosis, CTO date of initiation and conditions, psychotropic medication and date of SOAD certification for medication. This study was conducted in the first year of CTO legislation in England and Wales. A total of195 patients were sampled (mean age 40.6 years, 65% male, 52% black ethnic origin). There was significant geographical variability in rates of CTO use (χ(2) = 11.3, p = 0.012). A total of 53% had their place of residence specified as a condition and 29% were required to allow access into their homes. Of those with schizophrenia, 64% were prescribed an antipsychotic long-acting injection (LAI). Of the total group, 7% received high-dose antipsychotics, 10% were prescribed two antipsychotics and only 15% received SOAD certification in time. There was geographical and ethnic variation in CTO use but higher rates of hospital detention in minority ethnic groups may be contributory. Most patients were prescribed antipsychotic LAIs and CTO conditions may not follow the least restrictive principle.

  9. Risperidone-induced enuresis in a 12-year-old child

    Directory of Open Access Journals (Sweden)

    Reetika Dikshit

    2017-01-01

    Full Text Available Risperidone has been documented to be effective in the management of behavior problems, aggression, and conduct disorder in children. While metabolic side effects like weight gain and obesity have been attributed to Risperidone use in children, side effects of the drug related to the urinary bladder are rare. We present a case of Risperidone-induced enuresis in a 12-year-old boy with conduct disorder that resolved completely after stopping the medication.

  10. Pharmacokinetics of Short- and Long-acting Formulations of Oxytetracycline After Intramuscular Administration in Chickens.

    Science.gov (United States)

    Gberindyer, Aondover F; Okpeh, Ene R; Semaka, Asaaga A

    2015-12-01

    Both short- and long-acting formulations of oxytetracycline are commonly used in veterinary medicine to treat animals infected with gram-negative and gram-positive bacteria, rickettsiae, mycoplasma, and chlamydiae. To compare pharmacokinetics of short- and long-acting oxytetracycline in chickens, injectable formulations from the same pharmaceutical company were administered to healthy 6-week-old broiler chickens in accordance to the labeled instructions. Fourteen chickens were separated into 2 groups: chickens in group A (n = 7) were administered the short-acting formulation (10 mg/kg IM q24h) for 4 consecutive days, whereas those in group B (n = 7) were treated with a single dose (20 mg/kg IM) of the long-acting formulation. Blood samples were collected into heparinized tubes before and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, and 24 hours after initial treatment. Thereafter, blood samples were taken every 24 hours up to 120 hours. Plasma concentrations of oxytetracycline were determined by competitive enzyme-linked immunoabsorbent assay, and pharmacokinetic parameters were obtained. Both formulations delivered therapeutic plasma concentrations of oxytetracycline for approximately 100% of their respective dosing intervals as recommended. However, considering the additional labor, patient stress, and mortalities associated with handling, in addition to rejection of the carcass due to tissue necrosis resulting from multiple injections, we recommend use of the long-acting instead of the short-acting injectable formulation in broiler chickens.

  11. Initiating/maintaining long-acting injectable antipsychotics in schizophrenia/schizoaffective or bipolar disorder – expert consensus survey part 2

    Directory of Open Access Journals (Sweden)

    Sajatovic M

    2018-06-01

    Full Text Available Martha Sajatovic,1,2 Ruth Ross,3 Susan N Legacy,4 Matthew Byerly,5 John M Kane,6,7 Faith DiBiasi,8 Heather Fitzgerald,9 Christoph U Correll6,7 1Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, OH, USA; 2Departments of Psychiatry and Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA; 3Ross Editorial, Port Townsend, WA, USA; 4US Medical Affairs Neuroscience, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 5Cell Biology and Neuroscience, Center for Mental Health Research and Recovery, Montana State University, Bozeman, MT, USA; 6Psychiatry, The Zucker Hillside Hospital, Glen Oaks, NY, USA; 7Psychiatry, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Glen Oaks, NY, USA; 8Scientific Communications, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD, USA; 9Medical Affairs, Lundbeck LLC, Deerfield, IL, USA Objective: The aim of this study was to provide recommendations on initiating and maintaining long-acting injectable antipsychotics (LAIs in individuals with schizophrenia/schizoaffective or bipolar disorder. Methods: A 50-question survey comprising 916 response options was completed by 34 expert researchers and high prescribers with extensive LAI experience, rating relative appropriateness/importance on a 9-point scale. Consensus was determined using chi-square test of score distributions. Results of 21 questions comprising 339 response options regarding LAI initiation, maintenance treatment, adequate trial definition, identifying treatment nonresponse, and switching are reported. Results: Experts agreed that the most important LAI selection factor was patient response/tolerability to previous antipsychotics. An adequate therapeutic LAI trial was defined as the time to steady state ± 1–2 injection cycles. Experts suggested that oral efficacy and tolerability should be established before switching to an

  12. Treatment of delirium with risperidone in cancer patients.

    Science.gov (United States)

    Kishi, Yasuhiro; Kato, Masashi; Okuyama, Toru; Thurber, Steven

    2012-08-01

    Antipsychotic medications have frequently been regarded as the treatment of choice for delirium. This study examined the clinical efficacy of risperidone for the treatment of delirium in cancer patients, combined with a repeated assessment of underlying medical severity levels. The study included consecutive referrals of 29 delirious cancer patients (mean age, 68.9 ± 12.5 years; male, 69%) to the psychiatric consultation service. Risperidone was given orally once per day (mean dosage, 1.4 ± 1.3 mg/day). Study participants were assessed using quantitative standardized scales of cognitive function, delirium, and physical impairment at baseline and at the end of the study (seventh day). Risperidone with routine clinical management was effective for the treatment of delirium: 48% of the patients responded and 38% achieved remission. The reduction of delirium severity occurred in 79% of the patients. Changes in delirium severity were unrelated to age, gender, general cognitive dysfunction, or to severity of attendant medical conditions. In addition to changes in agitation and perceptional disturbances, risperidone was also effective for other specific delirium symptoms. Risperidone with routine clinical management is effective in the treatment of delirium in advanced cancer patients, independent of changes in the underlying medical condition. © 2012 The Authors. Psychiatry and Clinical Neurosciences © 2012 Japanese Society of Psychiatry and Neurology.

  13. Risperidone and Risk of Gynecomastia in Young Men.

    Science.gov (United States)

    Etminan, Mahyar; Carleton, Bruce; Brophy, James M

    2015-11-01

    The purpose of this study was to quantify the risk of gynecomastia with risperidone in adolescent and young adult males. We created a cohort of males 15-25 years of age from the IMS LifeLink database, and conducted a case-control study within the cohort by identifying all new cases of gynecomastia. For each case, 10 controls were selected and matched to the cases by age, follow-up, and calendar times (cases and controls had the same follow up time and cohort entry date). Rate ratios (RR) for current use of risperidone were computed adjusting for potential confounding variables. First diagnosis of gynecomastia was made based on International Classification of Diseases, 9th revision (ICD-9) for gynecomastia. There were 401,924 males ages 15-25 in the primary cohort. There were 1556 cases of gynecomastia and 15,560 corresponding controls. Current users of risperidone had approximately four times the risk of developing gynecomastia than non-users (RR=3.91, 95% CI=2.01-7.62). When the analysis was stratified to children and adolescents (≤18 years of age) taking risperidone, the risk of gynecomastia was five times higher than for non-users (RR=5.44, 95% CI=1.50-19.74). Risperidone is associated with an increase with the risk of gynecomastia in adolescent and young adult males.

  14. Impact of risperidone on leptin and insulin in children and adolescents with autistic spectrum disorders.

    Science.gov (United States)

    Srisawasdi, Pornpen; Vanwong, Natchaya; Hongkaew, Yaowaluck; Puangpetch, Apichaya; Vanavanan, Somlak; Intachak, Boontarika; Ngamsamut, Nattawat; Limsila, Penkhae; Sukasem, Chonlaphat; Kroll, Martin H

    2017-08-01

    To evaluate the influence of dose and duration of risperidone treatment on cardiovascular and diabetes risk biomarkers in children and adolescents with autistic spectrum disorders (ASDs). In this cross-sectional analysis, a total of 168 ASDs patients (89% male) treated with a risperidone-based regimen for ≥12months were included. Blood samples were analyzed for glucose and lipid metabolic markers, adiponectin, leptin, prolactin, cortisol and high sensitive C-reactive protein. The mean concentrations of glucose, insulin, prolactin and leptin and HOMA-IR significantly rose with risperidone dosage (all P<0.025), but those of adiponectin and cortisol did not. Using regression analysis, insulin, leptin, prolactin and glucose concentrations and HOMA-IR show significant association with dosage. None of the markers except adiponectin showed dependence on duration of treatment. However, insulin and leptin concentrations and HOMA-IR clearly increased with increasing both dosage and duration. Dosage and duration of treatment had minimal effect on standard lipid profile and lipoprotein subclasses. Risperidone treatment disturbed glucose homeostasis and endocrine regulation (particularly leptin) in children and adolescents with ASDs, in a dose- and duration-dependent manner, being suggestive of leptin and insulin resistance mechanisms. Metabolic adverse effects, especially development of type 2 diabetes mellitus should be closely monitored, particularly in individuals receiving high doses and/or long-term risperidone treatment. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  15. Proposing the Use of Partial AUC as an Adjunctive Measure in Establishing Bioequivalence Between Deltoid and Gluteal Administration of Long-Acting Injectable Antipsychotics.

    Science.gov (United States)

    Lee, Lik Hang N; Choi, Charles; Gershkovich, Pavel; Barr, Alasdair M; Honer, William G; Procyshyn, Ric M

    2016-12-01

    The maximum plasma concentration (C max ) and the area under the plasma concentration-time curve (AUC) are commonly used to establish bioequivalence between two formulations of the same oral medication. Similarly, these pharmacokinetic parameters have also been used to establish bioequivalence between two sites of administration for the same injectable formulation. However, these conventional methods of establishing bioequivalence are of limited use when comparing modified-release formulations of a drug, particularly those with rates of absorption that are amenable to change with the site of injection. Inherent differences in the rate of absorption can result in clinically significant differences in early exposure and drug response. Here, we propose the use of the partial AUC (pAUC) as a measure of early exposure to aid in the assessment of bioequivalence between the gluteal and the deltoid site of administration for long-acting injectable antipsychotics.

  16. Risperidone-associated urinary incontinence in patients with autistic disorder with mental retardation.

    Science.gov (United States)

    Kumazaki, Hirokazu; Watanabe, Koichiro; Imasaka, Yasushi; Iwata, Kazuhiko; Tomoda, Akemi; Mimura, Masaru

    2014-10-01

    We report several cases in which patients with autistic disorder with mental retardation who received risperidone experienced urinary incontinence. We retrospectively investigated the medical records of patients housed in facilities for patients with autistic disorder with mental retardation. Those who had undergone a medical examination at a hospital in Tokyo from April 1999 to March 2009 were included in the study.Retrospective data were gathered including age, sex, IQ, birth weight, dosage of risperidone, urinary density, as well as existence of urinary and fecal incontinence. We divided the participants into those who did and did not experience urinary incontinence after taking risperidone and compared the 2 groups. Risperidone had been prescribed to 35 patients. In spite of the fact that no patient had a history of urinary incontinence, 14 patients experienced urinary incontinence after receiving risperidone. Moreover, 4 of these 14 patients also had fecal incontinence. Among the variables we examined, the only significant difference between groups was in sex, with significantly more women experiencing incontinence compared with men. When the dose of risperidone was reduced or the patients switched to other drugs, urinary incontinence of the patients improved.Hence, risperidone may have a casual relationship with urinary incontinence. Further research is needed to understand the pathophysiology of possible effect.

  17. Risperidone reverses the spatial object recognition impairment and hippocampal BDNF-TrkB signalling system alterations induced by acute MK-801 treatment

    Science.gov (United States)

    Chen, Guangdong; Lin, Xiaodong; Li, Gongying; Jiang, Diego; Lib, Zhiruo; Jiang, Ronghuan; Zhuo, Chuanjun

    2017-01-01

    The aim of the present study was to investigate the effects of a commonly-used atypical antipsychotic, risperidone, on alterations in spatial learning and in the hippocampal brain-derived neurotrophic factor (BDNF)-tyrosine receptor kinase B (TrkB) signalling system caused by acute dizocilpine maleate (MK-801) treatment. In experiment 1, adult male Sprague-Dawley rats subjected to acute treatment of either low-dose MK801 (0.1 mg/kg) or normal saline (vehicle) were tested for spatial object recognition and hippocampal expression levels of BDNF, TrkB and the phophorylation of TrkB (p-TrkB). We found that compared to the vehicle, MK-801 treatment impaired spatial object recognition of animals and downregulated the expression levels of p-TrkB. In experiment 2, MK-801- or vehicle-treated animals were further injected with risperidone (0.1 mg/kg) or vehicle before behavioural testing and sacrifice. Of note, we found that risperidone successfully reversed the deleterious effects of MK-801 on spatial object recognition and upregulated the hippocampal BDNF-TrkB signalling system. Collectively, the findings suggest that cognitive deficits from acute N-methyl-D-aspartate receptor blockade may be associated with the hypofunction of hippocampal BDNF-TrkB signalling system and that risperidone was able to reverse these alterations. PMID:28451387

  18. Hyperprolactinemia in Thai children and adolescents with autism spectrum disorder treated with risperidone

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    Hongkaew Y

    2015-01-01

    Full Text Available Yaowaluck Hongkaew,1,2 Nattawat Ngamsamut,3 Apichaya Puangpetch,1,2 Natchaya Vanwong,1,2 Pornpen Srisawasdi,4 Montri Chamnanphon,1,2 Bhunnada Chamkrachchangpada,3 Teerarat Tan-kam,3 Penkhae Limsila,3 Chonlaphat Sukasem1,2 1Division of Pharmacogenomics and Personalized Medicine, Department of Pathology, Faculty of Medicine, 2Laboratory for Pharmacogenomics, Somdech Phra Debaratana Medical Center (SDMC, Ramathibodi Hospital, Mahidol University, 3Yuwaprasart Waithayopathum Child and Adolescent Psychiatric Hospital, Department of Mental Health Services, Ministry of Public Health, 4Division of Clinical Chemistry, Department of Pathology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand Abstract: Hyperprolactinemia is a common adverse effect observed in children with autism spectrum disorder (ASD during pharmacotherapy with risperidone. The main aim of this study was to investigate important clinical factors influencing the prolactin response in risperidone-treated Thai ASD. A total of 147 children and adolescents (127 males and 20 females aged 3–19 years with ASD received risperidone treatment (0.10–6.00 mg/day for up to 158 weeks. Prolactin levels were measured by chemiluminescence immunoassay. The clinical data of patients collected from medical records – age, weight, height, body mass index, dose of risperidone, duration of treatment, and drug-use pattern – were recorded. Hyperprolactinemia was observed in 66 of 147 (44.90% subjects. Median prolactin level at the high doses (24.00, interquartile range [IQR] 14.30–29.20 of risperidone was significantly found to be higher than at the recommended (16.20, IQR 10.65–22.30 and low (11.70, IQR 7.51–16.50 doses of risperidone. There was no relationship between prolactin levels and duration of risperidone treatment. Dose-dependence is identified as a main factor associated with hyperprolactinemia in Thai children and adolescents with ASD treated with

  19. Clinical outcomes with olanzapine long-acting injection: impact of the 3-hour observation period on patient satisfaction and well-being

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    Anand E

    2016-10-01

    Full Text Available Ernie Anand,1 Lovisa Berggren,2 John Landry,3 Ágoston Tóth,4 Holland C Detke5 1Neuroscience Medical Affairs, Eli Lilly & Company Ltd, Windlesham, UK; 2Global Statistical Sciences, Lilly Deutschland GmbH, Bad Homburg, Germany; 3Global Statistical Sciences, Eli Lilly Canada Inc., Toronto, ON, Canada; 4Neuroscience, Lilly Hungary, Budapest, Hungary; 5Psychiatry and Pain Disorders, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA Background: The objective of the present analysis is to determine the impact of the 3-hour observation period for olanzapine long-acting injection (LAI on patient satisfaction and well-being by comparing data collected before and after its implementation. Methods: This is a post hoc analysis of patients treated with olanzapine LAI in 1 a 6-month fixed-dose randomized controlled trial and/or 2 a 6-year open-label safety study. This analysis was limited to patients with schizophrenia who were treated with olanzapine LAI consistent with the approved indication and dosing recommendations of the European Union Summary of Product Characteristics (N=966. Of the 966 patients, the analysis further focused only on those patients who received both 1 at least one injection before the implementation of the 3-hour observation period and 2 at least one injection after implementation of the 3-hour observation period (N=487. Patient satisfaction was assessed with the three-item Patient Satisfaction with Medication Questionnaire-Modified. Responses were averaged across all postbaseline visits occurring before (ie, without the implementation of the 3-hour observation period and across all postbaseline visits occurring after (ie, with the implementation of the 3-hour observation period. In addition, the rate of postinjection delirium/sedation syndrome events was calculated. Results: There was no meaningful change after implementation of the 3-hour observation period in satisfaction (before: mean [SD] =4.0 [1.02] and

  20. Evidence based administration of risperidone and paliperidone for the treating conduct disorder

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    Ahmad Ghanizadeh

    2013-01-01

    Full Text Available Background: This study evaluates the evidence-based administration of risperidone and paliperidone for the treating children and adolescents with conduct disorder (CD. Materials and Methods: A review of the current literature from clinical trials that investigated the efficacy of risperidone and paliperidone on CD considering the inclusion criteria and search strategies was performed by a search of PubMed and Google Scholar databases. Results: Out of 53 titles, 31 were irrelevant. The abstract of 22 potentially related articles were studied. Only six articles reported the results of clinical trial. However, one of them reported the effect of risperidone on conduct behaviors in autistic disorders. One study was a re-analysis of two previous studies, one study reported the effects of maintenance versus withdrawal of risperidone treatment and two studies included children with sub-average intelligence. Headache, somnolence and increased appetite are among the most common reported adverse effects. No study examined the effect of paliperidone on CD was found. Conclusion: Current literature suggests that risperidone could be effective for treating some conduct behaviors in children and adolescents. The effect of risperidone on CD is not a well-researched area. There is no well-controlled evidence based reports about the safety and efficacy of risperidone for the treatment of CD. Further trials should examine the efficacy of these medications on CD rather than conduct behaviors or disruptive behavior disorders.

  1. Peripheral Edema Occurring during Treatment with Risperidone Combined with Citalopram

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    Seyed Hamzeh Hosseini

    2012-01-01

    Full Text Available An 80-year-old female presented with symptoms of depression, worthlessness, hopelessness, loss of energy, insomnia, impatience, and forgetfulness associated with persecutory delusion that had begun about one year before her visit. She was diagnosed with major depression with psychotic signs and began treatment with risperidone (2 mg/night and citalopram (20 mg/day. After 20 days, she returned and reported partial improvement in her symptoms, although she had developed severe swelling of the hands and feet. The results of liver and renal function tests and rheumatologic tests were found to be within normal limits. Risperidone was discontinued for a week, and the swelling resolved completely. Risperidone was then administered again, and the swelling returned so that the patient had to discontinue taking the drug. The reappearance of edema on rechallenge is strong evidence implicating risperidone as the cause of the swelling.

  2. Moderators, mediators, and other predictors of risperidone response in children with autistic disorder and irritability.

    Science.gov (United States)

    Arnold, L Eugene; Farmer, Cristan; Kraemer, Helena Chmura; Davies, Mark; Witwer, Andrea; Chuang, Shirley; DiSilvestro, Robert; McDougle, Christopher J; McCracken, James; Vitiello, Benedetto; Aman, Michael G; Scahill, Lawrence; Posey, David J; Swiezy, Naomi B

    2010-04-01

    The National Institute of Mental Health (NIMH) Research Units on Pediatric Psychopharmacology (RUPP) Autism Network found an effect size of d = 1.2 in favor of risperidone on the main outcome measure in an 8-week double-blind, placebo-controlled trial for irritability in autistic disorder. This paper explores moderators and mediators of this effect. Intention-to-treat (ITT) analyses were conducted with suspected moderators and mediators entered into the regression equations. MacArthur Foundation Network subgroup guidelines were followed in the evaluation of the results. Only baseline severity moderated treatment response: Higher severity showed greater improvement for risperidone but not for placebo. Weight gain mediated treatment response negatively: those who gained more weight improved less with risperidone and more with placebo. Compliance correlated with outcome for risperidone but not placebo. Higher dose correlated with worse outcome for placebo, but not risperidone. Of nonspecific predictors, parent education, family income, and low baseline prolactin positively predicted outcome; anxiety, bipolar symptoms, oppositional-defiant symptoms, stereotypy, and hyperactivity negatively predicted outcome. Risperidone moderated the effect of change in 5'-nucleotidase, a marker of zinc status, for which decrease was associated with improvement only with risperidone, not with placebo. The benefit-risk ratio of risperidone is better with greater symptom severity. Risperidone can be individually titrated to optimal dosage for excellent response in the majority of children. Weight gain is not necessary for risperidone benefit and may even detract from it. Socioeconomic advantage, low prolactin, and absence of co-morbid problems nonspecifically predict better outcome. Mineral interactions with risperidone deserve further study.

  3. Clinical Decision-Making in the Treatment of Schizophrenia: Focus on Long-Acting Injectable Antipsychotics

    Directory of Open Access Journals (Sweden)

    Ludovic Samalin

    2016-11-01

    Full Text Available The purpose of this study was to identify clinician characteristics associated with higher prescription rates of long-acting injectable (LAI antipsychotics, as well as the sources that influence medical decision-making regarding the treatment of schizophrenia. We surveyed 202 psychiatrists during six regional French conferences (Bordeaux, Lyon, Marseille, Nice, Paris, and Strasbourg. Data on the characteristics of practice, prescription rates of antipsychotic, and information sources about their clinical decisions were collected. Most psychiatrists used second-generation antipsychotics (SGAs, and preferentially an oral formulation, in the treatment of schizophrenia. LAI SGAs were prescribed to 30.4% of schizophrenic patients. The duration and type of practice did not influence the class or formulation of antipsychotics used. The clinicians following the higher percentage of schizophrenic patients were associated with a higher use of LAI antipsychotics and a lower use of oral SGAs. Personal experience, government regulatory approval, and guidelines for the treatment of schizophrenia were the three main contributing factors guiding clinicians’ decision-making regarding the treatment of schizophrenia. The more clinicians follow schizophrenic patients, the more they use LAI antipsychotics. The development of specialized programs with top specialists should lead to better use of LAI antipsychotics in the treatment of schizophrenia.

  4. CYP2D6 polymorphisms and their influence on risperidone treatment

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    Puangpetch A

    2016-12-01

    Full Text Available Apichaya Puangpetch,1 Natchaya Vanwong,1 Nopphadol Nuntamool,2 Yaowaluck Hongkaew,1 Monpat Chamnanphon,1 Chonlaphat Sukasem1 1Division of Pharmacogenomics and Personalized Medicine, Department of Pathology, Faculty of Medicine Ramathibodi Hospital, 2Molecular Medicine, Faculty of Science, Mahidol University, Bangkok, Thailand Abstract: Cytochrome P450 enzyme especially CYP2D6 plays a major role in biotransformation. The interindividual variations of treatment response and toxicity are influenced by the polymorphisms of this enzyme. This review emphasizes the effect of CYP2D6 polymorphisms in risperidone treatment in terms of basic knowledge, pharmacogenetics, effectiveness, adverse events, and clinical practice. Although the previous studies showed different results, the effective responses in risperidone treatment depend on the CYP2D6 polymorphisms. Several studies suggested that CYP2D6 polymorphisms were associated with plasma concentration of risperidone, 9-hydroxyrisperidone, and active moiety but did not impact on clinical outcomes. In addition, CYP2D6 poor metabolizer showed more serious adverse events such as weight gain and prolactin than other predicted phenotype groups. The knowledge of pharmacogenomics of CYP2D6 in risperidone treatment is increasing, and it can be used for the development of personalized medication in term of genetic-based dose recommendation. Moreover, the effects of many factors in risperidone treatment are still being investigated. Both the CYP2D6 genotyping and therapeutic drug monitoring are the important steps to complement the genetic-based risperidone treatment. Keywords: CYP2D6, risperidone, polymorphisms, adverse drug reaction, pharmacogenetics, pharmacokinetics, pharmacodynamics

  5. A Comparative Study between Olanzapine and Risperidone in the Management of Schizophrenia

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    Saeed Shoja Shafti

    2014-01-01

    Full Text Available Introduction. Since a variety of comparisons between risperidone and olanzapine have resulted in diverse outcomes, so safety and efficacy of them were compared again in a new trial. Method. Sixty female schizophrenic patients entered into one of the assigned groups for random allocation to olanzapine or risperidone (n=30 in each group in a double-blind, 12-week clinical trial. Scale for Assessment of Positive Symptoms (SAPS and Scale for Assessment of Negative Symptoms (SANS were used as the primary outcome measures. Clinical Global Impressions-Severity Scale (CGI-S, Schedule for Assessment of Insight (SAI, and finally Simpson Angus Scale (SAS as well were employed as secondary scales. Results. While both of olanzapine and risperidone were significantly effective for improvement of positive symptoms (P<0.0001, as regards negative symptoms, it was so only by means of olanzapine (P<0.0003. CGI-S and SAI, as well, were significantly improved in both of the groups. SAS increment was significant only in the risperidone group (P<0.02. Conclusion. While both of olanzapine and risperidone were equally effective for improvement of positive symptoms and insight, olanzapine showed superior efficacy with respect to negative symptoms, along with lesser extrapyramidal side effects, in comparison with risperidone.

  6. Identifying patients and clinical scenarios for use of long-acting injectable antipsychotics – expert consensus survey part 1

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    Sajatovic M

    2018-06-01

    Full Text Available Martha Sajatovic,1,2 Ruth Ross,3 Susan N Legacy,4 Christoph U Correll,5,6 John M Kane,5,6 Faith DiBiasi,7 Heather Fitzgerald,8 Matthew Byerly9 1Department of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, OH, USA; 2Departments of Psychiatry and Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA; 3Ross Editorial, Port Townsend, WA, USA; 4US Medical Affairs Neuroscience, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA; 5Psychiatry, The Zucker Hillside Hospital, Glen Oaks, NY, USA; 6Psychiatry, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Glen Oaks, NY, USA; 7Scientific Communications, Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD, USA; 8Medical Affairs, Lundbeck LLC, Deerfield, IL, USA; 9Cell Biology and Neuroscience, Center for Mental Health Research and Recovery, Montana State University, Bozeman, MT, USA Objective: To assess expert consensus on barriers and facilitators for long-acting injectable antipsychotic (LAI use and provide clinical recommendations on issues where clinical evidence is lacking, including identifying appropriate clinical situations for LAI use. Methods: A 50-question survey comprising 916 response options was distributed to 42 research experts and high prescribers with extensive LAI experience. Respondents rated options on relative appropriateness/importance using a 9-point scale. Consensus was determined using chi-square test of score distributions. Mean (standard deviation ratings were calculated. Responses to 29 questions (577 options relating to appropriate patients and clinical scenarios for LAI use are reported. Results: Recommendations aligned with research on risk factors for nonadherence and poor outcomes for patients with schizophrenia/schizoaffective or bipolar disorder. Findings suggested, contrary to general practice patterns, that LAI use may be appropriate earlier in

  7. Focus on risperidone.

    Science.gov (United States)

    Green, B

    2000-01-01

    Risperidone is a relatively new antipsychotic available world-wide since the early 1990s. It has been characterised as atypical, but shares some of the extrapyramidal side-effect profile of the earlier antipsychotics, when used at doses higher than those recommended by the manufacturer (4-6 mg/day). There is now adequate comparison with conventional antipsychotics to suggest its superiority, but a depot formulation is needed to complete the picture.

  8. Patient preference for a long-acting recombinant FSH product in ovarian hyperstimulation in IVF: a discrete choice experiment.

    Science.gov (United States)

    van den Wijngaard, L; Rodijk, I C M; van der Veen, F; Gooskens-van Erven, M H W; Koks, C A M; Verhoeve, H R; Mol, B W J; van Wely, M; Mochtar, M H

    2015-02-01

    What factors or attributes of a long-acting recombinant FSH (rFSH) or daily-administrated rFSH influence women's preferences IVF? Patients' preferences for rFSH products are primary influenced by the attribute 'number of injections', but a low 'number of injections' is exchanged for a high 'number of injections' at a 6.2% decrease in 'risk of cycle cancellation due to low response' and at a 4.5% decrease in 'chance of OHSS'. Injections of long-acting rFSH have been claimed to be preferred over daily-administrated rFSH injections, but patient preference studies to underpin this assumption have not been performed. A discrete choice experiment (DCE) was created to assess women's preference for long-acting or daily-administrated rFSH under varying attributes of efficiency, safety and burden. The selected attributes were the 'total number of injections', 'chance of ovarian hyperstimulation syndrome (OHSS)' and the 'risk of cycle cancellation due to low response'. Questionnaires were handed out during information gathering sessions in one academic hospital and two teaching hospitals in The Netherlands between April 2011 and April 2012. Women at the start of their first IVF treatment were asked to participate in this patient preference study. Participation was voluntary. We analysed the data by using mixed logit models to estimate the utility of each attribute. Questionnaires (n = 125) were handed out with a response rate of 77% (97/125). Four respondents did not complete the questionnaire. Hence, there were 93 questionnaires available for analysis. All attributes significantly influenced women's preference. Overall, the lower 'number of injections' was preferred above the higher 'number of injections' (mean coefficient 1.25; P lower 'number of injections' for a higher 'number of injections' when gaining a 6.2% reduction in 'cycle cancellation due to low response', or a 4.5% reduction in 'chance of OHSS'. The generalizability of this DCE is limited in time-span. Women may

  9. Granisetron Injection

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    Granisetron immediate-release injection is used to prevent nausea and vomiting caused by cancer chemotherapy and to ... nausea and vomiting that may occur after surgery. Granisetron extended-release (long-acting) injection is used with ...

  10. Long-lasting ovulation inhibition with a new injectable progestagen ORG-2154.

    Science.gov (United States)

    Coutinho, E M; De Souza, J C; Barbosa, I C; Dourado Silva, V

    1982-06-01

    A new long-acting injectable progestagen was tested in 15 women who volunteered for the study. The occurrence of ovulation was assumed by the elevation of progesterone levels above 2ng/ml following a pre-ovulatory estradiol peak. Following a 200mg injection, ovulation was inhibited in all 15 women for five to ten months. In four subjects the interval between the injection and the first progesterone peak was five months. For eight, the interval was six to eight months. In the other three women, ovulation occurred more than eight months following injection. Bleeding episodes, similar to menstruation, occurred in most patients. Bleeding intervals lasting longer than 45 days occurred in nine subjects but more prolonged amenorrhea lasting longer than 60 days was reported by only five subjects. Blood chemistry which included blood cell counts, cholesterol, glucose, alkaline phosphatase, transaminases, urea nitrogen and creatinine remained within normal limits throughout the treatment.

  11. Zinc salt enhances gastroprotective activity of risperidone in indomethacin-induced gastric ulcer.

    Science.gov (United States)

    Oluwole, F S; Onwuchekwa, C

    2016-09-01

    Zinc has been reported to mediate cellular responses to injury by producing cytoprotection via the scavenging of reactive oxygen species. Anti-stress medications are generally anti-psychotic drugs and anti- depressants. Some Anti-psychotic drugs such as risperidone have been reported to possess anti-ulcer activity. Risperidone as an antipsychotic drug blocks several neurotransmitter systems including dopaminergic, adrenergic, histaminergic and serotonergic pathways. The study investigated the antiulcer activity of Zinc Chloride (ZnCl(2)) in combination with risperidone in male Wistar rats. The animals were divided into two groups of twenty animals each for ZnCl(2) and risperidone groups. Each group was further divided into four subgroups. ZnCl(2) was administered orally at 20mg/kg, 40mg/kg and 80mg/kg to a subgroup, while 80mg/kg of ZnCl(2) was administered in combination with risperidone (0.1mg/kg, 0.3mg/kg and 0.5mg/kg) orally once daily for 21 days. The controls were treated with distilled water. Ulcer was induced using indomethacin. Histology of the stomach tissues was prepared with PAS and H& E stains. Ulcer score and ulcer area were assessed using standard methods. Data were analysed using student t-test and Graphpad Prism 5. There were decreases in ulcer scores using the different doses of ZnCl, (20mg/kg, 40mg/kg and 80mg/kg). Also using the highest dose ZnCl(2) (80mg/ kg) and different doses of risperidone there were decreases in ulcer scores compared to the control. This effect of the risperidone showed a significant dose- dependent reduction. The effect ZnCl(2), and risperidone were also reflected in the ulcer area and in the histology. These findings suggest that ZnCl(2), enhances the gastroprotective activity ofrisperidone in indomethacin- induced gastric ulcer. However, more detailed studies are necessary to confirm the relevance of this finding and its implications in clinical settings.

  12. Risperidone versus other atypical antipsychotics for schizophrenia

    Science.gov (United States)

    Komossa, Katja; Rummel-Kluge, Christine; Schwarz, Sandra; Schmid, Franziska; Hunger, Heike; Kissling, Werner; Leucht, Stefan

    2014-01-01

    Background In many countries of the industrialised world second-generation (“atypical”) antipsychotics (SGAs) have become the first line drug treatment for people with schizophrenia. The question as to whether and if so how much the effects of the various SGAs differ is a matter of debate. In this review we examined how the efficacy and tolerability of risperidone differs from that of other SGAs. Objectives To evaluate the effects of risperidone compared with other atypical antipsychotics for people with schizophrenia and schizophrenia-like psychosis. Search methods 1. Electronic searching We searched the Cochrane Schizophrenia Group Trials Register (April 2007) which is based on regular searches of BIOSIS, CENTRAL, CINAHL, EMBASE, MEDLINE and PsycINFO. 2. Reference searching We inspected the references of all identified studies for more trials. 3. Personal contact We contacted the first author of each included study for missing information. 4. Drug companies We contacted the manufacturers of all atypical antipsychotics included for additional data. Selection criteria We included all randomised, blinded trials comparing oral risperidone with oral forms of amisulpride, aripiprazole, clozapine, olanzapine, quetiapine, sertindole, ziprasidone or zotepine in people with schizophrenia or schizophrenia-like psychosis. Data collection and analysis We extracted data independently. For dichotomous data we calculated risk ratio (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis based on a random-effects model. We calculated numbers needed to treat/harm (NNT/NNH) where appropriate. For continuous data, we calculated mean differences (MD), again based on a random-effects model. Main results The review currently includes 45 blinded RCTs with 7760 participants. The number of RCTs available for each comparison varied: four studies compared risperidone with amisulpride, two with aripiprazole, 11 with clozapine, 23 with olanzapine, eleven with

  13. Risperidone in psychotic combat-related posttraumatic stress disorder: an open trial.

    Science.gov (United States)

    Kozarić-Kovacić, Dragica; Pivac, Nela; Mück-Seler, Dorotea; Rothbaum, Barbara Olasov

    2005-07-01

    Psychotic symptoms that frequently occur in combat-related posttraumatic stress disorder (PTSD) complicate its pharmacotherapy. We hypothesized that war veterans with psychotic PTSD, resistant to prior antidepressant treatment, would respond well to 6 weeks of treatment with the atypical antipsychotic risperidone, given as a monotherapy. Twenty-six male war veterans with psychotic PTSD (DSM-IV) completed the 6-week inpatient treatment with risperidone (2-4 mg/day) during the period from November 1999 through December 2002. The primary outcome measure was change from baseline to endpoint (6 weeks) in Positive and Negative Syndrome Scale (PANSS) total and subscale scores. Secondary outcome measures were changes in PTSD Interview (PTSD-I) and Clinical Global Impressions-Severity of Illness scale (CGI-S) total and subscale scores. Clinical improvement was assessed by CGI-S, CGI-Improvement scale, and Patient Global Impression of Improvement scale, while adverse events were recorded by Drug-Induced Extrapyramidal Symptoms Scale. Treatment with risperidone for either 3 or 6 weeks in an open trial significantly reduced total and subscales scores on the PANSS and on the PTSD-I and CGI-S when compared to baseline scores in patients with psychotic PTSD. Our preliminary data from the open trial indicate that risperidone decreased most of the psychotic and PTSD symptoms. Psychotic PTSD patients, unresponsive to antidepressant treatment, improved significantly after treatment for either 3 or 6 weeks with risperidone.

  14. Effects of 21-day d-amphetamine and risperidone treatment on cocaine vs food choice and extended-access cocaine intake in male rhesus monkeys.

    Science.gov (United States)

    Hutsell, Blake A; Negus, S Stevens; Banks, Matthew L

    2016-11-01

    Clinical trial data suggest amphetamine treatment is most efficacious in moderate to high frequency cocaine users. However, preclinical studies have examined amphetamine treatment effects under relatively limited cocaine access conditions with low to moderate cocaine intakes. This study determined d-amphetamine treatment effects on cocaine self-administration in rhesus monkeys under cocaine access conditions allowing for high daily cocaine intake. For comparison and as a negative control, treatment effects with the antipsychotic risperidone were also examined. Continuous 21-day treatments with ramping doses of d-amphetamine (days 1-7: 0.032mg/kg/h; days 8-21: 0.1mg/kg/h, i.v.) or risperidone (days 1-7: 0.001mg/kg/h; days 8-14: 0.0032mg/kg/h; days 15-21: 0.0056mg/kg/h, i.v.) were administered to rhesus monkeys (n=4) with daily access to two types of cocaine self-administration sessions: (1) a 2-h 'choice' session with concurrent availability of 1-g food pellets and intravenous cocaine injections (0-0.1mg/kg per injection) and (2) a 20-h 'extended-access' session with 0.1mg/kg per injection cocaine availability. Total daily cocaine intake increased >6-fold during extended cocaine access. d-Amphetamine significantly decreased total cocaine intake, but not cocaine vs food choice. In contrast, risperidone did not significantly alter either total cocaine intake or cocaine vs. food choice. These results confirm and extend previous results supporting treatment effectiveness for monoamine releasers, but not dopamine antagonists, to reduce cocaine self-administration. Moreover, these results suggest amphetamine treatment efficacy to decrease preclinical cocaine vs. food choice may depend upon cocaine access conditions. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  15. A case of neuroleptic malignant syndrome induced by risperidone in a schizophrenic woman.

    Science.gov (United States)

    Gallelli, Luca; Spagnuolo, Vincenzo; Palleria, Caterina; De Sarro, Giovambattista; Ferraro, Maria

    2009-05-01

    We report a case of neuroleptic malignant syndrome in a woman who assumed risperidone for schizoaffective disorders. A 45-year-old woman affected by schizoaffective disorders was admitted to Infectious Disease unit of Crotone Hospital because of a diagnosis of a fever of unknown origin. Clinical evaluation documented confusion and dysphoria, whereas chemical blood evaluation revealed acidosis and liver dysfunction. After few days she was transferred to the Operative Unit of Internal Medicine of San Giovanni in Fiore Hospital because of an increase in liver transaminases. Clinical evaluation showed the persistence of fever (38.8 degrees Celsius), with an increase in CPK, and liver enzymes. Pharmacological evaluation indicated a probable relationship between risperidone and NMS and led to a diagnosis of neuroleptic malignant syndrome associated with risperidone in a woman with schizophrenia. About seven days later, we recorded a complete resolution of her psychiatric symptoms. We postulate a possible interaction between risperidone and neuroleptic malignant syndrome and we suggest to use risperidone with caution in both young and middle aged people.

  16. Risperidone-induced weight gain is mediated through shifts in the gut microbiome and suppression of energy expenditure

    Directory of Open Access Journals (Sweden)

    Sarah M. Bahr

    2015-11-01

    Full Text Available Risperidone is a second-generation antipsychotic that causes weight gain. We hypothesized that risperidone-induced shifts in the gut microbiome are mechanistically involved in its metabolic consequences. Wild-type female C57BL/6J mice treated with risperidone (80 μg/day exhibited significant excess weight gain, due to reduced energy expenditure, which correlated with an altered gut microbiome. Fecal transplant from risperidone-treated mice caused a 16% reduction in total resting metabolic rate in naïve recipients, attributable to suppression of non-aerobic metabolism. Risperidone inhibited growth of cultured fecal bacteria grown anaerobically more than those grown aerobically. Finally, transplant of the fecal phage fraction from risperidone-treated mice was sufficient to cause excess weight gain in naïve recipients, again through reduced energy expenditure. Collectively, these data highlight a major role for the gut microbiome in weight gain following chronic use of risperidone, and specifically implicates the modulation of non-aerobic resting metabolism in this mechanism.

  17. Adjunctive Treatment of Acute Mania with Risperidone versus Typical Antipsychotics: A Retrospective Study

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    Jui-Hsiu Tsai

    2005-12-01

    Full Text Available Few studies have directly compared atypical antipsychotics (e.g. risperidone with typical antipsychotics as adjunctive therapy in patients hospitalized for acute mania, especially during a lengthy hospital stay. Our retrospective, case-controlled study is a chart review of 64 patients with Diagnostic and Statistical Manual of Mental Disorders, 4th edition, defined bipolar I disorder (current episode, mania. Patients were divided into two groups according to the adjunctive medications used: the risperidone group (mood stabilizers plus risperidone and the control group (mood stabilizers plus typical antipsychotics. Outcome at discharge, medications, adverse drug effects, and length of hospital stay were compared between groups, controlling for gender, age, number of prior admissions, and duration of illness. Results indicated no statistically significant differences between groups in the controlled factors, Global Assessment of Functioning and Clinical Global Impression-Improvement scores, and adverse drug events. Patients in the risperidone group used significantly lower doses of trihexyphenidyl than those in the control group (p < 0.05. Patients treated with risperidone had a shorter hospital stay than those treated with typical antipsychotics (p < 0.01. In conclusion, antipsychotics are effective as adjunctive agents in the treatment of acute mania. The use of risperidone, in particular, decreases the need for anticholinergics and may lead to a shorter hospital stay compared with typical antipsychotics.

  18. Efficacy, tolerability, and safety of aripiprazole once-monthly versus other long-acting injectable antipsychotic therapies in the maintenance treatment of schizophrenia: a mixed treatment comparison of double-blind randomized clinical trials.

    Science.gov (United States)

    Majer, Istvan M; Gaughran, Fiona; Sapin, Christophe; Beillat, Maud; Treur, Maarten

    2015-01-01

    Treatment with long-acting injectable (LAI) antipsychotic medication is an important element of relapse prevention in schizophrenia. Recently, the intramuscular once-monthly formulation of aripiprazole received marketing approval in Europe and the United States for schizophrenia. This study aimed to compare aripiprazole once-monthly with other LAI antipsychotics in terms of efficacy, tolerability, and safety. A systematic literature review was conducted to identify relevant double-blind randomized clinical trials of LAIs conducted in the maintenance treatment of schizophrenia. MEDLINE, MEDLINE In-Process, Embase, the Cochrane Library, PsycINFO, conference proceedings, clinical trial registries, and the reference lists of key review articles were searched. The literature search covered studies dating from January 2002 to May 2013. Studies were required to have ≥24 weeks of follow-up. Patients had to be stable at randomization. Studies were not eligible for inclusion if efficacy of acute and maintenance phase treatment was not reported separately. Six trials were identified (0.5% of initially identified studies), allowing comparisons of aripiprazole once-monthly, risperidone LAI, paliperidone palmitate, olanzapine pamoate, haloperidol depot, and placebo. Data extracted included study details, study duration, the total number of patients in each treatment arm, efficacy, tolerability, and safety outcomes. The efficacy outcome contained the number of patients that experienced a relapse, tolerability outcomes included the number of patients that discontinued treatment due to treatment-related adverse events (AEs), and that discontinued treatment due to reasons other than AEs (e.g., loss to follow-up). Safety outcomes included the incidence of clinically relevant weight gain and extrapyramidal symptoms. Data were analyzed by applying a mixed treatment comparison competing risks model (efficacy) and using binary models (safety). There was no statistically significant

  19. An open-label extension study of the safety and efficacy of risperidone in children and adolescents with autistic disorder.

    Science.gov (United States)

    Kent, Justine M; Hough, David; Singh, Jaskaran; Karcher, Keith; Pandina, Gahan

    2013-12-01

    The purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders. In this 6 month (26 week) open-label extension (OLE) study, patients (5-17 years of age, who completed the previous fixed-dose, 6 week, double-blind [DB] phase) were flexibly dosed with risperidone based on body weight. The maximum allowed dose was 1.25 mg/day for those weighing 20 to autistic, psychiatric, and behavioral disorders. Patients experienced some additional improvement in irritability and related behaviors. This phase-4 study is registered at ClinicalTrials.gov (NCT00576732).

  20. Patient preference for a long-acting recombinant FSH product in ovarian hyperstimulation in IVF: a discrete choice experiment

    NARCIS (Netherlands)

    van den Wijngaard, L.; Rodijk, I. C. M.; van der Veen, F.; Gooskens-van Erven, M. H. W.; Koks, C. A. M.; Verhoeve, H. R.; Mol, B. W. J.; van Wely, M.; Mochtar, M. H.

    2015-01-01

    What factors or attributes of a long-acting recombinant FSH (rFSH) or daily-administrated rFSH influence women's preferences IVF? Patients' preferences for rFSH products are primary influenced by the attribute 'number of injections', but a low 'number of injections' is exchanged for a high 'number

  1. The antidepressant- and anxiolytic-like effects following co-treatment with escitalopram and risperidone in rats.

    Science.gov (United States)

    Kaminska, K; Rogoz, Z

    2016-06-01

    Several clinical reports have documented a beneficial effect of the addition of a low dose of risperidone to the ongoing treatment with antidepressants, in particular selective serotonin reuptake inhibitors (SSRI), in the treatment of drug-resistant depression and treatment-resistant anxiety disorders. In the present study, we investigated the effect of treatment with the antidepressant escitalopram (SSRI) given separately or jointly with a low dose of risperidone (an atypical antipsychotic) in the forced swim test and in the elevated plus-maze test in rats. The obtained results showed that escitalopram at doses of 2.5 or 5 mg/kg evoked antidepressant-like effect in the forced swim test. Moreover, risperidone at low doses (0.05 or 0.1 mg/kg) enhanced the antidepressant-like activity of escitalopram (1 mg/kg) in this test by increasing the swimming time and decreasing the immobility time in those animals. WAY 100635 (a serotonin 5-HT1A receptor antagonist) at a dose of 0.1 mg/kg abolished the antidepressant-like effect induced by co-administration of escitalopram and risperidone. The active behavior in that test did not reflect an increase in general activity, since the combined treatment with escitalopram and risperidone failed to enhance the exploratory activity of rats. In the following experiment, we showed that escitalopram (5 mg/kg) and mirtazapine (5 or 10 mg/kg) or risperidone (0.1 mg/kg) induced an anxiolytic-like effect in the elevated plus-maze test, and the combined treatment with an ineffective dose of risperidone (0.05 mg/kg) enhanced the anxiolytic-like effects of escitalopram (2.5 mg/kg) or mirtazapine (1 and 2.5 mg/kg) in this test. The obtained results suggest that risperidone applied at a low dose enhances the antidepressant-like activity of escitalopram in the forced swim test, and that 5-HT1A receptors may play some role in these effects. Moreover, a low dose of risperidone may also enhance the anxiolytic-like action of the studied

  2. Aripiprazole versus risperidone for treating children and adolescents with tic disorder: a randomized double blind clinical trial.

    Science.gov (United States)

    Ghanizadeh, Ahmad; Haghighi, Alireza

    2014-10-01

    There are some uncontrolled studies about the efficacy and safety of both aripiprazole and risperidone for treating tic disorder. Moreover, the efficacy of these medications has never been compared. This is the first double blind randomized clinical trial comparing the safety and efficacy of aripiprazole and risperidone for treating patients with tic disorder. Sixty children and adolescents with tic disorder were randomly allocated into one of the two groups to receive either aripiprazole or risperidone for 2 months. The primary outcome measure was the score of Yale Global Tic Severity Scale. In addition, health related quality of life and adverse events were assessed. Both aripiprazole and risperidone decreased the Yale Global Tic Severity Scale score during this trial. Moreover, both medications increased the health related quality of life score. Both aripiprazole and risperidone were tolerated well. Aripiprazole [3.22 (1.9) mg/day] decreased tic score as much as risperidone [0.6 (0.2) mg/day]. Their adverse effects and their effects on health related quality of life were comparable. However, risperidone increased the patients' social functioning more than aripiprazole in short term.

  3. [Differences in cerebral blood flow following risperidone treatment in children with autistic disorder].

    Science.gov (United States)

    Ozdemir, Dilşad Foto; Karabacak, Neşe Ilgin; Akkaş, Burcu; Akdemir, Ozgür; Unal, Fatih; Senol, Selahattin

    2009-01-01

    Functional changes in the brains of autistic children due to risperidone treatment and theirs relationship to the symptom clusters are yet unknown. In this autistic disorder case series we aimed to comparatively evaluate the clinical findings before and after risperidone treatment, and regional cerebral blood flow (rCBF) findings with 99mTc-hexamethylpropyleneamine oxime (HMPAO) brain SPECT. Eleven autistic patients (age range: 6-7 years; 4 girls, 7 boys) received risperidone therapy (1.5-2.5 mg d(-1)) and were followed-up for 3 months. All the patients underwent neurologic examinations, psychometric examinations, and SPECT imaging, both at the start of risperidone treatment and 3 months after the treatment started. Clinical observations, and the observations of parents and teachers were recorded. These results were compared with cerebral perfusion indices obtained from SPECT data. After 3 months of treatment changes in rCBF were observed in various regions and to varying degrees. We observed relationships between clinical symptoms and pre-therapy rCBF findings, and between clinical improvement and rCBF changes. Findings in the present case series are the first to demonstrate a relationship between clinical improvement and regional perfusion patterns after risperidone treatment. We think that these findings may contribute to the understanding of the neurofunctional mechanisms and hypothetical models of autism.

  4. A Randomized Open Label Comparison of the Effects ofRisperidone and Haloperidol on Sexual Function

    Directory of Open Access Journals (Sweden)

    S. Jaber Mousavi

    2009-12-01

    Full Text Available "n Objective: "nSexual dysfunction in patients who take antipsychotics causes adecline in their quality of life and medication acceptance. Considering the restrictions in cross sectional design of many earlier researches, we used a clinical trial aimed at assessing sexual dysfunction by substituting Risperidone, an atypical antipsychotic drug, with Haloperidol, a typical one . "n "n "nMethod: This clinical trial was conducted on 51 patients who had been using Risperidone with a minimum dose of 2 mg/daily for at least 2 months. The patients were randomly divided into 2 groups. The first group continued taking Risperidone, whereas the second group was given Haloperidol. Sexual function prior to and after the drug substitution was assessed using a sexual questionnaire designed to assess four stages of sexual function . "nResults: Compared to those who changed their medication to Haloperidol, the patients who remained on Risperidone therapy suffered from more sexual dysfunction, especially in their tendency towards having sexual activities (P= 0.01, post menstrual sexual activity (P= 0.002, and reaching orgasm in their sexual activities (P= 0.04; however in the Haloperidol group, no significant difference was observed before and after the change in medication . "nConclusion: Although Risperidone and Haloperidol can both disturb patients'sexual function, the side effects of Risperidone are stronger. Hence toprevent the decline of medication acceptance or irregular consumption by patients which may lead to possible relapse, substitution of Risperidone withanother drug with fewer side effects on sexual activities is definitely to the advantage of the patients .

  5. Review of risperidone for the treatment of pediatric and adolescent bipolar disorder and schizophrenia

    Directory of Open Access Journals (Sweden)

    Jeffrey R Bishop

    2008-03-01

    Full Text Available Jeffrey R Bishop1,2, Mani N Pavuluri21Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy, Chicago, IL, USA; 2Department of Psychiatry, Pediatric Mood Disorders Program and Center for Cognitive Medicine, University of Illinois at Chicago College of Medicine, Chicago, IL, USAAbstract: Risperidone is a commonly used medication for the treatment of bipolar disorder and schizophrenia in children and adolescents. It has been studied as a monotherapy treatment in early onset schizophrenia and as both monotherapy and combination therapy for pediatric bipolar disorder. Studies to date indicate that risperidone is an effective treatment for positive and negative symptoms of schizophrenia and mania symptoms of bipolar disorder. In young patient populations, side effects such as weight gain, extrapyramidal side effects, and prolactin elevation require consideration when evaluating the risk benefit ratio for individual patients. Here we review published studies of risperidone for the treatment of bipolar disorder and schizophrenia in children and adolescents to provide practitioners with an overview of published data on the efficacy and safety of risperidone in these patient populations.Keywords: risperidone, bipolar disorder, schizophrenia, children, adolescents

  6. Risperidone – Solid-state characterization and pharmaceutical compatibility using thermal and non-thermal techniques

    Energy Technology Data Exchange (ETDEWEB)

    Daniel, Josiane Souza Pereira; Veronez, Isabela Pianna; Rodrigues, Larissa Lopes [Laboratório de Análise e Caracterização de Fármacos – LACFar, Instituto de Química, Universidade Federal de Alfenas, Alfenas, Minas Gerais (Brazil); Trevisan, Marcello G. [Laboratório de Análise e Caracterização de Fármacos – LACFar, Instituto de Química, Universidade Federal de Alfenas, Alfenas, Minas Gerais (Brazil); National Institute of Bioanalytics Science and Technology – INCTBio, Institute of Chemistry – UNICAMP, 13084-653, Campinas, São Paulo (Brazil); Garcia, Jerusa Simone, E-mail: jerusa.garcia@unifal-mg.edu.br [Laboratório de Análise e Caracterização de Fármacos – LACFar, Instituto de Química, Universidade Federal de Alfenas, Alfenas, Minas Gerais (Brazil)

    2013-09-20

    Highlights: • DSC was used to characterize Risperidone and study its compatibility with excipients. • FT-IR associated with PCA was used to complement DSC data. • LC analyzes confirmed the DSC and FT-IR/PCA results. • Risperidone was incompatible with three among five excipients evaluated. - Abstract: A full solid-state characterization of risperidone was conducted using differential scanning calorimetry (DSC), thermogravimetry (TG), powder X-ray diffraction (PXRD), Fourier transform infrared spectroscopy (FT-IR) and scanning electron microscopy (SEM) to examine its physicochemical properties and polymorphism. The primary aim of this work was to study the compatibility of risperidone with pharmaceutical excipients using DSC to obtain and compare the curves of the active pharmaceutical ingredient (API) and the excipients with their 1:1 (w/w) binary mixtures. These same binary mixtures were turned to room temperature and analyzed by FT-IR combined with principal component analysis (PCA) to evaluate solid-state incompatibilities. The chemical incompatibilities of these samples were verified using a stability-indicating liquid chromatography (LC) method to assay for the API and evaluate the formation of degradation products. All of these methods showed incompatibilities between risperidone and the excipients magnesium stearate, lactose and cellulose microcrystalline.

  7. Risperidone in the treatment of behavioral disorders associated with autism in children and adolescents

    Directory of Open Access Journals (Sweden)

    Roberto Canitano

    2008-09-01

    Full Text Available Roberto Canitano, Valeria ScandurraDivision of Child Neuropsychiatry, University Hospital of Siena, Siena, ItalyAbstract: This is a review of the clinical trials investigating the efficacy and safety of risperidone in the treatment of children with autistic spectrum disorders (ASD. The main clinical characteristics are impairment in social skills, communication difficulties, repetitive movements and behaviors, including stereotypies. Pharmacotherapy is mainly directed at the so-called target symptoms, ie, behavioral disorders and the various kinds of repetitions associated with ASD. According to the available data, risperidone seems to be moderately efficacious and safe for treating behavioral disorders. 4 double blind controlled trial. 3 reanalysis studies, and 12 open studies have documented the role of risperidone in children with ASD. Controlled studies have been thoroughly considered in this review.Keywords: autism, pervasive developmental disorders, risperidone

  8. Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial.

    Science.gov (United States)

    Hubacher, David; Spector, Hannah; Monteith, Charles; Chen, Pai-Lien; Hart, Catherine

    2017-02-01

    Measures of contraceptive effectiveness combine technology and user-related factors. Observational studies show higher effectiveness of long-acting reversible contraception compared with short-acting reversible contraception. Women who choose long-acting reversible contraception may differ in key ways from women who choose short-acting reversible contraception, and it may be these differences that are responsible for the high effectiveness of long-acting reversible contraception. Wider use of long-acting reversible contraception is recommended, but scientific evidence of acceptability and successful use is lacking in a population that typically opts for short-acting methods. The objective of the study was to reduce bias in measuring contraceptive effectiveness and better isolate the independent role that long-acting reversible contraception has in preventing unintended pregnancy relative to short-acting reversible contraception. We conducted a partially randomized patient preference trial and recruited women aged 18-29 years who were seeking a short-acting method (pills or injectable). Participants who agreed to randomization were assigned to 1 of 2 categories: long-acting reversible contraception or short-acting reversible contraception. Women who declined randomization but agreed to follow-up in the observational cohort chose their preferred method. Under randomization, participants chose a specific method in the category and received it for free, whereas participants in the preference cohort paid for the contraception in their usual fashion. Participants were followed up prospectively to measure primary outcomes of method continuation and unintended pregnancy at 12 months. Kaplan-Meier techniques were used to estimate method continuation probabilities. Intent-to-treat principles were applied after method initiation for comparing incidence of unintended pregnancy. We also measured acceptability in terms of level of happiness with the products. Of the 916

  9. Double-blind, placebo-controlled trial of risperidone plus topiramate in children with autistic disorder.

    Science.gov (United States)

    Rezaei, Vala; Mohammadi, Mohammad-Reza; Ghanizadeh, Ahmad; Sahraian, Ali; Tabrizi, Mina; Rezazadeh, Shams-Ali; Akhondzadeh, Shahin

    2010-10-01

    Autism is a complex neurodevelopmental disorder that forms part of a spectrum of related disorders referred to as Autism Spectrum Disorders. The present study assessed the effects of topiramate plus risperidone in the treatment of autistic disorder. Forty children between the ages of 4 and 12 years with a DSM IV clinical diagnosis of autism who were outpatients from a specialty clinic for children were recruited. The children presented with a chief complaint of severely disruptive symptoms related to autistic disorder. Patients were randomly allocated to topiramate+risperidone (Group A) or placebo+risperidone (Group B) for an 8-week, double-blind, placebo-controlled study. The dose of risperidone was titrated up to 2 mg/day for children between 10 and 40 kg and 3 mg/day for children weighting above 40 kg. The dose of topiramate was titrated up to 200 mg/day depending on weight (100 mg/day for 30 kg). Patients were assessed at baseline and after 2, 4, 6 and 8 weeks after starting medication. Measure of outcome was the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale. Difference between the two protocols was significant as the group that received topiramate had a greater reduction in ABC-C subscale scores for irritability, stereotypic behavior and hyperactivity/noncompliance. The results suggest that the combination of topiramate with risperidone may be superior to risperidone monotherapy for children with autistic disorder. However the results need to be further confirmed by a larger randomized controlled trial. Copyright © 2010 Elsevier Inc. All rights reserved.

  10. Long-acting insulins alter milk composition and metabolism of lactating dairy cows.

    Science.gov (United States)

    Winkelman, L A; Overton, T R

    2013-01-01

    This study investigated the effect of 2 different types of long-acting insulin on milk production, milk composition, and metabolism in lactating dairy cows. Multiparous cows (n=30) averaging 88 d in milk were assigned to one of 3 treatments in a completely randomized design. Treatments consisted of control (C), Humulin-N (H; Eli Lilly and Company, Indianapolis, IN), and insulin glargine (L). The H and L treatments were administered twice daily at 12-h intervals via subcutaneous injection for 10d. Cows were milked twice daily, and milk composition was determined every other day. Mammary biopsies were conducted on d 11, and mammary proteins extracted from the biopsies were analyzed by Western blot for components of insulin and mammalian target of rapamycin signaling pathways. Treatment had no effect on dry matter intake or milk yield. Treatment with both forms of long-acting insulin increased milk protein content and tended to increase milk protein yield over the 10-d treatment period. Analysis of milk N fractions from samples collected on d 10 of treatment suggested that cows administered L tended to have higher yields of milk protein fractions than cows administered H. Milk fat content and yield tended to be increased for cows administered long-acting insulins. Lactose content and yields were decreased by treatment with long-acting insulins. Administration of long-acting insulins, particularly L, tended to shift milk fatty acid composition toward increased short- and medium-chain fatty acids and decreased long-chain fatty acids. Plasma concentrations of glucose and urea N were lower for cows administered long-acting insulins; interactions of treatment and sampling time were indicative of more pronounced effects of L than H on these metabolites. Concentrations of nonesterified fatty acids and insulin were increased in cows administered long-acting insulins. Decreased concentrations of urea N in both plasma and milk suggested more efficient use of N in cows

  11. A prospective trial of customized adherence enhancement plus long-acting injectable antipsychotic medication in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder

    Science.gov (United States)

    Sajatovic, Martha; Levin, Jennifer; Ramirez, Luis F.; Hahn, David Y.; Tatsuoka, Curtis; Bialko, Christopher S.; Cassidy, Kristin A.; Fuentes-Casiano, Edna; Williams, Tiffany D.

    2014-01-01

    Background Treatment non-adherence in people with schizophrenia is associated with relapse and homelessness. Building upon the usefulness of long-acting medication, and our work in psychosocial interventions to enhance adherence, we conducted a prospective uncontrolled trial of customized adherence enhancement (CAE) plus long-acting injectable antipsychotic (LAI) using haloperidol decanoate in 30 homeless or recently homeless individuals with schizophrenia and schizoaffective disorder. Methods Participants received monthly CAE and LAI (CAE-L) for 6 months. Primary outcomes were adherence as measured by the Tablets Routine Questionnaire (TRQ) and housing status. Secondary outcomes included psychiatric symptoms, functioning, side effects, and hospitalizations. Results Mean age of participants was 41.8 years (SD 8.6), mainly minorities (90% African-American) and mainly single/never married (70%). Most (97%) had past or current substance abuse, and had been incarcerated (97%). Ten individuals (33%) terminated the study prematurely. CAE-L was associated with good adherence to LAI (76% at 6 months) and dramatic improvement in oral medication adherence, which changed from missing 46% of medication at study enrollment to missing only 10% at study end (p = 0.03). There were significant improvements in psychiatric symptoms (pschizoaffective disorder. Additional research is needed on effective and practical approaches to improving health outcomes for homeless people with serious mental illness. PMID:24434094

  12. Enhancement of the anti-immobility action of antidepressants by risperidone in the forced swimming test in mice.

    Science.gov (United States)

    Rogóż, Zofia; Kabziński, Marcin

    2011-01-01

    The aim of the present study was to examine the effect of antidepressants (ADs) belonging to different pharmacological groups and risperidone (an atypical antipsychotic drug), given separately or jointly, on immobility time in the forced swimming test in male C57BL/6J mice. The antidepressants: citalopram, fluvoxamine, sertraline, reboxetine, milnacipran (5 and 10 mg/kg), or risperidone in low doses (0.05 and 0.1 mg/kg) given alone did not change the immobility time of mice in the forced swimming test. Co-treatment with reboxetine or milnacipran (10 mg/kg) and risperidone in a lower dose of 0.05 mg/kg or with sertraline, reboxetine (5 and 10 mg/kg), citalopram, fluvoxamine, milnacipran (10 mg/kg) and risperidone in a higher dose of 0.1 mg/kg produced antidepressant-like effect in the forced swimming test. WAY100635 (a 5-HT(1A) receptor antagonist) inhibited the effects induced by co-administration of ADs and risperidone. Active behavior in the forced swimming test was not a consequence of an increased general activity, since the combined treatment with ADs and risperidone failed to enhance the locomotor activity of mice. The obtained results indicate that a low dose of risperidone enhances the activity of ADs in an animal model of depression, and that, among other mechanisms, 5-HT(1A) receptors may play a role in these effects.

  13. Long-acting injectable paliperidone palmitate versus oral paliperidone extended release: a comparative analysis from two placebo-controlled relapse prevention studies.

    Science.gov (United States)

    Markowitz, Michael; Fu, Dong-Jing; Levitan, Bennett; Gopal, Srihari; Turkoz, Ibrahim; Alphs, Larry

    2013-07-11

    Increasing availability and use of long-acting injectable antipsychotics have generated a need to compare these formulations with their oral equivalents; however, a paucity of relevant data is available. This post hoc comparison of the long-term efficacy, safety and tolerability of maintenance treatment with paliperidone palmitate (PP) versus oral paliperidone extended release (ER) used data from two similarly designed, randomised, double-blind (DB), placebo-controlled schizophrenia relapse prevention trials. Assessments included measures of time to relapse, symptom changes/functioning and treatment-emergent adverse events (TEAEs). Time to relapse between treatment groups was evaluated using a Cox proportional hazards model. Between-group differences for continuous variables for change scores during the DB phase were assessed using analysis of co-variance models. Categorical variables were evaluated using Chi-square and Fisher's exact tests. No adjustment was made for multiplicity. Approximately 45% of enrolled subjects in both trials were stabilised and randomised to the DB relapse prevention phase. Risk of relapse was higher in subjects treated with paliperidone ER than in those treated with PP [paliperidone ER/PP hazard ratio (HR), 2.52; 95% confidence interval (CI), 1.46-4.35; p 70, both approximately 58.5%; p = 1.000] compared with a 10.9% decrease for paliperidone ER (58.5% vs 47.6%, respectively; p = 0.048). The least squares mean change for Positive and Negative Syndrome Scale (PANSS) total score at DB end point in these previously stabilised subjects was 3.5 points in favour of PP (6.0 vs 2.5; p = 0.025). The rates of TEAEs and AEs of interest appeared similar. This analysis supports maintenance of effect with the injectable compared with the oral formulation of paliperidone in patients with schizophrenia. The safety profile of PP was similar to that of paliperidone ER. Future studies are needed to confirm these findings.

  14. Efficacy of olanzapine long-acting injection in patients with acutely exacerbated schizophrenia: an insight from effect size comparison with historical oral data

    Directory of Open Access Journals (Sweden)

    Detke Holland C

    2012-05-01

    Full Text Available Abstract Background To treat acute schizophrenia, a long-acting injectable antipsychotic needs a rapid onset of action and therapeutic profile similar to that of oral agents. The present post-hoc analyses compared results from a randomized, double-blind, placebo-controlled trial of olanzapine long-acting injection (LAI for acute schizophrenia with those observed in similarly designed trials of oral olanzapine. Methods Six-week results from the olanzapine LAI study (N = 404 were compared with those of 3 oral studies (study 1: olanzapine vs. haloperidol vs. placebo [N = 335]; study 2: olanzapine vs. haloperidol vs. low-dose olanzapine [N = 431]; study 3: olanzapine vs. placebo vs. low-dose olanzapine [N = 152]. All patients had baseline Brief Psychiatric Rating Scale (BPRS scores ≥24 (0–6 scale. Six-week effect sizes were calculated. Efficacy onset, pharmacokinetics, discontinuations, weight gain, and extrapyramidal symptoms were also assessed. Results At 6 weeks, mean BPRS scores decreased by 14 to 15 points for olanzapine LAI (405 mg/4 weeks, 210 or 300 mg/2 weeks, by 8 to 16 for oral olanzapine (10 ± 2.5 or 15 ± 2.5 mg/day, and by 12 to 13 for haloperidol (15 ± 5 mg/day. For those same dose groups, effect sizes vs. placebo for the BPRS were 0.7 to 0.8 for olanzapine LAI, 0.5 to 0.7 for oral olanzapine, and 0.6 for haloperidol. The first statistically significant separation from placebo on the BPRS occurred at 3 days for the olanzapine LAI groups and at 1 week for oral olanzapine and haloperidol (15 ± 5 mg/day in oral study 1 although as late as week 6 for the 10-mg/day olanzapine dose in oral study 3. Olanzapine concentrations were similar across studies. Weight gain ≥7% of baseline occurred in up to 35% of olanzapine LAI and oral patients versus up to 12% of haloperidol and placebo patients. Extrapyramidal symptoms were lowest in the olanzapine LAI groups and significantly greater

  15. Risperidone treatment for ADHD in children and adolescents with bipolar disorder

    Directory of Open Access Journals (Sweden)

    Joseph Biederman

    2008-03-01

    Full Text Available Joseph Biederman, Paul Hammerness, Robert Doyle, Gagan Joshi, Megan Aleardi, Eric MickPediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston, MA, USAObjective: Children and adolescents with bipolar disorder are also at high risk of having comorbid attention-deficit hyperactivity disorder (ADHD. The objective of this study was to estimate improvement in ADHD symptoms in children with bipolar disorder.Methods: This was an open-label, study of risperidone monotherapy for the treatment of pediatric bipolar disorder. Thirty-one children and adolescents 4–15 years of age (7.2 ± 2.8 years of both sexes (71%, N = 22 male with pediatric bipolar disorder (YMRS score = 32.9 ± 8.8 and ADHD (ADHD-RS score = 37.9 ± 8.9 were included in these analyses.Results: Improvement in ADHD symptoms was contingent on improvement in manic symptoms. Although both hyperactive/impulsive (−7.5 ± 5.5.6, p < 0.05 and inattentive (−6.8 ± 5.0, p < 0.05 ADHD symptoms were significantly improved with risperidone, improvement was modest, and only 29% of subjects (N = 6 showed a 30% reduction in ADHD rating scale scores and had a CGI-I ≤ 2.Conclusions: These results suggest that that treatment with risperidone is associated with tangible but generally modest improvement of symptoms of ADHD in children with bipolar disorder.Keywords: ADHD, bipolar disorder, children, risperidone

  16. Weight changes and their associations with demographic and clinical characteristics in risperidone maintenance treatment for schizophrenia.

    Science.gov (United States)

    Xiang, Y-T; Wang, C-Y; Ungvari, G S; Kreyenbuhl, J A; Chiu, H F K; Lai, K Y C; Lee, E H M; Bo, Q-J; Dixon, L B

    2011-06-01

    This study aimed to characterize weight changes in schizophrenia patients taking risperidone as part of a randomized, controlled, open-label clinical trial. A total of 374 patients with schizophrenia who had been clinically stabilized following an acute episode were randomly assigned to a 'no-dose-reduction' group (initial optimal therapeutic doses continued throughout the study), a '4-week group' (initial optimal therapeutic doses continued for 4 weeks followed by a half dose reduction that was maintained until the end of the study) or a '26-week group' (initial optimal therapeutic doses continued for 26 weeks followed by a half dose reduction until the end of the study). Participants were assessed monthly using standardized assessment instruments during the first 6 months, and then every 2 months until the last recruited patient completed the 1-year follow-up. Weight gain was defined as gaining at least 7% of initial body weight, weight loss as losing at least 7% of initial body weight. A BMI weight loss compared to being normal weight. No correlation was found between weight change and dose reduction. Weight change is a common, long-term, but heterogeneous side effect in risperidone maintenance treatment for stable schizophrenia patients. Special attention should be paid to fluctuations in weight that may occur throughout the course of treatment with risperidone. © Georg Thieme Verlag KG Stuttgart · New York.

  17. Comparing Efficacy and Side Effects of Memantine vs. Risperidone in the Treatment of Autistic Disorder.

    Science.gov (United States)

    Nikvarz, Nikvarz; Alaghband-Rad, Javad; Tehrani-Doost, Mehdi; Alimadadi, Abbas; Ghaeli, Padideh

    2017-01-01

    Introduction: This study was aimed to compare the efficacy and side effects of memantine, an antagonist of the NMDA receptor of glutamate, with risperidone given the fact that glutamate has been noted for its possible effects in the pathogenesis of autism. Risperidone, an atypical antipsychotic, has been approved by FDA for the management of irritability associated with autism. Methods: 30 children, aged 4-17 years, entered an 8-week, randomized trial. Patients were randomly assigned to receive either risperidone or memantine. Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS), Clinical Global Impressions - Improvement (CGI-I) and Clinical Global Impression-Severity (CGI-S) scales were used to assess behavioral symptoms of the patients. Results: Both risperidone and memantine reduced the scores of 4 subscales of ABC as well as the 10-item and the total score of CARS significantly. However, differences between the 2 drugs in the scores of each evaluating scale were not found to be significant. Relatively, larger number of patients on risperidone showed "very much improvement" when assessed by CGI-I scale when compared with those on memantine. Discussion and conclusion: The present study suggests that memantine may have beneficial effects in the treatment of many core symptoms of autism. Therefore, memantine may be considered as a potential medication in the treatment of those autistic children who do not respond or cannot tolerate side effects of risperidone. © Georg Thieme Verlag KG Stuttgart · New York.

  18. Postinjection delirium/sedation syndrome in patients with schizophrenia receiving olanzapine long-acting injection: results from a large observational study.

    Science.gov (United States)

    Meyers, Kristin J; Upadhyaya, Himanshu P; Landry, John L; Chhabra-Khanna, Rashna; Falk, Deborah M; Seetharama Rao, Balasubramanya; Jones, Meghan E

    2017-07-01

    Postinjection delirium/sedation syndrome (PDSS) has been reported uncommonly during treatment with olanzapine long-acting injection (LAI), a sustained-release formulation of olanzapine. The primary aim of the study was to estimate the incidence per injection and per patient of PDSS events in adult patients with schizophrenia who were receiving olanzapine LAI in real-world clinical practice. Secondary aims were to further characterise the clinical presentation of PDSS events, to identify potential risk factors associated with PDSS events and to characterise hospitalisations at baseline and post-baseline. A prospective observational study of adult patients with schizophrenia receiving olanzapine LAI from 24 countries. Data were collected on patient characteristics, olanzapine LAI treatment and any adverse events (AEs). All AEs were reviewed and adjudicated for PDSS using predetermined criteria. There were 46 confirmed PDSS events (0.044% of the 103 505 injections) in 45 patients (1.17% of the 3858 patients). Based on 45 confirmed events with time-to-onset information, 91.1% ( n =41) occurred within 1 h of injection. Time-to-recovery from the event was within 72 h for 95.6% of patients (range 6 h to 11 days). Risk factors for PDSS (per-injection) included high dose (odds ratio (OR) high/low =3.95; P =0.006) and male gender (OR female/male =0.42; P =0.017). Results of this study confirm previously reported PDSS rates, time to onset and recovery, and the severity of PDSS events, and suggest that higher doses and male gender are potential risk factors associated with PDSS. All authors are full-time employees and hold stock/stock options in Eli Lilly, which funded this study. This post-authorisation safety study (PASS) was proposed by Eli Lilly when submitting the original marketing authorisation application for olanzapine LAI in 2007. The protocol and final study report for this European Union regulatory commitment are publicly accessible via the European Network of

  19. Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? Findings from across Europe and their implications.

    Science.gov (United States)

    Godman, Brian; Petzold, Max; Bennett, Kathleen; Bennie, Marion; Bucsics, Anna; Finlayson, Alexander E; Martin, Andrew; Persson, Marie; Piessnegger, Jutta; Raschi, Emanuel; Simoens, Steven; Zara, Corinne; Barbui, Corrado

    2014-06-13

    Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments. Consequently, generally there have been limited demand-side measures by health authorities to encourage the preferential prescribing of generics. This is unlike the situation with hypertension, hypercholaesterolaemia or acid-related stomach disorders.The objectives of this study were to compare the effect of the limited demand-side measures in Western European countries and regions on the subsequent prescribing of risperidone following generics; to utilise the findings to provide future guidance to health authorities; and where possible, to investigate the utilisation of generic versus originator risperidone and the prices for generic risperidone. Principally, this was a segmented regression analysis of retrospective time-series data of the effect of the various initiatives in Belgium, Ireland, Scotland and Sweden following the introduction of generic risperidone. The study included patients prescribed at least one atypical antipsychotic drug up to 20 months before and up to 20 months after generic risperidone. In addition, retrospective observational studies were carried out in Austria and Spain (Catalonia) from 2005 to 2011 as well as one English primary care organisation (Bury Primary Care Trust (PCT)). There was a consistent steady reduction in risperidone as a percentage of total selected atypical antipsychotic utilisation following generics. A similar pattern was seen in Austria and Spain, with stable utilisation in one English PCT. However, there was considerable variation in the utilisation of generic risperidone, ranging from 98% of total risperidone in Scotland to only 14% in Ireland. Similarly, the price of generic risperidone varied considerably. In Scotland, generic risperidone was only 16% of pre-patent loss prices versus 72% in Ireland. Consistent

  20. Risperidone Versus Methylphenidate in Treatment of Preschool Children With Attention-Deficit Hyperactivity Disorder.

    Science.gov (United States)

    Arabgol, Fariba; Panaghi, Leily; Nikzad, Vahid

    2015-02-01

    Attention Deficit Hyperactivity Disorder (ADHD) is a common psychiatric diagnosis among preschool children. The aim of this study was to examine the Risperidone treatment compared to Methylphenidate (MPH) in preschool children with ADHD. Thirty three outpatient preschool children, aged 3-6 years, diagnosed with ADHD (The diagnosis of ADHD was established by two child and adolescent psychiatrists according to the DSM-IV-TR criteria), participated in a 6-week, double-blind clinical trial with risperidone (0.5-1.5 mg/d) and methylphenidate (5-20 mg/d), in two divided doses. Treatment outcomes were assessed using the Parent ADHD Rating Scale and Conners Rating Scale. Patients were assessed by a child psychiatrist at baseline, 2, 4 and 6 weeks after the medication started. Side effects were also rated by side effects questionnaire. There were no significant differences between the two protocols on the Parent ADHD Rating Scale scores (P > 0.05) and Parent Conners Rating Scale scores (P > 0.05). Both groups showed a significant improvement in ADHD symptoms over the 6 weeks of treatment for parent ADHD Rating Scale (P benefits and adverse effects in long term use and comorbid conditions.

  1. Quality of life and adverse effects of olanzapine versus risperidone therapy in patients with schizophrenia.

    Science.gov (United States)

    Chaves, Katarina Melo; Serrano-Blanco, Antoni; Ribeiro, Susana Barbosa; Soares, Luiz Alberto Lira; Guerra, Gerlane Coelho Bernardo; do Socorro Costa Feitosa Alves, Maria; de Araújo Júnior, Raimundo Fernandes; de Paula Soares Rachetti, Vanessa; Filgueira Júnior, Antônio; de Araújo, Aurigena Antunes

    2013-03-01

    This cross-sectional study aimed to compare the effects of treatment with an atypical antipsychotic drug (olanzapine or risperidone) on quality of life (QoL) and to document adverse effects in 115 patients diagnosed with schizophrenia who attended the ambulatory service of Hospital Dr. João Machado, Natal, Rio Grande do Norte, Brazil. Socioeconomic, sociodemographic, and clinical variables were compared. The QoL Scale validated for Brazil (QLS-BR) was used to evaluate QoL, and adverse effects were assessed using the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale. Data were analyzed using the χ(2) test and Student's t test, with a significance level of 5 %. Patients in both drug groups showed severe impairment in the occupational domain of the QLS-BR. Global QLS-BR scores indicated impairment among risperidone users and severe impairment among olanzapine users. The most significant side effects were associated with risperidone, including asthenia/lassitude/fatigue, somnolence/sedation, paresthesia, change in visual accommodation, increased salivation, diarrhea, orthostatic posture, palpitations/tachycardia, erythema, photosensitivity, weight loss, galactorrhea, decreased sexual desire, erectile/orgasmic dysfunction, vaginal dryness, headache, and physical dependence. QoL was impaired in patients using olanzapine and in those using risperidone. Risperidone use was associated with psychic, neurological, and autonomous adverse effects and other side effects.

  2. Case Report: Valproic Acid and Risperidone Treatment Leading to Development of Hyperammonemia and Mania

    Science.gov (United States)

    Carlson, Teri; Reynolds, Charles A.; Caplan, Rochelle

    2007-01-01

    This case report describes two children who developed hyperammonemia together with frank manic behavior during treatment with a combination of valproic acid and risperidone. One child had been maintained on valproic acid for years and risperidone was added. In the second case, valproic acid was introduced to a child who had been treated with…

  3. Dopamine D2/D3 receptor binding of [123I]epidepride in risperidone-treatment chronic MK-801-induced rat schizophrenia model using nanoSPECT/CT neuroimaging

    International Nuclear Information System (INIS)

    Huang, Y.R.; Pai, C.W.; Cheng, K.H.; Kuo, W.I.; Chen, M.W.; Chang, K.W.

    2014-01-01

    Introduction: Epidepride is a compound with an affinity in picomolar range for D 2 /D 3 receptors. The aim of this work was designed to investigate the diagnostic possibility of [ 123 I]epidepride imaging platform for risperidone-treatment chronic MK-801-induced rat schizophrenia model. Methods: Rats received repeated administration of MK-801 (dissolved in saline, i.p., 0.3 mg/kg/day) or saline for 4 weeks. After 1-week administration of MK-801, rats in MK-801 + risperidone group received risperidone (0.5 mg/kg/day) intraperitoneally 15 min prior to MK-801 administration for the rest of 3-week treatment. We obtained serial [ 123 I]epidepride neuroimages from nanoSPECT/CT and evaluated the alteration of specific binding in striatum and midbrain. Results: Risperidone reversed chronic MK-801-induced decrease in social interaction duration. IHC and ELISA analysis showed consistent results that chronic MK-801 treatment significantly decreased striatal and midbrain D 2 R expression but repeated risperidone administration reversed the effect of MK-801 treatment. In addition, [ 123 I]epidepride nanoSPECT/CT neuroimaging revealed that low specific [ 123 I]epidepride binding ratios caused by MK-801 in striatum and midbrain were statistically alleviated after 1- and 2-week risperidone administration, respectively. Conclusions: We established a rat schizophrenia model by chronic MK-801 administration for 4 weeks. [ 123 I]Epidepride nanoSPECT neuroimaging can trace the progressive alteration of D 2 R expression in striatum and midbrain caused by long-lasting MK-801 treatment. Besides diagnosing illness stage of disease, [ 123 I]epidepride can be a useful tool to evaluate therapeutic effects of antipsychotic drug in chronic MK-801-induced rat schizophrenia model

  4. Risperidone in the treatment of behavioral disorders associated with autism in children and adolescents.

    Science.gov (United States)

    Canitano, Roberto; Scandurra, Valeria

    2008-08-01

    This is a review of the clinical trials investigating the efficacy and safety of risperidone in the treatment of children with autistic spectrum disorders (ASD). The main clinical characteristics are impairment in social skills, communication difficulties, repetitive movements and behaviors, including stereotypies. Pharmacotherapy is mainly directed at the so-called target symptoms, ie, behavioral disorders and the various kinds of repetitions associated with ASD. According to the available data, risperidone seems to be moderately efficacious and safe for treating behavioral disorders. 4 double blind controlled trial. 3 reanalysis studies, and 12 open studies have documented the role of risperidone in children with ASD. Controlled studies have been thoroughly considered in this review.

  5. Disposition kinetics of long acting moxifloxacin following intravenous administration in Sheep

    Directory of Open Access Journals (Sweden)

    Chirag M. Modi

    Full Text Available Aim: The objective of the present study was to study the disposition kinetics and dosage regimens of long acting moxifloxacin following intravenous administration at the dose rate of 7.5 mg/kg-1 b. wt. in six male sheep and to calculate dosage regimens of the same in sheep. Materials and Methods: The study was conducted using six healthy male sheep. Long acting Moxifloxacin solution (10 % moxifloxacin in solution with L- arginine, N-butyl alcohol and benzyl alcohol was injected in jugular vein and periodical blood samples were collected from contra-lateral jugular vein in test tubes containing 30-50 IU heparin (anticoagulant at 0.083 (5 min, 0.166 (10 min, 0.5, 1, 2, 4, 8, 12, 24, 36, 48, 60, 72 and up to 96 h post administration of drug. Drug concentration in plasma was determined using High Performance Liquid Chromatography (HPLC with Fluorescence Detector. The blood concentrations versus time data were analyzed using software. Results: After single dose intravenous administration of long acting moxifloxacin the plasma concentration of 0.016 ± 0.001 μg/ml-1 was maintained for up to 72 h. Distribution half-life (t and elimination half-life (t were 1.637 ± 0.053 h, and 1/2 1/2 12.130 ± 0.202 h, following IV administration. The mean values of apparent volume of distribution V 5.436 ± 0.135 L/kg-1 d(area as well as mean residence time 10.02 ± 4.787 minute were detected with IV administration. Conclusion: The long acting Moxifloxacin @ the dose 7.5 mg/kg IV maintains the effective therapeutic concentration in the plasma of sheep for up to 72 hours. The long acting Moxifloxacin at this dose rate can be used to treat sensitive bacteria causing infectious diseases in sheep. [Vet World 2012; 5(9.000: 517-521

  6. Schizophrenia symptoms and functioning in patients receiving long-term treatment with olanzapine long-acting injection formulation: a pooled analysis

    Directory of Open Access Journals (Sweden)

    Peuskens Joseph

    2012-08-01

    Full Text Available Abstract Background This analysis of pooled data evaluates treatment outcomes of patients with schizophrenia receiving maintenance treatment with olanzapine long-acting injection (OLAI by means of a categorical approach addressing the symptomatic and functional status of patients at different times. Methods Patients were grouped into 5 categories at baseline, 6 months, and 12 months. Shifts between categories were assessed for individual patients and factors associated with improvement were analyzed. 1182 patients from 3 clinical trials were included in the current analysis. Results At baseline, 434 (36.8% patients had minimal Positive and Negative Syndrome Scale (PANSS symptoms but seriously impaired Heinrich Carpenter’s Quality of Life Scale (QLS functioning; 303 (25.6% had moderate to severe symptoms and seriously impaired function; 208 (17.6% had mild to moderate symptoms but good functioning, and 162 (13.7% had minimal symptoms and good functioning. Baseline category was significantly associated with Clinical Global Impression – Severity (CGI-S, extrapyramidal symptoms, working status, age, and number of previous episodes. The majority of all patients starting OLAI treatment maintained or improved (62% at 6 months and 52% at 12 months their symptom and functioning levels on OLAI maintenance treatment. Less than 8% of the patients showed worsening of symptoms or functioning. An improvement in category was associated with high PANSS positive and low CGI-S scores at baseline. Conclusions We present evidence that a composite assessment of schizophrenic patients including symptom severity and functioning is helpful in the evaluation of maintenance treatment outcomes. This approach could also be useful for the assessment of treatment options in clinical practice. The trials from which data are reported here were registered on clinicaltrials.gov as NCT00088491, NCT00088465, and NCT00320489.

  7. Development of Risperidone PLGA Microspheres

    Directory of Open Access Journals (Sweden)

    Susan D’Souza

    2014-01-01

    Full Text Available The aim of this study was to design and evaluate biodegradable PLGA microspheres for sustained delivery of Risperidone, with an eventual goal of avoiding combination therapy for the treatment of schizophrenia. Two PLGA copolymers (50 : 50 and 75 : 25 were used to prepare four microsphere formulations of Risperidone. The microspheres were characterized by several in vitro techniques. In vivo studies in male Sprague-Dawley rats at 20 and 40 mg/kg doses revealed that all formulations exhibited an initial burst followed by sustained release of the active moiety. Additionally, formulations prepared with 50 : 50 PLGA had a shorter duration of action and lower cumulative AUC levels than the 75 : 25 PLGA microspheres. A simulation of multiple dosing at weekly or 15-day regimen revealed pulsatile behavior for all formulations with steady state being achieved by the second dose. Overall, the clinical use of Formulations A, B, C, or D will eliminate the need for combination oral therapy and reduce time to achieve steady state, with a smaller washout period upon cessation of therapy. Results of this study prove the suitability of using PLGA copolymers of varying composition and molecular weight to develop sustained release formulations that can tailor in vivo behavior and enhance pharmacological effectiveness of the drug.

  8. Long-Acting Antiretrovirals: Where Are We now?

    Science.gov (United States)

    Nyaku, Amesika N; Kelly, Sean G; Taiwo, Babafemi O

    2017-04-01

    Current HIV treatment options require daily use of combination antiretroviral drugs. Many persons living with HIV experience treatment fatigue and suboptimal adherence as a result. Long-acting antiretroviral drugs are being developed to expand options for HIV treatment. Here, we review the agents in development, and evaluate data from recent clinical trials. In addition, we anticipate challenges to successful widespread use of long-acting antiretrovirals. Parenteral nanosuspensions of cabotegravir and rilpivirine, and dapivirine vaginal ring are the farthest in clinical development. Long-acting modalities in earlier development stages employ drug-loaded implants, microparticles, or targeted mutagenesis, among other innovations. Long-acting antiretroviral drugs promise new options for HIV prevention and treatment, and ways to address poor adherence and treatment fatigue. Further studies will identify the long-acting agents or combinations that are suitable for routine use. Creative solutions will be needed for anticipated implementation challenges.

  9. Symptom response and side-effects of olanzapine and risperidone in young adults with recent onset schizophrenia

    NARCIS (Netherlands)

    van Bruggen, Johanna; Tijssen, Jans; Dingemans, Petrus; Gersons, Berthold; Linszen, Donald

    2003-01-01

    The symptom response and side-effects of olanzapine and risperidone were compared in patients with recent onset schizophrenia. Actively symptomatic patients n=44) randomly, received olanzapine 15 mg (median dose) or risperidone 4 mg (median dose). Symptom response and side-effects were measured

  10. Double-blind comparison of ziprasidone and risperidone in the treatment of Chinese patients with acute exacerbation of schizophrenia

    Directory of Open Access Journals (Sweden)

    Hongyan Zhang

    2011-03-01

    Full Text Available Hongyan Zhang1, Huafang Li2, Liang Shu1, Niufan Gu2, Gang Wang3, Yongzhen Weng3, Shiping Xie4, Xinbao Zhang4, Ting Li5, Cui Ma5, Wei Yu6, Bruce Parsons7, Manjula Schou81Institute of Mental Health, Peking University, Beijing, China; 2Shanghai Mental Health Center, Shanghai, China; 3Capital Medical University, Beijing An Ding Hospital, Beijing, China; 4Nanjing Brain Hospital, Nanjing, China; 5Guangzhou Brain Hospital, Guangzhou, China; 6Pfizer China, Beijing, China; 7Pfizer Inc, New York, NY, USA; 8Pfizer Australia, Sydney, AustraliaBackground: The aim of the study was to evaluate the efficacy and safety of ziprasidone versus risperidone in Chinese subjects with acute exacerbation of schizophrenia.Methods: In patients meeting the Chinese Classification of Mental Disorders criteria for schizophrenia and with a Positive and Negative Syndrome Scale (PANSS total score ≥60 were randomly assigned to six weeks of double-blind treatment with ziprasidone 40–80 mg twice daily or risperidone 1–3 mg bid, flexibly dosed. Noninferiority was demonstrated if the upper limit of the two-sided 95% confidence interval (CI for the difference in PANSS total score improvement from baseline in the evaluable population was smaller than the prespecified noninferiority margin of 10 units.Results: The intent-to-treat population comprised 118 ziprasidone-treated and 121 risperidone-treated subjects. Improvement (reduction from baseline to week 6 in PANSS total score was (-35.6 [95% CI: -38.6, -32.6] for ziprasidone and (-37.1 [95% CI: -39.9, -34.4] for risperidone. Noninferiority was demonstrated in the evaluable population with a difference score of 1.5 [95% CI: -2.5, 5.5]. Mean prolactin levels decreased at week 6 compared with baseline for ziprasidone (-3.5 ng/mL, but significantly increased for risperidone (61.1 ng/mL; P < 0.001. More risperidone-treated subjects (14.9% than ziprasidone-treated subjects (4.2% reported weight gain ≥7%. Akathisia and somnolence in

  11. Delphi's new direct acting common rail injection system; Das neue Direct Acting Common Rail System von Delphi

    Energy Technology Data Exchange (ETDEWEB)

    Schoeppe, Detlev; Zuelch, Stefan; Geurts, Derk; Gris, Christian; Jorach, Rainer W. [Delphi Diesel Systems, Europe (United Kingdom)

    2009-07-01

    With the serial start of the Direct Acting Common Rail injection system with 2.000 bar Delphi Diesel Systems could supplement its product portfolio with a valuable component. In Delphi's directly propelled Common Rail injector, the Injection needle directly is set in operation with the help of a piezo-ceramic actuator instead of only controlling this with a conventional servo-hydraulic circuit indirectly. This enables a fast opening and closing of the nozzle needle possible independently from the rail pressure. The process of injection is controllable accurately at any time with the again developed two-stage needle movement amplifier. The additionally in the injector integrated fuel storage works as a 'Rail in the Injector' and improves the quality particularly during multiple injection. The injector completely works leakage-free and thereby helps to reach the future CO{sub 2} targets. The use of piezo-actuators as driving force behind the directly working injector leads to a set of requirements to the electronics. A control electronics was developed in order to head optimally the Direct Acting Injector. The sum of all advantages of the Direct Acting of CR systems enables lowest emissions with simultaneously small fuel consumption while new dimensions are reached with power density and engine torque. The authors of the contribution under consideration report on the construction, on the work principle of the Direct Acting CR system and on its performance characteristics as a basis for the premium diesel engine.

  12. Benzathine penicillin G: a model for long-term pharmacokinetic comparison of parenteral long-acting formulations.

    Science.gov (United States)

    Shahbazi, M A; Azimi, K; Hamidi, M

    2013-04-01

      Long-acting intramuscular penicillin G injection is an important product for the management of some severe infections. However, testing the bioequivalence of such long-acting formulations is difficult. Our aim was to undertake such a test using a generic formulation containing 1 200 000 IU of benzathine penicillin G powder and an innovator's product (Retarpen(®) 1·2 million units; Sandoz, Switzerland).   In an open, double-blind, randomized, two-periods, two-group crossover study, 12 healthy male volunteers received both formulations of benzathine penicillin G on two different days with a 5-month washout period between the doses and a sampling period of over 500 h. A simple, sensitive and rapid high-performance liquid chromatography (HPLC)-UV method was developed and validated for determination of penicillin G plasma concentrations and other pharmacokinetic (PK) parameters.   The analytical method used produced linear responses within a wide analyte concentration range with average within-run and between-run variations of below 15% with acceptable recovery, accuracy and sensitivity. The primary PK parameters we used were maximum plasma concentration (Cmax ), time to reach the maximal concentration (Tmax ) and the area under the plasma concentration vs. time curve from time zero to the last sampling time (AUC0→t ) using a standard non-compartmental approach. Based on these parameters, the two formulations were bioequivalent.   We illustrate the bioequivalence testing of a very long-acting product. The data indicate that the generic test formulation and the branded reference formulation were bioequivalent in fasting healthy Iranian male volunteers. © 2013 Blackwell Publishing Ltd.

  13. A double-blind, placebo-controlled study of risperidone in adults with autistic disorder and other pervasive developmental disorders.

    Science.gov (United States)

    McDougle, C J; Holmes, J P; Carlson, D C; Pelton, G H; Cohen, D J; Price, L H

    1998-07-01

    Neurobiological research has implicated the dopamine and serotonin systems in the pathogenesis of autism. Open-label reports suggest that the serotonin2A-dopamine D2 antagonist risperidone may be safe and effective in reducing the interfering symptoms of patients with autism. Thirty-one adults (age [mean+/-SD], 28.1+/-7.3 years) with autistic disorder (n=17) or pervasive developmental disorder not otherwise specified (n=14) participated in a 12-week double-blind, placebo-controlled trial of risperidone. Patients treated with placebo subsequently received a 12-week open-label trial of risperidone. For persons completing the study, 8 (57%) of 14 patients treated with risperidone were categorized as responders (daily dose [mean+/-SD], 2.9+/-1.4 mg) compared with none of 16 in the placebo group (Pautism (Pautism in adults.

  14. Long-Acting Diclofenac Ester Prodrugs for Joint Injection

    DEFF Research Database (Denmark)

    Mertz, Nina; Larsen, Susan Weng; Kristensen, Jesper

    2016-01-01

    A prodrug approach for local and sustained diclofenac action after injection into joints based on ester prodrugs having a pH-dependent solubility is presented. Inherent ester prodrug properties influencing the duration of action include their pH-dependent solubility and charge state, as well...... as susceptibility to undergo esterase facilitated hydrolysis. In this study, physicochemical properties and pH rate profiles of 3 diclofenac ester prodrugs differing with respect to the spacer carbon chain length between the drug and the imidazole-based promoiety were determined and a rate equation for prodrug...... degradation in aqueous solution in the pH range 1-10 was derived. In the pH range 6-10, the prodrugs were subject to parallel degradation to yield diclofenac and an indolinone derivative. The prodrug degradation was found to be about 6-fold faster in 80% (vol/vol) human plasma as compared to 80% (vol...

  15. Parenteral nanoemulsions as promising carriers for brain delivery of risperidone: Design, characterization and in vivo pharmacokinetic evaluation.

    Science.gov (United States)

    Đorđević, Sanela M; Cekić, Nebojša D; Savić, Miroslav M; Isailović, Tanja M; Ranđelović, Danijela V; Marković, Bojan D; Savić, Saša R; Timić Stamenić, Tamara; Daniels, Rolf; Savić, Snežana D

    2015-09-30

    This paper describes design and evaluation of parenteral lecithin-based nanoemulsions intended for brain delivery of risperidone, a poorly water-soluble psychopharmacological drug. The nanoemulsions were prepared through cold/hot high pressure homogenization and characterized regarding droplet size, polydispersity, surface charge, morphology, drug-vehicle interactions, and physical stability. To estimate the simultaneous influence of nanoemulsion formulation and preparation parameters--co-emulsifier type, aqueous phase type, homogenization temperature--on the critical quality attributes of developed nanoemulsions, a general factorial experimental design was applied. From the established design space and stability data, promising risperidone-loaded nanoemulsions (mean size about 160 nm, size distribution Solutol(®) HS15 as co-emulsifier, were produced by hot homogenization and their ability to improve risperidone delivery to the brain was assessed in rats. Pharmacokinetic study demonstrated erratic brain profiles of risperidone following intraperitoneal administration in selected nanoemulsions, most probably due to their different droplet surface properties (different composition of the stabilizing layer). Namely, polysorbate 80-costabilized nanoemulsion showed increased (1.4-7.4-fold higher) risperidone brain availability compared to other nanoemulsions and drug solution, suggesting this nanoemulsion as a promising carrier worth exploring further for brain targeting. Copyright © 2015 Elsevier B.V. All rights reserved.

  16. Risperidone oral disintegrating mini-tablets: A robust-product for pediatrics

    Directory of Open Access Journals (Sweden)

    El-Say Khalid M.

    2015-12-01

    Full Text Available This study was aimed at developing risperidone oral disintegrating mini-tablets (OD-mini-tablets as age-appropriate formulations and to assess their suitability for infants and pediatric use. An experimental Box-Behnken design was applied to assure high quality of the OD-mini-tablets and reduce product variability. The design was employed to understand the influence of the critical excipient combinations on the production of OD-mini-tablets and thus guarantee the feasibility of obtaining products with dosage form uniformity. The variables selected were mannitol percent in Avicel (X1, swelling pressure of the superdisintegrant (X2, and the surface area of Aerosil as a glidant (X3. Risperidone-excipient compatibilities were investigated using FTIR and the spectra did not display any interaction. Fifteen formulations were prepared and evaluated for preand post-compression characteristics. The prepared ODmini- tablet batches were also assessed for disintegration in simulated salivary fluid (SSF, pH 6.2 and in reconstituted skimmed milk. The optimized formula fulfilled the requirements for crushing strength of 5 kN with minimal friability, disintegration times of 8.4 and 53.7 s in SSF and skimmed milk, respectively. This study therefore proposes the risperidone OD-mini-tablet formula having robust mechanical properties, uniform and precise dosing of medication with short disintegration time suitable for pediatric use.

  17. Risperidone oral disintegrating mini-tablets: A robust-product for pediatrics.

    Science.gov (United States)

    El-Say, Khalid M; Ahmed, Tarek A; Abdelbary, Maged F; Ali, Bahaa E; Aljaeid, Bader M; Zidan, Ahmed S

    2015-12-01

    This study was aimed at developing risperidone oral disintegrating mini-tablets (OD-mini-tablets) as age-appropriate formulations and to assess their suitability for infants and pediatric use. An experimental Box-Behnken design was applied to assure high quality of the OD-mini-tablets and reduce product variability. The design was employed to understand the influence of the critical excipient combinations on the production of OD-mini-tablets and thus guarantee the feasibility of obtaining products with dosage form uniformity. The variables selected were mannitol percent in Avicel (X1), swelling pressure of the superdisintegrant (X2), and the surface area of Aerosil as a glidant (X3). Risperidone-excipient compatibilities were investigated using FTIR and the spectra did not display any interaction. Fifteen formulations were prepared and evaluated for pre- and post-compression characteristics. The prepared OD-mini-tablet batches were also assessed for disintegration in simulated salivary fluid (SSF, pH 6.2) and in reconstituted skimmed milk. The optimized formula fulfilled the requirements for crushing strength of 5 kN with minimal friability, disintegration times of 8.4 and 53.7 s in SSF and skimmed milk, respectively. This study therefore proposes the risperidone OD-mini-tablet formula having robust mechanical properties, uniform and precise dosing of medication with short disintegration time suitable for pediatric use.

  18. A reproducible accelerated in vitro release testing method for PLGA microspheres.

    Science.gov (United States)

    Shen, Jie; Lee, Kyulim; Choi, Stephanie; Qu, Wen; Wang, Yan; Burgess, Diane J

    2016-02-10

    The objective of the present study was to develop a discriminatory and reproducible accelerated in vitro release method for long-acting PLGA microspheres with inner structure/porosity differences. Risperidone was chosen as a model drug. Qualitatively and quantitatively equivalent PLGA microspheres with different inner structure/porosity were obtained using different manufacturing processes. Physicochemical properties as well as degradation profiles of the prepared microspheres were investigated. Furthermore, in vitro release testing of the prepared risperidone microspheres was performed using the most common in vitro release methods (i.e., sample-and-separate and flow through) for this type of product. The obtained compositionally equivalent risperidone microspheres had similar drug loading but different inner structure/porosity. When microsphere particle size appeared similar, porous risperidone microspheres showed faster microsphere degradation and drug release compared with less porous microspheres. Both in vitro release methods investigated were able to differentiate risperidone microsphere formulations with differences in porosity under real-time (37 °C) and accelerated (45 °C) testing conditions. Notably, only the accelerated USP apparatus 4 method showed good reproducibility for highly porous risperidone microspheres. These results indicated that the accelerated USP apparatus 4 method is an appropriate fast quality control tool for long-acting PLGA microspheres (even with porous structures). Copyright © 2015 Elsevier B.V. All rights reserved.

  19. IVIVC from Long Acting Olanzapine Microspheres

    Directory of Open Access Journals (Sweden)

    Susan D'Souza

    2014-01-01

    Full Text Available In this study, four PLGA microsphere formulations of Olanzapine were characterized on the basis of their in vitro behavior at 37°C, using a dialysis based method, with the goal of obtaining an IVIVC. In vivo profiles were determined by deconvolution (Nelson-Wagner method and using fractional AUC. The in vitro and in vivo release profiles exhibited the same rank order of drug release. Further, in vivo profiles obtained with both approaches were nearly superimposable, suggesting that fractional AUC could be used as an alternative to the Nelson-Wagner method. A comparison of drug release profiles for the four formulations revealed that the in vitro profile lagged slightly behind in vivo release, but the results were not statistically significant (P0.96 between in vitro release and in vivo measurements confirmed the excellent relationship between in vitro drug release and the amount of drug absorbed in vivo. The results of this study suggest that proper selection of an in vitro method will greatly aid in establishing a Level A IVIVC for long acting injectables.

  20. Damage Modeling Of Injection-Molded Short- And Long-Fiber Thermoplastics

    International Nuclear Information System (INIS)

    Nguyen, Ba Nghiep; Kunc, Vlastimil; Bapanapalli, Satish K.; Phelps, Jay; Tucker, Charles L. III

    2009-01-01

    This article applies the recent anisotropic rotary diffusion - reduced strain closure (ARD-RSC) model for predicting fiber orientation and a new damage model for injection-molded long-fiber thermoplastics (LFTs) to analyze progressive damage leading to total failure of injection-molded long-glass-fiber/polypropylene (PP) specimens. The ARD-RSC model was implemented in a research version of the Autodesk Moldflow Plastics Insight (MPI) processing code, and it has been used to simulate injection-molding of a long-glass-fiber/PP plaque. The damage model combines micromechanical modeling with a continuum damage mechanics description to predict the nonlinear behavior due to plasticity coupled with damage in LFTs. This model has been implemented in the ABAQUS finite element code via user-subroutines and has been used in the damage analyses of tensile specimens removed from the injection-molded long-glass-fiber/PP plaques. Experimental characterization and mechanical testing were performed to provide input data to support and validate both process modeling and damage analyses. The predictions are in agreement with the experimental results.

  1. Prospective trial of customized adherence enhancement plus long-acting injectable antipsychotic medication in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder.

    Science.gov (United States)

    Sajatovic, Martha; Levin, Jennifer; Ramirez, Luis F; Hahn, David Y; Tatsuoka, Curtis; Bialko, Christopher S; Cassidy, Kristin A; Fuentes-Casiano, Edna; Williams, Tiffany D

    2013-12-01

    Treatment nonadherence in people with schizophrenia is associated with relapse and homelessness. Building on the usefulness of long-acting medication and our work in psychosocial interventions to enhance adherence, we conducted a prospective uncontrolled trial of customized adherence enhancement (CAE) plus long-acting injectable antipsychotic (LAI) using haloperidol decanoate in 30 homeless or recently homeless individuals with DSM-IV-defined schizophrenia or schizoaffective disorder. Participants received monthly CAE and LAI (CAE-L) for 6 months. Primary outcomes were adherence, as measured by the Tablets Routine Questionnaire, and housing status. Secondary outcomes included psychiatric symptoms, functioning, side effects, and hospitalizations. The study was conducted from July 2010 to December 2012. The mean age of participants was 41.8 years (SD = 8.6); they were mainly minorities (90%, n = 27 African-American) and mainly single/never married (70%, n = 21). Most (97%, n = 29) had past or current substance abuse and had been incarcerated (97%, n = 29). Ten individuals (33%) terminated the study prematurely. CAE-L was associated with good adherence to LAI (at 6 months, 76%) and dramatic improvement in oral medication adherence, which changed from missing 46% of medication at study enrollment to missing only 10% at study end (P = .03). There were significant improvements in psychiatric symptoms (P effect with LAI. While interpretation of findings must be tempered by the methodological limitations, CAE-L appears to be associated with improved adherence, symptoms, and functioning in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder. Additional research is needed on effective and practical approaches to improving health outcomes for homeless people with serious mental illness. ClinicalTrials.gov identifier: NCT01152697. © Copyright 2013 Physicians Postgraduate Press, Inc.

  2. Frequency of sexual dysfunction and other reproductive side-effects in patients with schizophrenia treated with risperidone, olanzapine, quetiapine, or haloperidol: the results of the EIRE study.

    Science.gov (United States)

    Bobes, J; Garc A-Portilla, M P; Rejas, J; Hern Ndez, G; Garcia-Garcia, M; Rico-Villademoros, F; Porras, A

    2003-01-01

    Atypical antipsychotics seem to differ mainly in their tolerability profile. The aim of this cross-sectional study, the Estudio de Investigaci n de Resultados en Esquizofrenia (Outcomes Research Study in Schizophrenia; EIRE study), was to assess in a clinical setting the frequency of several side-effects related to haloperidol, risperidone, olanzapine, and quetiapine. This article addresses sexual dysfunction and other reproductive side-effects (gynecomastia, menorrhage, amenorrhea, and galactorrhea). We recruited outpatients diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV; American Psychiatric Association, 1994) criteria and who had received a single antipsychotic (risperidone, olanzapine, quetiapine, or haloperidol) for at least 4 weeks. During a single visit, we collected data, including demographic and clinical characteristics, current antipsychotic and concomitant treatment, and adverse effects listed in a modified version of the UKU Scale. We used a Chi-squared test to determine pairs comparisons of the frequency of adverse reactions between treatments. To estimate risk of a given adverse reaction with a given treatment, we used a logistic regression method. We assessed 636 evaluable patients out of 669 recruited. Frequency of sexual dysfunction was high with haloperidol (38.1%) and also with olanzapine (35.3%), quetiapine (18.2%), and risperidone (43.2%). We found the frequency of other reproductive side-effects to be relatively low with all four drugs: haloperidol (6.9%), olanzapine (6.4%), quetiapine (2.7%), and risperidone (11.7%). Sexual dysfunction appeared to be dose-related with haloperidol, risperidone, and olanzapine. Risperidone and olanzapine showed a higher risk of sexual dysfunction and other reproductive sideeffects than haloperidol. Quetiapine showed a lower risk of sexual dysfunction during short-term treatment ( 12 weeks) are lacking. Our results suggest that none of the atypical

  3. Dopamine transporter density assessed with [123]IPT SPECT before and after risperidone treatment in children with tourette's disorder

    International Nuclear Information System (INIS)

    Ryu, Young Hoon; Kim, Tae Hoon; Ryu, Won Gee

    2004-01-01

    Tourette's disorder (TD), which is characterized by multiple waxing and waning motor tics and one or more vocal tics, is known to be associated with abnormalities in the dopaminergic system. To testify our hypothesis that risperidone would improve tic symptoms of TD patients through the change of the dopaminergic system, we measured the dopamine transporter (DAT) densities between drug-naive children with TD and normal children, and investigated the DAT density before and after treatment with risperidone in drug-naive children with TD, using iodine-123 labelled N-(3-iodopropen-2-yl)-2β-carbomethoxy-3beta-(4-chlorophenyl)tropane ([ 123 I]IPT) single photon emission computed tomography (SPECT). [ 123I ]IPT SPECT imaging and Yale Global Tic Severity Scale-Korean version (YGTSS-K) for assessing the tic symptom severity were carried out before and after treatment with risperidone for 8 weeks in nine drug-naive children with TD. Eleven normal children also underwent SPECT imaging 2 hours after an intravenous administration of [ 123 I]IPT. Drug-naive children with TD had a significantly greater increase in the specific/nonspecific DAT binding ratio of both basal ganglia compared with the normal children. However, no significant difference in the specific/nonspecific DAT binding ratio of the basal ganglia before and after treatment with risperidone in children with TD was found, although tic symptoms were significantly improved with risperidone. These findings suggest that DAT densities are directly associated with the pathophysiology of TD, however, that the effect of risperidone on tic symptoms in children with TD is not attributed to the change of dopaminergic system

  4. Comparison of intramuscular olanzapine, orally disintegrating olanzapine tablets, oral risperidone solution, and intramuscular haloperidol in the management of acute agitation in an acute care psychiatric ward in Taiwan.

    Science.gov (United States)

    Hsu, Wen-Yu; Huang, Si-Sheng; Lee, Bo-Shyan; Chiu, Nan-Ying

    2010-06-01

    The purpose of this study was to compare efficacy and safety among intramuscular olanzapine, intramuscular haloperidol, orally disintegrating olanzapine tablets, and oral risperidone solution for agitated patients with psychosis during the first 24 hours of treatment in an acute care psychiatric ward. Forty-two inpatients from an acute care psychiatric ward of a medical center in central Taiwan were enrolled. They were randomly assigned to 1 of the 4 treatment groups (10-mg intramuscular olanzapine, 10-mg olanzapine oral disintegrating tablet, 3-mg oral risperidone solution, or 7.5-mg intramuscular haloperidol). Agitation was measured by using the excited component of the Positive and Negative Syndrome Scale (PANSS-EC), the Agitation-Calmness Evaluation Scale, and the Clinical Global Impression--Severity Scale during the first 24 hours. There were significant differences in the PANSS-EC total scores for the 4 intervention groups at 15, 30, 45, 60, 75, and 90 minutes after the initiation of treatment. More significant differences were found early in the treatment. In the post hoc analysis, the patients who received intramuscular olanzapine or orally disintegrating olanzapine tablets showed significantly greater improvement in PANSS-EC scores than did patients who received intramuscular haloperidol at points 15, 30, 45, 60, 75, and 90 minutes after injection. These findings suggest that intramuscular olanzapine, orally disintegrating olanzapine tablets, and oral risperidone solution are as effective treatments as intramuscular haloperidol for patients with acute agitation. Intramuscular olanzapine and disintegrating olanzapine tablets are more effective than intramuscular haloperidol in the early phase of the intervention. There is no significant difference in effectiveness among intramuscular olanzapine, orally disintegrating olanzapine tablets, and oral risperidone solution.

  5. Commercial air travel after intraocular gas injection.

    Science.gov (United States)

    Houston, Stephen; Graf, Jürgen; Sharkey, James

    2012-08-01

    Passengers with intraocular gas are at risk of profound visual loss when exposed to reduced absolute pressure within the cabin of a typical commercial airliner. Information provided on the websites of the world's 10 largest airlines offer a considerable range of opinion as to when it might be safe to fly after gas injection. Physicians responsible for clearing pseassengers as 'fit to fly' should be aware modern retinal surgical techniques increasingly employ long-acting gases as vitreous substitutes. The kinetics of long-acting intraocular gases must be considered when deciding how long after surgery it is safe to travel. It is standard practice to advise passengers not to fly in aircraft until the gas is fully resorbed. To achieve this, it may be necessary to delay travel for approximately 2 wk after intraocular injection of sulfur hexafluoride (SF6) and for 6 wk after injection of perfluoropropane (C3F8).

  6. Model of Management (Mo.Ma) for the patient with schizophrenia: crisis control, maintenance, relapse prevention, and recovery with long-acting injectable antipsychotics (LAIs).

    Science.gov (United States)

    Brugnoli, Roberto; Rapinesi, Chiara; Kotzalidis, Georgios D; Marcellusi, Andrea; Mennini, Francesco S; De Filippis, Sergio; Carrus, Dario; Ballerini, Andrea; Francomano, Antonio; Ducci, Giuseppe; Del Casale, Antonio; Girardi, Paolo

    2016-01-01

    Schizophrenia is a severe mental disease that affects approximately 1% of the population with a relevant chronic impact on social and occupational functioning and daily activities. People with schizophrenia are 2-2.5 times more likely to die early than the general population. Non-adherence to antipsychotic medications, both in chronic and first episode schizophrenia, is one of the most important risk factors for relapse and hospitalization, that consequently contributes to increased costs due to psychiatric hospitalization. Atypical long-acting injectable (LAI) antipsychotics can improve treatment adherence and decrease re-hospitalization rates in patients with schizophrenia since its onset. The primary goals in the management of schizophrenia are directed not only at symptom reduction in the short and long term, but also at maintaining physical and mental functioning, improving quality of life, and promoting patient recovery. To propose a scientific evidence-based integrated model that provides an algorithm for recovery of patients with schizophrenia and to investigate the effectiveness and safety of antipsychotics LAI in the treatment, maintenance, relapse prevention, and recovery of schizophrenia. After an accurate literature review we identified, collected and analyzed the crucial points in taking care schizophrenia patients, through which we defined the steps described in the model of management and the choice of the better treatment option. Results. In the management model we propose, the choice of a second generation long acting antipsychotic, could allow from the earliest stages of illness better patient management, especially for young individuals with schizophrenia onset, a better recovery and significant reductions of relapse and health care costs. LAI formulations of antipsychotics are valuable, because they help patients to remain adherent to their medication through regular contact with healthcare professionals and to prevent covert non-adherence. The

  7. Analysis of risperidone and 9-hydroxyrisperidone in human plasma, urine and saliva by MEPS-LC-UV.

    Science.gov (United States)

    Mandrioli, Roberto; Mercolini, Laura; Lateana, Domenico; Boncompagni, Giancarlo; Raggi, Maria Augusta

    2011-01-15

    Risperidone is currently one of the most frequently prescribed atypical antipsychotic drugs; its main active metabolite 9-hydroxyrisperidone contributes significantly to the therapeutic effects observed. An original analytical method is presented for the simultaneous analysis of risperidone and the metabolite in plasma, urine and saliva by high-performance liquid chromatography coupled to an original sample pre-treatment procedure based on micro-extraction by packed sorbent (MEPS). The assays were carried out using a C8 reversed-phase column and a mobile phase composed of 73% (v/v) acidic phosphate buffer (30 mM, pH 3.0) containing 0.23% triethylamine and 27% (v/v) acetonitrile. The UV detector was set at 238 nm and diphenhydramine was used as the internal standard. The sample pre-treatment by MEPS was carried out on a C8 sorbent. The extraction yields values were higher than 92% for risperidone and 90% for 9-hydroxyrisperidone, with RSD for precision always lower than 7.9% for both analytes. Limit of quantification values in the different matrices were 4 ng/mL or lower for risperidone and 6 ng/mL or lower for the metabolite. The method was successfully applied to plasma, urine and saliva samples from psychotic patients undergoing therapy with risperidone, with satisfactory accuracy results (recovery>89%) and no interference from other drugs. Thus, the method seems to be suitable for the therapeutic drug monitoring of schizophrenic patients using the three different biological matrices plasma, urine and saliva. Copyright © 2010 Elsevier B.V. All rights reserved.

  8. Long fiber polymer composite property calculation in injection molding simulation

    Science.gov (United States)

    Jin, Xiaoshi; Wang, Jin; Han, Sejin

    2013-05-01

    Long fiber filled polymer composite materials have attracted a great attention and usage in recent years. However, the injection and compression molded long fiber composite materials possess complex microstructures that include spatial variations in fiber orientation and length. This paper presents the recent implemented anisotropic rotary diffusion - reduced strain closure (ARD-RSC) model for predicting fiber orientation distribution[1] and a newly developed fiber breakage model[2] for predicting fiber length distribution in injection and compression molding simulation, and Eshelby-Mori-Tanaka model[3,4] with fiber-matrix de-bonding model[5] have been implemented to calculate the long fiber composite property distribution with predicted fiber orientation and fiber length distributions. A validation study on fiber orientation, fiber breakage and mechanical property distributions are given with injection molding process simulation.

  9. METABOLIC SIDE EFFECTS OF HALOPERIDOL AND RISPERIDONE- A SIX MONTHS FOLLOWUP STUDY

    Directory of Open Access Journals (Sweden)

    Kalaimathi B

    2017-03-01

    Full Text Available BACKGROUND To compare and analyse the metabolic side effects of Risperidone and Haloperidol in newly diagnosed drug-naive schizophrenic disorder patients attending Govt. Stanley Medical College Hospital during initial 6 months of therapy. MATERIALS AND METHODS Newly diagnosed drug-naïve Schizophrenic Patients (n = 60 aged between 18 - 45 years are recruited and randomly allocated into Group A (Risperidone 4 - 6 mg daily and Group B (Haloperidol 5 - 10 mg daily after getting informed consent from the patient’s family members. Patients are followed up monthly for the occurrence of metabolic abnormalities like weight gain, rise in blood pressure, elevated fasting, post-prandial blood sugar level, dyslipidaemia for a period of 6 months. RESULTS Risperidone group showed the mean body weight increase from 64.40 to 69.27, SBP/DBP increase from 123.80/79 to 129.90/83.13; FBS/PPBS increase from 100.20/129.30 to 135.40/185.00; TC increase from 177.23 to 206.23; LDL from 124.30 to 158.30; HDL 48.83 to 50.07; TG 133.47 to 197.83: Haloperidol group showed the mean body weight increase from 64.07 to 68.48, SBP/DBP increase from 123.80/79.00 to 124.27/81.67; FBS/PPBS increase from 100.20/129.30 to 119.87/167.10; TC increase from 177.23 to 197.40; LDL from 119.77 to 139.00; HDL remained 48.83; TG 133.47 to 171.40. CONCLUSION This study showed that patients in both the groups had weight gain, rise in blood sugar, LDL cholesterol and Triglycerides level, but the rise was significant in patients on Risperidone when compared to those on Haloperidol during the 6-month followup.

  10. Risk of Hyperprolactinemia and Sexual Side Effects in Males 10-20 Years Old Diagnosed with Autism Spectrum Disorders or Disruptive Behavior Disorder and Treated with Risperidone

    NARCIS (Netherlands)

    Roke, Yvette; Buitelaar, Jan K.; Boot, Annemieke M.; Tenback, Diederik; van Harten, Peter N.

    2012-01-01

    Objective: The aim of this study was to investigate the long-term treatment effects of risperidone on prolactin levels and prolactin-related side effects in pubertal boys with autism spectrum disorders (ASD) and disruptive behavior disorders (DBD). Method: Physical healthy 10-20-year-old males with

  11. Persistent efficacy of a long acting injectable formulation of moxidectin against natural infestations of the sheep nasal bot (Oestrus ovis) in Spain.

    Science.gov (United States)

    Rugg, Douglas; Ferrer, Luis Miguel; Sarasola, Patxi; Figueras, Luis; Lacasta, Delia; Liu, Bo; Bartram, David

    2012-09-10

    Cydectin(®) 2% LA Solution for Injection for Sheep (Pfizer Animal Health) is a long-acting (LA) formulation of moxidectin for the treatment and prevention of mixed infections of gastro-intestinal nematodes, respiratory nematodes and certain arthropod parasites in sheep. To evaluate the duration of persistent efficacy against nasal bots (Oestrus ovis), a natural exposure study was conducted in Spain during the summer of 2011. One hundred and twenty nasal bot-free, Rasa Aragonesa sheep were randomly allocated to eight groups of 15 animals each. On Day 0, four groups were treated at the recommended dose rate of 1 mg moxidectin/kg bodyweight. Four groups remained untreated as negative controls. All animals were held in nasal bot-proof housing except for exposure to natural challenge when one group of treated sheep and one of group of control animals were transferred to a local pasture at either 0-20, 20-40, 40-60, or 60-80 days after treatment. Following challenge, sheep were scored for clinical signs of bot infestation, necropsied and the heads sectioned for larval recovery. Nasal bot larvae were retrieved from 7 to 11 control sheep following each exposure period indicating that adult bots were active throughout the study. In the first challenge up to 20 days after treatment, when sheep were slaughtered immediately after exposure, the majority of larvae were first instar (L1) and only 3 of the 15 control sheep were infested with second instars (L2). There was 100% efficacy against L2 and 38.1% reduction in the number of live L1 in the treated sheep but mean counts were not significantly different between treatment and control groups (P ≥ 0.05). For the subsequent exposure periods 20-80 days after treatment (necropsies 7-9 days after challenge), 6-10 sheep were infested with L1 and 9-11 control sheep were infested with L2 and third instars (L3). There was negligible efficacy against L1, but treatment with moxidectin resulted in 100% control of L2 and L3. These

  12. Patterns of faecal nematode egg shedding after treatment of sheep with a long-acting formulation of moxidectin.

    Science.gov (United States)

    Crilly, James Patrick; Jennings, Amy; Sargison, Neil

    2015-09-15

    Much of the current information on the effects of long-acting anthelmintics on nematode populations derives either from research farms or mathematical models. A survey was performed with the aim of establishing how moxidectin is currently being used on sheep farms in the south-east of Scotland. A study was undertaken on a subsection of the surveyed farms to examine the effects of long-acting moxidectin treatments in both spring and autumn on faecal nematode egg output. The survey showed that whole flock treatments of injectable 2% moxidectin were used to control sheep scab on 21% of farms. Injectable 2% moxidectin and oral moxidectin were used to control the periparturient rise in faecal nematode egg shedding by ewes on 13% and 55% of farms respectively. The effects of injectable 2% moxidectin treatment on faecal nematode egg shedding post-treatment in both the autumn and spring were investigated by faecal nematode egg counts at the time of treatment and at 2-weekly interval thereafter on eight and six farms in the autumn and spring, respectively. Faecal egg shedding recommenced at 8 weeks (autumn) and 4 weeks (spring) post-treatment. Counts increased to a peak and then declined. The mean (95% confidence interval) peak counts post-treatment were 2.8 (0.6, 5.1), 3.6 (1.7, 5.5) and 53.5 (25.1, 82.0) eggs per gram (EPG) for autumn-treated ewes, autumn-treated lambs and spring-treated ewes respectively. The spring treated sheep showed a statistically significantly earlier return to faecal egg shedding (p=0.0125, p=0.0342) compared to both other groups, statistically significantly higher peak in egg counts than the autumn treated sheep (pegg counts (p=0.0148). There was no statistically significant difference in the timing of the peak FECs between autumn and spring (p=0.211). The FECs of all groups of sheep treated with an injectable long-acting formulation of moxidectin became positive earlier than would be expected from the period of persistence given on the datasheet

  13. Alterations in brain extracellular dopamine and glycine levels following combined administration of the glycine transporter type-1 inhibitor Org-24461 and risperidone.

    Science.gov (United States)

    Nagy, Katalin; Marko, Bernadett; Zsilla, Gabriella; Matyus, Peter; Pallagi, Katalin; Szabo, Geza; Juranyi, Zsolt; Barkoczy, Jozsef; Levay, Gyorgy; Harsing, Laszlo G

    2010-12-01

    The most dominant hypotheses for the pathogenesis of schizophrenia have focused primarily upon hyperfunctional dopaminergic and hypofunctional glutamatergic neurotransmission in the central nervous system. The therapeutic efficacy of all atypical antipsychotics is explained in part by antagonism of the dopaminergic neurotransmission, mainly by blockade of D(2) dopamine receptors. N-methyl-D-aspartate (NMDA) receptor hypofunction in schizophrenia can be reversed by glycine transporter type-1 (GlyT-1) inhibitors, which regulate glycine concentrations at the vicinity of NMDA receptors. Combined drug administration with D(2) dopamine receptor blockade and activation of hypofunctional NMDA receptors may be needed for a more effective treatment of positive and negative symptoms and the accompanied cognitive deficit in schizophrenia. To investigate this type of combined drug administration, rats were treated with the atypical antipsychotic risperidone together with the GlyT-1 inhibitor Org-24461. Brain microdialysis was applied in the striatum of conscious rats and determinations of extracellular dopamine, DOPAC, HVA, glycine, glutamate, and serine concentrations were carried out using HPLC/electrochemistry. Risperidone increased extracellular concentrations of dopamine but failed to influence those of glycine or glutamate measured in microdialysis samples. Org-24461 injection reduced extracellular dopamine concentrations and elevated extracellular glycine levels but the concentrations of serine and glutamate were not changed. When risperidone and Org-24461 were added in combination, a decrease in extracellular dopamine concentrations was accompanied with sustained elevation of extracellular glycine levels. Interestingly, the extracellular concentrations of glutamate were also enhanced. Our data indicate that coadministration of an antipsychotic with a GlyT-1 inhibitor may normalize hypofunctional NMDA receptor-mediated glutamatergic neurotransmission with reduced

  14. Effects of co-treatment with mirtazapine and low doses of risperidone on immobility time in the forced swimming test in mice.

    Science.gov (United States)

    Rogóż, Zofia

    2010-01-01

    The aim of the present study was to examine the effect of mirtazapine (MIR) and risperidone (an atypical antipsychotic drug), given separately or jointly, on immobility time in the forced swimming test in male C57BL/6J mice. Fluoxetine (FLU) was used as a reference drug. MIR (2.5, 5 and 10 mg/kg) and FLU (5 and 10 mg/kg), or risperidone in low doses (0.05 and 0.1 mg/kg) given alone did not change the immobility time of mice in the forced swimming test. Joint administration of MIR (5 and 10 mg/kg) or FLU (10 mg/kg) and risperidone (0.1 mg/kg) produced antidepressant-like activity in the forced swimming test. WAY100636 (a 5-HT(1A) receptor antagonist) inhibited, while yohimbine (an α(2)-adrenergic receptor antagonist) potentiated the antidepressant-like effect induced by co-administration of MIR and risperidone. Active behavior in that test did not reflect an increase in general activity, since combined administration of antidepressants and risperidone failed to enhance the locomotor activity of mice. The obtained results indicate that risperidone applied in a low dose enhances the antidepressant-like activity of MIR and that, among other mechanisms, 5-HT(1A)-, and α(2)-adrenergic receptors may play a role in this effect.

  15. Comparative study on clinically latent aggressiveness inoutpatients with schizophrenia treated with classical antipsychotics and with risperidone

    Directory of Open Access Journals (Sweden)

    Konstantinos Tsirigotis

    2014-03-01

    Full Text Available Objective: The use of neuroleptics causes not only regression of psychotic symptoms; neuroleptics affect also the patients’ mental state which is changing not only due to medications effects but also secondarily, as a result of regression of psychotic symptoms. The aim of this study was evaluation of subjectively felt “silent” (clinically latent hostility and aggressiveness in patients with paranoid schizophrenia treated with typical neuroleptics and risperidone. Material and methods: Sixty patients (30 patients treated with typical neuroleptics and the other 30 – with risperidone were examined with the Polish version of the following tools: Minnesota Multiphasic Personality Inventory (MMPI, Adjective Check List (ACL and Stern Activities Index (SAI. Results: The statistical analysis of the obtained results yielded many statistically significant differences within the intensity of hostility and aggressiveness in the examined groups. Conclusions: The results of this study showed a higher severity of psychological and personality problems in patients treated with typical neuroleptics, as compared to those treated with risperidone. In patients with paranoid schizophrenia treated with risperidone a lower severity of psychopathological, especially schizophrenic and paranoid, symptoms and lower hostility and aggressiveness were found. Considering that risperidone improves verbal functions, it can be assumed that this entails an improvement in the patients’ communicative competences, thereby improving also their interpersonal relationships. The results of this study indicate a higher susceptibility of people in this group to social influences and less hostility and negativity experienced by them.

  16. Successful treatment with risperidone increases 5-HT 3A receptor gene expression in patients with paranoid schizophrenia - data from a prospective study.

    Science.gov (United States)

    Chen, Hongying; Fan, Yong; Zhao, Lei; Hao, Yong; Zhou, Xiajun; Guan, Yangtai; Li, Zezhi

    2017-09-01

    The relationship between peripheral 5-HT3A receptor mRNA level and risperidone efficiency in paranoid schizophrenia patients is still unknown. A total 52 first-episode and drug-naive paranoid schizophrenia patients who were treated with risperidone and 53 matched healthy controls were enrolled. Patients were naturalistically followed up for 8 weeks. Positive and Negative Syndrome Scale (PANSS) was applied to assess symptom severity of the patients at baseline and at the end of 8th week. There was no difference in 5-HT3A receptor mRNA level between paranoid schizophrenia patients and healthy controls at baseline ( p  = .24). Among 47 patients who completed 8-week naturalistic follow-up, 37 were responders to risperidone treatment. 5-HT3A receptor mRNA level of paranoid schizophrenia patients did not change in overall patients after 8-week treatment with risperidone ( p  = .29). However, 5-HT3A receptor mRNA level in responders increased significantly ( p  = .04), but not in nonresponders ( p  = .81). Successful treatment with risperidone increases 5-HT3A receptor gene expression in patients with paranoid schizophrenia, indicating that 5-HT3A receptor may be involved in the mechanism of risperidone effect.

  17. Haloperidol, risperidone, olanzapine and aripiprazole in the management of delirium: A comparison of efficacy, safety, and side effects.

    Science.gov (United States)

    Boettger, Soenke; Jenewein, Josef; Breitbart, William

    2015-08-01

    The aim of this study was to compare the efficacy and side-effect profile of the typical antipsychotic haloperidol with that of the atypical antipsychotics risperidone, olanzapine, and aripiprazole in the management of delirium. The Memorial Delirium Assessment Scale (MDAS), the Karnofsky Performance Status (KPS) scale, and a side-effect rating were recorded at baseline (T1), after 2-3 days (T2), and after 4-7 days (T3). Some 21 cases were case-matched by age, preexisting dementia, and baseline MDAS scores, and subsequently analyzed. The baseline characteristics of the medication groups were not different: The mean age of the patients ranged from 64.0 to 69.6 years, dementia was present in between 23.8 and 28.6%, and baseline MDAS scores were 19.9 (haloperidol), 18.6 (risperidone), 19.4 (olanzapine), and 18.0 (aripiprazole). The doses of medication at T3 were 5.5 mg haloperidol, 1.3 mg risperidone, 7.1 mg olanzapine, and 18.3 mg aripiprazole. Over one week, the decline in MDAS scores between medications was equal, and no differences between individual MDAS scores existed at T2 or T3. After one week, the MDAS scores were 6.8 (haloperidol), 7.1 (risperidone), 11.7 (olanzapine), and 8.3 (aripiprazole). At T2, delirium resolution occurred in 42.9-52.4% of cases and at T3 in 61.9-85.7%; no differences in assessments between medications existed. Recorded side effects were extrapyramidal symptoms (EPSs) in haloperidol- and risperidone-managed patients (19 and 4.8%, respectively) and sedation with olanzapine (28.6%). Haloperidol, risperidone, aripiprazole, and olanzapine were equally effective in the management of delirium; however, they differed in terms of their side-effect profile. Extrapyramidal symptoms were most frequently recorded with haloperidol, and sedation occurred most frequently with olanzapine.

  18. A comparison of low-dose risperidone to paroxetine in the treatment of panic attacks: a randomized, single-blind study

    Directory of Open Access Journals (Sweden)

    Galynker Igor I

    2009-05-01

    Full Text Available Abstract Background Because a large proportion of patients with panic attacks receiving approved pharmacotherapy do not respond or respond poorly to medication, it is important to identify additional therapeutic strategies for the management of panic symptoms. This article describes a randomized, rater-blind study comparing low-dose risperidone to standard-of-care paroxetine for the treatment of panic attacks. Methods Fifty six subjects with a history of panic attacks were randomized to receive either risperidone or paroxetine. The subjects were then followed for eight weeks. Outcome measures included the Panic Disorder Severity Scale (PDSS, the Hamilton Anxiety Scale (Ham-A, the Hamilton Depression Rating Scale (Ham-D, the Sheehan Panic Anxiety Scale-Patient (SPAS-P, and the Clinical Global Impression scale (CGI. Results All subjects demonstrated a reduction in both the frequency and severity of panic attacks regardless of treatment received. Statistically significant improvements in rating scale scores for both groups were identified for the PDSS, the Ham-A, the Ham-D, and the CGI. There was no difference between treatment groups in the improvement in scores on the measures PDSS, Ham-A, Ham-D, and CGI. Post hoc tests suggest that subjects receiving risperidone may have a quicker clinical response than subjects receiving paroxetine. Conclusion We can identify no difference in the efficacy of paroxetine and low-dose risperidone in the treatment of panic attacks. Low-dose risperidone appears to be tolerated equally well as paroxetine. Low-dose risperidone may be an effective treatment for anxiety disorders in which panic attacks are a significant component. Trial Registration ClinicalTrials.gov Identifier: NCT100457106

  19. Long acting systemic HIV pre-exposure prophylaxis: an examination of the field.

    Science.gov (United States)

    Lykins, William R; Luecke, Ellen; Johengen, Daniel; van der Straten, Ariane; Desai, Tejal A

    2017-12-01

    Oral pre-exposure prophylaxis for the prevention of HIV-1 transmission (HIV PrEP) has been widely successful as demonstrated by a number of clinical trials. However, studies have also demonstrated the need for patients to tightly adhere to oral dosing regimens in order to maintain protective plasma and tissue concentrations. This is especially true for women, who experience less forgiveness from dose skipping than men in clinical trials of HIV PrEP. There is increasing interest in long-acting (LA), user-independent forms of HIV PrEP that could overcome this adherence challenge. These technologies have taken multiple forms including LA injectables and implantables. Phase III efficacy trials are ongoing for a LA injectable candidate for HIV PrEP. This review will focus on the design considerations for both LA injectable and implantable platforms for HIV PrEP. Additionally, we have summarized the existing LA technologies currently in clinical and pre-clinical studies for HIV PrEP as well as other technologies that have been applied to HIV PrEP and contraceptives. Our discussion will focus on the potential application of these technologies in low resource areas, and their use in global women's health.

  20. Long-acting reversible hormonal contraception

    African Journals Online (AJOL)

    Abstract. Long-acting reversible hormonal contraceptives are effective methods of birth control that provide contraception for an extended ... The World Health Organization (WHO) has online tools available .... trials and marketing experience.

  1. Long-term use of short- and long-acting nitrates in stable angina pectoris.

    Science.gov (United States)

    Kosmicki, Marek Antoni

    2009-05-01

    Long-acting nitrates are effective antianginal drugs during initial treatment. However, their therapeutic value is compromised by the rapid development of tolerance during sustained therapy, which means that their clinical efficacy is decreased during long-term use. Sublingual nitroglycerin (NTG), a short-acting nitrate, is suitable for the immediate relief of angina. In patients with stable angina treated with oral long-acting nitrates, NTG maintains its full anti-ischemic effect both after initial oral ingestion and after intermittent long-term oral administration. However, NTG attenuates this effect during continuous treatment, when tolerance to oral nitrates occurs, and this is called cross-tolerance. In stable angina long-acting nitrates are considered third-line therapy because a nitrate-free interval is required to avoid the development of tolerance. Nitrates vary in their potential to induce the development of tolerance. During long-lasting nitrate therapy, except pentaerythritol tetranitrate (PETN), one can observe the development of reactive oxygen species (ROS) inside the muscular cell of a vessel wall, and these bind with nitric oxide (NO). This leads to decreased NO activity, thus, nitrate tolerance. PETN has no tendency to form ROS, and therefore during long-term PETN therapy, there is probably no tolerance or cross-tolerance, as during treatment with other nitrates.

  2. Bronchodilator treatment of stable COPD: long-acting anticholinergics

    Directory of Open Access Journals (Sweden)

    W. Vincken

    2005-09-01

    Full Text Available Since airflow obstruction in chronic obstructive pulmonary disease (COPD is to some extent reversible, bronchodilators play an important role in the maintenance treatment of COPD the more they reduce hyperinflation and, as a result, improve dyspnoea and exercise capacity. Since parasympathetic activity is the dominant reversible component of airflow obstruction in COPD, inhaled short-acting anticholinergic agents (SAAC, in particular ipratropium, became an efficient and safe first-line treatment, especially when combined with a short-acting beta2-adrenergic receptor agonist. Even better results were obtained when combining the SAAC ipratropium to a long-acting beta2-adrenergic receptor agonist (LABA, once they became available. Recently, tiotropium bromide, the first of a new class of selective and long-acting anticholinergic agents was introduced for once-daily maintenance treatment of COPD patients. Several large long-term randomised clinical trials comparing tiotropium to placebo as well as to the SAAC ipratropium and the LABA salmeterol, have confirmed the long-acting and superior bronchodilator effect of tiotropium without any evidence of drug tolerance developing. These studies also have clearly demonstrated that tiotropium positively affects several other important health outcomes, such as dyspnoea sensation, exercise capacity, utilisation of rescue bronchodilators, health-related quality of life, COPD exacerbations and hospitalisations because of exacerbations. The improvement in these real-life outcomes appears related to the reduction in both static and dynamic hyperinflation. In all these studies, tiotropium was well tolerated and safe; the only relevant side-effect encountered being dry mouth, usually mild and often transitory. Finally, it has been shown that the combination of tiotropium with a LABA affords superior bronchodilatation than both agents alone, indicating that both classes of long-acting bronchodilators should be

  3. Long-acting reversible contraceptives: intrauterine devices and the contraceptive implant.

    Science.gov (United States)

    Espey, Eve; Ogburn, Tony

    2011-03-01

    The provision of effective contraception is fundamental to the practice of women's health care. The most effective methods of reversible contraception are the so-called long-acting reversible contraceptives, intrauterine devices and implants. These methods have multiple advantages over other reversible methods. Most importantly, once in place, they do not require maintenance and their duration of action is long, ranging from 3 to 10 years. Despite the advantages of long-acting reversible contraceptive methods, they are infrequently used in the United States. Short-acting methods, specifically oral contraceptives and condoms, are by far the most commonly used reversible methods. A shift from the use of short-acting methods to long-acting reversible contraceptive methods could help reduce the high rate of unintended pregnancy in the United States. In this review of long-acting reversible contraceptive methods, we discuss the intrauterine devices and the contraceptive implant available in the United States, and we describe candidates for each method, noncontraceptive benefits, and management of complications.

  4. Effect of co-treatment with fluoxetine or mirtazapine and risperidone on the active behaviors and plasma corticosterone concentration in rats subjected to the forced swim test.

    Science.gov (United States)

    Rogóż, Zofia; Kabziński, Marcin; Sadaj, Witold; Rachwalska, Paulina; Gądek-Michalska, Anna

    2012-01-01

    Several clinical reports have postulated a beneficial effect of the addition of a low dose of risperidone to the ongoing treatment with antidepressants in treatment-resistant depression. The present study aimed to examine the effect of treatment with fluoxetine or mirtazapine, given separately or jointly with risperidone, on active behavior and plasma corticosterone level in male Wistar rats subjected to the forced swim test (FST). The obtained results showed that fluoxetine (5 mg/kg), mirtazapine (5 and 10 mg/kg) or risperidone (0.05 and 0.1 mg/kg) did not change the active behavior of rats in the FST. However, co-treatment with fluoxetine (10 mg/kg) and risperidone (0.1 mg/kg) induced an antidepressant-like effect in that test because it significantly increased the swimming time and decreased the immobility time, while combined treatment with mirtazapine at 5 and 10 mg/kg and risperidone at 0.05 and 0.1 mg/kg evoked a significant increase in the swimming time and also climbing, and decreased the immobility time. WAY 100635 (a 5-HT(1A) receptor antagonist) at a dose of 0.1 mg/kg inhibited the antidepressant-like effect induced by co-administration of fluoxetine or mirtazapine and risperidone. Active behavior in that test did not reflect an increase in general activity, since combined treatment with fluoxetine or mirtazapine and risperidone failed to enhance the exploratory activity of rats. Co-treatment with fluoxetine or mirtazapine and risperidone did not reduce the stress-induced increase in plasma corticosterone concentration in animals subjected to the FST. The obtained results indicate that risperidone applied in a low dose enhances the antidepressant-like activity of fluoxetine and mirtazapine in the FST (but does not normalize the stress-induced increase in corticosterone level in these rats), and that 5-HT(1A) receptors may play some role in these effects.

  5. Effect of switching to risperidone after unsuccessful treatment with aripiprazole on plasma monoamine metabolites level in the treatment of acute schizophrenia.

    Science.gov (United States)

    Miura, Itaru; Takeuchi, Satoshi; Katsumi, Akihiko; Kanno, Keiko; Watanabe, Kenya; Mashiko, Hirobumi; Niwa, Shin-Ichi

    2012-09-01

    In the treatment of acute schizophrenia, risperidone and aripiprazole are both placed the first line antipsychotics. These two antipsychotics have different pharmacological effects. We investigated the effects of risperidone on plasma levels of homovanillic acid (HVA) and 3-methoxy-4hydroxyphenylglycol after unsuccessful aripiprazole treatment in acute schizophrenia. Ten Japanese patients with acute schizophrenia were enrolled to this study. Plasma levels of monoamine metabolites were analyzed with high-performance liquid chromatography with electrochemical detection. Risperidone improved the symptoms and 4 of 10 patients were responders. Risperidone showed a tendency to decrease plasma HVA (pHVA) levels in responders (p = 0.068), but not in non-responders (p = 1.0). At baseline, pHVA levels of responders were significantly higher than that of non-responders (p = 0.033). A trend for negative correlation was found between pHVA at baseline and the changes in Positive and Negative Syndrome Scale-Total (p = 0.061, r = -0.61). Our results suggest that high pHVA level before switching may predict good response to the second line antipsychotics after unsuccessful first antipsychotic treatment. If aripiprazole is not effective in acute schizophrenia, switching to risperidone may be effective and reasonable strategy for improving symptoms. Copyright © 2012 John Wiley & Sons, Ltd.

  6. New Modified UPLC/Tandem Mass Spectrometry Method for Determination of Risperidone and Its Active Metabolite 9-Hydroxyrisperidone in Plasma: Application to Dose-Dependent Pharmacokinetic Study in Sprague-Dawley Rats

    Directory of Open Access Journals (Sweden)

    Essam Ezzeldin

    2017-01-01

    Full Text Available Sensitive and specific liquid-chromatography tandem mass spectrometry (UPLC-MS/MS assay has been developed and validated for simultaneous quantification of risperidone (RIS and its active metabolite 9-hydroxyrisperidone (9-OH-RIS in rat plasma using olanzapine (OLA as internal standard (IS. Pharmacokinetics of risperidone and its active metabolite 9-hydroxyrisperidone was compared across different doses (0.3, 1.0, and 6.0 mg/kg. Serial blood sample was collected over a time of 48 hours and analyzed for risperidone and its active metabolite 9-hydroxyrisperidone. The pharmacokinetics parameters including Cmax, tmax, and AUC were determined for risperidone and its active ingredient. The method was linear in the concentration range of 0.2–500 ng/mL for risperidone and 9-OH-risperidone, with coefficients of determination greater than 0.998 and lower limit of quantitation of 0.2 ng/mL. Blood levels of risperidone and its active metabolite were roughly dose-proportional. The method developed herein is simple and rapid and was successfully applied for dose-dependent pharmacokinetic study.

  7. Spotlight on once-monthly long-acting injectable aripiprazole and its potential as maintenance treatment for bipolar I disorder in adult patients

    Directory of Open Access Journals (Sweden)

    Torres-Llenza V

    2018-01-01

    Full Text Available Vanessa Torres-Llenza, Pooja Lakshmin, Daniel Z Lieberman Department of Psychiatry and Behavioral Sciences, George Washington University School of Medicine and Health Sciences, Washington, DC, USA Abstract: The lack of long-term medication adherence is a challenge in the treatment of bipolar disorder, particularly during the maintenance phase when symptoms are less prominent. The rate of nonadherence is ~20%–60% depending on how strict a definition is used. Nonadherence worsens the course of bipolar disorder and can add hundreds of thousands of dollars to the lifetime cost of treating the illness. Long-acting injectable (LAI medication is an attractive alternative to daily dosing of oral medication, especially among patients who are ambivalent about treatment. The purpose of this paper is to review the evidence for the safety and efficacy of LAI aripiprazole, which was recently approved for the treatment of bipolar disorder. The approval was based on a single double-blind, placebo-controlled, multisite trial that recruited participants from 103 sites in 7 countries. A total of 731 participants with bipolar disorder were enrolled in the study. Out of that total, 266 were successfully stabilized on LAI aripiprazole and entered the randomization phase. Treatment-emergent adverse events were, for the most part, mild to moderate. Akathisia was the most common adverse event, which, combined with restlessness, was experienced by 23% of the sample. At the end of the 52-week study period, nearly twice as many LAI-treated participants remained stable compared to those treated with placebo. Stability during the maintenance phase is arguably the most important goal of treatment. It is during this period of relative freedom from symptoms that patients are able to build a meaningful and satisfying life. The availability of a new treatment agent, particularly one that has the potential to enhance long-term adherence, is a welcome development. Keywords

  8. Long-term follow-up of high-pressure injection injuries to the hand

    NARCIS (Netherlands)

    Wieder, Anat; Lapid, Oren; Plakht, Ygal; Sagi, Amiram

    2006-01-01

    High-pressure injection injury is an injury caused by accidental injection of substances by industrial equipment. This injury may have devastating sequelae. The goal of this study was to assess the long-term outcome of high-pressure injection injury to the hand. In this historical prospective study,

  9. Dopamine transporter density assessed with [{sup 123}]IPT SPECT before and after risperidone treatment in children with tourette's disorder

    Energy Technology Data Exchange (ETDEWEB)

    Ryu, Young Hoon; Kim, Tae Hoon; Ryu, Won Gee [College of Medicine, Yonsei Univ., Seoul (Korea, Republic of)] [and others

    2004-02-01

    Tourette's disorder (TD), which is characterized by multiple waxing and waning motor tics and one or more vocal tics, is known to be associated with abnormalities in the dopaminergic system. To testify our hypothesis that risperidone would improve tic symptoms of TD patients through the change of the dopaminergic system, we measured the dopamine transporter (DAT) densities between drug-naive children with TD and normal children, and investigated the DAT density before and after treatment with risperidone in drug-naive children with TD, using iodine-123 labelled N-(3-iodopropen-2-yl)-2{beta}-carbomethoxy-3beta-(4-chlorophenyl)tropane ([{sup 123}I]IPT) single photon emission computed tomography (SPECT). [{sup 123I}]IPT SPECT imaging and Yale Global Tic Severity Scale-Korean version (YGTSS-K) for assessing the tic symptom severity were carried out before and after treatment with risperidone for 8 weeks in nine drug-naive children with TD. Eleven normal children also underwent SPECT imaging 2 hours after an intravenous administration of [{sup 123}I]IPT. Drug-naive children with TD had a significantly greater increase in the specific/nonspecific DAT binding ratio of both basal ganglia compared with the normal children. However, no significant difference in the specific/nonspecific DAT binding ratio of the basal ganglia before and after treatment with risperidone in children with TD was found, although tic symptoms were significantly improved with risperidone. These findings suggest that DAT densities are directly associated with the pathophysiology of TD, however, that the effect of risperidone on tic symptoms in children with TD is not attributed to the change of dopaminergic system.

  10. Risperidone and Divalproex Differentially Engage the Fronto-Striato-Temporal Circuitry in Pediatric Mania: A Pharmacological Functional Magnetic Resonance Imaging Study

    Science.gov (United States)

    Pavuluri, Mani N.; Passarotti, Alessandra M.; Fitzgerald, Jacklynn M.; Wegbreit, Ezra; Sweeney, John A.

    2012-01-01

    Objective: The current study examined the impact of risperidone and divalproex on affective and working memory circuitry in patients with pediatric bipolar disorder (PBD). Method: This was a six-week, double-blind, randomized trial of risperidone plus placebo versus divalproex plus placebo for patients with mania (n = 21; 13.6 [plus or minus] 2.5…

  11. The influence of risperidone on attentional functions in children and adolescents with attention-deficit/hyperactivity disorder and co-morbid disruptive behavior disorder.

    Science.gov (United States)

    Günther, Thomas; Herpertz-Dahlmann, Beate; Jolles, Jellemer; Konrad, Kerstin

    2006-12-01

    This study aims to examine the influence of risperidone on various attentional functions, including intensity and selectivity aspects of attention plus inhibitory control in children with attention deficit/hyperactivity disorder (ADHD) with co-morbid Disruptive Behavior Disorders (DBD) and normal IQ. Children with ADHD and DBD, aged 8-15 years, were treated with risperidone (mean daily dose: 1.5 mg; n = 23) and examined with three attentional paradigms before and after a 4-week treatment period. Age- and IQ-matched normal controls (n = 23) were also tested without medication on the same two occasions. No influence of the medication could be detected for any neuropsychological variable, neither as a positive enhancement nor as adverse side effects. However, clinical symptoms of ADHD and DBD assessed on the IOWA Conners Scale significantly improved after the 4-week treatment period. Divergent behavioral and cognitive effects of risperidone on ADHD symptoms were observed, with a significant reduction in behavioral symptoms, whereas no positive treatment effects were found on laboratory tasks of impulsivity. Thus, the cognitive effects of risperidone seem to differ from the cognitive effects of stimulant treatments in children with ADHD + DBD. However, no negative impact of risperidone was observed on attentional functions either, i.e., there was no slowing of cognitive speed.

  12. Different mechanisms of risperidone result in improved interpersonal trust, social engagement and cooperative behavior in patients with schizophrenia compared to trifluoperazine.

    Science.gov (United States)

    Tse, Wai Shing; Wong, Ann Siu Wah; Chan, Fu; Pang, Alfred Hin Tat; Bond, Alyson Jane; Chan, Chau Kiu Raymond

    2016-05-01

    Atypical antipsychotic treatment (e.g. risperidone) has been found to improve social functioning more than standard antipsychotic treatment. However, it is unclear which specific social behaviors are implicated in this improvement. The current study employed an interactive puzzle game to examine how social behaviors contribute to the improvement of social functioning by comparing patients receiving risperidone with those receiving trifluoperazine. Scores on the Positive and Negative Syndrome Scale, executive functioning, and social functioning were obtained from 24 patients with schizophrenia receiving either risperidone (n = 12) or trifluoperazine (n = 12), before their social behavior was measured in the interactive Tangrams Game. Immediately after the Tangrams Game, participants filled in two questionnaires measuring their interpersonal trust and rejection toward their game partner. Patients receiving risperidone showed more social engagement, cooperative behavior and interpersonal trust toward their game partners than those receiving trifluoperazine. Additional multivariate analysis of variance revealed that lower affiliative behavior was a function of positive symptoms; interpersonal trust had an impact on social engagement but executive functioning did not explain lower interpersonal trust or social disengagement. Improvement of social competence by risperidone might be related to the enhancement of both social behaviors and interpersonal trust as well as better symptom resolution. © 2016 The Authors. Psychiatry and Clinical Neurosciences © 2016 Japanese Society of Psychiatry and Neurology.

  13. Clozapine usage increases the incidence of pneumonia compared with risperidone and the general population: a retrospective comparison of clozapine, risperidone, and the general population in a single hospital over 25 months.

    Science.gov (United States)

    Stoecker, Zachary R; George, Wales T; O'Brien, Jeffrey B; Jancik, Jon; Colon, Eduardo; Rasimas, Joseph J

    2017-05-01

    The aim of this study was to determine whether the incidence of pneumonia in patients taking clozapine was more frequent compared with those taking risperidone or no atypical antipsychotics at all before admission to a tertiary care medical center. This was a retrospective, case-matched study of 465 general medicine patients over a 25 month period from 1 July 2010 to 31 July 2012. Detailed electronic medical records were analyzed to explore the association between the use of two atypical antipsychotics and incidence of pneumonia. Of the 155 patients in the clozapine group, 54 (34.8%) had documented pneumonia compared with 22 (14.2%) in the risperidone group and 18 (11.6%) in the general population group. Clozapine, when compared with the untreated general population, was associated with an increased risk of pneumonia (odds ratio=4.07; 95% confidence interval=2.25-7.36). There was, however, no significant increase in the risk of pneumonia associated with the use of risperidone (odds ratio=1.26; 95% confidence interval=0.65-2.45). Clozapine use is associated with increased risk of pneumonia that may be related to immunologic factors or side effects of sedation and drooling that make aspiration more likely, although causative mechanisms require further investigation. These findings suggest that providers should use added caution in choosing candidates for clozapine therapy.

  14. Long-acting beta(2)-agonists in management of childhood asthma

    DEFF Research Database (Denmark)

    Bisgaard, H

    2000-01-01

    This review assesses the evidence regarding the use of long-acting beta(2)-agonists in the management of pediatric asthma. Thirty double-blind, randomized, controlled trials on the effects of formoterol and salmeterol on lung function in asthmatic children were identified. Single doses of inhaled......, long-acting beta(2)-agonists provide effective bronchodilatation and bronchoprotection when used as intermittent, single-dose treatment of asthma in children, but not when used as regular treatment. Future studies should examine the positioning of long-acting beta(2)-agonists as an "as needed" rescue...... medication instead of short-acting beta(2)-agonists for pediatric asthma management....

  15. Long-acting rilpivirine as potential pre-exposure prophylaxis for HIV-1 prevention (the MWRI-01 study): an open-label, phase 1, compartmental, pharmacokinetic and pharmacodynamic assessment.

    Science.gov (United States)

    McGowan, Ian; Dezzutti, Charlene S; Siegel, Aaron; Engstrom, Jarret; Nikiforov, Alexiy; Duffill, Kathryn; Shetler, Cory; Richardson-Harman, Nicola; Abebe, Kaleab; Back, David; Else, Laura; Egan, Deidre; Khoo, Saye; Egan, James E; Stall, Ronald; Williams, Peter E; Rehman, Khaleel K; Adler, Amy; Brand, Rhonda M; Chen, Beatrice; Achilles, Sharon; Cranston, Ross D

    2016-12-01

    Long-acting injectable antiretroviral agents are being developed for HIV-1 prevention. The MWRI-01 study was done to characterise the safety, acceptability, and pharmacokinetic and pharmacodynamic profile of long-acting rilpivirine. We did a phase 1 open-label study at the University of Pittsburgh. We enrolled healthy individuals (aged 18-45 years) who were seronegative for HIV-1. Participants were assigned alternately one intramuscular dose of either 1200 mg or 600 mg long-acting rilpivirine, beginning with the 1200 mg dose. We obtained plasma specimens, genital and rectal fluids, and tissue samples (rectal, cervical, and vaginal) before and after exposure to long-acting rilpivirine for assessment of pharmacokinetics and ex-vivo biopsy challenge with HIV-1. Our primary objective was to characterise product safety, and the analysis included all enrolled participants. This trial is registered with ClinicalTrials.gov, number NCT01656018. 36 participants were enrolled into the study, of whom 24 were women and 12 men. 12 women and six men received each dose. 204 adverse events were reported among the 36 participants, of which 200 (98%) were grade 1-2. The most common adverse event was injection site reaction. All grade 3 and 4 adverse events were deemed not related to rilpivirine. Geometric mean (90% CI) concentrations in plasma of rilpivirine at day 28 post dose were 53 ng/mL (38-67) in women and 43 ng/mL (23-63) in men for the 1200 mg dose and 28 ng/mL (19-37) in women and 17 ng/mL (9-24) in men for the 600 mg dose. The tissue-to-plasma ratio for rilpivirine in rectal tissue was about two-fold higher than in vaginal and cervical tissue (1·10-1·53 vs 0·61-0·72 and 0·50-0·71, respectively). Exposure to long-acting rilpivirine suppressed viral replication significantly in rectal tissue (psuppression persisted for up to 4 months. By contrast, no viral suppression was seen in cervical or vaginal tissue. Ongoing research will characterise longer term safety and

  16. Risperidone for the core symptom domains of autism: results from the study by the autism network of the research units on pediatric psychopharmacology.

    Science.gov (United States)

    McDougle, Christopher J; Scahill, Lawrence; Aman, Michael G; McCracken, James T; Tierney, Elaine; Davies, Mark; Arnold, L Eugene; Posey, David J; Martin, Andrès; Ghuman, Jaswinder K; Shah, Bhavik; Chuang, Shirley Z; Swiezy, Naomi B; Gonzalez, Nilda M; Hollway, Jill; Koenig, Kathleen; McGough, James J; Ritz, Louise; Vitiello, Benedetto

    2005-06-01

    Risperidone has been found efficacious for decreasing severe tantrums, aggression, and self-injurious behavior in children and adolescents with autistic disorder (autism). The authors report on whether risperidone improves the core symptoms of autism, social and communication impairment and repetitive and stereotyped behavior. The database from an 8-week double-blind, placebo-controlled trial (N=101) and 16-week open-label continuation study (N=63) of risperidone for children and adolescents with autism was used to test for drug effects on secondary outcome measures: scores on the Ritvo-Freeman Real Life Rating Scale, the Children's Yale-Brown Obsessive Compulsive Scale, and the maladaptive behavior domain of the Vineland Adaptive Behavior Scales. Compared to placebo, risperidone led to a significantly greater reduction in the overall score on the Ritvo-Freeman Real Life Rating Scale, as well as the scores on the subscales for sensory motor behaviors (subscale I), affectual reactions (subscale III), and sensory responses (subscale IV). No statistically significant difference was observed, however, on the subscale for social relatedness (subscale II) or language (subscale V). Risperidone also resulted in significantly greater reductions in scores on the Children's Yale-Brown Obsessive Compulsive Scale and Vineland maladaptive behavior domain. This pattern of treatment response was maintained for 6 months. Risperidone led to significant improvements in the restricted, repetitive, and stereotyped patterns of behavior, interests, and activities of autistic children but did not significantly change their deficit in social interaction and communication. Further research is necessary to develop effective treatments for the core social and communicative impairments of autism.

  17. Memantine as adjunctive treatment to risperidone in children with autistic disorder: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Ghaleiha, Ali; Asadabadi, Mahtab; Mohammadi, Mohammad-Reza; Shahei, Maryam; Tabrizi, Mina; Hajiaghaee, Reza; Hassanzadeh, Elmira; Akhondzadeh, Shahin

    2013-05-01

    Autism is a neurodevelopmental disorder that causes significant impairment in socialization and communication. It is also associated with ritualistic and stereotypical behaviour. Recent studies propose both hyper-and hypoglutamatergic ideologies for autism. The objective of this study was to assess the effects of memantine plus risperidone in the treatment of children with autism. Children with autism were randomly allocated to risperidone plus memantine or placebo plus risperidone for a 10-wk, double-blind, placebo-controlled study. The dose of risperidone was titrated up to 3 mg/d and memantine was titrated to 20 mg/d. Children were assessed at baseline and after 2, 4, 6, 8 and 10 wk of starting medication protocol. The primary outcome measure was the irritability subscale of Aberrant Behavior Checklist-Community (ABC-C). Difference between the two treatment arms was significant as the group that received memantine had greater reduction in ABC-C subscale scores for irritability, stereotypic behaviour and hyperactivity. Eight side-effects were observed over the trial, out of the 25 side-effects that the checklist included. The difference between the two groups in the frequency of side-effects was not significant. The present study suggests that memantine may be a potential adjunctive treatment strategy for autism and it was generally well tolerated. This trial is registered with the Iranian Clinical Trials Registry (IRCT1138901151556N10; www.irct.ir).

  18. Comparison of olanzapine and risperidone in the EMBLEM Study: translation of randomized controlled trial findings into clinical practice.

    Science.gov (United States)

    Novick, Diego; Reed, Catherine; Haro, Josep Maria; Gonzalez-Pinto, Ana; Perrin, Elena; Aguado, Jaume; Tohen, Mauricio

    2010-09-01

    Data from the EMBLEM Study, a 2-year, prospective, observational study of health outcomes associated with acute treatment of patients experiencing a manic/mixed episode of bipolar disorder, was used to compare the effectiveness of olanzapine monotherapy versus risperidone monotherapy, and to investigate whether the treatment effects were similar to those reported in a 3-week, randomized controlled trial assessing the same treatments. Symptom severity measures included the Young Mania Rating Scale (YMRS), the 5-item Hamilton Depression Rating Scale, and the Clinical Global Impression-Bipolar Disorder Scale. A total of 245 EMBLEM inpatients were analyzed with YMRS >or=20: olanzapine (n=209), risperidone (n=36). Both the treatment groups had similar improvements in YMRS from baseline to 6 weeks, but there was a significantly greater improvement in 5-item Hamilton Depression Rating Scale in the olanzapine group. There was a similar improvement in Clinical Global Impression-Bipolar Disorder Scale in both the groups and the occurrence of treatment-emergent adverse events and weight gain did not differ between the treatment groups. The EMBLEM results partly support those of the randomized controlled trial, which suggests olanzapine and risperidone have similar improvements in mania but that olanzapine monotherapy may be more effective than risperidone monotherapy in the treatment of depressive symptoms associated with mania. Limitations include differences in study design, patient population, and length of follow-up.

  19. Movement disorders in elderly users of risperidone and first generation antipsychotic agents: a Canadian population-based study.

    Directory of Open Access Journals (Sweden)

    Irina Vasilyeva

    Full Text Available Despite concerns over the potential for severe adverse events, antipsychotic medications remain the mainstay of treatment of behaviour disorders and psychosis in elderly patients. Second-generation antipsychotic agents (SGAs; e.g., risperidone, olanzapine, quetiapine have generally shown a better safety profile compared to the first-generation agents (FGAs; e.g., haloperidol and phenothiazines, particularly in terms of a lower potential for involuntary movement disorders. Risperidone, the only SGA with an official indication for the management of inappropriate behaviour in dementia, has emerged as the antipsychotic most commonly prescribed to older patients. Most clinical trials evaluating the risk of movement disorders in elderly patients receiving antipsychotic therapy have been of limited sample size and/or of relatively short duration. A few observational studies have produced inconsistent results.A population-based retrospective cohort study of all residents of the Canadian province of Manitoba aged 65 and over, who were dispensed antipsychotic medications for the first time during the time period from April 1, 2000 to March 31, 2007, was conducted using Manitoba's Department of Health's administrative databases. Cox proportional hazards models were used to determine the risk of extrapyramidal symptoms (EPS in new users of risperidone compared to new users of FGAs.After controlling for potential confounders (demographics, comorbidity and medication use, risperidone use was associated with a lower risk of EPS compared to FGAs at 30, 60, 90 and 180 days (adjusted hazard ratios [HR] 0.38, 95% CI: 0.22-0.67; 0.45, 95% CI: 0.28-0.73; 0.50, 95% CI: 0.33-0.77; 0.65, 95% CI: 0.45-0.94, respectively. At 360 days, the strength of the association weakened with an adjusted HR of 0.75, 95% CI: 0.54-1.05.In a large population of elderly patients the use of risperidone was associated with a lower risk of EPS compared to FGAs.

  20. Celecoxib as adjunctive treatment to risperidone in children with autistic disorder: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Asadabadi, Mahtab; Mohammadi, Mohammad-Reza; Ghanizadeh, Ahmad; Modabbernia, Amirhossein; Ashrafi, Mandana; Hassanzadeh, Elmira; Forghani, Saeedeh; Akhondzadeh, Shahin

    2013-01-01

    Autism is associated with activation of the inflammatory response system. This study aims to assess the efficacy of a cyclooxygenase-2 inhibitor, celecoxib, as adjunctive therapy in the treatment of autism In a 10-week randomized double-blind placebo-controlled study, 40 outpatient children with a Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision clinical diagnosis of autism were randomly allocated to celecoxib plus risperidone or placebo plus risperidone. The dose of risperidone and celecoxib were titrated up to 3 and 300 mg/day, respectively. Patients were assessed at baseline and after 2, 4, 6, and 10 weeks of starting medication using the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale. Primary outcome measure was the change in irritability subscale of ABC-C. Significant time × treatment interaction was observed for Irritability (F (1.658, 63.021) = 13.580, P autism. (Registration, www.irct.ir ; IRCT138711091556N2).

  1. Why are US women not using long-acting contraceptives?

    Science.gov (United States)

    Tanfer, K; Wierzbicki, S; Payn, B

    2000-01-01

    Given the level of unintended pregnancy in the United States, it is somewhat surprising that hormonal implants and injectables-methods that are long-acting, reversible, highly effective and convenient--have not attained the popularity enjoyed by other medical methods. Knowing the reasons why women have so far spurned these methods might lead to the design and implementation of interventions and targeted social marketing to promote their use. Data from the 1993 and 1995 rounds of the National Survey of Women are used to examine the reasons women gave for not having used the implant or injectables, whether they intended to use these methods and how their attitudes toward them may influence their decision to use such methods in the future. Logistic regression models were used to identify the social and demographic characteristics that influence women's decisions not to use these methods. Fewer than 2% of women who were at risk of an unintended pregnancy in 1995 were using the implant, and under 3% were using the injectable. Women gave three major reasons for not using either of these methods: lack of knowledge; fear of side effects or health hazards; and satisfaction with the method they were currently using. Age, education, marital status, parity and current contraceptive method strongly predicted fear of side effects, lack of knowledge and satisfaction with the current method as reasons for not using the implant or the injectable. For example, women aged 30 or older and those with a college education were half as likely as younger women and those with no college education to mention fear of side effects as their main reason for not using the implant. Likewise, single women, women with one or more children and those using a barrier method were 2-3 times as likely as married women, childless women and those using a medical method to attribute nonuse to the implant's side effects. Few women said they intended to use these methods in the next 12 months: 5% for the

  2. Long-term continuous energy injection in the afterglow of GRB 060729

    International Nuclear Information System (INIS)

    Xu Ming; Huang Yongfeng; Lu Tan

    2009-01-01

    A long plateau phase and an amazing level of brightness have been observed in the X-ray afterglow of GRB 060729. This peculiar light curve is likely due to long-term energy injection in external shock. Here, we present a detailed numerical study of the energy injection process of magnetic dipole radiation from a strongly magnetized millisecond pulsar and model the multi-band afterglow observations. It is found that this model can successfully explain the long plateaus in the observed X-ray and optical afterglow light curves. The sharp break following the plateaus could be due to the rapid decline of the emission power of the central pulsar. At an even later time (∼ 5 x 10 6 s), an obvious jet break appears, which implies a relatively large half opening angle of θ ∼ 0.3 for the GRB ejecta. Due to the energy injection, the Lorentz factor of the outflow is still larger than two even at 10 7 s after the GRB trigger, making the X-ray afterglow of this burst detectable by Chandra even 642 d after the burst.

  3. Riboflavin laurate nanosuspensions as an intramuscular injection for long-term riboflavin supplementation.

    Science.gov (United States)

    Du, Lina; Li, Guanglong; Jin, Yiguang; Wang, Lin; Xu, Qishou; Dong, Junxing

    2013-06-25

    The aim of this study was to prepare riboflavin laurate (RFL) nanosuspensions as an intramuscular injection for long-term riboflavin supplementation. Stable RFL nanosuspensions were obtained by injecting RFL/poloxamer solution in N,N-dimethyl formamide into a trehalose solution. Long soft nanostructures initially appeared and then tube-like rigid nanostructures were obtained after removal of solvents according to the transmission electron microscopic images. The nanosuspensions had narrow size distribution and the mean size was about 300 nm. Molecular self-assembly of RFL may drive the formation of nanostructures. RFL formed a monolayer at the air/water interface and poloxamer 188 could insert into the monolayer. The nanosuspensions were intramuscularly injected into rats to provide long-term riboflavin supplementation for more than 30 days in light of body weight, food intake, and urinary riboflavin. The nanosuspensions were also used to resist the riboflavin deficiency induced by methotrexate chemotherapy. RFL nanosuspensions are a promising nanomedicine for long-term riboflavin supplementation. Copyright © 2013 Elsevier B.V. All rights reserved.

  4. No change of dopamine transporter density in basal ganglia after risperidone treatment in drug-naive children with Tourette's disorder

    International Nuclear Information System (INIS)

    Ryu, W. K.; Ryu, Y. H.; Yoon, M. J.; Chun, K. A.; Lee, J. D.; Zee, D. Y.; Choi, T. H.

    2003-01-01

    Tourette's disorder (TD), which is characterized by multiple waxing and waning motor tics and one or more vocal tics, is known to be associated with abnormalities in the dopaminergic system. To testify our hypothesis that risperidone would improve tic symptoms of TD patients through the change of the dopaminergic system, we measured the DAT densities between drug-naive children with TD and normal children investigated the DAT density before and after treatment with risperidone in drug-naive children with TD, using lodine-123 labelled N-(3-iodopropen-2-yl)-2beta-carbomethoxy-3beta-(4-chlorophenyl) tropane(I-123 IPT) single photon emission computed tomography (SPECT). I-123 IPT SPECT imaging and Yale Global Tic Severity Scale-Korean version (YGTSS-K) for assessing the tic symptom severity were carried out before and after treatment with risperidone for 8 weeks in eight drug-naive children with TD. Eight normal children also underwent SPECT imaging 2 hours after an intravenous administration of I-123 IPT and carried out both quantitative and qualitative analyses using the obtained SPECT data, which were reconstructed for the assessment of the specific/non-specific DAT binding ratio in the basal ganglia. The drug-naive children with TD had a significantly greater increase in the specific/nonspecific DAT binding ratio of both basal ganglia compared with the normal children. However, no significant difference in the specific/nonspecific DAT binding ratio of the basal ganglia before and after treatment with riperidone in children with TD was not found, although tic symptoms were significantly improved with risperidone. These findings suggest that DAT densities are directly associated with the pathophysiology of TD, however, that the effect of risperidone on tic symptoms in children with TD is not attributed to the change of dopaminergic system

  5. Bioequivalence study of a generic Risperidone (Iperdal® in healthy Thai male volunteers

    Directory of Open Access Journals (Sweden)

    Werawath Mahatthanatrakul

    2008-05-01

    Full Text Available The objective of this study was to compare the rate and extent of absorption of a generic risperidone (Iperdal® with a reference formulation (Risperdal® when given orally. The study was an open label, randomized, two-period, two-sequence,single dose cross-over design with a 2 weeks washout period in 16 healthy Thai male volunteers. Single oral dose of two 2-mg tablets of risperidone were administered and serial blood samples were collected from the antecubital vein before and at0.17, 0.33, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 and 48 hours post dose. Risperidone plasma concentrations were assayed using a validated High Performance Liquid Chromatographic (HPLC-UV method modified from Avenosoet al. (2000. Pharamcokinetic parameters i.e. Cmax, AUC0à48 and Tmax were analyzed by noncompartment analysis. Variations of the data were analyzed by “Two Way Analysis of Variance” (ANOVA. Statistics were tested as stated in USP 28 guidelinefor bioequivalence study. The maximum concentration (Cmax, ng/ml of risperidone for the innovator and the generic product were 31.11±17.24 (range 5.64-56.78 and 32.58±19.77 (range 5.29-84.56 ng/ml, respectively. The area under theplasma concentration-time curve (AUC0®48 of the innovator and the generic product were 160.64±152.89 (range 18.57- 550.32 and 144.03±127.37 (range 16.27-456.0 ng.hr/ml, respectively. The time to maximum concentration (Tmax of theinnovator and the generic product were 0.97±0.41(range 0.5-2 and 1.02±0.32 (range 0.5-1.5 hr, respectively. The 90% confidence interval of the ratio of the ln-transformed of Cmax and AUC0à48 of both preparations were 89.39-112.99% and80.02-107.28% respectively which were within the acceptance range of 80.00-125.00%. Therefore, it can be concluded that both preparations used in this study are bioequivalent in terms of both the rate and extent of absorption.

  6. Risperidone in Children and Adolescents with Conduct Disorder: A Single-Center, Open-Label Study

    OpenAIRE

    Ercan, Eyüp Sabri; Kutlu, Ayşe; Çıkoğlu, Sibel; Veznedaroğlu, Baybars; Erermiş, Serpil; Varan, Azmi

    2003-01-01

    Background: Risperidone is one of the most commonly used atypical antipsychotic drugs in the treatment of children and adolescents. However, the data about its use in children and adolescents with conduct disorder (CD) are limited.

  7. A comparison of risperidone and haloperidol for the risk of ischemic stroke in the elderly: a propensity score-matched cohort analysis.

    Science.gov (United States)

    Shin, Ju-Young; Choi, Nam-Kyong; Lee, Joongyub; Park, Mi-Ju; Lee, Shin Haeng; Park, Byung-Joo

    2015-08-01

    With an increase in antipsychotic use in the elderly, the safety profile of antipsychotics has been emphasized. Strong concerns have been raised about whether the risk of ischemic stroke differs between risperidone and haloperidol. This study compared the risk of ischemic stroke between elderly patients taking risperidone and haloperidol. We conducted a retrospective cohort study using the Korea Health Insurance Review and Assessment Service database, applying a propensity-matched analysis. The cohort consisted of elderly patients who were newly prescribed haloperidol or risperidone between January 1, 2006 and December 31, 2009. Patients with prior cerebrovascular diseases (ICD-10, I60-I69), transient ischemic attack (ICD-10, G45), or cerebral tumors (ICD-10, C31) during 365 days prior to the initiation date were excluded. The study subjects were selected by propensity score matching. The outcome was defined as the first hospitalization for ischemic stroke (ICD-10, I63). Cox regression models were used to estimate the hazard ratio (HR) and 95% confidence intervals (95% CI) for ischemic stroke with haloperidol compared with risperidone use. A total of 14,103 patients were included in the propensity-matched cohort for each drug. Overall, the incidence rate was higher for haloperidol users compared to the risperidone users (6.43 per 1000 person-years vs. 2.88 per 1000 person-years). A substantially increased risk was observed in haloperidol users (adjusted HR = 2.02, 95% CI, 1.12-3.62). The evidence showed that haloperidol should be prescribed in the elderly with caution. © The Author(s) 2015.

  8. The effect of combined treatment with risperidone and antidepressants on the MK-801-induced deficits in the social interaction test in rats.

    Science.gov (United States)

    Kamińska, Katarzyna; Rogóż, Zofia

    2015-12-01

    Several clinical reports have suggested that augmentation of atypical antipsychotics' activity by antidepressants may efficiently improve the treatment of negative and some cognitive symptoms of schizophrenia. The aim of the present study was to investigate the effect of antidepressant mirtazapine or escitalopram and risperidone (an atypical antipsychotic), given separately or jointly, on the MK-801-induced deficits in the social interaction test in rats. Antidepressants and risperidone were given 60 and 30 min before the test, respectively. The social interaction of male Wistar rats was measured for 10 min, starting 4 h after MK-801 (0.1 mg/kg) administration. In the social interaction test, MK-801-induced deficits in the parameters studied, i.e. the number of episodes and the time of interactions. Risperidone at a higher dose (0.1 mg/kg) reversed that effect. Co-treatment with an ineffective dose of risperidone (0.01 mg/kg) and mirtazapine (2.5 or 5 mg/kg) or escitalopram only at a dose of 5 mg/kg (but not 2.5 and 10 mg/kg) abolished the deficits evoked by MK-801. The obtained results suggest that especially mirtazapine, and to a smaller degree escitalopram may enhance the antipsychotic-like effect of risperidone in the animal test modeling some negative symptoms of schizophrenia. Copyright © 2015 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

  9. Risperidone-induced type 2 diabetes presenting with diabetic ketoacidosis

    Directory of Open Access Journals (Sweden)

    Clarissa Ern Hui Fang

    2018-05-01

    Full Text Available A 28-year-old male presented with 2 days of vomiting and abdominal pain, preceded by 2 weeks of thirst, polyuria and polydipsia. He had recently started risperidone for obsessive-compulsive disorder. He reported a high dietary sugar intake and had a strong family history of type 2 diabetes mellitus (T2DM. On admission, he was tachycardic, tachypnoeic and drowsy with a Glasgow Coma Scale (GCS of 10/15. We noted axillary acanthosis nigricans and obesity (BMI 33.2 kg/m2. Dipstick urinalysis showed ketonuria and glycosuria. Blood results were consistent with diabetic ketoacidosis (DKA, with hyperosmolar state. We initiated our DKA protocol, with intravenous insulin, fluids and potassium, and we discontinued risperidone. His obesity, family history of T2DM, acanthosis nigricans and hyperosmolar state prompted consideration of T2DM presenting with ‘ketosis-prone diabetes’ (KPD rather than T1DM. Antibody markers of beta-cell autoimmunity were subsequently negative. Four weeks later, he had modified his diet and lost weight, and his metabolic parameters had normalised. We reduced his total daily insulin dose from 35 to 18 units and introduced metformin. We stopped insulin completely by week 7. At 6 months, his glucometer readings and glycated haemoglobin (HbA1c level had normalised.

  10. Effects of risperidone on core symptoms of autistic disorder based on childhood autism rating scale: an open label study.

    Science.gov (United States)

    Ghaeli, Padideh; Nikvarz, Naemeh; Alaghband-Rad, Javad; Alimadadi, Abbas; Tehrani-Doost, Mehdi

    2014-01-01

    The aim of the present study was to evaluate the effect of risperidone in patients afflicted by autistic disorder especially with regards to its three core symptoms, including "relating to others", "communication skills", and "stereotyped behaviors" based on Childhood Autism Rating Scale (CARS). An 8-week open-label study of risperidone for treatment of autistic disorder in children 4-17 years old was designed. Risperidone dose titration was as follow: 0.02 mg/kg/day at the first week, 0.04 mg/kg/day at the second week, and 0.06 mg/kg/day at the third week and thereafter. The outcome measures were scores obtained by CARS, Aberrant Behavior Checklist (ABC), and Clinical Global Impression-Improvement (CGI-I) scale. Fifteen patients completed this study. After 8 weeks, CARS total score decreased significantly, (P=0.001). At the end of the study, social interactions and verbal communication skills of the patients were significantly improved (Pautistic disorder.

  11. Efficacy of Oral Risperidone, Haloperidol, or Placebo for Symptoms of Delirium Among Patients in Palliative Care: A Randomized Clinical Trial.

    Science.gov (United States)

    Agar, Meera R; Lawlor, Peter G; Quinn, Stephen; Draper, Brian; Caplan, Gideon A; Rowett, Debra; Sanderson, Christine; Hardy, Janet; Le, Brian; Eckermann, Simon; McCaffrey, Nicola; Devilee, Linda; Fazekas, Belinda; Hill, Mark; Currow, David C

    2017-01-01

    Antipsychotics are widely used for distressing symptoms of delirium, but efficacy has not been established in placebo-controlled trials in palliative care. To determine efficacy of risperidone or haloperidol relative to placebo in relieving target symptoms of delirium associated with distress among patients receiving palliative care. A double-blind, parallel-arm, dose-titrated randomized clinical trial was conducted at 11 Australian inpatient hospice or hospital palliative care services between August 13, 2008, and April 2, 2014, among participants with life-limiting illness, delirium, and a delirium symptoms score (sum of Nursing Delirium Screening Scale behavioral, communication, and perceptual items) of 1 or more. Age-adjusted titrated doses of oral risperidone, haloperidol, or placebo solution were administered every 12 hours for 72 hours, based on symptoms of delirium. Patients also received supportive care, individualized treatment of delirium precipitants, and subcutaneous midazolam hydrochloride as required for severe distress or safety. Improvement in mean group difference of delirium symptom score (severity range, 0-6) between baseline and day 3. Five a priori secondary outcomes: delirium severity, midazolam use, extrapyramidal effects, sedation, and survival. Two hundred forty-seven participants (mean [SD] age, 74.9 [9.8] years; 85 women [34.4%]; 218 with cancer [88.3%]) were included in intention-to-treat analysis (82 receiving risperidone, 81 receiving haloperidol, and 84 receiving placebo). In the primary intention-to-treat analysis, participants in the risperidone arm had delirium symptom scores that were significantly higher than those among participants in the placebo arm (on average 0.48 Units higher; 95% CI, 0.09-0.86; P = .02) at study end. Similarly, for those in the haloperidol arm, delirium symptom scores were on average 0.24 Units higher (95% CI, 0.06-0.42; P = .009) than in the placebo arm. Compared with placebo, patients in both

  12. Young women's attitudes towards, and experiences of, long-acting reversible contraceptives.

    Science.gov (United States)

    Bracken, Jennifer; Graham, Cynthia A

    2014-08-01

    To identify factors involved in women's decisions to choose particular contraceptive methods and more specifically, incentives and disincentives to use three long-acting reversible contraceptive (LARC) methods: injectables, implants, and intrauterine devices/systems (IUDs/IUSs). A total of 502 women aged 18 to 30 completed a cross-sectional online questionnaire. The three most important factors in choosing a contraceptive method were: high efficacy at preventing pregnancy, protection against sexually transmitted infections, and non-interference with sexual intercourse. The most common incentives for LARC use were the high efficacy and long duration of action. Disincentives included the possibility of irregular bleeding and concerns about effects on fertility; fear of needles and pain was a particular disincentive for IUD/IUS use. Only 93 (18%) of the participants reported ever having used a LARC. Reported disincentives to LARC use (e.g., concern about effects on future fertility) indicated that many young women hold inaccurate beliefs about these methods. The relatively high proportions of women who held neutral attitudes about LARCs (21-40%, depending on the method) highlight the importance of education and contraceptive counselling to improve knowledge about the advantages of these methods.

  13. A Pilot Study of Cultural/Racial Differences in Patient Perspectives on Long-Acting Injectable Antipsychotics for the Treatment of Schizophrenia.

    Science.gov (United States)

    Potkin, Steven G; Bera, Rimal; Eramo, Anna; Lau, Gina

    Long-acting injectable (LAI) antipsychotics improve treatment outcomes in patients with schizophrenia but are often reserved for only the most severely affected or nonadherent. Studies show cultural/racial differences in prescribing. This pilot study examined prescriber-patient interactions and cultural/racial differences in perceptions of LAIs among patients. A linguist analyzed 120 prescriber-patient conversations representing selected patient cultural/racial subgroups (European American, African American, Latino American; n=40 each) to identify similarities and differences in conceptualization and attitudes toward LAIs. Of 35 LAI-naive patients offered LAIs, 9% (3/35) responded favorably, 46% (16/35) were neutral/passive, and 46% (16/35) had concerns or viewed LAIs as unfavorable. Among LAI-naive patients, favorable or neutral/passive responses were reported for 50% (7/14) of European Americans, 63% (10/16) of African Americans, and 40% (2/5) of Latino Americans. The majority of LAI-naive patients (57% [20/35]) accepted LAI prescriptions, including 53% (17/32) of those who initially were neutral/passive or refused treatment (European American, 42% [5/12]; African American, 53% [8/15]; Latino American, 80% [4/5]). Fifty-seven percent (68/120) of patients expressed treatment goals. Goals of positive/negative symptom control were associated with positive attitudes toward LAIs while patients with goals focused on control of anxiety and insomnia tended to have negative attitudes toward LAIs. Latino-American patients who expressed treatment goals seemed more focused on discomfort control (67% [12/18]); goals of European Americans and African Americans were more equally distributed. Equal numbers of LAI-naive patients had unfavorable/concerned or neutral/passive attitudes toward treatment; relatively few patients responded favorably. The limited sample size precludes cultural/racial-specific conclusions.

  14. Decision-tree model for health economic comparison of two long-acting somatostatin receptor ligand devices in France, Germany, and the UK.

    Science.gov (United States)

    Marty, Rémi; Roze, Stéphane; Kurth, Hannah

    2012-01-01

    Long-acting somatostatin receptor ligands (SRL) with product-specific formulation and means of administration are injected periodically in patients with acromegaly and neuroendocrine tumors. A simple decision-tree model aimed at comparing cost savings with ready-to-use Somatuline Autogel(®) (lanreotide) and Sandostatin LAR(®) (octreotide) for the UK, France, and Germany. The drivers of cost savings studied were the reduction of time to administer as well as a reduced baseline risk of clogging during product administration reported for Somatuline Autogel(®). The decision-tree model assumed two settings for SRL administration, ie, by either hospital-based or community-based nurses. In the case of clogging, the first dose was assumed to be lost and a second injection performed. Successful injection depended on the probability of clogging. Direct medical costs were included. A set of scenarios were run, varying the cost drivers, such as the baseline risk of clogging, SRL administration time, and percentage of patients injected during a hospital stay. Costs per successful injection were less for Somatuline Autogel(®)/Depot, ranging from Euros (EUR) 13-45, EUR 52-108, and EUR 127-151, respectively, for France, Germany, and the UK. The prices for both long-acting SRL were the same in France, and cost savings came to 100% from differences other than drug prices. For Germany and the UK, the proportion of savings due to less clogging and shorter administration time was estimated to be around 32% and 20%, respectively. Based on low and high country-specific patient cohort size estimations of individuals eligible for SRL treatment among the patient population with acromegaly and neuroendocrine tumors, annual savings were estimated to be up to EUR 2,000,000 for France, EUR 6,000,000 for Germany, and EUR 7,000,000 for the UK. This model suggests that increasing usage of the Somatuline device for injection of SRL might lead to substantial savings for health care providers

  15. [Early hypertrophic scar after surgery on the nasal region: value of long-acting corticosteroid injections].

    Science.gov (United States)

    Amici, J-M

    2014-01-01

    "Pincushioning" is a complication of post-surgical scarring following use of transposition flaps particularly when surgery is performed on the nasal region. The transposition flap technique is very useful for the repair of certain defects of the tip of the nose, the medial canthus or of the ala nasi. The aim of this study is to define the clinical characteristics of this scarring dystrophy, which we propose to call "early hypertrophy scarring", to clarify the nature thereof and to assess the efficacy of intralesional injection of corticosteroids at the first signs of hypertrophy. A prospective, open, non-comparative, single-centre study examined the clinical and histological characteristics of early hypertrophy scarring and the effectiveness of therapy with one or two injections of corticosteroids performed on the 15th day post-operatively and optionally repeated at D45 depending on the outcome. From January 2011 to January 2013, 12 consecutive patients with early hypertrophy scarring were included (ten men and two women - mean age: 64 years). All had undergone surgery for basal cell carcinoma under local anaesthesia with one-stage repair by means of a rhombic flap or a bilobed flap located in the nasal area. Scars were injected strictly intra-lesionally with triamcinolone acetate (40 mg/1 mL) until whitening occurred. A single injection was performed in three cases of rhombic flap while a second injection was given at D45 in the remaining nine cases. Complete regression of the early hypertrophy scarring was obtained in ten of the 12 patients by D90. Incomplete regression was observed but with a marked improvement in the other two patients. Early hypertrophy scarring is distinguished by its clinical characteristics of hypertrophic or keloid scars. Biopsy performed in two cases showed the fibrous but non-fatty nature of early hypertrophy scarring. Biomechanical factors particular to the nasal region and the transposition flap technique could account for the early

  16. Neuropathic Pain Following Poly-L-Lactic Acid (Sculptra) Injection.

    Science.gov (United States)

    Vrcek, Ivan; El-Sawy, Tarek; Chou, Eva; Allen, Theresa; Nakra, Tanuj

    Injectable fillers have become a prevalent means of facial rejuvenation and volume expansion. While typically well tolerated, serious complications have been reported. The authors present a case in which an otherwise healthy female with a history of multiple filler injections including poly-L-lactic acid, developed 3 weeks of neuropathic pain in the left temporal fossa following injection. To the best of the authors knowledge, neuropathic pain has not been reported as a complication following poly-L-lactic acid injection. The patient was treated with an injection of steroid and long-acting anesthetic with resolution of symptoms.

  17. Determinants of long acting and permanent contraceptive methods ...

    African Journals Online (AJOL)

    Introduction: In Ethiopia information on the level of utilization of the long term and ... determinant factors of long acting and permanent contraceptive methods use ... number of live children (AOR = 2.42, 95% CI: 1.46- 4.02), joint fertility related ...

  18. Clinical and pharmacokinetic evaluation of risperidone for the management of autism spectrum disorder

    NARCIS (Netherlands)

    Dinnissen, Mariken; Dietrich, Andrea; van den Hoofdakker, Barbara J.; Hoekstra, Pieter J.

    Introduction: Autism spectrum disorder (ASD) is a neurodevelopmental disorder that is often accompanied by psychiatric comorbidity. Although there is no medication currently available to treat the core symptoms of ASD, risperidone was the first drug to be approved for use in ASD and is still the

  19. Determinants of long acting and permanent contraceptive methods ...

    African Journals Online (AJOL)

    Introduction: in Ethiopia information on the level of utilization of the long-term and ... determinant factors of long-acting and permanent contraceptive methods use ... 95% CI: 1.46- 4.02), joint fertility related decision (AOR = 6.11, 95% CI: 2.29- ...

  20. Comparison of two long acting pre-lambing anthelmintic treatments on the productivity of ewes in low body condition.

    Science.gov (United States)

    Bingham, C; Hodge, A; Mariadass, B

    2017-05-01

    To determine if there was a benefit from treating ewes with a low body condition score (BCS) with long acting anthelmintic products pre-lambing and to compare the effects of two commonly used treatment options. The study was conducted on a single commercial hill country sheep and beef property in the central North Island of New Zealand. Mixed age twin-bearing ewes were preselected by the farmer as being in poor condition 4 weeks before the planned start of lambing, and were sequentially drafted into three equal groups identified with coloured ear tags. The negative control group (n=199) received no anthelmintic treatment; the other two groups received either a controlled release capsule (CRC) containing abamectin, albendazole, Se and Co (n=200) or a long-acting injection of moxidectin (n=200). All ewes were body condition scored (1-5 scale) and weighed at pre-lambing, docking (65 days after treatment) and at weaning (127 days after treatment). Faecal nematode egg counts (FEC) were carried out on 10 ewes from each group at these three times. Most lambs were matched to the ewe treatment groups at weaning, and weighed. At weaning the mean body weight of ewes treated with moxidectin was 3.2 (95% CI=2.3-4.3) kg heavier than controls, and of ewes treated with CRC was 3.6 (95% CI=2.5-4.5) kg heavier than control ewes (pewes had a BCS≥3. At weaning, more ewes treated with CRC (140/194; 72%) or moxidectin (122/187; 65%) had a BCS≥3 than control ewes (55/179 (31%); pewes from the treatment groups, the mean weight at weaning of lambs from ewes treated with moxidectin was 2.6 (95% CI=1.9-3.3) kg heavier, and from ewes treated with CRC was 2.6 (95% CI=1.9-3.4) kg heavier than lambs from control ewes (pewes with low BCS pre-lambing with long acting anthelmintic treatments (moxidectin long acting injection or CRC) resulted in an increase in mean body weight of the ewes and lambs at weaning. There were no significant differences between the two pre-lambing treatments used

  1. Tic Reduction with Risperidone Versus Pimozide in a Randomized, Double-Blind, Crossover Trial

    Science.gov (United States)

    Gilbert, Donald L.; Batterson, J. Robert; Sethuraman, Gopalan; Sallee, Floyd R.

    2004-01-01

    Objective: To compare the tic suppression, electrocardiogram (ECG) changes, weight gain, and side effect profiles of pimozide versus risperidone in children and adolescents with tic disorders. Method: This was a randomized, double-blind, crossover (evaluable patient analysis) study. Nineteen children aged 7 to 17 years with Tourette's or chronic…

  2. Long-acting beta 2-agonists in chronic obstructive pulmonary disease.

    Science.gov (United States)

    Llewellyn-Jones, Carol

    2002-01-01

    Until recently, the use of long-acting beta 2-agonists in chronic obstructive pulmonary disease has been understated. There is now evidence that they may offer benefits beyond bronchodilation. This article reviews the management of chronic obstructive pulmonary disease and looks at the place of long-acting beta 2-agonists as a first-line treatment option.

  3. Linking instantaneous rate of injection to X-ray needle lift measurements for a direct-acting piezoelectric injector

    International Nuclear Information System (INIS)

    Viera, Juan P.; Payri, Raul; Swantek, Andrew B.; Duke, Daniel J.; Sovis, Nicolas; Kastengren, Alan L.; Powell, Christopher F.

    2016-01-01

    Highlights: • A direct-acting prototype diesel injector is utilized to control needle lift. • The effects of partial needle lift on rate of injection are analyzed. • Time-resolved needle lift is measured from fast phase-contrast X-ray images. • The link between instantaneous needle lift and rate of injection is analyzed. - Abstract: Internal combustion engines have been and still are key players in today’s world. Ever increasing fuel consumption standards and the ongoing concerns about exhaust emissions have pushed the industry to research new concepts and develop new technologies that address these challenges. To this end, the diesel direct injection system has recently seen the introduction of direct-acting piezoelectric injectors, which provide engineers with direct control over the needle lift, and thus instantaneous rate of injection (ROI). Even though this type of injector has been studied previously, no direct link between the instantaneous needle lift and the resulting rate of injection has been quantified. This study presents an experimental analysis of the relationship between instantaneous partial needle lifts and the corresponding ROI. A prototype direct-acting injector was utilized to produce steady injections of different magnitude by partially lifting the needle. The ROI measurements were carried out at CMT-Motores Térmicos utilizing a standard injection rate discharge curve indicator based on the Bosch method (anechoic tube). The needle lift measurements were performed at the Advanced Photon Source at Argonne National Laboratory. The analysis seeks both to contribute to the current understanding of the influence that partial needle lifts have over the instantaneous ROI and to provide experimental data with parametric variations useful for numerical model validations. Results show a strong relationship between the steady partial needle lift and the ROI. The effect is non-linear, and also strongly dependent on the injection pressure. The

  4. No change of dopamine transporter density in basal ganglia after risperidone treatment in drug-naive children with Tourette's disorder

    Energy Technology Data Exchange (ETDEWEB)

    Ryu, W. K.; Ryu, Y. H.; Yoon, M. J.; Chun, K. A.; Lee, J. D. [College of Medicine, Univ. of Yonsei, Seoul (Korea, Republic of); Zee, D. Y. [Univ. of Inhwa, Incheon (Korea, Republic of); Choi, T. H. [Korea Cancer Center Hospital, Seoul (Korea, Republic of)

    2003-07-01

    Tourette's disorder (TD), which is characterized by multiple waxing and waning motor tics and one or more vocal tics, is known to be associated with abnormalities in the dopaminergic system. To testify our hypothesis that risperidone would improve tic symptoms of TD patients through the change of the dopaminergic system, we measured the DAT densities between drug-naive children with TD and normal children investigated the DAT density before and after treatment with risperidone in drug-naive children with TD, using lodine-123 labelled N-(3-iodopropen-2-yl)-2beta-carbomethoxy-3beta-(4-chlorophenyl) tropane(I-123 IPT) single photon emission computed tomography (SPECT). I-123 IPT SPECT imaging and Yale Global Tic Severity Scale-Korean version (YGTSS-K) for assessing the tic symptom severity were carried out before and after treatment with risperidone for 8 weeks in eight drug-naive children with TD. Eight normal children also underwent SPECT imaging 2 hours after an intravenous administration of I-123 IPT and carried out both quantitative and qualitative analyses using the obtained SPECT data, which were reconstructed for the assessment of the specific/non-specific DAT binding ratio in the basal ganglia. The drug-naive children with TD had a significantly greater increase in the specific/nonspecific DAT binding ratio of both basal ganglia compared with the normal children. However, no significant difference in the specific/nonspecific DAT binding ratio of the basal ganglia before and after treatment with riperidone in children with TD was not found, although tic symptoms were significantly improved with risperidone. These findings suggest that DAT densities are directly associated with the pathophysiology of TD, however, that the effect of risperidone on tic symptoms in children with TD is not attributed to the change of dopaminergic system.

  5. Risperidone treatment for ADHD in children and adolescents with bipolar disorder

    OpenAIRE

    Biederman, Joseph

    2008-01-01

    Joseph Biederman, Paul Hammerness, Robert Doyle, Gagan Joshi, Megan Aleardi, Eric MickPediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston, MA, USAObjective: Children and adolescents with bipolar disorder are also at high risk of having comorbid attention-deficit hyperactivity disorder (ADHD). The objective of this study was to estimate improvement in ADHD symptoms in children with bipolar disorder.Methods: This was an open-label, study of risperidone monot...

  6. Different effects of paliperidone and risperidone therapy on blood lipid and Hcy metabolism as well as endocrine hormones in patients with schizophrenia

    OpenAIRE

    Bei-Fang Fan; Ze-Hui Li; Shuo Yang; Cai-Hong Gao

    2017-01-01

    Objective: To explore the different effects of paliperidone and risperidone therapy on blood lipid and Hcy metabolism as well as endocrine hormones in patients with schizophrenia. Methods: A total of 118 patients with schizophrenia who were treated in the hospital between December 2014 and February 2017 were collected as the research subjects and divided into control group and study group by random number table, each group with 59 cases. Control group received risperidone thera...

  7. Frequency of Extrapyramidal Adverse Reactions in Schizophrenic Outpatients Treated with Risperidone, Olanzapine, Quetiapine or Haloperidol : Results of the EIRE Study.

    Science.gov (United States)

    Bobes, Julio; Rejas, J; Garcia-Garcia, M; Rico-Villademoros, F; García-Portilla, M P; Madrigal, M; Hernández, G

    2002-09-01

    The EIRE (Estudio de Investigaciön de Resultados en Esquizofrenia - Outcomes Research Study in Schizophrenia) study was initiated in order to assess the frequency of adverse reactions [extrapyramidal symptoms (EPS), hyperprolactinaemia, sexual dysfunction and weight gain] caused by atypical antipsychotics and haloperidol in patients with schizophrenia during routine treatment in clinical practice. This paper presents the results of the assessment of extrapyramidal adverse reactions. Outpatients diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of mental disorders, 4th edition (DSM-IV), criteria and receiving a single antipsychotic (risperidone, olanzapine, quetiapine or haloperidol) for at least 4 weeks were consecutively recruited. In this cross-sectional and non-interventional study data were collected in a single visit; this included demographic and clinical characteristics, current antipsychotic and concomitant treatment, and data on several adverse effects listed in a modified version of the UKU (Udvalg for Kliniske Undersogelser - Committee on Clinical Investigations) scale. For paired comparisons of the frequency of adverse reactions between treatments the Chi-squared (χ 2 ) test was used. For estimation of the risk of a given adverse reaction with a given treatment a logistic regression method was used. 636 evaluable patients (of 669 recruited) were assessed. The frequency of EPS with haloperidol (78.3% of the cases) was higher than with risperidone (55.1%), quetiapine (39.5%) and olanzapine (35.8%) [χ 2 : p < 0.05], and the difference between risperidone and olanzapine was also statistically significant (χ 2 : p < 0.05). Very similar results were obtained in the individualised analysis of the items as regards the occurrence of akathisia, which was also more frequent in the haloperidol (36.8%) and risperidone (19.7%) groups than in the olanzapine (11.4%) and quetiapine (2.6%) groups (χ 2 : p < 0.05). Olanzapine, quetiapine

  8. Anti-depressive effectiveness of olanzapine, quetiapine, risperidone and ziprasidone: a pragmatic, randomized trial

    Directory of Open Access Journals (Sweden)

    Løberg Else-Marie

    2011-08-01

    Full Text Available Abstract Background Efficacy studies indicate anti-depressive effects of at least some second generation antipsychotics (SGAs. The Bergen Psychosis Project (BPP is a 24-month, pragmatic, industry-independent, randomized, head-to-head comparison of olanzapine, quetiapine, risperidone and ziprasidone in patients acutely admitted with psychosis. The aim of the study is to investigate whether differential anti-depressive effectiveness exists among SGAs in a clinically relevant sample of patients acutely admitted with psychosis. Methods Adult patients acutely admitted to an emergency ward for psychosis were randomized to olanzapine, quetiapine, risperidone or ziprasidone and followed for up to 2 years. Participants were assessed repeatedly using the Positive and Negative Syndrome Scale - Depression factor (PANSS-D and the Calgary Depression Scale for Schizophrenia (CDSS. Results A total of 226 patients were included. A significant time-effect showing a steady decline in depressive symptoms in all medication groups was demonstrated. There were no substantial differences among the SGAs in reducing the PANSS-D score or the CDSS sum score. Separate analyses of groups with CDSS sum scores > 6 or ≤6, respectively, reflecting degree of depressive morbidity, revealed essentially identical results to the primary analyses. There was a high correlation between the PANSS-D and the CDSS sum score (r = 0.77; p Conclusions There was no substantial difference in anti-depressive effectiveness among olanzapine, quetiapine, risperidone or ziprasidone in this clinically relevant sample of patients acutely admitted to hospital for symptoms of psychosis. Based on our findings we can make no recommendations concerning choice of any particular SGA for targeting symptoms of depression in a patient acutely admitted with psychosis. Trial Registration ClinicalTrials.gov ID; URL: http://www.clinicaltrials.gov/: NCT00932529

  9. Polydimethylsiloxane Injection Laryngoplasty for Unilateral Vocal Fold Paralysis: Long-Term Results.

    Science.gov (United States)

    Mattioli, Francesco; Bettini, Margherita; Botti, Cecilia; Busi, Giulia; Tassi, Sauro; Malagoli, Andrea; Molteni, Gabriele; Trebbi, Marco; Luppi, Maria Pia; Bergamini, Giuseppe; Presutti, Livio

    2017-07-01

    To analyze the long-term objective, perceptive, and subjective outcomes after endoscopic polydimethylsiloxane (PDMS) injection laryngoplasty in unilateral vocal fold paralysis. A retrospective study carried out between January 2008 and January 2012. Head and Neck Department, University Hospital of Modena, Modena, Italy. This was a retrospective analysis of 26 patients with unilateral vocal fold paralysis who underwent endoscopic injection of PDMS under general anesthesia. A voice evaluation protocol was performed for all patients, which included videolaryngostroboscopy, maximum phonation time, fundamental frequency, analysis of the harmonic structure of the vowel /a/ and the word /aiuole/, Grade of Dysphonia, Instability, Roughness, Breathiness, Asthenia, and Strain scale, and Voice Handicap Index. The protocol was performed before surgery, in the immediate postoperative period, and at least 3 years after surgery. The mean follow-up period was 73 months (range 39-119 months). The statistical analysis showed a significant improvement (P injection laryngoplasty with PDMS guarantees long-lasting effects over time. No complications were reported in our series. Injection laryngoplasty with PDMS can be considered to be a minimally invasive and safe technique for the treatment of unilateral vocal fold paralysis. Moreover, it allows very good and stable results to be obtained over time, avoiding repeated treatments and improving the quality of life of the patients. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  10. Dopamine D2 receptor occupancy by olanzapine or risperidone in young patients with schizophrenia

    NARCIS (Netherlands)

    Lavalaye, J.; Linszen, D. H.; Booij, J.; Reneman, L.; Gersons, B. P.; van Royen, E. A.

    1999-01-01

    A crucial characteristic of antipsychotic medication is the occupancy of the dopamine (DA) D2 receptor. We assessed striatal DA D2 receptor occupancy by olanzapine and risperidone in 36 young patients [31 males, 5 females; mean age 21.1 years (16-28)] with first episode schizophrenia, using

  11. Synthesis, recognition and evaluation of molecularly imprinted polymer nanoparticle using miniemulsion polymerization for controlled release and analysis of risperidone in human plasma samples

    International Nuclear Information System (INIS)

    Asadi, Ebadullah; Azodi-Deilami, Saman; Abdouss, Majid; Kordestani, Davood; Rahimi, Alireza; Asadi, Somayeh

    2014-01-01

    We prepared high selective imprinted nanoparticle polymers by a miniemulsion polymerization technique, using risperidone as the template, MAA as the functional monomers, and TRIM as the cross-linker in acetonitrile as solvent. The morphology of the nanoparticles determined by scanning electron microscopy (SEM) images and drug release, binding properties and dynamic light scattering (DLS) of molecularly imprinted polymers (MIPs) were studied. Controlled release of risperidone from nanoparticles was investigated through in 1% wt sodium dodecyl sulfate aqueous solution and by measuring the absorbance by HPLC-UV. The results showed that the imprinted nanoparticles exhibited a higher binding level and slower release rate than non-imprinted nanoparticles, which contributed to interaction of risperidone with imprinted cavities within nanoparticles. Furthermore, the results from HPLC showed good precision (5% for 50.0 µg L -1 ) and recoveries (between 86-91) using MIP from human plasma samples

  12. Cost-Utility Analysis of Depot Atypical Antipsychotics for Chronic Schizophrenia in Croatia.

    Science.gov (United States)

    Jukic, Vlado; Jakovljevic, Miro; Filipcic, Igor; Herceg, Miroslav; Silic, Ante; Tomljanovic, Tatjana; Zilbershtein, Roman; Jensen, Rasmus C D; Hemels, Michiel E H; Einarson, Thomas R

    As a nation with a developing economy, Croatia is faced with making choices between pharmaceutical products, including depot injectable antipsychotics. We conducted a pharmacoeconomic analysis to determine the cost-effectiveness of atypical depots in Croatia. A 1-year decision-analytic framework modeled drug use. We determined the average direct cost to the Croatian Institute for Health Insurance of using depot formulations of paliperidone palmitate long-acting injectable (PP-LAI), risperidone LAI (RIS-LAI), or olanzapine LAI (OLZ-LAI). An expert panel plus literature-derived clinical rates populated the core model, along with costs adjusted to 2012 by using the Croatian consumer price index. Clinical outcomes included quality-adjusted life-years, hospitalization rates, emergency room treatment rates, and relapse days. Robustness of results was examined with one-way sensitivity analyses on important inputs; overall, all inputs were varied over 10,000 simulations in a Monte Carlo analysis. Costs (quality-adjusted life-years) per patient were €5061 (0.817) for PP-LAI, €5168 (0.807) for RIS-LAI, and €6410 (0.812) for OLZ-LAI. PP-LAI had the fewest relapse days, emergency room visits, and hospitalizations. Results were sensitive against RIS-LAI with respect to drug costs and adherence rates, but were generally robust overall, dominating OLZ-LAI in 77.3% and RIS-LAI in 56.8% of the simulations. PP-LAI dominated the other drugs because it had the lowest cost and best clinical outcomes. Compared with depots of olanzapine and risperidone and oral olanzapine, PP-LAI was the cost-effective atypical LAI for treating chronic schizophrenia in Croatia. Using depot paliperidone in place of either olanzapine or risperidone would reduce the overall costs of caring for these patients. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

  13. Progestogen-only injectable contraceptive: Experience of women in ...

    African Journals Online (AJOL)

    Background: Progestogen-only injectable contraceptive is a long-acting contraceptive given intramuscularly to give protection against unwanted pregnancy for a period of 2 or 3 months, depending on the type. Alterations in menstrual pattern are a well known side effect of this effective contraceptive method. Objectives: To ...

  14. Uptake of long-acting reversible contraceptive devices in Western ...

    African Journals Online (AJOL)

    2015-07-01

    Jul 1, 2015 ... The use of long acting reversible methods (LARC) is proposed as a strategy to ... The chance of pregnancy over a year of use is significant- ly lower than ... Therefore, LARC is associated with sustained long-term potential to ...

  15. Gabapentin adjunctive to risperidone or olanzapine in partially responsive schizophrenia: an open-label pilot study

    Directory of Open Access Journals (Sweden)

    Adel Gabriel

    2010-10-01

    Full Text Available Adel GabrielDepartments of Psychiatry and Community Health Sciences, University of Calgary, Alberta, CanadaBackground: There is a great need in the treatment of schizophrenia for a drug, or drug ­combinations, to improve clinical response with fewer serious side effects. The objective of this study was to explore the therapeutic effects and tolerability of the anticonvulsant gabapentin as an adjunctive in the treatment of patients with partially responsive schizophrenia.Methods: Ten consenting patients with a confirmed Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision diagnosis of schizophrenia were identified. All patients failed at least one 12-week treatment trial with risperidone or olanzapine. Gabapentin was added to ongoing antipsychotic treatment with olanzapine or risperidone for eight weeks. The primary outcome measure was the Positive and Negative Syndrome Scale (PANSS. Other scales included the Calgary Depression Scale (CDSS and the Abnormal Involuntary Movement Scale (AIMS. Repeated-measures multivariate analysis of variance was utilized to examine changes in outcome measures over time with adjunctive treatment with gabapentin.Results: There was a significant drop in the PANSS and CDSS scores at endpoint (week 8. There were no significant differences between the two treatment groups with regard to changes in all outcome measures or in AIMS score. The adjunctive treatments were well tolerated and side effects were transient.Conclusion: Gabapentin could be used successfully as an adjunct to novel antipsychotics in partially responsive schizophrenia. However, large controlled studies are needed to examine the effectiveness of gabapentin in psychotic disorders.Keywords: schizophrenia, refractory, adjunctive treatment, gabapentin, risperidone, olanzapine

  16. Use of combinatorial pharmacogenomic testing in two cases from community psychiatry

    Directory of Open Access Journals (Sweden)

    Fields ES

    2016-08-01

    Full Text Available Eve S Fields,1 Raymond A Lorenz,2 Joel G Winner2 1Northwest Center for Community Mental Health, Reston, VA, USA; 2Assurex Health, Mason, OH, USA Abstract: This report describes two cases in which pharmacogenomic testing was utilized to guide medication selection for difficult to treat patients. The first patient is a 29-year old male with bipolar disorder who had severe akathisia due to his long acting injectable antipsychotic. The second patient is a 59-year old female with major depressive disorder who was not ­responding to her medication. In both cases, a proprietary combinatorial pharmacogenomic test was used to inform medication changes and improve patient outcomes. The first patient was switched to a long acting injectable that was not affected by his genetic profile and his adverse effects abated. The second patient had her medications discontinued due to the results of the genetic testing and more intense psychotherapy initiated. While pharmacogenomic testing may be ­helpful in cases such as these presented here, it should never serve as a proxy for a comprehensive biopsychosocial approach. The pharmacogenomic information may be selectively added to this comprehensive approach to support medication treatment. Keywords: pharmacogenomics, adverse effects, risperidone, nortriptyline, paliperidone

  17. Handwriting Movement Analyses for Monitoring Drug-Induced Motor Side Effects in Schizophrenia Patients Treated with Risperidone

    Science.gov (United States)

    Caligiuri, Michael P.; Teulings, Hans-Leo; Dean, Charles E.; Niculescu, Alexander B.; Lohr, James

    2009-01-01

    Epidemiologic studies indicate that nearly 60% of schizophrenia (SZ) patients treated with conventional antipsychotic drugs develop extrapyramidal side effects (EPS) such as parkinsonism and tardive dyskinesia. Although the prevalence of EPS has decreased due to the newer antipsychotics, EPS continue to limit the effectiveness of these medicines. Ongoing monitoring of EPS is likely to improve treatment outcome or compliance and reduce the frequency of re-hospitalization. A quantitative analysis of handwriting kinematics was used to evaluate effects of antipsychotic medication type and dose in schizophrenia patients. Twenty-seven schizophrenia patients treated with risperidone, six schizophrenia patients who received no antipsychotic medication and 46 healthy comparison participants were enrolled. Participants performed a 20-minute handwriting task consisting of loops of various sizes and a sentence. Data were captured and analyzed using MovAlyzeR software. Results indicated that risperidone-treated participants exhibited significantly more dysfluent handwriting movements than either healthy or untreated SZ participants. Risperidone-treated participants exhibited lower movement velocities during production of simple loops compared to unmedicated patients. Handwriting dysfluency during sentence writing increased with dose. A 3-factor model consisting of kinematic variables derived from sentence writing accounted for 83% (r = .91) of the variability in medication dose. In contrast, we found no association between observer-based EPS severity ratings and medication dose. These findings support the importance of handwriting-based measures to monitor EPS in medicated schizophrenia patients. PMID:19692133

  18. Divergent long-term consequences of chronic treatment with haloperidol, risperidone, and bromocriptine on traumatic brain injury-induced cognitive deficits.

    Science.gov (United States)

    Phelps, Thomas I; Bondi, Corina O; Ahmed, Rashid H; Olugbade, Yewande T; Kline, Anthony E

    2015-04-15

    Antipsychotic drugs (APDs) are provided in the clinic to manage traumatic brain injury (TBI)-induced agitation and aggression. Experimental TBI studies consistently show that daily administration of the APDs, haloperidol (HAL) and risperidone (RISP), hinder recovery. However, it is unknown how long the adverse effects remain after cessation of treatment. To elucidate this clinically relevant issue, anesthetized male rats were randomly assigned to four TBI (controlled cortical impact) and four sham groups administered HAL (0.5 mg/kg), RISP (0.45 mg/kg), bromocriptine (BRO; 5.0 mg/kg, included as a control for D2 receptor action), or vehicle (VEH; 1 mL/kg) 24 h after surgery and once-daily for 19 days. Motor and cognitive recovery was assessed on days 1-5 and 14-19, respectively, and again at 1 and 3 months after drug withdrawal. No overall group differences were observed for motor function among the TBI groups, although the HAL group showed a greater beam-walk deficit on day 5 versus the VEH and BRO groups. Cognitive recovery was significantly impaired in the HAL and RISP groups during the treatment phase versus VEH and BRO. Further, BRO was superior to VEH (p=0.0042). At 1 month, both groups that received APDs continued to exhibit significant cognitive impairment versus VEH and BRO; at 3 months, only the HAL group was impaired. Moreover, the HAL, RISP, and VEH groups continued to be cognitively deficient versus BRO, which also reduced cortical damage. These data replicate previous reports that HAL and RISP impede cognitive recovery after TBI and expand the literature by revealing that the deleterious effects persist for 3 months after drug discontinuation. BRO conferred cognitive benefits when administered concomitantly with behavioral testing, thus replicating previous findings, and also after cessation demonstrating enduring efficacy.

  19. Number needed to treat and number needed to harm with paliperidone palmitate relative to long-acting haloperidol, bromperidol, and fluphenazine decanoate for treatment of patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Srihari Gopal

    2011-03-01

    Full Text Available Srihari Gopal1, Joris Berwaerts1, Isaac Nuamah1, Kasem Akhras2, Danielle Coppola1, Ella Daly1, David Hough1, Joseph Palumbo11Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, NJ, USA; 2Johnson & Johnson Pharmaceutical Services, LLC, Raritan, NJ, USABackground: We analyzed data retrieved through a PubMed search of randomized, placebo-controlled trials of first-generation antipsychotic long-acting injectables (haloperidol decanoate, bromperidol decanoate, and fluphenazine decanoate, and a company database of paliperidone palmitate, to compare the benefit-risk ratio in patients with schizophrenia.Methods: From the eight studies that met our selection criteria, two efficacy and six safety parameters were selected for calculation of number needed to treat (NNT, number needed to harm (NNH, and the likelihood of being helped or harmed (LHH using comparisons of active drug relative to placebo. NNTs for prevention of relapse ranged from 2 to 5 for paliperidone palmitate, haloperidol decanoate, and fluphenazine decanoate, indicating a moderate to large effect size.Results: Among the selected maintenance studies, NNH varied considerably, but indicated a lower likelihood of encountering extrapyramidal side effects, such as akathisia, tremor, and tardive dyskinesia, with paliperidone palmitate versus placebo than with first-generation antipsychotic depot agents versus placebo. This was further supported by an overall higher NNH for paliperidone palmitate versus placebo with respect to anticholinergic use and Abnormal Involuntary Movement Scale positive score. LHH for preventing relapse versus use of anticholinergics was 15 for paliperidone palmitate and 3 for fluphenazine decanoate, favoring paliperidone palmitate.Conclusion: Overall, paliperidone palmitate had a similar NNT and a more favorable NNH compared with the first-generation long-acting injectables assessed.Keywords: long-acting injectables, first-generation antipsychotics

  20. Risperidone, quetiapine, and olanzapine adjunctive treatments in major depression with psychotic features: a comparative study

    Directory of Open Access Journals (Sweden)

    Gabriel A

    2013-04-01

    Full Text Available A Gabriel Departments of Psychiatry and Community Health Sciences, University of Calgary, Calgary, AB, Canada Objectives: The purpose of this study was to compare the effectiveness of novel antipsychotics in the treatment of psychotic depression. Method: Consecutive patients who were admitted (n = 51 with a confirmed diagnosis of major depression with psychotic features (delusions or hallucinations or both participated in this open-label, naturalistic study. All patients were treated with selective serotonin reuptake inhibitors (SSRIs and serotonin–norepinephrine reuptake inhibitors (SNRIs (citalopram or venlafaxine extended release [XR], and atypical antipsychotic agents were added, as tolerated, during the first week of initiating the citalopram or venlafaxine. There were patients (n = 16 who received risperidone, who received quetiapine (n = 20, and who received olanzapine (n = 15, as an adjunctive treatment to either citalopram or venlafaxine for at least 8 weeks. Outcome measures included the Clinical Global Impression-Severity subscale (CGI-S, as the primary outcome measure, as well as the Hamilton Rating Scale for Depression-21 item (HAM-D21 and the Brief Psychiatric Rating Scale (BPRS. Tolerance to treatments and weight changes were monitored over the period of the trial. Results: All patients completed the trial with no drop outs. At 8 weeks, there was a statistically significant (P 0.01 in the olanzapine group. Conclusion: Quetiapine, risperidone, and olanzapine, given as adjunctive treatment with SSRIS or SNRIs can significantly and equally improve depressive and psychotic symptoms, in the short-term treatment of major depression with psychotic features. The author recommends that large controlled trials be conducted to examine the differences in long-term efficacy and tolerance between the atypical antipsychotic agents, in the treatment of major depression with or without psychotic features. Keywords: depression, novels

  1. Reducing Prescriptions of Long-acting Benzodiazepine Drugs in Denmark

    DEFF Research Database (Denmark)

    Eriksen, Sophie Isabel; Bjerrum, Lars

    2015-01-01

    Prolonged consumption of benzodiazepine drugs (BZD) and benzodiazepine receptor agonists (zolpidem, zaleplon, zopiclone; altogether Z drugs) is related to potential physiological and psychological dependence along with other adverse effects. This study aimed to analyse the prescribing of long...... to the prescription. The observed reduction in BZD use was correlated to the introduction of new national guidelines on prescription of addictive drugs, but this study was not designed to detect a causal relationship. The prescribing of long-acting BZD decreased considerably more than the prescribing of short......-acting BZD (half-life >10 hr), compared to short-acting BZD in Denmark during a 10-year period. Descriptive analysis of total sales data from the Danish Register of Medicinal Product Statistics, to individuals in the primary healthcare sector, of all BZD and Z-drugs in the period of 2003-2013. Prescription...

  2. Assessment of strategies for switching patients from olanzapine to risperidone: A randomized, open-label, rater-blinded study

    Directory of Open Access Journals (Sweden)

    Berry Sally A

    2008-06-01

    Full Text Available Abstract Background In clinical practice, physicians often need to change the antipsychotic medications they give to patients because of an inadequate response or the presence of unacceptable or unsafe side effects. However, there is a lack of consensus in the field as to the optimal switching strategy for antipsychotics, especially with regards to the speed at which the dose of the previous antipsychotic should be reduced. This paper assesses the short-term results of strategies for the discontinuation of olanzapine when initiating risperidone. Methods In a 6-week, randomized, open-label, rater-blinded study, patients with schizophrenia or schizoaffective disorder, on a stable drug dose for more than 30 days at entry, who were intolerant of or exhibiting a suboptimal symptom response to more than 30 days of olanzapine treatment, were randomly assigned to the following switch strategies (common risperidone initiation scheme; varying olanzapine discontinuation: (i abrupt strategy, where olanzapine was discontinued at risperidone initiation; (ii gradual 1 strategy, where olanzapine was given at 50% entry dose for 1 week after risperidone initiation and then discontinued; or (iii gradual 2 strategy, where olanzapine was given at 100% entry dose for 1 week, then at 50% in the second week, and then discontinued. Results The study enrolled 123 patients on stable doses of olanzapine. Their mean age was 40.3 years and mean (± standard deviation (SD baseline Positive and Negative Syndrome Scale (PANSS total score of 75.6 ± 11.5. All-cause treatment discontinuation was lowest (12% in the group with the slowest olanzapine dose reduction (gradual 2 and occurred at half the discontinuation rate in the other two groups (25% in abrupt and 28% in gradual 1. The relative risk of early discontinuation was 0.77 (confidence interval 0.61–0.99 for the slowest dose reduction compared with the other two strategies. After the medication was changed, improvements at

  3. Treatment adherence and persistence with long-acting somatostatin analog therapy for the treatment of acromegaly: a retrospective analysis.

    Science.gov (United States)

    Gurel, Michelle H; Han, Yi; Stevens, Andrea L; Furtado, Aaron; Cox, David

    2017-04-04

    Many patients with acromegaly require medical treatment that includes somatostatin analogs (SSAs). Long-acting SSA formulations are widely used, due in part to increased patient convenience and increased treatment adherence vs daily medications. Although medication compliance can be poor in patients with chronic conditions, adherence and persistence with these SSAs in patients with acromegaly has not been evaluated. This analysis utilized claims data to estimate treatment adherence and persistence for lanreotide depot and long-acting octreotide in this population. This retrospective analysis used the MarketScan® database (~100 payors, 500 million claims in the US), which was searched between January 2007 and June 2012 to identify patients with acromegaly taking either lanreotide depot or long-acting octreotide. Patients switching treatments were excluded. Treatment adherence was assessed using medication possession ratio (MPR; number of doses dispensed in relation to dispensing period; ≥80% is considered adherent), injection count, and treatment time. Persistence was estimated by Kaplan-Meier analyses and Cox proportional hazards modeling. A washout period, defined as no acromegaly-related prescription activity 180 days prior to the index date, was employed to minimize effects of prior therapy and focus on patients more likely to be treatment-naïve. Altogether 1308 patients with acromegaly receiving a single SSA for treatment (1127 octreotide, 181 lanreotide) who had not switched treatments were identified. Mean MPR in patients with a 180-day washout (n = 663) was 89% for those receiving octreotide (n = 545) and 87% for those receiving lanreotide (n = 118). Median number of days on therapy was 169 (95% CI 135-232) for octreotide patients and 400 (95% CI 232-532) for lanreotide patients. The point estimate of the Cox proportional hazard ratio for stopping treatment was 1.385 for octreotide vs lanreotide (95% CI 1.079-1.777), suggesting a 38

  4. Profile of long-acting reversible contraception users in Europe.

    Science.gov (United States)

    Haimovich, Sergio

    2009-06-01

    To assess the profile of long-acting reversible contraceptives (LARCs) users in Europe. A random sample of women aged 15-49 years in 14 European countries (Germany, France, UK, Spain, Italy, Russian Federation, Estonia, Latvia, Lithuania, Austria, Czech Republic, Denmark, Norway, and Sweden) underwent web-based or computer-aided face-to-face interviews in June 2006. In this paper data pertaining to a subgroup of women using LARCs are presented. A total of 11,490 women participated in the full study. Of these, 1,188 (10%) women were LARC (hormonal implant, injectables, levonorgestrel-releasing intrauterine system [LNG-IUS], copper intrauterine device [Cu-IUD]) users. The age of the LARC users exceeded 30 years for 57-91% of them. Furthermore, more than half of them found convenience an extremely important factor when selecting the LARC as a contraceptive method. As compared to those wearing a Cu-IUD, women using hormonal LARCs experienced fewer physical and emotional symptoms that appeared or worsened during menstruation. LARCs have their place in the contraceptive market in Europe. The most popular LARCs among European women were the LNG-IUS and the Cu-IUD; both were mainly used by women who had children and had no wish to have more in the future.

  5. Rats and rabbits as pharmacokinetic screening tools for long acting intramuscular depots: case study with paliperidone palmitate suspension.

    Science.gov (United States)

    Patel, Harilal; Patel, Prakash; Modi, Nirav; Patel, Pinakin; Wagh, Yogesh; George, Alex; Desai, Nirmal; Srinivas, Nuggehally R

    2018-05-08

    Development of prodrug of 9-hydroxyrisperidone (paliperidone) long-acting intramuscular injection has enabled delivery over four-week time period with improved compliance. The key aim of this work was to establish a reliable preclinical model which may potentially serve as a screening tool for judging the pharmacokinetics of paliperidone formulation(s) prior to human clinical work. Sparse sampling composite study was used in rats, (Wistar/Sprague-Dawley (SD; n = 10)) and a serial blood sampling study design was used in rabbits (n = 4). Animals received intramuscular injection of paliperidone palmitate in the thigh muscle at dose of 16 (rats) and 4.5 mg/kg (rabbits). Samples were drawn in rats (retro-orbital sinus) and rabbits (central ear artery) and were analysed for paliperidone using liquid chromatography-mass spectrometry/ mass spectrometry (LC-MS/MS) assay. The plasma data was subjected to pharmacokinetic analysis. Following intramuscular injection of depot formulation in Wistar/SD rats and rabbits, absorption of paliperidone was slow and gradual with median value of time to reach maximum concentration (T max ) occurring on day 7. The exposures (i.e. area under the curve (AUC; 0-28) days) were 18,597, 21,865 and 18,120 ng.h/mL, in Wistar, SD and rabbits, respectively. The clearance was slow and supported long half-life (8-10 days). Either one of the two models can serve as a research tool for establishing pharmacokinetics of paliperidone formulation(s).

  6. Long acting reversible contraception | Kluge | Obstetrics and ...

    African Journals Online (AJOL)

    Long acting reversible contraception (LARC) has great potential in reducing these pregnancies as they are highly effective and do not rely a great deal on compliance and correct use. They have better continuation rates than short term hormonal contraception and as per definition require administration less than once per ...

  7. Comparative study of clozapine versus risperidone in treatment-naive, first-episode schizophrenia: A pilot study

    Directory of Open Access Journals (Sweden)

    Sukhtej Sahni

    2016-01-01

    Interpretation & conclusions: The findings of this preliminary study showed clozapine as a better choice than risperidone in terms of efficacy, tolerability and better quality of life in treatment-naive, first-episode schizophrenia. However, further studies need to be done on a larger group of patients to confirm the findings.

  8. ANÁLISIS COSTO-BENEFICIO DE CUATRO MEDICAMENTOS ANTIPSICÓTICOS EN PACIENTES CON ESQUIZOFRENIA EN COLOMBIA

    Directory of Open Access Journals (Sweden)

    Diego Rosselli

    2009-01-01

    effects. According to the model, the use of long acting risperidone injection or clozapine over a one-year period, save around $1 million pesos (US$500 to the system when compared with olanzapine, and two million (US$1000 when compared with pipotiazine.
    This economic benefit with risperidone injection would be added to the direct and indirect benefits to the patient and his community due to relapse reduction.

    Keywords: risperidone, depot, antipsychotics, schizophrenia, cost-benefit

  9. Comparison between risperidone, an atypical antipsychotic agent and haloperidol, a conventional agent used to treat schizophrenia

    International Nuclear Information System (INIS)

    Rehman, A.; Jawed, M.; Maheshwari, M.P.

    2012-01-01

    An observational and comparative study was conducted to compare the functional outcome between the patients treated with conventional antipsychotic agent haloperidol and typical antipsychotic agent, Risperidone (Risperidal). A total of 32 patients were included in the study with established schizophrenia according to (DSM iv). The data was processed on SSPE 10th version. The primary outcome measure was the improvement of negative symptoms of schizophrenia and secondary outcome measure was to observe the superiority of the atypical drug Risperid one over conventional agent haloperidol regarding side effects. Patients were assessed at baseline, 2nd and 8th week, using four tools of assessment. For treatment group receiving haloperidol mean was 47.2+-11.50 at 8th week and for Risperidone treatment group mean was 43+-14.68. The P values for all the parameters in the Clozapine group were significant as compared to haloperidol. (author)

  10. Risperidone Added to Psychostimulant in Children with Severe Aggression and Attention-Deficit/Hyperactivity Disorder: Lack of Effect on Attention and Short-Term Memory.

    Science.gov (United States)

    Farmer, Cristan A; Epstein, Jeffery N; Findling, Robert L; Gadow, Kenneth D; Arnold, L Eugene; Kipp, Heidi; Kolko, David J; Butter, Eric; Schneider, Jayne; Bukstein, Oscar G; McNamara, Nora K; Molina, Brooke S G; Aman, Michael G

    2017-03-01

    Professionals have periodically expressed concern that atypical antipsychotics may cause cognitive blunting in treated patients. In this study, we report data from a double-blind, randomized, controlled study of stimulant plus placebo versus combined stimulant and risperidone to evaluate the effects of the atypical antipsychotic on attention and short-term memory. A total of 165 (n = 83 combined treatment; n = 82 stimulant plus placebo) children with attention-deficit/hyperactivity disorder and severe physical aggression, aged 6-12 years, were evaluated with Conners' Continuous Performance Test (CPT-II) and the Wechsler Intelligence Scale for Children-III (WISC) Digit Span subscale at baseline, after 3 weeks of stimulant-only treatment, and after six additional weeks of randomized treatment (stimulant+placebo vs. stimulant+risperidone). At 3 weeks, improvement on CPT-II performance (Commissions and Reaction Time Standard Error; p memory performance (p attention and short-term memory associated with short-term use of risperidone. NCT00796302.

  11. Olanzapine has better efficacy compared to risperidone for treatment of negative symptoms in schizophrenia

    Directory of Open Access Journals (Sweden)

    P N Suresh Kumar

    2016-01-01

    Conclusions: Both treatments were well-tolerated and efficacious. Greater reductions in severity of the illness and negative symptoms were seen with olanzapine consistently through 1 year. The frequency and severity of extrapyramidal symptoms were negligible and similar in the two treatment groups. Weight gain, hyperlipidemia, and hyperglycemia were comparable in both groups. Risperidone produced significant hyperprolactinemia.

  12. A Naturalistic Comparison of Methylphenidate and Risperidone Monotherapy in Drug-Naive Youth With Attention-Deficit/Hyperactivity Disorder Comorbid With Oppositional Defiant Disorder and Aggression.

    Science.gov (United States)

    Masi, Gabriele; Manfredi, Azzurra; Nieri, Giulia; Muratori, Pietro; Pfanner, Chiara; Milone, Annarita

    2017-10-01

    Attention-deficit/hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) are frequently co-occurring in youth, but data about the pharmacological management of this comorbidity are scarce, especially when impulsive aggression is prominent. Although stimulants are the first-line medication for ADHD, second-generation antipsychotics, namely, risperidone, are frequently used. We aimed to assess effectiveness and safety of monotherapy with the stimulant methylphenidate (MPH) and risperidone in a consecutive sample of 40 drug-naive male youths diagnosed as having ADHD-combined presentation, comorbid with ODD and aggression, without psychiatric comorbidities, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria and a structured clinical interview (Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version). Twenty males treated with MPH (mean age, 8.95 ± 1.67 years) and 20 males treated with risperidone (mean age, 9.35 ± 2.72 years), followed up to 6 months, were assessed according to efficacy measures (Child Behavior Checklist [CBCL], Clinical Global Impression-Severity [CGI-S] and Improvement [CGI-I], Children Global Assessment Scale), and safety measures. At the end of the follow-up, both medications were similarly effective based on CBCL subscales of aggression and rule-breaking behaviors, on Diagnostic and Statistical Manual of Mental Disorders-oriented oppositional defiant problems and conduct problems, and on CGI-S, CGI-I, and Children Global Assessment Scale, but only MPH was effective on CBCL attention problems and attention-deficit/hyperactivity problems. Risperidone was associated with weight gain and elevated prolactin levels. Although the nonrandomized, nonblind design limits the conclusions of our exploratory study, our findings suggest that when ADHD is comorbid with ODD and aggression MPH and risperidone are both effective on aggressive behavior, but

  13. Validation of an analytical method applicable to study of 1 mg/mL oral Risperidone solution stability

    International Nuclear Information System (INIS)

    Abreu Alvarez, Maikel; Garcia Penna, Caridad Margarita; Martinez Miranda, Lissette

    2010-01-01

    A validated analytical method by high-performance liquid chromatography (HPLC) was applicable to study of 1 mg/mL Risperidone oral solution stability. The above method was linear, accurate, specific and exact. A stability study of the 1 mg/mL Risperidone oral solution was developed determining its expiry date. The shelf life study was conducted for 24 months at room temperature; whereas the accelerated stability study was conducted with product under influence of humidity and temperature; analysis was made during 3 months. Formula fulfilled the quality specifications described in Pharmacopeia. The results of stability according to shelf life after 24 months showed that the product maintains the parameters determining its quality during this time and in accelerated studies there was not significant degradation (p> 0.05) in the product. Under mentioned conditions expiry date was of 2 years

  14. Dietary Status and Impact of Risperidone on Nutritional Balance in Children with Autism: A Pilot Study

    Science.gov (United States)

    Lindsay, Ronald L.; Arnold, L. Eugene; Aman, Michael G.; Vitiello, Benedetto; Posey, David J.; McDougle, Christopher J.; Scahill, Lawrence; Pachler, Maryellen; McCracken, James T.; Tierney, Elaine; Bozzolo, Dawn

    2006-01-01

    Background: Risperidone may be effective in improving tantrums, aggression, or self-injurious behaviour in children with autism, but often leads to weight gain. Method: Using a quantitative Food Frequency Questionnaire (FFQ), we prospectively examined the nutritional intake of 20 children with autism participating in a randomised…

  15. Efficacy of Risperidone Augmentation with Ondansetron in the Treatment of Negative and Depressive Symptoms in Schizophrenia: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Roya Samadi

    2017-01-01

    Full Text Available Background: Given the potential role of the 5-hydroxytryptamine-3 receptor in the pathogenesis of schizophrenia, this study was performed to determine whether ondansetron plus risperidone could reduce the negative and depressive symptoms in patients with treatment-resistant schizophrenia. Methods: In a double-blinded, placebo-controlled, randomized trial (IRCT registration # 201112125280N7, in 2012–2013 in Mashhad, Iran, 38 patients with treatment-resistant schizophrenia received risperidone either combined with a fixed dose (4–8 mg/d of ondansetron (n=18 or with a placebo (n=20 for 12 weeks. The patients were evaluated using the Positive and Negative Syndrome Scale (PANSS, Wechsler’s Adult Intelligence Scale-Revised (WAIS-R, and Hamilton’s Rating Scale for Depression (HRSD at baseline and 12 weeks later. Changes in the inventories were used to evaluate the efficacy of the treatment. The t test, Chi-square test, and SPSS (version 16 were used to analyze the data. The statistical significance was set at P<0.05. Results: Ondansetron plus risperidone was associated with a significantly larger improvement in the PANSS overall scale and subscales for negative symptoms and cognition than was risperidone plus placebo (P<0.001. The WAIS-R scale results indicated significant differences between the 2 groups before and after administrating the medicine and the placebo. The administration of ondansetron significantly improved visual memory based on the subtests of the WAIS (P<0.05. Ondansetron had no positive effects on depressive symptoms (effect size=0.13. Conclusion: This study confirmed that ondansetron, as an adjunct treatment, reduces negative symptoms in patients with schizophrenia and can be used as a potential adjunctive strategy particularly for negative symptoms and cognitive impairments. Trial Registration Number: IRCT201112125280N7

  16. Effects of aripiprazole versus risperidone on brain activation during planning and social-emotional evaluation in schizophrenia: A single-blind randomized exploratory study.

    Science.gov (United States)

    Liemburg, Edith J; van Es, Frank; Knegtering, Henderikus; Aleman, André

    2017-10-03

    Impaired function of prefrontal brain networks may be the source of both negative symptoms and neurocognitive problems in psychotic disorders. Whereas most antipsychotics may decrease prefrontal activation, the partial dopamine D2-receptor agonist aripiprazole is hypothesized to improve prefrontal function. This study investigated whether patients with a psychotic disorder would show stronger activation of prefrontal areas and associated regions after treatment with aripiprazole compared to risperidone treatment. In this exploratory pharmacological neuroimaging study, 24 patients were randomly assigned to either aripiprazole or risperidone. At baseline and after nine weeks treatment they underwent an interview and MRI session. Here we report on brain activation (measured with arterial spin labeling) during performance of two tasks, the Tower of London and the Wall of Faces. Aripiprazole treatment decreased activation of the middle frontal, superior frontal and occipital gyrus (ToL) and medial temporal and inferior frontal gyrus, putamen and cuneus (WoF), while activation increased after risperidone. Activation increased in the ventral anterior cingulate and posterior insula (ToL), and superior frontal, superior temporal and precentral gyrus (WoF) after aripiprazole treatment and decreased after risperidone. Both treatment groups had increased ventral insula activation (ToL) and middle temporal gyrus (WoF), and decreased occipital cortex, precuneus and caudate head activation (ToL) activation. In conclusion, patients treated with aripiprazole may need less frontal resources for planning performance and may show increased frontotemporal and frontostriatal reactivity to emotional stimuli. More research is needed to corroborate and extend these preliminary findings. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Augmentation by escitalopram, but not citalopram or R-citalopram, of the effects of low-dose risperidone: behavioral, biochemical, and electrophysiological evidence.

    Science.gov (United States)

    Marcus, Monica M; Jardemark, Kent; Malmerfelt, Anna; Gertow, Jens; Konradsson-Geuken, Asa; Svensson, Torgny H

    2012-04-01

    Antidepressant drugs are frequently used to treat affective symptoms in schizophrenia. We have recently shown that escitalopram, but not citalopram or R-citalopram, increases firing rate and burst firing of midbrain dopamine neurons, potentiates cortical N-methyl-D-aspartate (NMDA) receptor-mediated transmission and enhances cognition, effects that might influence the outcome of concomitant antipsychotic medication. Here, we studied, in rats, the behavioral and neurobiological effects of adding escitalopram, citalopram, or R-citalopram to the second-generation antipsychotic drug risperidone. We examined antipsychotic efficacy using the conditioned avoidance response (CAR) test, extrapyramidal side effect (EPS) liability using a catalepsy test, dopamine outflow in the medial prefrontal cortex (mPFC) and nucleus accumbens using in vivo microdialysis in freely moving animals, and NMDA receptor-mediated transmission in the mPFC using intracellular electrophysiological recording in vitro. Only escitalopram (5 mg/kg), but not citalopram (10 mg/kg), or R-citalopram (10 mg/kg), dramatically enhanced the antipsychotic-like effect of a low dose of risperidone (0.25 mg/kg), without increasing catalepsy. Given alone, escitalopram, but not citalopram or R-citalopram, markedly enhanced both cortical dopamine output and NMDA receptor-mediated transmission. Addition of escitalopram and to some extent R-citalopram, but not citalopram, significantly enhanced both cortical dopamine output and cortical NMDA receptor-mediated transmission induced by a suboptimal dose/concentration of risperidone. These results suggest that adjunct treatment with escitalopram, but not citalopram, may enhance the effect of a subtherapeutic dose of risperidone on positive, negative, cognitive, and depressive symptoms in schizophrenia, yet without increased EPS liability. Copyright © 2011 Wiley Periodicals, Inc.

  18. Very Low-Dose Risperidone in First-Episode Psychosis: A Safe and Effective Way to Initiate Treatment

    Directory of Open Access Journals (Sweden)

    Patrick D. McGorry

    2011-01-01

    Full Text Available Patients experiencing a first psychotic episode have high rates of extrapyramidal symptoms (EPSs when treated with the doses of neuroleptics used in multiepisode or chronic schizophrenia. There is some evidence that lower doses may be equally, if not more, effective but less toxic in this population. Here, we report the results of a biphasic open label trial designed to assess the efficacy, safety, and tolerability of low-dose (2–4 mg/day risperidone treatment in a group of 96 first-episode nonaffective psychosis patients. At the end of the trial, 62% of patients met the response criteria although approximately 80% had achieved a response at some time during the study. Reports of EPS remained low, and there were no dystonic reactions. We conclude that even at a dose of 2 mg/day, risperidone was highly effective in reducing acute symptomatology in a real world sample of young first-episode psychosis patients.

  19. Risperidone Versus Methylphenidate in Treatment of Preschool Children With Attention-Deficit Hyperactivity Disorder

    OpenAIRE

    Arabgol, Fariba; Panaghi, Leily; Nikzad, Vahid

    2015-01-01

    Background: Attention Deficit Hyperactivity Disorder (ADHD) is a common psychiatric diagnosis among preschool children. Objectives: The aim of this study was to examine the Risperidone treatment compared to Methylphenidate (MPH) in preschool children with ADHD. Patients and Methods: Thirty three outpatient preschool children, aged 3-6 years, diagnosed with ADHD (The diagnosis of ADHD was established by two child and adolescent psychiatrists according to the DSM-IV-TR criteria), participated i...

  20. [Compliance of long-acting atypical antipsychotics: from an image problem to a question of indication].

    Science.gov (United States)

    Naudin, J; Dassa, D; Cermolacce, M

    2009-09-01

    This paper focuses on the questions asked to practitioners regarding compliance to new long-acting atypical antipsychotics (LAAA): how does the comprehensive approach of patients' and carers' attitudes facing treatment challenge it? A review of recent literature shows that LAAA, are still suffering from an "image problem". We aim to describe these negative beliefs and suggest that LAAA indications be reconsidered. Following a comprehensive approach, we interpreted our review on the basis of anthropological criteria. We focused on value-based health and disease models that organize the attitude of patients and carers regarding the depot injection. Multiple negative beliefs attached to the pain, side-effects, and stigmas are well-known to impair adhesion to treatment. Carers understand disease as a lack of insight. Patients experience it as a threat for the Self and a loss of autonomy. The nurse-patient relationship involving injections is an important factor of compliance. When time is devoted by the carer to paying attention to the patient's experience, in order to perceive the patient as a participant, patients are more likely to adopt the injectable route themselves. By doing so, the patient considers the injection as a "protective net" a "lesser evil" by integrating it within his(her) biography. A comprehensive approach links the lack of insight to the patient's perception of stigma. Hope for recovery is related by the person him(her)self to his(her) own ability for autonomy. Persons with schizophrenia usually struggle for norms (agonomia). This trend has to be taken into account. LAAA are better indicated when patients are compliant. There is no indication when patients are "pure agonomics" and fight to deny both stigma and medication.

  1. Dried Blood Spots Combined With Ultra-High-Performance Liquid Chromatography-Mass Spectrometry for the Quantification of the Antipsychotics Risperidone, Aripiprazole, Pipamperone, and Their Major Metabolites.

    Science.gov (United States)

    Tron, Camille; Kloosterboer, Sanne M; van der Nagel, Bart C H; Wijma, Rixt A; Dierckx, Bram; Dieleman, Gwen C; van Gelder, Teun; Koch, Birgit C P

    2017-08-01

    Risperidone, aripiprazole, and pipamperone are antipsychotic drugs frequently prescribed for the treatment of comorbid behavioral problems in children with autism spectrum disorders. Therapeutic drug monitoring (TDM) could be useful to decrease side effects and to improve patient outcome. Dried blood spot (DBS) sample collection seems to be an attractive technique to develop TDM of these drugs in a pediatric population. The aim of this work was to develop and validate a DBS assay suitable for TDM and home sampling. Risperidone, 9-OH risperidone, aripiprazole, dehydroaripiprazole, and pipamperone were extracted from DBS and analyzed by ultra-high-performance liquid chromatography-tandem mass spectrometry using a C18 reversed-phase column with a mobile phase consisting of ammonium acetate/formic acid in water or methanol. The suitability of DBS for TDM was assessed by studying the influence of specific parameters: extraction solution, EDTA carryover, hematocrit, punching location, spot volume, and hemolysis. The assay was validated with respect to conventional guidelines for bioanalytical methods. The method was linear, specific without any critical matrix effect, and with a mean recovery around 90%. Accuracy and imprecision were within the acceptance criteria in samples with hematocrit values from 30% to 45%. EDTA or hemolysis did not skew the results, and no punching carryover was observed. No significant influence of the spot volume or the punch location was observed. The antipsychotics were all stable in DBS stored 10 days at room temperature and 1 month at 4 or -80°C. The method was successfully applied to quantify the 3 antipsychotics and their metabolites in patient samples. A UHPLC-MS/MS method has been successfully validated for the simultaneous quantification of risperidone, 9-OH risperidone, aripiprazole, dehydroaripiprazole, and pipamperone in DBS. The assay provided good analytical performances for TDM and clinical research applications.

  2. Characterization of the pH and Temperature in the Rabbit, Pig, and Monkey Eye: Key Parameters for the Development of Long-Acting Delivery Ocular Strategies.

    Science.gov (United States)

    Lorget, Florence; Parenteau, Audrey; Carrier, Michel; Lambert, Daniel; Gueorguieva, Ana; Schuetz, Chris; Bantseev, Vlad; Thackaberry, Evan

    2016-09-06

    Many long-acting delivery strategies for ocular indications rely on pH- and/or temperature-driven release of the therapeutic agent and degradation of the drug carrier. Yet, these physiological parameters are poorly characterized in ocular animal models. These strategies aim at reducing the frequency of dosing, which is of particular interest for the treatment of chronic disorders affecting the posterior segment of the eye, such as macular degeneration that warrants monthly or every other month intravitreal injections. We used anesthetized white New Zealand rabbits, Yucatan mini pigs, and cynomolgus monkeys to characterize pH and temperature in several vitreous locations and the central aqueous location. We also established post mortem pH changes in the vitreous. Our data showed regional and species differences, which need to be factored into strategies for developing biodegradable long-acting delivery systems.

  3. Needle-free jet injection of rapid-acting insulin improves early postprandial glucose control in patients with diabetes

    NARCIS (Netherlands)

    Engwerda, E.E.; Tack, C.J.J.; Galan, B.E. de

    2013-01-01

    OBJECTIVE: Clamp studies have shown that the absorption and action of rapid-acting insulin are faster with injection by a jet injector than with administration by conventional pen. To determine whether these pharmacokinetic changes also exist in patients with diabetes and benefit postprandial

  4. Peginterferon Alfa-2b Injection (Sylatron)

    Science.gov (United States)

    ... Naprosyn), ondansetron (Zofran), paroxetine (Paxil, Pexeva), phenytoin (Dilantin), piroxicam (Feldene), propafenone (Rhythmol), risperidone (Risperdal), rosiglitazone (Avandia), sulfamethoxazole ( ...

  5. A double-blind placebo controlled trial of piracetam added to risperidone in patients with autistic disorder.

    Science.gov (United States)

    Akhondzadeh, Shahin; Tajdar, Hamid; Mohammadi, Mohammad-Reza; Mohammadi, Mohammad; Nouroozinejad, Gholam-Hossein; Shabstari, Omid L; Ghelichnia, Hossein-Ali

    2008-09-01

    It has been reported that autism is a hypoglutamatergic disorder. Therefore, it was of interest to assess the efficacy of piracetam, a positive modulator of AMPA-sensitive glutamate receptors in autistic disorder. About 40 children between the ages three and 11 years (inclusive) with a DSM IV clinical diagnosis of autism and who were outpatients from a specialty clinic for children were recruited. The children presented with a chief complaint of severely disruptive symptoms related to autistic disorder. Patients were randomly allocated to piracetam + risperidone (Group A) or placebo + risperidone (Group B) for a 10-week, double-blind, placebo-controlled study. The dose of risperidone was titrated up to 2 mg/day for children between 10 and 40 kg and 3 mg/day for children weighting above 40 kg. The dose of piracetam was titrated up to 800 mg/day. Patients were assessed at baseline and after 2, 4, 6, 8 and 10 weeks of starting medication. The measure of the outcome was the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale (total score). The ABC-C Rating Scale scores improved with piracetam. The difference between the two protocols was significant as indicated by the effect of group, the between subjects factor (F = 5.85, d.f. = 1, P = 0.02). The changes at the endpoint compared with baseline were: -11.90 +/- 3.79 (mean +/- SD) and -5.15 +/- 3.04 for group A and B respectively. A significant difference was observed on the change in scores in the ABC-C Rating Scale in week 10 compared with baseline in the two groups (t = 6.017, d.f. = 38, P treatment of autism.

  6. Regional trends in the use of short-acting and long-acting contraception accessed through the private and public sectors.

    Science.gov (United States)

    Ugaz, Jorge I; Chatterji, Minki; Gribble, James N; Mitchell, Susan

    2015-08-01

    To examine trends in the source of modern contraception (public versus private sector); method choice (long-acting or permanent methods versus short-acting methods); and method and source combined. A retrospective analysis was conducted using data collected by national Demographic and Health Surveys and Reproductive Health Surveys during the period 1992-2012. The dataset included 18 low-income countries in Sub-Saharan Africa, 10 from Latin America and the Caribbean (LAC), and 8 from Asia. A substantial proportion-between 40% and 49%-of modern contraceptive users relied on the private sector in Asia and LAC in the last 20years, yet the proportion has been smaller in Sub-Saharan Africa, between 27% and 30%. Increased use of short-acting methods from both public and private sectors has driven the rise in contraceptive prevalence in Asia and LAC. Similarly, increased contraceptive prevalence in Sub-Saharan Africa reflected the increased use of short-acting methods obtained mainly through the public sector, with only limited use of long-acting or permanent methods through the private sector. The private sector has played a key role in the increase of modern CPR and the provision of modern contraceptives around the world, providing almost half of them in low-income countries. Yet, such increase was driven primarily by a more substantial role in the provision of short-acting methods than long acting and permanent methods. Crown Copyright © 2015. Published by Elsevier Ireland Ltd. All rights reserved.

  7. Pregnancy exposure to olanzapine, quetiapine, risperidone, aripiprazole and risk of congenital malformations. A systematic review

    DEFF Research Database (Denmark)

    Ennis, Zandra Nymand; Damkier, Per

    2015-01-01

    /22 (5.1%) and 100/5 (5.0%), respectively. Relative risk estimates and 95% confidence intervals were 1.0 (0.7-1.4) (olanzapine), 1.0 (0.6-1.7) (quetiapine), 1.5 (0.9-2.2) (risperidone) and 1.4 (0.5-3.1) (aripiprazole). First-trimester exposure to olanzapine is not associated with an increased risk...

  8. Long-Term Effects of Botulinum Toxin Complex Type A Injection on Mechano- and Metabo-Sensitive Afferent Fibers Originating from Gastrocnemius Muscle.

    Directory of Open Access Journals (Sweden)

    Guillaume Caron

    Full Text Available The aim of the present study was to investigate long term effects of motor denervation by botulinum toxin complex type A (BoNT/A from Clostridium Botulinum, on the afferent fibers originating from the gastrocnemius muscle of rats. Animals were divided in 2 experimental groups: 1 untreated animals acting as control and 2 treated animals in which the toxin was injected in the left muscle, the latter being itself divided into 3 subgroups according to their locomotor recovery with the help of a test based on footprint measurements of walking rats: i no recovery (B0, ii 50% recovery (B50 and iii full recovery (B100. Then, muscle properties, metabosensitive afferent fiber responses to potassium chloride (KCl and lactic acid injections and Electrically-Induced Fatigue (EIF, and mechanosensitive responses to tendon vibrations were measured. At the end of the experiment, rats were killed and the toxin injected muscles were weighted. After toxin injection, we observed a complete paralysis associated to a loss of force to muscle stimulation and a significant muscle atrophy, and a return to baseline when the animals recover. The response to fatigue was only decreased in the B0 group. The responses to KCl injections were only altered in the B100 groups while responses to lactic acid were altered in the 3 injected groups. Finally, our results indicated that neurotoxin altered the biphasic pattern of response of the mechanosensitive fiber to tendon vibrations in the B0 and B50 groups. These results indicated that neurotoxin injection induces muscle afferent activity alterations that persist and even worsen when the muscle has recovered his motor activity.

  9. Long-Term Effects of Botulinum Toxin Complex Type A Injection on Mechano- and Metabo-Sensitive Afferent Fibers Originating from Gastrocnemius Muscle.

    Science.gov (United States)

    Caron, Guillaume; Marqueste, Tanguy; Decherchi, Patrick

    2015-01-01

    The aim of the present study was to investigate long term effects of motor denervation by botulinum toxin complex type A (BoNT/A) from Clostridium Botulinum, on the afferent fibers originating from the gastrocnemius muscle of rats. Animals were divided in 2 experimental groups: 1) untreated animals acting as control and 2) treated animals in which the toxin was injected in the left muscle, the latter being itself divided into 3 subgroups according to their locomotor recovery with the help of a test based on footprint measurements of walking rats: i) no recovery (B0), ii) 50% recovery (B50) and iii) full recovery (B100). Then, muscle properties, metabosensitive afferent fiber responses to potassium chloride (KCl) and lactic acid injections and Electrically-Induced Fatigue (EIF), and mechanosensitive responses to tendon vibrations were measured. At the end of the experiment, rats were killed and the toxin injected muscles were weighted. After toxin injection, we observed a complete paralysis associated to a loss of force to muscle stimulation and a significant muscle atrophy, and a return to baseline when the animals recover. The response to fatigue was only decreased in the B0 group. The responses to KCl injections were only altered in the B100 groups while responses to lactic acid were altered in the 3 injected groups. Finally, our results indicated that neurotoxin altered the biphasic pattern of response of the mechanosensitive fiber to tendon vibrations in the B0 and B50 groups. These results indicated that neurotoxin injection induces muscle afferent activity alterations that persist and even worsen when the muscle has recovered his motor activity.

  10. Effects of oral versus long-acting antipsychotics on social functioning: A psychiatrists' survey in India.

    Science.gov (United States)

    Gundugurti, Prasad Rao; Nagpal, Rajesh; Sheth, Ashit; Narang, Prashant; Gawande, Sonal; Singh, Vikram

    2017-12-01

    Schizophrenia is associated with functional challenges for patients; relapses in schizophrenia may lead to increased treatment costs and poor quality of life. This SUSTAIN-I study was conducted to establish psychiatrists' perspective on impact of long-acting injectables (LAIs) antipsychotics on the socio-economic and functional burden of schizophrenia. This cross-sectional, survey-based study was conducted in 5 cities in India. Psychiatrists (≥5years of experience) working in clinics, psychiatric, government hospitals and rehabilitation centers were included and administered a specially designed questionnaire to elicit information on their clinical practice and prescription patterns. Perceived treatment costs for LAI versus oral antipsychotic treatments (OATs) and relapse rates were assessed. Descriptive statistics were used to summarize results. Total 31 physicians completed this survey. In acute phase, OAT prescription was higher whereas chronic patients were treated with either OATs or LAIs. Treatment with LAIs was the preferred treatment in 9% of chronic cases. Reduced relapse rates were observed with LAI treatment: 12% patients on LAIs relapsed as compared with 60% patients on OATs. Monthly medication cost for oral medications was lower ($8-$17) than short-acting injectables ($22-$50). For chronic cases, atypical antipsychotics cost (oral: $11.7-25, LAI: $150-167) was higher than typical antipsychotics (oral: $4-5, LAI: $5-25). Of the total expenses incurred, cost for hospital admissions was the largest component (78%). Despite enhanced treatment adherence and potential to lower risk of rehospitalizations from relapse, LAIs are not the preferred treatment choice for patients with schizophrenia in India, owing to their perceived high costs. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. Pharmacogenetics of Risperidone-Induced Insulin Resistance in Children and Adolescents with Autism Spectrum Disorder.

    Science.gov (United States)

    Sukasem, Chonlaphat; Vanwong, Natchaya; Srisawasdi, Pornpen; Ngamsamut, Nattawat; Nuntamool, Nopphadol; Hongkaew, Yaowaluck; Puangpetch, Apichaya; Chamkrachangpada, Bhunnada; Limsila, Penkhae

    2018-07-01

    The purpose of this study was to explore the association of genetic polymorphism of genes related to pharmacokinetics or pharmacodynamics with insulin resistance in children and adolescents with autism spectrum disorder (ASD) and treated with risperidone. All 89 subjects underwent measurement of fasting blood glucose and insulin levels, body-weight and height. Genotyping was performed by TaqMan real-time polymerase chain reaction (PCR) (pharmacokinetics genes: cytochrome P450 2D6 (CYP2D6) *4 (rs3892097), *5 (gene deletion), *10 (rs1065852) and *41 (rs28371725), ATP-binding cassette transporter B1 (ABCB1) 2677 G>T/A (rs2032582) and 3435C>T (rs1045642) and pharmacodynamics genes: dopamine receptor D2 (DRD2) Tag-SNP (C>T) (rs4436578), DRD2 Tag1A (C>T) (rs1800497), leptin gene (LEP) -2548G>A (rs7799039), ghrelin gene (GHRL) -604G>A (rs27647) and brain-derived neurotrophic factor (BDNF) 196G>A (rs6265)). Drug levels were analysed by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The results revealed that 5 (5.62%) patients presented with hyperglycaemia. Insulin resistance was detected in 15 (16.85%) patients. Insulin resistance was associated with LEP 2548 G>A and BDNF 196 G>A polymorphism (p = 0.051 and p = 0.03). There was no association of pharmacokinetic gene polymorphisms (CYP2D6 and ABCB1) and risperidone levels with insulin resistance. Multiple regression analysis indicated that BDNF 196 G>A polymorphism was significantly associated with insulin resistance (p = 0.025). This finding suggested that BDNF 196 G>A polymorphism may be a genetic marker for predicting insulin resistance before initiating treatment in patients treated with risperidone. Because of the small sample size, further studies are needed to confirm these results. © 2018 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  12. Comparison of long-term voice outcomes after vocal fold augmentation using autologous fat injection by direct microlaryngoscopy versus office-based calcium hydroxylapatite injection.

    Science.gov (United States)

    Zeleník, Karol; Walderová, Radana; Kučová, Hana; Jančatová, Debora; Komínek, Pavel

    2017-08-01

    The objective is to compare the long-term voice outcomes of vocal fold augmentation (VFA) using autologous fat injection via direct microlaryngoscopy versus office-based calcium hydroxylapatite (CaHA) injection. Patients with glottal insufficiency and a gap no greater than 3 mm caused by unilateral vocal fold paralysis or vocal fold atrophy were prospectively recruited to the study from September 2012 to September 2015. From September 2012 to May 2014, VFA was only performed using autologous fat via direct microlaryngoscopy under general anesthesia (N = 14). From May 2014 to September 2015, VFA was performed as an office-based procedure using a transoral approach to inject CaHA (N = 17). Videolaryngostroboscopic evaluation, subjective satisfaction with voice, voice handicap index (VHI), and maximal phonation time (MPT) were analyzed pre-injection and 12 months after VFA. A total of 31 patients were analyzed. One year after VFA, 67.8% of the patients were satisfied with their voice, with no significant difference between groups (P = 0.247). The mean improvement in VHI in the autologous fat group was 31.6 ± 16.82 versus 35 ± 27.24 in the CaHA group (P = 0.664). MPT improvement was also similar in the two groups: 5.5 ± 2.52 for the autologous fat group versus 6.0 ± 3.98 for the CaHA group (P = 0.823). Both autologous fat injection via direct microlaryngoscopy and office-based CaHA injection have good long-term results. There were no differences in the treatment results of the two procedures 1 year after injection.

  13. A Proof-of-Concept Clinical Trial of A Single Luteal Use of Long-Acting Gonadotropin-Releasing Hormone Antagonist Degarelix in Controlled Ovarian Stimulation for In Vitro Fertilization: Long Antagonist Protocol

    Directory of Open Access Journals (Sweden)

    Evangelos G. Papanikolaou

    2018-03-01

    Full Text Available IntroductionA drawback of gonadotropin-releasing hormone (GnRH antagonist protocols in in vitro fertilization (IVF is that they have limited flexibility in cycle programming. This proof of concept study explored the efficacy of a single-dose, long-acting GnRH antagonist IVF protocol. Trial registration number is NCT03240159, retrospectively registered on March 08, 2017.Materials and methodsThe efficacy of a single-dose long-acting antagonist, degarelix, was explored initially in healthy donors and subsequently in infertile patients. In the first part, five healthy oocyte donors underwent ovarian stimulation with this new protocol: in the late luteal phase, at day 24, a bolus injection of degarelix was administered subcutaneously to control the LH surge in the follicular phase. Ovarian stimulation with gonadotropins was initiated subsequently from day 7 to day 10. End points were first to inhibit the LH surge later in the follicular phase and, second, to retrieve mature oocytes for IVF. In the second part, five infertile women received the same bolus injection of degarelix administered during the luteal phase at day 24. Different gonadotropin starting days (day 2 through day 8 were tested in order to observe possible differences in ovarian stimulation. In these infertile patients, fresh embryo transfers were performed to assess the pregnancy efficacy of this protocol on pregnancy outcomes and to address any possible negative effects on endometrium receptivity.ResultsIn the first part of the study, all donors were effectively downregulated with a single luteal dose of 0.5 ml of degarelix for up to 22 days until the final oocyte maturation triggering day. Mature oocytes were retrieved after 36 h from all patients and all produced 2–7 blastocysts. In the second part, all five infertile patients achieved sufficient LH downregulation and completed ovarian stimulation without any LH surge. All patients (except one with freeze all strategy had

  14. Long-term CO2 injection and its impact on near-surface soil microbiology.

    Science.gov (United States)

    Gwosdz, Simone; West, Julia M; Jones, David; Rakoczy, Jana; Green, Kay; Barlow, Tom; Blöthe, Marco; Smith, Karon; Steven, Michael; Krüger, Martin

    2016-12-01

    Impacts of long-term CO 2 exposure on environmental processes and microbial populations of near-surface soils are poorly understood. This near-surface long-term CO 2 injection study demonstrated that soil microbiology and geochemistry is influenced more by seasonal parameters than elevated CO 2 Soil samples were taken during a 3-year field experiment including sampling campaigns before, during and after 24 months of continuous CO 2 injection. CO 2 concentrations within CO 2 -injected plots increased up to 23% during the injection period. No CO 2 impacts on geochemistry were detected over time. In addition, CO 2 -exposed samples did not show significant changes in microbial CO 2 and CH 4 turnover rates compared to reference samples. Likewise, no significant CO 2 -induced variations were detected for the abundance of Bacteria, Archaea (16S rDNA) and gene copy numbers of the mcrA gene, Crenarchaeota and amoA gene. The majority (75%-95%) of the bacterial sequences were assigned to five phyla: Firmicutes, Proteobacteria, Actinobacteria, Acidobacteria and Bacteroidetes The majority of the archaeal sequences (85%-100%) were assigned to the thaumarchaeotal cluster I.1b (soil group). Univariate and multivariate statistical as well as principal component analyses showed no significant CO 2 -induced variation. Instead, seasonal impacts especially temperature and precipitation were detected. © FEMS 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  15. Effect of risperidone versus haloperidol on emotional responding in schizophrenic patients.

    Science.gov (United States)

    Fakra, E; Khalfa, S; Da Fonseca, D; Besnier, N; Delaveau, P; Azorin, J M; Blin, O

    2008-10-01

    Studies on emotional processing report that schizophrenic patients present a specific pattern of emotional responding that usually includes deficits in emotional expressiveness, increased feelings of unpleasant emotion but decreased feelings of pleasant emotion, and increased physiological reactivity. However, studies have rarely controlled the nature of antipsychotic medication. Yet, the influence of these drugs on emotional response is uncertain and could vary depending on their pharmacological profile. This prospective and randomized study aimed to compare the effects of an atypical antipsychotic, risperidone, to a typical one, haloperidol, on patients' emotional responding during an emotional induction task. Twenty-five schizophrenic patients underwent two emotional and clinical evaluations: one before treatment initiation and a second 4 weeks after. Emotional states of fear, sadness, anger, joy, and disgust were induced, as well as a neutral baseline state. Video recordings of patients during the induction task allowed for assessment of emotional expressiveness. Self-reports and measures of skin conductance and heart rate were performed to determine both subjective and physiological reactions to emotional experience. Compared to haloperidol, risperidone did not reduce patients' facial expressiveness, decreased physiological reactivity, and decreased experience of unpleasant emotion but maintained experience of pleasant emotion. Emotional expressiveness was negatively correlated to parkisonism. Our preliminary results suggest that atypical antipsychotics allow for better-adapted patterns of emotional responding than typical ones do. We suggest that this effect is due to reduced striatal D2 blockade, therefore, attenuating akinesia, coupled with increased 5HT and DA levels in prefrontal cortex, which improves emotional regulation.

  16. Ziprasidone versus olanzapine, risperidone or quetiapine in patients with chronic schizophrenia: a 12-week open-label, multicentre clinical trial

    DEFF Research Database (Denmark)

    Lublin, Henrik; Haug, Hans-Joachim; Koponen, Hannu

    2009-01-01

    The efficacy, safety and tolerability of ziprasidone versus the comparators olanzapine, risperidone or quetiapine were investigated in adult patients with chronic schizophrenia, schizoaffective and schizophreniform disorders, with lack of efficacy or intolerance to their previous antipsychotic tr...

  17. Application of a disease-specific mapping function to estimate utility gains with effective treatment of schizophrenia

    Directory of Open Access Journals (Sweden)

    Rupnow Marcia FT

    2005-09-01

    Full Text Available Abstract Background Most tools for estimating utilities use clinical trial data from general health status models, such as the 36-Item Short-Form Health Survey (SF-36. A disease-specific model may be more appropriate. The objective of this study was to apply a disease-specific utility mapping function for schizophrenia to data from a large, 1-year, open-label study of long-acting risperidone and to compare its performance with an SF-36-based utility mapping function. Methods Patients with schizophrenia or schizoaffective disorder by DSM-IV criteria received 25, 50, or 75 mg long-acting risperidone every 2 weeks for 12 months. The Positive and Negative Syndrome Scale (PANSS and SF-36 were used to assess efficacy and health-related quality of life. Movement disorder severity was measured using the Extrapyramidal Symptom Rating Scale (ESRS; data concerning other common adverse effects (orthostatic hypotension, weight gain were collected. Transforms were applied to estimate utilities. Results A total of 474 patients completed the study. Long-acting risperidone treatment was associated with a utility gain of 0.051 using the disease-specific function. The estimated gain using an SF-36-based mapping function was smaller: 0.0285. Estimates of gains were only weakly correlated (r = 0.2. Because of differences in scaling and variance, the requisite sample size for a randomized trial to confirm observed effects is much smaller for the disease-specific mapping function (156 versus 672 total subjects. Conclusion Application of a disease-specific mapping function was feasible. Differences in scaling and precision suggest the clinically based mapping function has greater power than the SF-36-based measure to detect differences in utility.

  18. Comparison of risperidone and aripiprazole in the treatment of preschool children with disruptive behavior disorder and attention deficit-hyperactivity disorder: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Parvin Safavi

    2016-01-01

    Full Text Available Although pharmacotherapy with atypical antipsychotics is common in child psychiatry, there has been little research on this issue. To compare the efficacy and safety of risperidone and aripiprazole in the treatment of preschool children with disruptive behavior disorders comorbid with attention deficit-hyperactivity disorder (ADHD. Randomized clinical trial conducted in a university-affiliated child psychiatry clinic in southwest Iran. Forty 3-6-year-old children, diagnosed with oppositional defiant disorder comorbid with ADHD, were randomized to an 8-week trial of treatment with risperidone or aripiprazole (20 patients in each group. Assessment was performed by Conners′ rating scale-revised and clinical global impressions scale, before treatment, and at weeks 2, 4, and 8 of treatment. The data were analyzed by SPSS version 16. Mean scores between the two groups were compared by analysis of variance and independent and paired t-test. Mean scores of Conners rating scales were not different between two groups in any steps of evaluation. Both groups had significantly reduced scores in week 2 of treatment (P = 0.00, with no significant change in subsequent measurements. Rates of improvement, mean increase in weight (P = 0.894, and mean change in fasting blood sugar (P = 0.671 were not significantly different between two groups. Mean serum prolactin showed a significant increase in risperidone group (P = 0.00. Both risperidone and aripiprazole were equally effective in reducing symptoms of ADHD and oppositional defiant disorder, and relatively safe, but high rates of side effects suggest the cautious use of these drugs in children.

  19. A case report of schizoaffective disorder with ritualistic behaviors and catatonic stupor: successful treatment by risperidone and modified electroconvulsive therapy.

    Science.gov (United States)

    Bai, Yuanhan; Yang, Xi; Zeng, Zhiqiang; Yang, Haichen

    2018-03-13

    Ritualistic behaviors are common in obsessive compulsive disorder (OCD), while catatonic stupor occasionally occurs in psychotic or mood disorders. Schizoaffective disorder is a specific mental disorder involving both psychotic and affective symptoms. The syndrome usually represents a specific diagnosis, as in the case of the 10th edition of the International Classification of Diseases (ICD-10) or the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). However, symptom-based diagnosis can result in misdiagnosis and hinder effective treatment. Few cases of ritualistic behaviors and catatonic stupor associated with schizoaffective disorder have been reported. Risperidone and modified electroconvulsive therapy (MECT) were effective in our case. A 35-year-old man with schizoaffective disorder-depression was admitted to the hospital because of ritualistic behaviors, depression, and distrust. At the time of admission, prominent ritualistic behaviors and depression misled us to make the diagnosis of OCD. Sertraline add-on treatment exacerbated the psychotic symptoms, such as pressure of thoughts and delusion of control. In the presence of obvious psychotic symptoms and depression, schizoaffective disorder-depression was diagnosed according to ICD-10. Meanwhile, the patient unfortunately developed catatonic stupor and respiratory infection, which was identified by respiratory symptoms, blood tests, and a chest X-ray. To treat psychotic symptoms, catatonic stupor, and respiratory infection, risperidone, MECT, and ceftriaxone were administered. As a result, we successfully cured the patient with the abovementioned treatment strategies. Eventually, the patient was diagnosed with schizoaffective disorder-depression with ritualistic behaviors and catatonia. Risperidone and MECT therapies were dramatically effective. Making a differential diagnosis of mental disorders is a key step in treating disease. Sertraline was not recommended for treating

  20. Intrathecal injection of naked plasmid DNA provides long-term expression of secreted proteins.

    Science.gov (United States)

    Hughes, Travis S; Langer, Stephen J; Johnson, Kirk W; Chavez, Raymond A; Watkins, Linda R; Milligan, Erin D; Leinwand, Leslie A

    2009-01-01

    Therapeutic benefit has been reported to result from intrathecal (i.t.) injection of transgene vectors, including naked DNA. However, most studies using naked DNA have measured only the transgene expression of intracellular proteins. Here we demonstrate that i.t. injection of naked DNA can result in long-term expression of secreted proteins. Plasmids expressing either secreted alkaline phosphatase (SEAP) or human interleukin-10 (hIL-10) were injected into the i.t. space in rats, and transgene products were repeatedly measured in the cerebrospinal fluid (CSF). Both SEAP and hIL-10 were maximal at 1 and 2 days after the injection and still detectable at 4 months. The utilization of a plasmid having two features that are hypothesized to increase gene expression (matrix attachment regions (MARs) and lack of CpG dinucleotides) resulted in a significant increase in gene expression. Reinjection of SEAP or hIL-10 plasmids after 4 months significantly increased protein levels at 1 and 14 days after the reinjection. SEAP was uniformly distributed between the DNA delivery site (approximately vertebral level T13) and the lumbar puncture site (L5/L6 inter-vertebral space), was reduced at the cisterna magna, and was detectable, though at much lower levels, in serum. These data suggest that naked DNA has the potential to be used as a therapeutic tool for applications that require long-term release of transgenes into the CSF.

  1. 76 FR 42125 - Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for...

    Science.gov (United States)

    2011-07-18

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9440-3] Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for Exemption--Class I Hazardous Waste Injection; ConocoPhillips... Restrictions, under the 1984 Hazardous and Solid Waste Amendments to the Resource Conservation and Recovery Act...

  2. 78 FR 76294 - Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for...

    Science.gov (United States)

    2013-12-17

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9904-21-OW] Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for Exemption--Class I Hazardous Waste Injection; Mosaic... Restrictions, under the 1984 Hazardous and Solid Waste Amendments to the Resource Conservation and Recovery Act...

  3. 75 FR 60457 - Underground Injection Control Program Hazardous Waste Injection Restrictions; Petition for...

    Science.gov (United States)

    2010-09-30

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9208-4] Underground Injection Control Program Hazardous Waste Injection Restrictions; Petition for Exemption--Class I Hazardous Waste Injection Dow Chemical Company (DOW... 1984 Hazardous and Solid Waste Amendments to the Resource Conservation and Recovery Act have been...

  4. Long-acting β2-agonists in asthma

    DEFF Research Database (Denmark)

    Jacobson, Glenn A; Raidal, Sharanne; Hostrup, Morten

    2018-01-01

    Long-acting β2-agonists (LABAs) such as formoterol and salmeterol are used for prolonged bronchodilatation in asthma, usually in combination with inhaled corticosteroids (ICSs). Unexplained paradoxical asthma exacerbations and deaths have been associated with LABAs, particularly when used without...... and effects on BHR, particularly that (S)-enantiomers of β2-agonists may be deleterious to asthma control. LABAs display enantioselective pharmacokinetics and pharmacodynamics. Biological plausibility of the deleterious effects of β2-agonists (S)-enantiomers is provided by in vitro and in vivo studies from...... mechanism in rapid asthma deaths. More effort should therefore be applied to investigating potential enantiospecific effects of LABAs on safety, specifically bronchoprotection. Safety studies directly assessing the effects of LABA (S)-enantiomers on BHR are long overdue....

  5. Study of injection moulded long glass fibre-reinforced polypropylene and the effect on the fibre length and orientation distribution

    Science.gov (United States)

    Parveeen, B.; Caton-Rose, P.; Costa, F.; Jin, X.; Hine, P.

    2014-05-01

    Long glass fibre (LGF) composites are extensively used in manufacturing to produce components with enhanced mechanical properties. Long fibres with length 12 to 25mm are added to a thermoplastic matrix. However severe fibre breakage can occur in the injection moulding process resulting in shorter fibre length distribution (FLD). The majority of this breakage occurs due to the melt experiencing extreme shear stress during the preparation and injection stage. Care should be taken to ensure that the longer fibres make it through the injection moulding process without their length being significantly degraded. This study is based on commercial 12 mm long glass-fibre reinforced polypropylene (PP) and short glass fibre Nylon. Due to the semi-flexiable behaviour of long glass fibres, the fibre orientation distribution (FOD) will differ from the orientation distribution of short glass fibre in an injection molded part. In order to investigate the effect the change in fibre length has on the fibre orientation distribution or vice versa, FOD data was measured using the 2D section image analyser. The overall purpose of the research is to show how the orientation distribution chnages in an injection moulded centre gated disc and end gated plaque geometry and to compare this data against fibre orientation predictions obtained from Autodesk Moldflow Simulation Insight.

  6. Once-daily glycopyrronium bromide, a long-acting muscarinic antagonist, for chronic obstructive pulmonary disease

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli

    2012-01-01

    Long-acting bronchodilators are central in the pharmacological management of patients with chronic obstructive pulmonary disease (COPD). The aim of this systematic review is to provide an overview of the studies evaluating the safety and clinical efficacy of inhaled glycopyrronium bromide, a novel...... long-acting muscarinic antagonist, in patients with COPD....

  7. Policy and programmatic considerations for introducing a longer-acting injectable contraceptive: perspectives of stakeholders from Kenya and Rwanda

    Science.gov (United States)

    McKenna, Kevin; Arcara, Jennet; Rademacher, Kate H; Mackenzie, Caroline; Ngabo, Fidele; Munyambanza, Emmanuel; Wesson, Jennifer; Tolley, Elizabeth E

    2014-01-01

    ABSTRACT Background: More than 40 million women use injectable contraceptives to prevent pregnancy, and most current or previous injectable users report being satisfied with the method. However, while women may find injectables acceptable, they may not always find them accessible due to stock-outs and difficulties with returning to the clinic for reinjections. FHI 360 is spearheading efforts to develop a longer-acting injectable (LAI) contraceptive that could provide at least 6 months of protection against pregnancy. This article addresses systems-level considerations for the introduction of a new LAI. Methods: We conducted qualitative case studies in Kenya and Rwanda—two countries that have high levels of injectable use but with different service delivery contexts. Between June and September 2012, we conducted in-depth interviews with 27 service providers and 19 policy makers and program implementers focusing on 4 themes: systems-level barriers and facilitators to delivering LAI services; process for introducing an LAI; LAI distribution approaches; and potential LAI characteristics. We also obtained electronic feedback from 28 international family planning opinion leaders. Results: Respondents indicated strong interest in an LAI and thought it would appeal to existing injectable users as well as new family planning clients, both for spacing and for limiting births. Providers appreciated the potential for a lighter workload due to fewer follow-up visits, but they were concerned that fewer visits would also decrease their ability to help women manage side effects. The providers also appreciated the 1-month grace period for follow-up LAI injections; some seemed unaware of the latest international guidance that had increased the grace period from 2 weeks to 4 weeks for the currently available 3-month injectable. The majority of policy makers and program implementers were supportive of letting community health workers provide the method, but many nurses and midwives

  8. Targets, attitudes, and goals of psychiatrists treating patients with schizophrenia: key outcome drivers, role of quality of life, and place of long-acting antipsychotics

    Directory of Open Access Journals (Sweden)

    de Bartolomeis A

    2016-01-01

    Full Text Available Andrea de Bartolomeis,1 Andrea Fagiolini,2 Marco Vaggi,3 Claudio Vampini4 1Section of Psychiatry and Treatment Resistant Psychosis, Department of Neuroscience, University of Naples Federico II, Naples, Italy; 2Department of Molecular and Developmental Medicine, School of Medicine, University of Siena, Siena, Italy; 3Mental Health and Drug Addiction Department, Genovese, Genoa, Italy; 4Department of Mental Health, Ospedale Civile Maggiore and ULSS 20, Verona, Italy Purpose: This survey of Italian psychiatrists was conducted to better define drivers of schizophrenia treatment choice in real-life practice, particularly for use of long-acting injectable (LAI antipsychotics.Methods: Between October 15 and December 15, 2014, 1,000 surveys were sent to psychiatrists who treat schizophrenic patients; 709 completed questionnaires were analyzed (71% response rate.Results: The two most important factors determining therapy success were efficacy (75% of responses and tolerability (45% followed by global functioning (24% and quality of life (17%. LAI antipsychotics were most often used to facilitate regular treatment monitoring (49%, and 41% of psychiatrists thought that patients with low adherence who had failed oral therapy were well-suited for LAI antipsychotics. Only 4% of respondents saw LAI antipsychotics as appropriate for patients without other therapeutic options.Conclusion: Although efficacy and tolerability were the most common factors used to evaluate treatment success in schizophrenia, psychiatrists also consider QoL and global functioning to be important. Keywords: quality of life, long-acting injectable antipsychotics, schizophrenia, survey

  9. Evaluation of the long-term efficacy of CT-guided epidural steroid injection for the treatment of sciatica

    International Nuclear Information System (INIS)

    Tong Guohai; Wang Wei; Chen Wei; Chen Kemin

    2005-01-01

    Objective: To evaluate the long-term efficacy of CT-guided epidural steroid injection for the treatment of sciatica. Methods: CT-guided epidural steroid injection was performed in 180 patients with sciatica from May 1998 to March 2004, and all patients had failure to previous conservative treatment. Visual analogue scale was used to evaluate the pain of the patient before and after the treatment. Results: Follow-up was taken for 112 cases during 1-6 years after the treatment, 89 patients (79.5%) had successful long-term outcome and 80 patients (71.4%) were satisfied. Conclusions: CT-guided epidural steroid injection can reduce low back pain and radical pain. It should be preferentially considered as the first choice when conservative treatments are failed. (authors)

  10. Resource Conservation and Recovery Act closure report: Area 2 Bitcutter and Postshot Containment Shops Injection Wells, Correction Action Unit 90

    International Nuclear Information System (INIS)

    1996-12-01

    This Closure Report provides documentation of the activities conducted during the Resource Conservation and Recovery Act (RCRA) closure of the Bitcutter and Postshot Containment Shops Injection Wells located in Area 2 of the Nevada Test Site (NTS), Oak Spring Quadrangle (USGS, 1986), Township 10 South, Range 53 East, Nye County, Nevada. This report discusses the Bitcutter Shop Inside Injection Well (CAU 90-A) closure-in-place and the Bitcutter Shop Outside Injection Well (CAU 90-B) and Postshot Containment Shop Injection Well (CAU 90-C) clean closures. This Closure Report provides background information about the unit, the results of the characterization activities and actions conducted to determine the closure design. It also provides a discussion of the drainage analysis, preliminary closure activities, final closure activities, waste management activities, and the Post-Closure Care requirements

  11. Uptake of long-acting reversible contraceptive devices in Western ...

    African Journals Online (AJOL)

    Background: The contraceptive method has become an essential factor in the life of most women of reproductive age group; although it varies in different stages of their life course. The use of long acting reversible methods (LARC) is proposed as a strategy to reverse undesirable maternal health consequences in ...

  12. A Comparison Study of Quetiapine and Risperidone's Effectiveness and Safety on Treating Alcohol-induced Mental Disorder.

    Science.gov (United States)

    Lv, Bei; Duan, Haishui

    2016-08-25

    Compared with Risperidone, Quetiapine's effectiveness and safety on treating alcohol-induced mental disorder is still unclear. To investigate the clinical effectiveness and safety of Quetiapine on treating alcohol-induced mental disorder. One hundred and forty-eight patients with alcohol-induced mental disorder were divided into the experimental group (75 patients) and the control group (73 patients) by the treatments they received. The patients in the experimental group were treated with Quetiapine by taking it three times per day orally. The mean (sd) maintenance dose was 151.2(27.3) mg/d, and the treatment cycle was 6 weeks. Patients in the control group received Risperidone once per day orally with a mean (sd) maintenance dose being 2.3(0.9) mg/d, and the treatment cycle was 6 weeks as well. The PANSS scale was used to assess patients' before and after treatment. The researchers also observed any adverse reactions in both treatment strategies and evaluated the effectiveness and safety of both treatment strategies. The mean (sd) PANSS scale score of the experimental group after two weeks of treatment was 71.9 (10.2), which was clearly better than the mean (sd) score before treatment (82.6 [11.4]), and was significantly better than the control group's mean (sd) score after two weeks (76.5[12.8]). Also, the experimental group's scores after 4 weeks of treatment and 6 weeks of treatment were significantly better than the control group. The experimental group's efficacy rate (94.7%) was higher than the control group's (90.4%); the cure rate of the experimental group (33.3%) was higher than that of the control group (24.7%), and the difference was statistically significant. The rates of adverse reactions in the experimental and control groups were 13.3% and 19.2% respectively, and they were significantly different from each other. Treating alcohol-induced mental disorder with Quetiapine is more effective than treating it with Risperidone. Quetiapine can improve

  13. Comparison between the efficacies of Risperidone with Haloperidol in the treatment of attention-deficit hyperactivity disorder (ADHD) among preschoolers: a randomized double-blind clinical trial.

    Science.gov (United States)

    Riahi, Forough; Tashakori, Ashraf; Abdi, Leila

    2016-09-01

    Attention-deficit hyperactivity disorder (ADHD) is a common psychiatric disease with a worldwide pooled prevalence of 5.29%. To compare the efficacy of Risperidone with Haloperidol in the treatment of attention-deficit hyperactivity disorder (ADHD) among 3- to 6-year-old children. In a 6-week double-blind clinical trial, the efficacy of Risperidone 0.5-2 mg with a dose of maximum Haloperidol 0.075 mg/kg was assessed in 39 children aged 3-6 years. This study was conducted at the Golestan Psychiatric Clinic (Ahvaz, Iran). Measurement tools included the Conners' Parent Rating Scale (CPRS-48), Children's Global Assessment Scale (CGAS), and the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS). Data were analyzed using the Wilcoxon, Mann-Whitney, and Fisher's exact tests in the SPSS 19. During the 6 weeks, the decline in points was seen in Conner's rating scale and in ADHD-RS score in Risperidone and Haloperidol groups (pscale, an increase of performance in both groups for six weeks was statistically significant (pscales of ADHD-RS and CPRS-48, no statistically significant difference was observed between the two treatment groups; i.e., in terms of reducing the rate during weeks of two, four, and six (p>0.05). Haloperidol and Risperidone possibly can be an acceptable treatment choice in the ADHD treatment of 3- to 6-year-old children. The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the Irct ID: IRCT2015082623766N1. This work was financially supported by grant (ref. no.: U-93130) from the vice chancellor for Research Affairs of Ahvaz Jundishapur University of Medical Sciences.

  14. Long-term Dose Stability of OnabotulinumtoxinA Injection for Adductor Spasmodic Dysphonia: A 19-Year Single Institution Experience

    Directory of Open Access Journals (Sweden)

    Paul Paddle

    2017-11-01

    Full Text Available ObjectivesAdductor spasmodic dysphonia (AdSD is a focal dystonia predominantly involving the laryngeal adductor muscles. AdSD is reported to be a largely non-progressive neurological disorder, though fluctuations in symptom severity do occur. Repeated laryngeal onabotulinumtoxinA (BTX-A injections are the primary management for AdSD. A number of studies have demonstrated long-term dose stability as evidence of this long-term disease stability.MethodsA retrospective review was performed on all patients undergoing BTX-A injections for AdSD from April 1994 to September 2013 by a single laryngologist at a tertiary referral laryngology center. Patient demographics, injection doses, use of diazepam and/or lidocaine, and self-reported vocal function were recorded. Multiple linear regression analyses were performed.Results83 patients underwent a total of 1,168 injections over 19 years. The mean starting dose was 2.35 MU (0.79 SD. The mean long-term dose was 2.36 MU (0.79 SD. After adjusting for confounders, the change in the relative dose of BTX-A, with every year elapsed since initial dose was 0.13% (95% confidence interval −0.31 to 0.57%, p = 0.568.ConclusionBTX-A dose is stable over time in our large cohort of patients treated with bilateral thyroarytenoid injections for AdSD.

  15. Paroxetine and Low-dose Risperidone Induce Serotonin 5-HT1A and Dopamine D2 Receptor Heteromerization in the Mouse Prefrontal Cortex.

    Science.gov (United States)

    Kolasa, Magdalena; Solich, Joanna; Faron-Górecka, Agata; Żurawek, Dariusz; Pabian, Paulina; Łukasiewicz, Sylwia; Kuśmider, Maciej; Szafran-Pilch, Kinga; Szlachta, Marta; Dziedzicka-Wasylewska, Marta

    2018-05-01

    Recently, it has been shown that serotonin 5-HT 1A receptor interacts with dopamine D2 receptor in vitro. However, the existence of 5-HT 1A -D2 heteromers in native tissue remains unexplored. In the present study, we investigated 5-HT 1A -D2 receptor heteromerization in mice treated acutely or chronically with paroxetine (10 mg/kg) or risperidone (0.05 mg/kg). Receptor heteromerization was visualized and quantified in the mouse brain by in situ proximity ligation assay (PLA). Additionally, we aimed to determine the cellular localization of 5-HT 1A -D2 receptor heteromers in mouse adult primary neuronal cells by immunofluorescent staining with markers for astrocytes (GFAP) and neurons (NeuN and MAP2). The results from the current study demonstrated that 5-HT 1A and D2 receptor co-localization and heteromerization occurred in the mouse prefrontal cortex. Counterstaining after PLA confirmed neuronal (pyramidal and GABAergic) as well as astrocytal localization of 5-HT 1A -D2 receptor heteromers. Chronic administration of paroxetine or risperidone increased the level of 5-HT 1A -D2 receptor heteromers in the prefrontal cortex. These changes were not accompanied by any changes in the expression of mRNAs (measured by in situ hybridization) or densities of 5-HT 1A and D2 receptors (quantified by receptor autoradiography with [3H]8-OH-DPAT and [3H]domperidone, respectively), what all indicated that paroxetine and risperidone facilitated 5-HT 1A -D2 heteromer formation independently of the receptor expression. In vitro homogenous time-resolved FRET (HTRF) study confirmed the ability of tested drugs to influence the human 5-HT 1A -D2 heteromer formation. The obtained data indicate that the increase in 5-HT 1A -D2 receptor heteromerization is a common molecular characteristic of paroxetine and low-dose risperidone treatment. Copyright © 2018 IBRO. Published by Elsevier Ltd. All rights reserved.

  16. Laryngeal electromyography-guided hyaluronic acid vocal fold injection for unilateral vocal fold paralysis: a prospective long-term follow-up outcome report.

    Science.gov (United States)

    Wang, Chen-Chi; Chang, Ming-Hong; Jiang, Rong-San; Lai, Hsiu-Chin; De Virgilio, Armando; Wang, Ching-Ping; Wu, Shang-Heng; Liu, Shi-An; Liang, Kai-Li

    2015-03-01

    Unilateral vocal fold paralysis (UVFP) is a common voice disorder that may cause glottal closure insufficiency with hoarseness of voice. Laryngeal electromyography (LEMG)-guided hyaluronic acid vocal fold (VF) injection has been proposed as a treatment option to improve glottal closure with a satisfactory short-term effect. To our knowledge, this study reports the first long-term follow-up result of this treatment modality. To present the long-term treatment results of LEMG-guided hyaluronic acid VF injection for UVFP. Prospective study of the treatment results of 74 patients who received LEMG-guided hyaluronic acid VF injection for UVFP at a tertiary referral medical center from March 2010 to February 2013. In the office-based procedure, 1.0 mL of hyaluronic acid was injected via a 26-gauge monopolar injectable needle electrode into paralyzed thyroarytenoid muscles by LEMG guidance. Various glottal closure evaluations such as normalized glottal gap area, maximal phonation time, phonation quotient, mean airflow rate, perceptual GRBAS (grade, roughness, breathiness, asthenia, strain) scale, and Voice Handicap Index were compared before and after injection using the nonparametric Wilcoxon signed rank test within 1 month, at 6 months, and at the last follow-up examination. Sixty patients had been followed up for at least 6 months. Forty-four patients received only 1 injection, and 16 patients received repeated injections (2 injections for 13 patients and 3 for 3 patients). All the glottal closure parameters improved significantly (P injection and 16 (22%) who received repeated injections did not require another treatment after long-term follow-up. Laryngeal electromyography-guided hyaluronic acid VF injection is an option for treating UVFP with satisfactory results.

  17. A very long engagement: The Children's Act 38 of 2005 and the ...

    African Journals Online (AJOL)

    A very long engagement: The Children's Act 38 of 2005 and the 1993 Hague Convention on the Protection of Children and Cooperation in Respect of ... Act is a dramatic improvement on the current regime of intercountry adoptions and that it has the potential to make this institution work in the best interests of children.

  18. Long-term persistence with injectable therapy in relapsing-remitting multiple sclerosis: an 18-year observational cohort study.

    Directory of Open Access Journals (Sweden)

    Simon Zhornitsky

    Full Text Available Disease modifying therapies (DMTs reduce the frequency of relapses and accumulation of disability in multiple sclerosis (MS. Long-term persistence with treatment is important to optimize treatment benefit. This long-term, cohort study was conducted at the Calgary MS Clinic. All consenting adults with relapsing-remitting MS who started either glatiramer acetate (GA or interferon-β 1a/1b (IFN-β between January 1st, 1996 and July 1st, 2011 were included. Follow-up continued to February 1st, 2014. Time-to-discontinuation of the initial and subsequently-prescribed DMTs (switches was analysed using Kaplan-Meier survival analyses. Group differences were compared using log-rank tests and multivariable Cox regression models. Analysis included 1471 participants; 906 were initially prescribed GA and 565 were initially prescribed IFN-β. Follow-up information was available for 87%; 29 (2% were lost to follow-up and 160 (11% moved from Southern Alberta while still using DMT. Median time-to-discontinuation of all injectable DMTs was 11.1 years. Participants with greater disability at treatment initiation, those who started treatment before age 30, and those who started between 2006 and 2011 were more likely to discontinue use of all injectable DMTs. Median time-to-discontinuation of the initial DMT was 8.6 years. Those initially prescribed GA remained on treatment longer. Of 610 participants who discontinued injectable DMT, 331 (54% started an oral DMT, or a second-line DMT, or resumed injectable DMT after 90 days. Persistence with injectable DMTs was high in this long-term population-based study. Most participants who discontinued injectable DMT did not remain untreated. Further research is required to understand treatment outcomes and outcomes after stopping DMT.

  19. Factors influencing use of long-acting versus short-acting contraceptive methods among reproductive-age women in a resource-limited setting.

    Science.gov (United States)

    Tibaijuka, Leevan; Odongo, Robert; Welikhe, Emma; Mukisa, Wilber; Kugonza, Lilian; Busingye, Imelda; Nabukalu, Phelomena; Ngonzi, Joseph; Asiimwe, Stephen B; Bajunirwe, Francis

    2017-04-04

    Unplanned pregnancy remains a common problem in many resource-limited settings, mostly due to limited access to modern family planning (FP) services. In particular, use of the more effective long-acting reversible contraceptive (LARC) methods (i.e., intrauterine devices and hormonal implants) remains low compared to the short-acting methods (i.e., condoms, hormonal pills, injectable hormones, and spermicides). Among reproductive-age women attending FP and antenatal care clinics in Uganda, we assessed perceptions and practices regarding the use of modern contraceptive methods. We specifically aimed to evaluate factors influencing method selection. We performed a mixed-methods cross-sectional study, in which we administered structured interviews to 180 clients, and conducted 4 focus group discussions (FGDs) with 36 clients and 8 in-depth personal qualitative interviews with health service providers. We summarized quantitative data and performed latent content analysis on transcripts from the FGDs and qualitative interviews. The prevalence of ever use for LARC methods was 23%. Method characteristics (e.g., client control) appeared to drive method selection more often than structural factors (such as method availability) or individual client characteristics (such as knowledge and perceptions). The most common reasons for choosing LARC methods were: longer protection; better child-spacing; and effectiveness. The most common reasons for not choosing LARC methods included requiring a client-controlled method and desiring to conceive in the near future. The most common reasons for choosing short-acting methods were ease of access; lower cost; privacy; perceived fewer side effects; and freedom to stop using a method without involving the health provider. The personal characteristics of clients, which appeared to be important were client knowledge and number of children. The structural factor which appeared to be important was method availability. Our results suggest that

  20. Bioequivalence and pharmacokinetic evaluation of two formulations of risperidone 2 mg : an open-label, single-dose, fasting, randomized-sequence, two-way crossover study in healthy male Chinese volunteers.

    Science.gov (United States)

    Liu, Yun; Zhang, Meng-qi; Jia, Jing-ying; Liu, Yan-mei; Liu, Gang-yi; Li, Shui-jun; Wang, Wei; Weng, Li-ping; Yu, Chen

    2013-03-01

    Risperidone is a benzisoxazole derivate and is effective in the treatment of schizophrenia and other psychiatric illnesses in adults and children. Although there are a few reports in the literature regarding the pharmacokinetic characteristics of risperidone, insufficient data on its pharmacokinetic properties in a Chinese population are available. To meet the requirements for marketing a new generic product, this study was designed to compare the pharmacokinetic properties and bioequivalence of two 2 mg tablet formulations of risperidone: a newly developed generic formulation (test) and a branded formulation (reference) in healthy adult male Chinese volunteers. A single-dose, open-label, randomized-sequence, 2 × 2 crossover study was conducted in fasted healthy male Chinese volunteers. Eligible participants were randomly assigned in a 1:1 ratio to receive 1 tablet (2 mg each) of the test formulation (Risperidone tablet; Dr. Reddy's Laboratories Ltd., Hyderabad, India) or the reference formulation (Risperdal(®) tablet; Xian-Janssen Pharmaceutical Ltd., Xi-an, China), followed by a 2-week washout period and subsequent administration of the alternate formulation. The study drugs were administered after a 10-hour overnight fast. Plasma samples were collected over 96 hours. Plasma concentrations of the parent drug, risperidone, and its active metabolite, 9-hydroxy-risperidone, were analyzed by a liquid chromatography-tandem mass spectrometry method. The formulations would be considered bioequivalent if the 90% confidence intervals (CIs) of the natural log-transformed values were within the predetermined 80-125% equivalence range for the maximum plasma drug concentration (Cmax) and the area under the plasma concentration-time curve (AUC), in accordance with guidelines issued by the US Food and Drug Administration. Assessment of tolerability was based on recording of adverse events (AEs), monitoring of vital signs, electrocardiograms, and laboratory tests at baseline

  1. Particle fuelling for long pulse with standard gas puff and supersonic pulsed gas injection

    International Nuclear Information System (INIS)

    Bucalossi, J.; Tsitrone, E.; Martin, G.

    2003-01-01

    In addition to the standard gas puff and to the technically complex pellet injection, a novel intermediate method, based on the injection of a supersonic high density cloud of neutrals, has been recently implemented on the Tore Supra tokamak. Fuelling efficiency, in the 30-50% range are found while it lies in the 10-20% range for the gas puff. It is not sensitive to the plasma density and to the additional heating. According to modelling, the increased efficiency is attributed to the very short injection duration compared to the particle confinement time and to the strong cooling of the plasma edge resulting from the massive injection of matter. A feedback loop on the frequency of the injector has been successfully implemented to control the plasma density. In long pulse experiments (>200s), wall saturation has not been reached. Gas puffing rate was typically around 1 Pa.m 3 s -1 while dynamic wall retention around 0.6 Pa.m 3 s -1 . Co-deposited carbon layer could trap such large amounts of gas. A discharge fuelled by supersonic pulsed gas injections exhibits lower wall retention than a gas puff fuelled discharge. (author)

  2. Switching to aripiprazole in outpatients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues with risperidone: a randomized, multicentre, open-label study.

    Science.gov (United States)

    Ryckmans, V; Kahn, J P; Modell, S; Werner, C; McQuade, R D; Kerselaers, W; Lissens, J; Sanchez, R

    2009-05-01

    This study evaluated the safety/tolerability and effectiveness of aripiprazole titrated-dose versus fixed-dose switching strategies from risperidone in patients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues. Patients were randomized to an aripiprazole titrated-dose (starting dose 5 mg/day) or fixed-dose (dose 15 mg/day) switching strategy with risperidone down-tapering. Primary endpoint was rate of discontinuation due to adverse events (AEs) during the 12-week study. Secondary endpoints included positive and negative syndrome scale (PANSS), clinical global impressions - improvement of illness scale (CGI-I), preference of medication (POM), subjective well-being under neuroleptics (SWN-K) and GEOPTE (Grupo Español para la Optimización del Tratamiento de la Esquizofrenia) scales. Rates of discontinuations due to AEs were similar between titrated-dose and fixed-dose strategies (3.5% vs. 5.0%; p=0.448). Improvements in mean PANSS total scores were similar between aripiprazole titrated-dose and fixed-dose strategies (-14.8 vs. -17.2; LOCF), as were mean CGI-I scores (2.9 vs. 2.8; p=0.425; LOCF) and SWN-K scores (+8.6 vs.+10.3; OC,+7.8 vs.+9.8; LOCF). Switching can be effectively and safely achieved through a titrated-dose or fixed-dose switching strategy for aripiprazole, with down-titration of risperidone.

  3. Prevalence and factors affecting use of long acting and permanent ...

    African Journals Online (AJOL)

    Introduction: In Ethiopia, knowledge of contraceptive methods is high though there is low contraceptive prevalence rate. This study was aimed to assess prevalence and associated factors of long acting and permanent contraceptive methods in Jinka town, southern Ethiopia. Methods: Community based cross sectional ...

  4. Regulatory challenges in developing long-acting antiretrovirals for treatment and prevention of HIV infection.

    Science.gov (United States)

    Arya, Vikram; Au, Stanley; Belew, Yodit; Miele, Peter; Struble, Kimberly

    2015-07-01

    To outline some of the regulatory challenges inherent to the development of long-acting antiretrovirals (ARVs) for the treatment or prevention of HIV infection. Despite advances in drug development that have reduced ARV dosing to once daily, suboptimal drug adherence remains an obstacle to successful HIV treatment. Further, large randomized trials of once daily oral ARVs for preexposure prophylaxis (PrEP) have shown that drug adherence correlates strongly with prophylactic effect and study outcomes. Thus, the prospect of developing long-acting ARVs, which may mitigate drug adherence issues, has attracted considerable attention lately. Because of their pharmacokinetic properties, the development of long-acting ARVs can present novel regulatory challenges. Chief among them is determining the appropriate dosing regimen, the need for an oral lead-in, and whether existing data with an approved oral agent, if available, can be leveraged for a treatment or prevention indication. For PrEP, because validated biomarkers are lacking, additional nonclinical studies and evaluation of tissue concentrations in multiple compartments may be necessary to identify optimal dosages. Study design and choice of controls for registrational trials of new long-acting PrEP agents might also prove challenging following the availability of an oral PrEP drug.

  5. Willingness of community-recruited men who have sex with men in Washington, DC to use long-acting injectable HIV pre-exposure prophylaxis.

    Directory of Open Access Journals (Sweden)

    Matthew E Levy

    Full Text Available Clinical trials are currently investigating the safety and efficacy of long-acting injectable (LAI agents as HIV pre-exposure prophylaxis (PrEP. Using National HIV Behavioral Surveillance data, we assessed the self-reported willingness of men who have sex with men (MSM to use LAI PrEP and their preference for LAI versus daily oral PrEP.In 2014, venue-based sampling was used to recruit MSM aged ≥18 years in Washington, DC. Participants completed an interviewer-administered survey followed by voluntary HIV testing. This analysis included MSM who self-reported negative/unknown HIV status at study entry. Correlates of being "very likely" to use LAI PrEP and preferring it to daily oral PrEP were identified using multivariable logistic regression.Of 314 participants who self-reported negative/unknown HIV status, 50% were <30 years old, 41% were non-Hispanic Black, 37% were non-Hispanic White, and 14% were Hispanic. If LAI PrEP were offered for free or covered by health insurance, 62% were very likely, 25% were somewhat likely, and 12% were unlikely to use it. Regarding preferred PrEP modality, 67% chose LAI PrEP, 24% chose oral PrEP, and 9% chose neither. Correlates of being very likely versus somewhat likely/unlikely to use LAI PrEP included age <30 years (aOR 1.64; 95% CI 1.00-2.68, reporting ≥6 (vs. 1 sex partners in the last year (aOR 2.60; 95% CI 1.22-5.53, previous oral PrEP use (aOR 3.67; 95% CI 1.20-11.24, and being newly identified as HIV-infected during study testing (aOR 4.83; 95% CI 1.03-22.67. Black (vs. White men (aOR 0.48; 95% CI 0.24-0.96 and men with an income of <$20,000 (vs. ≥$75,000; aOR 0.37; 95% CI 0.15-0.93 were less likely to prefer LAI to oral PrEP.If LAI PrEP were found to be efficacious, its addition to the HIV prevention toolkit could facilitate more complete PrEP coverage among MSM at risk for HIV.

  6. Initiation and continuation of long-acting reversible contraception in the United States military healthcare system.

    Science.gov (United States)

    Chiles, Daniel P; Roberts, Timothy A; Klein, David A

    2016-09-01

    Long-acting reversible contraception is more effective for pregnancy prevention than shorter-acting contraceptive methods and has the potential to reduce healthcare disparities and costs. However, long-acting reversible contraception is underused in the United States. One population of interest is beneficiaries of the United States military healthcare system who have access to universal healthcare, including no-cost, no-copay contraception with unlimited method switching, and comprise a large, actual use cohort. Efforts to increase long-acting reversible contraception initiation and continuation in this population may improve health outcomes and mitigate the profound consequences of unintended or mistimed pregnancy on readiness and cost to the military. We aimed to determine long-acting reversible contraception initiation and continuation rates among the diverse population with universal healthcare who are enrolled in the US military healthcare system. This study is a retrospective cohort of >1.7 million women, aged 14-40 years, who were enrolled in the US military healthcare system, TRICARE Prime, between October 2009 and September 2014. Individuals were assessed for long-acting reversible contraception initiation and continuation with the use of medical billing records. Method continuation and factors that were associated with early method discontinuation were evaluated with the Kaplan-Meier estimator and Cox proportional hazard models. During the study dates, 188,533 women initiated long-acting reversible contraception. Of these, 74.6% women selected intrauterine contraceptives. Method initiation rates remained relatively stable (41.7-50.1/1000 women/year) for intrauterine methods, although the rate for subdermal implants increased from 6.1-23.0/1000 women/year. In analysis of women who selected intrauterine contraceptives, 61.2% continued their method at 36 months, and 48.8% continued at 60 months. Among women who selected the implant, 32.0% continued their

  7. A Non-Interventional Naturalistic Study of the Prescription Patterns of Antipsychotics in Patients with Schizophrenia from the Spanish Province of Tarragona.

    Directory of Open Access Journals (Sweden)

    Ana M Gaviria

    Full Text Available The analysis of prescribing patterns in entire catchment areas contributes to global mapping of the use of antipsychotics and may improve treatment outcomes.To determine the pattern of long-term antipsychotic prescription in outpatients with schizophrenia in the province of Tarragona (Catalonia-Spain.A naturalistic, observational, retrospective, non-interventional study based on the analysis of registries of computerized medical records from an anonymized database of 1,765 patients with schizophrenia treated between 2011 and 2013.The most used antipsychotic was risperidone, identified in 463 (26.3% patients, followed by olanzapine in 249 (14.1%, paliperidone in 225 (12.7%, zuclopenthixol in 201 (11.4%, quetiapine in 141 (8%, aripiprazole in 100 (5.7%, and clozapine in 100 (5.7%. Almost 8 out of 10 patients (79.3% were treated with atypical or second-generation antipsychotics. Long-acting injectable (LAI formulations were used in 44.8% of patients. Antipsychotics were generally prescribed in their recommended doses, with clozapine, ziprasidone, LAI paliperidone, and LAI risperidone being prescribed at the higher end of their therapeutic ranges. Almost 7 out of 10 patients (69.6% were on antipsychotic polypharmacy, and 81.4% were on psychiatric medications aside from antipsychotics. Being prescribed quetiapine (OR 14.24, 95% CI 4.94-40.97, LAI (OR 9.99, 95% CI 6.45-15.45, psychiatric co-medications (OR 4.25, 95% CI 2.72-6.64, and paliperidone (OR 3.13, 95% CI 1.23-7.92 were all associated with an increased likelihood of polypharmacy. Being prescribed risperidone (OR 0.54, 95% CI 0.35-0.83 and older age (OR 0.98, 95% CI 0.97-0.99 were related to a low polypharmacy probability.Polypharmacy is the most common pattern of antipsychotic use in this region of Spain. Use of atypical antipsychotics is extensive. Most patients receive psychiatric co-medications such as anxiolytics or antidepressants. Polypharmacy is associated with the use of quetiapine or

  8. Policy and programmatic considerations for introducing a longer-acting injectable contraceptive: perspectives of stakeholders from Kenya and Rwanda.

    Science.gov (United States)

    McKenna, Kevin; Arcara, Jennet; Rademacher, Kate H; Mackenzie, Caroline; Ngabo, Fidele; Munyambanza, Emmanuel; Wesson, Jennifer; Tolley, Elizabeth E

    2014-10-15

    More than 40 million women use injectable contraceptives to prevent pregnancy, and most current or previous injectable users report being satisfied with the method. However, while women may find injectables acceptable, they may not always find them accessible due to stock-outs and difficulties with returning to the clinic for reinjections. FHI 360 is spearheading efforts to develop a longer-acting injectable (LAI) contraceptive that could provide at least 6 months of protection against pregnancy. This article addresses systems-level considerations for the introduction of a new LAI. We conducted qualitative case studies in Kenya and Rwanda-two countries that have high levels of injectable use but with different service delivery contexts. Between June and September 2012, we conducted in-depth interviews with 27 service providers and 19 policy makers and program implementers focusing on 4 themes: systems-level barriers and facilitators to delivering LAI services; process for introducing an LAI; LAI distribution approaches; and potential LAI characteristics. We also obtained electronic feedback from 28 international family planning opinion leaders. Respondents indicated strong interest in an LAI and thought it would appeal to existing injectable users as well as new family planning clients, both for spacing and for limiting births. Providers appreciated the potential for a lighter workload due to fewer follow-up visits, but they were concerned that fewer visits would also decrease their ability to help women manage side effects. The providers also appreciated the 1-month grace period for follow-up LAI injections; some seemed unaware of the latest international guidance that had increased the grace period from 2 weeks to 4 weeks for the currently available 3-month injectable. The majority of policy makers and program implementers were supportive of letting community health workers provide the method, but many nurses and midwives in Kenya had reservations about the

  9. Seventeen-Year Nationwide Trends in Use of Long-acting Bronchodilators and Inhaled Corticosteroids among Adults

    DEFF Research Database (Denmark)

    Reilev, Mette; Pottegård, Anton; Davidsen, Jesper Rømhild

    2018-01-01

    , the total annual amount of prescribed long-acting bronchodilators and ICS increased by 39%. Similarly, the proportion of adult users increased from 2.6% to 4.5%, mainly driven by the introduction of combination therapy and long-acting muscarinic antagonist (LAMA). Though the rate of new users of fixed......-acting bronchodilators and ICS over time, mainly driven by the introduction of combination drugs and LAMA. Special attention should be paid to the low level of persistence, especially among young individuals and users of ICS. This article is protected by copyright. All rights reserved....

  10. A new dual injection system for AMS facility

    International Nuclear Information System (INIS)

    Liu Lin; Zhou Weijian; Cheng Peng; Yu Huagui; Chen Maobai

    2007-01-01

    In order to measure long-lived radioisotopes such as 10 Be with high sensitivity using an HVEE model 4130 AMS system, as well as to guarantee 14 C measurements of high precision, a new dual injection system for the AMS system is proposed. The proposal is to add a Wien filter located between the ion source system and the recombinator of the HVEE model 4130. When a pulsing voltage is optionally applied to the Wien filter, a sequential injection mode is turned on. The isotopes would alternately pass on different trajectories through the recombinator. When the pulsing voltage and magnetic field are turned off, the Wien filter acts as a field-free drift space and the standard simultaneous injection mode is on. Beam optics calculation show that the new dual injection system will increase the number of radio-nuclides which can be analyzed, keep the high precision capability for radiocarbon dating and achieve high sensitivity for 10 Be and 26 Al measurements, together with simplifying the layout as compared to existing dual-injector and dual high-energy beam line systems

  11. Long-term follow-up after urethral injection with polyacrylamide hydrogel for female stress incontinence

    DEFF Research Database (Denmark)

    Mouritsen, Lone; Lose, Gunnar; Møller-Bek, Karl

    2014-01-01

    Urethral injection therapy for treatment of stress urinary incontinence has been in use for years, but only a few long-term follow-up studies have been published. Twenty-five women, injected with polyacrylamide hydrogel 8 years earlier, were invited for follow-up. Twenty-four could be contacted; 15...... had had no further treatment, seven had been re-operated with placement of mid-urethral slings, and two had been re-injected with polyacrylamide hydrogel. Eleven women attended for objective examination; all non-attenders were interviewed by telephone. Subjectively, in 44% the stress incontinence...... was cured or much improved, with a positive outcome according to the King's Health Questionnaire. Objectively, all patients had visible polyacrylamide hydrogel deposits on vaginal ultrasonography. No local adverse reactions were seen in the vaginal mucosa. The results of a later mid-urethral sling were...

  12. Risperidone increases the cortical silent period in drug-naive patients with first-episode schizophrenia: A transcranial magnetic stimulation study.

    Science.gov (United States)

    Ustohal, Libor; Mayerova, Michaela; Hublova, Veronika; Prikrylova Kucerova, Hana; Ceskova, Eva; Kasparek, Tomas

    2017-04-01

    Schizophrenia is accompanied by impaired cortical inhibition, as measured by several markers including the cortical silent period (CSP). It is thought that CSP measures gamma-aminobutyric acid receptors B (GABA B ) mediated inhibitory activity. But the mutual roles of schizophrenia as a disease and the drugs used for the treatment of psychosis on GABA mediated neurotransmission are not clear. We recruited 13 drug-naive patients with first-episode schizophrenia. We used transcranial magnetic stimulation to assess CSP prior to initiating risperidone monotherapy and again four weeks later. At the same time, we rated the severity of psychopathology using the Positive and Negative Syndrome Scale (PANSS). We obtained data from 12 patients who showed a significant increase in CSP, from 134.20±41.81 ms to 162.95±61.98 ms ( p=0.041; Cohen's d=0.544). After the treatment, the PANSS total score was significantly lower, as were the individual subscores ( pschizophrenia demonstrated an association between risperidone monotherapy and an increase in GABA B mediated inhibitory neurotransmission.

  13. Injection Laryngoplasty Materials

    OpenAIRE

    Haldun Oðuz

    2013-01-01

    Injection laryngoplasty is one of the treatment options for voice problems. In the recent years, more safe and more biocompatible injection materials are available on the market. Long and short term injection materials are discussed in this review.

  14. Obsessive-compulsive symptoms during treatment with olanzapine and risperidone: A prospective study of 113 patients with recent-onset schizophrenia or related disorders

    NARCIS (Netherlands)

    de Haan, Lieuwe; Beuk, Nico; Hoogenboom, Britt; Dingemans, Peter; Linszen, Don

    2002-01-01

    Objective: To determine whether severity of obsessive-compulsive symptoms (OCS) differs during treatment with olanzapine or risperidone and to establish whether duration of antipsychotic treatment is related to severity of OCS. Method: We conducted a prospective study of consecutively hospitalized

  15. Successful management of stuttering priapism using home self-injections of the alpha-agonist metaraminol

    Directory of Open Access Journals (Sweden)

    Mcdonald Michael

    2004-01-01

    Full Text Available Low-flow priapism can result in impotence if treatment is delayed, yet patients with recurrent priapism often suffer delay before therapy. We describe management of recurrent priapism using self-administered injections of intracavernosal metaraminol (Aramine™, Merck, a long-acting vasoconstricting amine that is considered safer than epinephrine. The patient injects as often as once daily using 5-10 mg of drug. Our patient reports rapid detumescence and has not required emergency room visits since starting injections. He denies complications. Treatment of priapism using metaraminol has been suggested in the hospital setting; however, this is the first report of successful home self-administration of the drug.

  16. Conspicuous by Their Absence: Studies Comparing and Combining Risperidone and Applied Behavior Analysis to Reduce Challenging Behavior in Children with Autism

    Science.gov (United States)

    Weeden, Marc; Ehrhardt, Kristal; Poling, Alan

    2009-01-01

    Both risperidone, an atypical antipsychotic drug, and function-based behavior-analytic interventions are popular and empirically validated treatments for reducing challenging behavior in children with autism. The kind of research that supports their effectiveness differs, however, and no published study has directly compared their effects or…

  17. Pharmacokinetics of a long-acting ceftiofur formulation (ceftiofur crystalline free acid) in the ball python (Python regius).

    Science.gov (United States)

    Adkesson, Michael J; Fernandez-Varon, Emilio; Cox, Sherry; Martín-Jiménez, Tomás

    2011-09-01

    The objective of this study was to determine the pharmacokinetics of a long-acting formulation of ceftiofur crystalline-free acid (CCFA) following intramuscular injection in ball pythons (Python regius). Six adult ball pythons received an injection of CCFA (15 mg/kg) in the epaxial muscles. Blood samples were collected by cardiocentesis immediately prior to and at 0.5, 1, 2, 4, 8, 12, 18, 24, 48, 72, 96, 144, 192, 240, 288, 384, 480, 576, 720, and 864 hr after CCFA administration. Plasma ceftiofur concentrations were determined by high-performance liquid chromatography. A noncompartmental pharmacokinetic analysis was applied to the data. Maximum plasma concentration (Cmax) was 7.096 +/- 1.95 microg/ml and occurred at (Tmax) 2.17 +/- 0.98 hr. The area under the curve (0 to infinity) for ceftiofur was 74.59 +/- 13.05 microg x h/ml and the elimination half-life associated with the terminal slope of the concentration-time curve was 64.31 +/- 14.2 hr. Mean residence time (0 to infinity) was 46.85 +/- 13.53 hr. CCFA at 15 mg/kg was well tolerated in all the pythons. Minimum inhibitory concentration (MIC) data for bacterial isolates from snakes are not well established. For MIC values of python. For MICs > or =0.5 microg/ml, more frequent dosing or a higher dosage may be required.

  18. Long-term follow-up of ultrasound-guided botulinum toxin-A injections for sialorrhea in neurological dysphagia.

    Science.gov (United States)

    Barbero, Pierangelo; Busso, Marco; Tinivella, Marco; Artusi, Carlo Alberto; De Mercanti, Stefania; Cucci, Angele; Veltri, Andrea; Avagnina, Paolo; Calvo, Andrea; Chio', Adriano; Durelli, Luca; Clerico, Marinella

    2015-12-01

    Literature provides reports only of a limited follow-up single injection of botulinum toxin-A (BoNT-A) in patients with sialorrhea. The aim of our study is to evaluate the long-lasting efficacy and safety of ultrasound-guided BoNT-A injections for severe sialorrhea secondary to neurological dysphagia. We enrolled 38 severe adult sialorrhea patients referred consecutively to the neurology unit and performed bilateral parotid and submandibular gland BoNT-A injections under ultrasound guidance. The outcomes of the study were reduction of sialorrhea, duration of therapeutic effect, and subjective patient- and caregiver-reported satisfaction. A total of 113 BoNT-A administrations were given during the study period with a mean duration of follow-up of 20.2 ± 4.4 months. We observed a significant decrease from baseline in mean number of daily aspirations and a significant improvement in patient- and caregiver-reported outcomes following ultrasound-guided BoNT-A injections (p < 0.001 vs baseline for all comparisons) and the mean duration of the efficacy was 5.6 ± 1 months. No major treatment-related adverse events occurred and a low incidence of minor adverse events was reported. This study confirms the long-lasting efficacy and safety of ultrasound-guided BoNT-A injections for sialorrhea, regardless of the causative neurological disorder. These results should encourage the use of BoNT-A in the treatment of severe sialorrhea and highlight the role of ultrasound guidance to obtain optimal results in terms of safety and reproducible outcomes.

  19. Irreversible muscle damage in bodybuilding due to long-term intramuscular oil injection.

    Science.gov (United States)

    Banke, I J; Prodinger, P M; Waldt, S; Weirich, G; Holzapfel, B M; Gradinger, R; Rechl, H

    2012-10-01

    Intramuscular oil injections generating slowly degrading oil-based depots represent a controversial subject in bodybuilding and fitness. However they seem to be commonly reported in a large number of non-medical reports, movies and application protocols for 'site-injections'. Surprisingly the impact of long-term (ab)use on the musculature as well as potential side-effects compromising health and sports ability are lacking in the medical literature. We present the case of a 40 year old male semi-professional bodybuilder with systemic infection and painful reddened swellings of the right upper arm forcing him to discontinue weightlifting. Over the last 8 years he daily self-injected sterilized sesame seed oil at numerous intramuscular locations for the purpose of massive muscle building. Whole body MRI showed more than 100 intramuscular rather than subcutaneous oil cysts and loss of normal muscle anatomy. 2-step septic surgery of the right upper arm revealed pus-filled cystic scar tissue with the near-complete absence of normal muscle. MRI 1 year later revealed the absence of relevant muscle regeneration. Persistent pain and inability to perform normal weight training were evident for at least 3 years post-surgery. This alarming finding indicating irreversible muscle mutilation may hopefully discourage people interested in bodybuilding and fitness from oil-injections. The impact of such chronic tissue stress on other diseases like malignancy remains to be determined. © Georg Thieme Verlag KG Stuttgart · New York.

  20. Predicting treatable traits for long-acting bronchodilators in patients with stable COPD

    Directory of Open Access Journals (Sweden)

    Kang J

    2017-12-01

    Full Text Available Jieun Kang,1,* Ki Tae Kim,2,* Ji-Hyun Lee,3 Eun Kyung Kim,3 Tae-Hyung Kim,4 Kwang Ha Yoo,5 Jae Seung Lee,1 Woo Jin Kim,6 Ju Han Kim,2 Yeon-Mok Oh1 1Department of Pulmonology and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, 2Seoul National University Biomedical Informatics and Systems Biomedical Informatics Research Center, Division of Biomedical Informatics, Seoul National University College of Medicine, Seoul, 3Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, 4Division of Pulmonology, Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, 5Department of Internal Medicine, Konkuk University Hospital, Konkuk University School of Medicine, Seoul, 6Department of Internal Medicine and Environmental Health Center, Kangwon National University Hospital, School of Medicine, Kangwon National University, Chuncheon, South Korea *These authors contributed equally to this work Purpose: There is currently no measure to predict a treatability of long-acting β-2 agonist (LABA or long-acting muscarinic antagonist (LAMA in patients with chronic obstructive pulmonary disease (COPD. We aimed to build prediction models for the treatment response to these bronchodilators, in order to determine the most responsive medication for patients with COPD.Methods: We performed a prospective open-label crossover study, in which each long-acting bronchodilator was given in a random order to 65 patients with stable COPD for 4 weeks, with a 4-week washout period in between. We analyzed 14 baseline clinical traits, expression profiles of 31,426 gene transcripts, and damaged-gene scores of 6,464 genes acquired from leukocytes. The gene expression profiles were measured by RNA microarray and the damaged-gene scores were obtained after DNA exome sequencing. Linear regression analyses were performed to build prediction models after using

  1. Demand for long acting and permanent contraceptive methods and associated factors among family planning service users, Batu town, Central Ethiopia.

    Science.gov (United States)

    Haile, Anley; Fantahun, Mesganaw

    2012-01-01

    Evidence suggests a high unsatisfied demand for long acting and permanent contraceptive methods in sub-Saharan Africa. However, there is limited knowledge on demand for long acting and permanent contraceptive methods and associated factors in Ethiopia. The objective of this study was to assess demand for long acting and permanent contraceptive methods and associated factors among women of age group 18-49 years in Batu town, East Shoa Zone, Ethiopia. A facility based cross-sectional survey was conducted in six service delivery points from March to April 2009 on 398 women of age 18-49 years old. Thirteen (3%) were using long acting and permanent contraceptive methods and 89 (22.4%) wanted no more child in the future making the total demand of long acting and permanent contraceptive methods 24.4%. Older age group, multiparty, that the provider asked about reproductive intention, and the provider explained side effects of method selected were significantly associated with using LA and MPs (P demand and several socio demographic and family planning service quality related factors were associated with demand for long acting and permanent contraceptive methods indicating that multi-dimensional measures are needed to improve the use of long acting and permanent contraceptive methods.

  2. Study on the luminescence behavior of sulfobutylether-β-cyclodextrin with risperidone and its analytical application.

    Science.gov (United States)

    Wu, Min; Chen, Donghua; Song, Zhenghua

    2012-10-01

    The interaction of sulfobutylether-β-cyclodextrin (SBE-β-CD) with risperidone (RISP) was first described with luminol-SBE-β-CD chemiluminescence (CL) system by flow injection analysis (FIA). In luminol-SBE-β-CD CL system, the 1:1 SBE-β-CD···luminol(*) complexation could enhance CL intensity of luminol and produce the effect of complexation enhancement of CL (CEC). It was found that RISP could quench the CL intensity of SBE-β-CD···luminol(*) and caused the effect of complexation enhancement of quenching (CEQ), the formation constant K(R-CD) 3.4×10(4) L mol(-1) and the stoichiometric ratio 1:1 of RISP···SBE-β-CD complex were obtained by the proposed CL model. Association degree α 0.036 of RISP···SBE-β-CD complex was also given by CL method. Based on the linear relationship to the decrement of luminol-SBE-β-CD-RISP CL intensity and the logarithm of RISP concentration, RISP also can be quantified in the linear range of 3.0-500.0 nmol L(-1) with a detection limit of 1.0 nmol L(-1) (3σ). The proposed method was successfully applied to monitoring excreted RISP in human urine. It was found that RISP reached its maximum after oral administration for 1.5 h with the total excretion of 14.26% within 8.5 h; the elimination rate constant k and half-life time t(1/2) were 0.474 and 1.5 h, respectively. Copyright © 2012 Elsevier B.V. All rights reserved.

  3. A Prodrug Approach Involving In Situ Depot Formation to Achieve Localized and Sustained Action of Diclofenac After Joint Injection

    DEFF Research Database (Denmark)

    Thing, Mette; Agårdh, Li; Larsen, Susan

    2014-01-01

    Long-acting nonsteroidal anti-inflammatory drug formulations for intra-articular injection might be effective in the management of joint pain and inflammation associated sports injuries and osteoarthritis. In this study, a prodrug-based delivery system was evaluated. The synthesized diclofenac...

  4. Degludec, a new ultra-long-acting basal insulin for the treatment of diabetes mellitus type 1 and 2: advances in clinical research.

    Science.gov (United States)

    Muñoz Torres, Manuel

    2014-03-01

    Degludec is the most recent molecule of the ultra-long-acting basal insulin analogues approved for human use. It forms soluble multihexamers which after subcutaneous injection are converted into monomers, and are thus slowly and continuously absorbed into the bloodstream. This absorption mechanism confers degludec an ultra-long and stable action profile, with no concentration peaks. This paper discusses the most recent studies in patients with type 1 and 2 diabetes mellitus, which showed degludec to be non inferior in decreasing HbA1c, ensuring optimum glycemic control similar to that achieved with insulin glargine or detemir. Degludec also had an improved safety profile, as it was associated to a significantly lower rate of nocturnal hypoglycemia in both types of diabetes and to a potentially lower overall hypoglycemia rate in type 2 DM. Degludec also opens the possibility to use more flexible regimens. Copyright © 2013 SEEN. Published by Elsevier Espana. All rights reserved.

  5. From Process Modeling to Elastic Property Prediction for Long-Fiber Injection-Molded Thermoplastics

    International Nuclear Information System (INIS)

    Nguyen, Ba Nghiep; Kunc, Vlastimil; Frame, Barbara J.; Phelps, Jay; Tucker III, Charles L.; Bapanapalli, Satish K.; Holbery, James D.; Smith, Mark T.

    2007-01-01

    This paper presents an experimental-modeling approach to predict the elastic properties of long-fiber injection-molded thermoplastics (LFTs). The approach accounts for fiber length and orientation distributions in LFTs. LFT samples were injection-molded for the study, and fiber length and orientation distributions were measured at different locations for use in the computation of the composite properties. The current fiber orientation model was assessed to determine its capability to predict fiber orientation in LFTs. Predicted fiber orientations for the studied LFT samples were also used in the calculation of the elastic properties of these samples, and the predicted overall moduli were then compared with the experimental results. The elastic property prediction was based on the Eshelby-Mori-Tanaka method combined with the orientation averaging technique. The predictions reasonably agree with the experimental LFT data

  6. Critical appraisal of 3-monthly paliperidone depot injections in the treatment of schizophrenia

    Directory of Open Access Journals (Sweden)

    Carpiniello B

    2016-05-01

    Full Text Available Bernardo Carpiniello, Federica Pinna Department of Public Health, Clinical and Molecular Medicine – Psychiatry Research Unit and Psychiatric Clinic, University Hospital, Cagliari, Italy Aims: Three-monthly injections of paliperidone palmitate (PP-3M represent a new and recently introduced long-acting antipsychotic therapeutic option. This review focuses on available data relating to the efficacy and safety of PP-3M and its position in the current therapeutic scenario.Method: An analysis of PubMed, Scopus, and ISI Web of Knowledge databases was conducted, and all available papers on PP-3M, including poster presentations, were selected and considered for the purpose of the present review. Findings: to date, three full papers have been published, the first, a Phase 1 randomized, open label study investigating the pharmacokinetics, safety, and tolerability of the drug; the second, a Phase 3 double blind study vs placebo focusing on efficacy and tolerability; and the last relating to the practical use of PP-3M. The five posters identified describe data reported in the above-cited papers. Overall, the pharmacokinetic findings obtained in these studies highlight the feasibility of administering PP-3M on a 3-monthly basis, subsequent to the administration of four 1-monthly injections of PP at doses 3.5 times higher than the stabilized dose of 1-monthly injections of PP (ie, 175, 300, 450, and 525 mgs. The published studies highlight a significantly longer time to relapse compared to placebo, and significantly better results compared to placebo for all secondary end-points (Positive and Negative Syndrome Scale, Clinical Global Impression-Severity Scale, Personal and Social Performance Scale scores, in addition to reasonably good safety and tolerability profiles.Conclusion: PP-3M emerges as a potential candidate for use as a first-line long-acting agent in the maintenance treatment of patients with schizophrenia. Further studies should however be

  7. Vocal Fold Augmentation with Injectable Polycaprolactone Microspheres/Pluronic F127 Hydrogel: Long-Term In Vivo Study for the Treatment of Glottal Insufficiency

    Science.gov (United States)

    Kwon, Seong Keun; Kim, Hee-Bok; Song, Jae-Jun; Cho, Chang Gun; Park, Seok-Won; Choi, Jong-Sun; Ryu, Junsun; Oh, Se Heang; Lee, Jin Ho

    2014-01-01

    There is increasing demand for reconstruction of glottal insufficiency. Several injection materials have been examined for this purpose, but all had limitations, such as poor long-term durability, migration from the injection site, inflammation, granuloma formation, and interference with vocal fold vibration due to viscoelastic mismatch. Here, we developed a novel injection material, consisting of polycaprolactone (PCL) microspheres, which exhibits better viscoelasticity than conventional materials, and Pluronic F127 carrier, which decreases the migration of the injection materials. The material was injected into rabbits with glottal insufficiency and compared with the FDA-approved injection material, calcium hydroxylapatite (CaHA). Endoscopic and histological examinations indicated that PCL/Pluronic F127 remained at the injection site with no inflammatory response or granuloma formation, whereas CaHA leaked out and migrated from the injection site. Therefore, vocal fold augmentation was almost completely retained during the 12-month follow-up period in this study. Moreover, induced phonation and high-speed recording of vocal fold vibration showed decreased vocal fold gap area in the PCL/Pluronic F127 group. Our newly developed injection material, PCL/Pluronic F127, permits efficient augmentation of paralyzed vocal fold without complications, a concept that can be applied clinically, as demonstrated by the successful long-term follow-up. PMID:24465582

  8. Response of different injector typologies to dwell time variations and a hydraulic analysis of closely-coupled and continuous rate shaping injection schedules

    International Nuclear Information System (INIS)

    Ferrari, A.; Mittica, A.

    2016-01-01

    Highlights: • Direct and indirect acting injectors are tested considering multiple injections. • The injection fusion threshold is higher for ballistic injectors than for stroke-end limited injectors. • The internal dynamics of the injector is analyzed for closely-coupled double injections. • Different regimes are identified and classified in the short dwell time range. • Innovative rate shaping injection schedules are defined for solenoid injectors. - Abstract: The multiple injection performance of Common Rail injectors has been analyzed at a hydraulic test rig as the dwell time was varied. The dependence of the injected volume on the dwell time has been investigated for direct acting piezoelectric and hydraulically-controlled (or indirect-acting) servo injectors. The injected fuel volumes in the long dwell-time range have been shown to be affected by the pressure waves that travel along the high pressure circuit for hydraulically-controlled servo injectors. On the other hand, the influence of pressure-wave-induced disturbances on multiple injection performance has been shown to be negligible for direct acting piezoelectric injectors. An analysis of closely-coupled injections has been conducted on a solenoid injector. When the dwell time is progressively reduced below a critical value, an increase in the fuel quantity that is injected in the second shot is observed. Injection fusion phenomena occur as the dwell time is diminished below a certain threshold and a maximum in the fuel volume, which is injected during the joint injections, is eventually detected for a very short electric dwell time value close to 100 μs. The cycle-to-cycle dispersion around this dwell time value results to be reduced significantly. A previously developed 1D model of the fuel injection system has been applied to analyze the injector transients. Detailed knowledge of the injection dynamics in the short dwell time region is of fundamental importance to optimize the

  9. Dose reduction of risperidone and olanzapine can improve cognitive function and negative symptoms in stable schizophrenic patients: A single-blinded, 52-week, randomized controlled study.

    Science.gov (United States)

    Zhou, Yanling; Li, Guannan; Li, Dan; Cui, Hongmei; Ning, Yuping

    2018-05-01

    The long-term effects of dose reduction of atypical antipsychotics on cognitive function and symptomatology in stable patients with schizophrenia remain unclear. We sought to determine the change in cognitive function and symptomatology after reducing risperidone or olanzapine dosage in stable schizophrenic patients. Seventy-five stabilized schizophrenic patients prescribed risperidone (≥4 mg/day) or olanzapine (≥10 mg/day) were randomly divided into a dose-reduction group ( n=37) and a maintenance group ( n=38). For the dose-reduction group, the dose of antipsychotics was reduced by 50%; for the maintenance group, the dose remained unchanged throughout the whole study. The Positive and Negative Syndrome Scale, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects, and Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery were measured at baseline, 12, 28, and 52 weeks. Linear mixed models were performed to compare the Positive and Negative Syndrome Scale, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects and MATRICS Consensus Cognitive Battery scores between groups. The linear mixed model showed significant time by group interactions on the Positive and Negative Syndrome Scale negative symptoms, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects, speed of processing, attention/vigilance, working memory and total score of MATRICS Consensus Cognitive Battery (all pNegative Syndrome Scale negative subscale, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects, speed of processing, working memory and total score of MATRICS Consensus Cognitive Battery for the dose reduction group compared with those for the maintenance group (all pnegative symptoms in patients with stabilized schizophrenia.

  10. Development of a Medication Monitoring System for an Integrated Multidisciplinary Program of Assertive Community Treatment (IMPACT Team

    Directory of Open Access Journals (Sweden)

    Nicole B. Washington, DO, Assistant Professor

    2012-01-01

    Full Text Available Purpose: The primary goal was to improve medication management oversight for a severely mentally ill (SMI community-based population by developing a medication monitoring system based on current guidelines to optimize pharmacotherapy and minimize potential medication-related adverse effects. The secondary goal was improvement in coordination of care between healthcare providers. Methods: Guidelines for medication used for psychiatric indications were reviewed. A database of medication for psychiatric indications with monitoring recommendation was developed. Results: Medication regimens for 68 members of the Integrated Multidisciplinary Program of Assertive Community Treatment (IMPACT program qualified for review. Fourteen medications, carbamazepine, chlorpromazine, clozapine, fluphenazine and fluphenazine long-acting injections (LAI, haloperidol and haloperidol LAI, lithium, lurasidone, olanzapine, paliperidone and paliperidone LAI, perphenazine, quetiapine, risperidone and risperidone LAI, valproic acid/divalproex, and ziprasidone, were identified. In total, 111 medications are used on a monthly basis. Each member receives more than one medication qualifying for review. Additional monitoring parameters that were evaluated included changes in laboratory orders for members with insulin-dependent diabetes. Annual lipid panels were changed to every 6 months, if applicable. Conclusions and Future Directions: This medication monitoring program was developed to help ensure IMPACT members receive the most effective care and minimize potential medication-related adverse effects. The secondary goal was to improve coordination of care. Medication monitoring will be added as a continuous quality assurance measure. Lab results will be reviewed at least monthly. The medication monitoring program will be evaluated annually.

  11. Depletion of long-acting ampicillin in goat milk following intramuscular administration.

    Science.gov (United States)

    Ferrini, Anna Maria; Trenta, Simona; Mannoni, Veruscka; Rosati, Remo; Coni, Ettore

    2010-12-08

    Although goat milk production represents today a very small percentage of the world milk market, this percentage has been growing continuously during the past 20 years. Goat milk is the basic milk supply in many developing countries and provides tasteful derivative products in developed countries. Goats, as well as all milk-producing animals, can be affected by mastitis, but goats being considered a minor species, few drugs are specifically registered for these animals; most, at least for mastitis treatment, are usually tested and registered for use in cows. This situation leads often to the adoption for goat milk of withdrawal periods defined for cows even if these extrapolations prove almost never valid for goats. In the present study, the elimination of the β-lactam antibacterial agent ampicillin in goat milk was investigated. Ampicillin was chosen because it is one of the most common antibiotics used by goat farmers against mastitis due to the fact that it is well tolerated and has short elimination times in cows. Goats were treated with long-acting ampicillin at 15 mg (kg of body weight)(-1) by double intramuscular injection at 72 h interval. Milk was collected in a 12 h milking scheme. The method used to determine the levels of ampicillin in goat milk was based on a liquid-liquid extraction of this drug from the matrix, successive derivatization with formaldehyde, and final separation by HPLC with fluorescence detection. The results point out a slow depletion of ampicillin and, consequently, a withdrawal period (13 milkings) longer than that extrapolated and authorized for cows and sheep.

  12. Rural women are more likely to use long acting contraceptive in Tigray region, Northern Ethiopia: a comparative community-based cross sectional study.

    Science.gov (United States)

    Alemayehu, Mussie; Kalayu, Aster; Desta, Alem; Gebremichael, Hailay; Hagos, Tesfalem; Yebyo, Henock

    2015-09-04

    In the latest report of Ethiopian Demographic and Health Survey (EDHS) 2011, the maternal mortality ratio (MMR) was estimated at 676/100,000 live births, with total fertility rate at 4.8 and contraceptive prevalence rate at 29 %. Knowledge and utilization of long acting contraceptive in the Tigray region are low. This study aims at comparing and identifying factors related to the utilization of long acting contraceptive in urban versus rural settings of Ethiopia. A comparative community-based cross-sectional study, comprised of quantitative and qualitative methods, was conducted among 1035 married women in Wukro (urban area) and Kilteawlaelo district (rural area) in March, 2013. Stratified sampling technique was employed to approach the study participants. Data were analyzed using SPSS version 20. Multiple logistic regression analysis was used to identify the respective effect of independent predictors on utilization of long acting contraceptive. The proportion of long acting contraceptive use among the respondents was 19.9 % in the town of Wukro and 37.8 % in the district of Kilteawlaelo. Implanon was the most common type of contraceptive used in both districts, urban (75 %) and rural (94 %). The odds of using the long acting contraceptive method were three times higher among married women in the rural areas as compared with the urban women [AOR = 3. 30; 95 %, CI:2.17, 5.04]. No or limited support from male partners was an obstacle to using long acting contraceptive method [AOR = 0. 24, 95 of CI: 0.13, 0.44]. Moreover, married women whose partner did not permit them to use long acting contraceptive [AOR = 0. 47, 95 % of CI: 0.24, 0.92] and women who attended primary education [AOR = 0.24, 95 %, CI: 0.13, 0.44] were significantly associated with long acting contraceptive use. Overall, the proportion of long acting contraceptive use has found to be low. Rural women were more likely to use long acting contraceptives as compared to urban women

  13. Long-term efficacy and safety of self-intracavernous injection of prostaglandin E1 for treatment of erectile dysfunction in China.

    Science.gov (United States)

    He, L; Wen, J; Jiang, X; Chen, H; Tang, Y

    2011-06-01

    The study evaluated the long-term efficacy and safety profiles of self-intracavernous injection of prostaglandin E1 (PGE1) for erectile dysfunction (ED). Four hundred and sixteen ED patients were treated with self-intracavernous injection of PGE1 from January 1998 to December 2007 in our outpatient service. Follow-up was made to investigate the efficacy and side effects of this treatment. It was found that 261 patients (62.7%) felt satisfied and kept using this treatment due to its advantages of satisfactory efficacy and reasonable expense. Twenty-seven of them (6.5%) got rid of PGE1 treatment after five times injections and did not need any other drugs to maintain satisfactory sexual lives. Two hundred and fourteen (51.4%) patients kept using this treatment for over 1 year, 26 (6.2%) over 5 years, 12 (2.9%) over 8 years and 7 (1.7%) over 10 years. The major complications of self-intracavernous injection of PGE1 include fibrosis of corpus cavernosum (three cases), ecchymosis associated with vascular injury due to injection (23 cases) and pain associated with injection (295 cases). There were no patients displaying priapism. It is concluded that self-intracavernous injection of PGE1 is a safe and effective treatment for ED with various aetiologies and a broad range of severity, and no serious complications were observed after long-term application. © 2011 Blackwell Verlag GmbH.

  14. How Do Dual Long-acting Bronchodilators Prevent Exacerbations of Chronic Obstructive Pulmonary Disease?

    DEFF Research Database (Denmark)

    Beeh, Kai M; Burgel, Pierre-Regis; Franssen, Frits M E

    2017-01-01

    that combinations of long-acting β2-adrenergic agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) provide greater reductions in exacerbation frequency than either their monocomponents or LABA/inhaled corticosteroids (LABA/ICS) combinations in patients at low and high risk for these events....... In this review, small groups of experts critically evaluated mechanisms potentially responsible for the increased benefit of LABA/LAMA combinations over single LABDs or LABA/ICS in decreasing exacerbation. These included effects on lung hyperinflation and mechanical stress, inflammation, excessive mucus...... production with impaired mucociliary clearance, and symptom severity. The data assembled and analyzed by each group were reviewed by all authors and combined into this manuscript. Available clinical results support the possibility that effects of LABA/LAMA combinations on hyperinflation, mucociliary...

  15. Dose-associated changes in safety and efficacy parameters observed in a 24-week maintenance trial of olanzapine long-acting injection in patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Watson Susan B

    2011-02-01

    Full Text Available Abstract Background In a recently published 24-week maintenance study of olanzapine long-acting injection (LAI in schizophrenia (Kane et al., 2010, apparent dose-associated changes were noted in both efficacy and safety parameters. To help clinicians balance safety and efficacy when choosing a dose of olanzapine LAI, we further studied these changes. Methods Outpatients with schizophrenia who had maintained stability on open-label oral olanzapine for 4 to 8 weeks were randomly assigned to "low" (150 mg/2 weeks; N = 140, "medium" (405 mg/4 weeks; N = 318, or "high" (300 mg/2 weeks; N = 141 dosages of olanzapine LAI for 24 weeks. Potential relationships between dose and several safety or efficacy measures were examined via regression analysis, the Jonckheere-Terpstra test (continuous data, or the Cochran-Armitage test (categorical data. Results Safety parameters statistically significantly related to dose were mean weight change (low: +0.67 [SD = 4.38], medium: +0.89 [SD = 3.87], high: +1.70 [SD = 4.14] kg, p = .024; effect size [ES] = 0.264 high vs. low dose, mean change in prolactin (low: -5.61 [SD = 12.49], medium: -2.76 [SD = 19.02], high: +3.58 [SD = 33.78] μg/L, p = .001; ES = 0.410 high vs. low dose, fasting triglycerides change from normal at baseline to high (low: 3.2%, medium: 6.0%, high: 18.9%, p = .001; NNT = 7 high vs. low dose and fasting high-density lipoprotein cholesterol change from normal at baseline to low (low: 13.8%, medium: 19.6%, high: 30.7%, p = .019; NNT = 6 high vs. low dose. Efficacy measures significantly related to dose included Positive and Negative Syndrome Scale total score mean change (low: +2.66 [SD = 14.95], medium: -0.09 [SD = 13.47], high: -2.19 [SD = 13.11], p Conclusions Analyses of several safety and efficacy parameters revealed significant associations with dose of olanzapine LAI, with the highest dose generally showing greater efficacy as well as greater adverse changes in metabolic safety measures. When

  16. A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study

    Science.gov (United States)

    Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

    2011-01-01

    Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

  17. Comparison of the Local Tolerability to 5 Long-acting Drug Nanosuspensions with Different Stabilizing Excipients, Following a Single Intramuscular Administration in the Rat.

    Science.gov (United States)

    Chamanza, Ronnie; Darville, Nicolas; van Heerden, Marjolein; De Jonghe, Sandra

    2018-01-01

    To investigate the effects of common nanosuspension-stabilizing excipients on the nature and temporal evolution of histopathological changes at intramuscular (i.m.) administration sites, 5 groups of 39 male rats per group received a single injection of 1 of the 5 analogous crystalline drug nanosuspensions containing 200 mg/ml of an antiviral compound with particle sizes of ±200 nm and identical vehicle compositions, except for the type of nanosuspension stabilizer. The investigated stabilizers were poloxamer 338, poloxamer 407, d-α-tocopherol polyethylene glycol 1,000-succinate (TPGS), polysorbate 80, and polysorbate 80 combined with egg phosphatidylglycerol. Histopathology and immunohistochemistry revealed progressive inflammatory changes at the i.m. administration sites and the draining lymph nodes that differed according to the time point of sacrifice and the type of stabilizer. Although the overall time course of inflammatory changes was similar across the groups, differences in the nature, severity, and timing of the inflammatory response were observed between animals injected with poloxamer- or TPGS-containing nanosuspensions and those injected with formulations containing polysorbate 80. A more severe and prolonged active inflammatory phase, the presence of multinucleate giant cells, prolonged macrophage infiltration of the formulation depot, and more persistent histiocytic infiltrates in the lymph nodes were observed in the polysorbate 80-containing nanosuspension groups. Such vehicle-mediated effects could influence the overall tolerability profile of long-acting nanosuspensions.

  18. Influence of Aripiprazole, Risperidone, and Amisulpride on Sensory and Sensorimotor Gating in Healthy ‘Low and High Gating' Humans and Relation to Psychometry

    Science.gov (United States)

    Csomor, Philipp A; Preller, Katrin H; Geyer, Mark A; Studerus, Erich; Huber, Theodor; Vollenweider, Franz X

    2014-01-01

    Despite advances in the treatment of schizophrenia spectrum disorders with atypical antipsychotics (AAPs), there is still need for compounds with improved efficacy/side-effect ratios. Evidence from challenge studies suggests that the assessment of gating functions in humans and rodents with naturally low-gating levels might be a useful model to screen for novel compounds with antipsychotic properties. To further evaluate and extend this translational approach, three AAPs were examined. Compounds without antipsychotic properties served as negative control treatments. In a placebo-controlled, within-subject design, healthy males received either single doses of aripiprazole and risperidone (n=28), amisulpride and lorazepam (n=30), or modafinil and valproate (n=30), and placebo. Prepulse inhibiton (PPI) and P50 suppression were assessed. Clinically associated symptoms were evaluated using the SCL-90-R. Aripiprazole, risperidone, and amisulpride increased P50 suppression in low P50 gaters. Lorazepam, modafinil, and valproate did not influence P50 suppression in low gaters. Furthermore, low P50 gaters scored significantly higher on the SCL-90-R than high P50 gaters. Aripiprazole increased PPI in low PPI gaters, whereas modafinil and lorazepam attenuated PPI in both groups. Risperidone, amisulpride, and valproate did not influence PPI. P50 suppression in low gaters appears to be an antipsychotic-sensitive neurophysiologic marker. This conclusion is supported by the association of low P50 suppression and higher clinically associated scores. Furthermore, PPI might be sensitive for atypical mechanisms of antipsychotic medication. The translational model investigating differential effects of AAPs on gating in healthy subjects with naturally low gating can be beneficial for phase II/III development plans by providing additional information for critical decision making. PMID:24801767

  19. The value of short-term pain relief in predicting the long-term outcome of 'indirect' cervical epidural steroid injections.

    Science.gov (United States)

    Joswig, Holger; Neff, Armin; Ruppert, Christina; Hildebrandt, Gerhard; Stienen, Martin Nikolaus

    2018-05-01

    The predictive value of short-term arm pain relief after 'indirect' cervical epidural steroid injection (ESI) for the 1-month treatment response has been previously demonstrated. It remained to be answered whether the long-term response could be estimated by the early post-interventional pain course as well. Prospective observational study, following a cohort of n = 45 patients for a period of 24 months after 'indirect' ESI for radiculopathy secondary to a single-level cervical disk herniation (CDH). Arm and neck pain on the visual analog scale (VAS), health-related quality of life with the Short Form-12 (SF-12), and functional outcome with the Neck Pain and Disability (NPAD) Scale were assessed. Any additional invasive treatment after a single injection (second injection or surgery) defined treatment outcome as 'non-response'. At 24 months, n = 30 (66.7%) patients were responders and n = 15 (33.3%) were non-responders. Non-responders exited the follow-up at 1 month (n = 10), at 3 months (n = 4), and at 6 months (n = 1). No patients were injected again or operated on between the 6- and 24-month follow-up. Patients with favorable treatment response at 24 months had significantly lower VAS arm pain (p  50% short term pain reduction was not a reliable predictor of the 24-month responder status. SF-12 and NPAD scores were better among treatment responders in the long term. Patients who require a second injection or surgery after 'indirect' cervical ESI for a symptomatic CDH do so within the first 6 months. Short-term pain relief cannot reliably predict the long-term outcome.

  20. Radioimmunoassay for 6-D-tryptophan analog of luteinizing hormone-releasing hormone: measurement of serum levels after administration of long-acting microcapsule formulations

    International Nuclear Information System (INIS)

    Mason-Garcia, M.; Vigh, S.; Comaru-Schally, A.M.; Redding, T.W.; Somogyvari-Vigh, A.; Horvath, J.; Schally, A.V.

    1985-01-01

    A sensitive and specific radioimmunoassay for [6-D-tryptophan]luteinizing hormone-releasing hormone ([D-Trp 6 ]LH-RH) was developed and used for following the rate of liberation of [D-Trp 6 ]LH-RH from a long-acting delivery systems based on a microcapsule formulation. Rabbit antibodies were generated against [D-Trp 6 ]LH-RH conjugated to bovine serum albumin with glutaraldehyde. Crossreactivity with LH-RH was less than 1%; there was no significant cross-reactivity with other peptides. The minimal detectable dose of [D-Trp 6 ]LH-RH was 2 pg per tube. In tra- and interassay coefficients of variation were 8% and 10%, respectively. The radioimmunoassay was suitable for direct determination of [D-Trp 6 ]LH-RH in serum, permitting the study of blood levels of the analog after single injections into normal men and after one-a-month administration of microcapsules to rats. In men, 90 min after subcutaneous injection of 250 μg of the peptide, serum [D-Trp 6 ]LH-RH rose to 6-12 ng/ml. Luteinizing hormone was increased 90 min and 24 hr after the administration of the analog. Several batches of microcapsules were tested in rats and the rate of release of [D-Trp 6 ]LH-RH was followed. The improved batch of microcapsules of [D-Trp 6 ]LH-RH increased serum concentrations of the analog for 30 days or longer after intramuscular injection

  1. Achieving a long-lived high-beta plasma state by energetic beam injection

    Science.gov (United States)

    Guo, H. Y.; Binderbauer, M. W.; Tajima, T.; Milroy, R. D.; Steinhauer, L. C.; Yang, X.; Garate, E. G.; Gota, H.; Korepanov, S.; Necas, A.; Roche, T.; Smirnov, A.; Trask, E.

    2015-04-01

    Developing a stable plasma state with high-beta (ratio of plasma to magnetic pressures) is of critical importance for an economic magnetic fusion reactor. At the forefront of this endeavour is the field-reversed configuration. Here we demonstrate the kinetic stabilizing effect of fast ions on a disruptive magneto-hydrodynamic instability, known as a tilt mode, which poses a central obstacle to further field-reversed configuration development, by energetic beam injection. This technique, combined with the synergistic effect of active plasma boundary control, enables a fully stable ultra-high-beta (approaching 100%) plasma with a long lifetime.

  2. Automatic estimation of aquifer parameters using long-term water supply pumping and injection records

    Science.gov (United States)

    Luo, Ning; Illman, Walter A.

    2016-09-01

    Analyses are presented of long-term hydrographs perturbed by variable pumping/injection events in a confined aquifer at a municipal water-supply well field in the Region of Waterloo, Ontario (Canada). Such records are typically not considered for aquifer test analysis. Here, the water-level variations are fingerprinted to pumping/injection rate changes using the Theis model implemented in the WELLS code coupled with PEST. Analyses of these records yield a set of transmissivity ( T) and storativity ( S) estimates between each monitoring and production borehole. These individual estimates are found to poorly predict water-level variations at nearby monitoring boreholes not used in the calibration effort. On the other hand, the geometric means of the individual T and S estimates are similar to those obtained from previous pumping tests conducted at the same site and adequately predict water-level variations in other boreholes. The analyses reveal that long-term municipal water-level records are amenable to analyses using a simple analytical solution to estimate aquifer parameters. However, uniform parameters estimated with analytical solutions should be considered as first rough estimates. More accurate hydraulic parameters should be obtained by calibrating a three-dimensional numerical model that rigorously captures the complexities of the site with these data.

  3. MultiSimplex optimization of chromatographic separation and dansyl derivatization conditions in the ultra performance liquid chromatography-tandem mass spectrometry analysis of risperidone, 9-hydroxyrisperidone, monoamine and amino acid neurotransmitters in human urine.

    Science.gov (United States)

    Cai, Hua-Lin; Zhu, Rong-Hua; Li, Huan-De; Zhang, Jun; Li, Lan-Fang

    2011-07-01

    A pre-column dansylated ultra-performance liquid chromatography-electrospray ionization tandem mass spectrometry (UPLC-MS/MS) method for simultaneous determination of risperidone (RIP), 9-hydroxyrisperidone (9-OH-RIP), monoamine and amino acid neurotransmitters in human urine was developed with the aim of providing data on how neurotransmitters may influence each other or change simultaneously in response to risperidone treatment. MultiSimplex based on the simplex algorithm and the fuzzy set theory was applied to the optimization of chromatographic separation and dansyl derivatization conditions during method development. This method exhibited excellent linearity for all the analytes with regression coefficients higher than 0.997. The lower limit of quantification (LLOQ) values for 9-OH-RIP and RIP were 0.11 and 0.06 ng/ml, respectively, and for neurotrasmitters ranged from 0.31 to 12.8 nM. The mean accuracy ranged from 94.7% to 108.5%. The mean recovery varied between 81.6% and 97.5%. All the RSD of precision and stability were below 9.7%. Finally, the optimized method was applied to analyze the first morning urine samples of schizophrenic patients treated with risperidone and healthy volunteers. Copyright © 2011 Elsevier B.V. All rights reserved.

  4. Inflammation in Patients with Schizophrenia: the Therapeutic Benefits of Risperidone Plus Add-On Dextromethorphan

    Science.gov (United States)

    Chen, Shiou-Lan; Lee, Sheng-Yu; Chang, Yun-Hsuan; Chen, Shih-Heng; Chu, Chun-Hsieh; Tzeng, Nian-Sheng; Lee, I-Hui; Chen, Po-See; Yeh, Tzung Lieh; Huang, San-Yuan; Yang, Yen-Kuang; Lu, Ru-Band; Hong, Jau-Shyong

    2013-01-01

    Objectives Increasing evidence suggests that inflammation contributes to the etiology and progression of schizophrenia. Molecules that initiate inflammation, such as virus- and toxin-induced cytokines, are implicated in neuronal degeneration and schizophrenia-like behavior. Using therapeutic agents with anti-inflammatory or neurotrophic effects may be beneficial for treating schizophrenia. Methods One hundred healthy controls and 95 Han Chinese patients with schizophrenia were tested in this double-blind study. Their PANSS scores, plasma interleukin (IL)-1β, TNF-α and brain-derived neurotrophic factor (BDNF) levels were measured before and after pharmacological treatment. Results Pretreatment, plasma levels of IL-1β and TNF-α were significantly higher in patients with schizophrenia than in controls, but plasma BDNF levels were significantly lower. Patients were treated with the atypical antipsychotic risperidone (Risp) only or with Risp+add-on dextromethorphan (DM). PANSS scores and plasma IL-1β levels significantly decreased, but plasma TNF-α and BDNF levels significantly increased after 11 weeks of Risp treatment. Patients in the Risp+DM group showed a greater and earlier reduction of symptoms than did those in the Risp-only group. Moreover, Risp+DM treatment attenuated Risp-induced plasma increases in TNF-α. Conclusion Patients with schizophrenia had a high level of peripheral inflammation and a low level of peripheral BDNF. Long-term Risp treatment attenuated inflammation and potentiated the neurotrophic function but also produced a certain degree of toxicity. Risp+DM was more beneficial and less toxic than Risp-only treatment. PMID:22730040

  5. Pediatricians' Attitudes and Beliefs about Long-Acting Reversible Contraceptives Influence Counseling.

    Science.gov (United States)

    Berlan, Elise D; Pritt, Nicole M; Norris, Alison H

    2017-02-01

    Adolescents are at high risk for unintended pregnancy. Because of pediatricians' potential role in contraceptive counseling, understanding their attitudes and beliefs and counseling practices about use of long-acting reversible contraceptives (LARC; ie, etonogestrel implant and intrauterine devices [IUDs]) is vital. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: We interviewed primary care pediatricians (N = 23) in a Midwestern city in June-August 2014. We transcribed the interviews, developed a coding schema, and analyzed these qualitative data using a priori and open coding of transcripts. Few pediatricians had favorable views on adolescent IUD use and most did not include IUDs in routine contraception counseling. Pediatricians perceived IUDs to impose significant risks for adverse reproductive outcomes and to be poorly tolerated by adolescents. Poor and/or outdated knowledge influenced inaccurate beliefs and unsupportive attitudes. Whereas some pediatricians were advocates for adolescent use of IUDs, many others had concerns that IUDs were not appropriate and not favored by adolescents. In contrast, participants viewed the etonogestrel implant more favorably and often included it in routine counseling. Some pediatricians focused on the familiar and readily available methods (injectable and oral contraceptives) or assumed patients had predetermined expectations for those methods. Time spent counseling on LARC was also perceived as a barrier. Pediatricians described how education and increased familiarity with LARC changed viewpoints. A variety of beliefs and attitudes, as well as factors such as time and personal habits, influence pediatricians' contraceptive counseling practices. Until knowledge deficits are addressed, uninformed viewpoints and unfavorable attitudes will limit adolescents' access to LARC, especially IUDs. Copyright © 2016 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All

  6. Medroxyprogesterone acetate or long-acting progesterone in the biostimulation of lambs

    Directory of Open Access Journals (Sweden)

    Luis C.O. Magalhães

    2010-09-01

    Full Text Available The aim of this study was to evaluate the response of prepubertal ewe lambs to exogenous administration of either medroxyprogesterone acetate (MAP or long-acting progesterone (LAP together with biostimulation. Two Pool Dorset adult males and 75 mixed-breed prepubertal ewe lambs (average of 179 days-old and 30.0kg were used. The females were randomly assigned to three different groups. In the first group the females were submitted to the insertion of intravaginal sponges containing MAP (60 mg for 12 days and were then biostimulated for eight weeks. In the second group the females were submitted to a single injection of LAP (225 mg and then to biostimulation for eight weeks. In the last group, the females were only submitted to biostimulation for eight weeks. Animals were considered cyclic when plasma progesterone (P4 concentration exceeded 1.0 ng/mL in at least one of two consecutive blood samples taken within a 7-day interval in three distinct experimental moments. After treatments 93.3% of the females disregarding their group started their cyclicity and most of them (92.0%, continued to be cyclic after 63 days of either MAP or LAP together with biostimulation under both male and female effect. We conclude that prepubertal ewe lambs when submitted to protocols of either MAP or LAP followed by biostimulation result in puberty at the 7 month of age. It can be deducted that some ewe lambs submitted to the administration of either MAP or LAP together with biostimulation promoted a multiplier effect upon the other young females that were then stimulated to start cyclicity.

  7. Weight change during long-term treatment with lurasidone: pooled analysis of studies in patients with schizophrenia.

    Science.gov (United States)

    Meyer, Jonathan M; Mao, Yongcai; Pikalov, Andrei; Cucchiaro, Josephine; Loebel, Antony

    2015-11-01

    The objective of this analysis was to evaluate the effect of 12 months of treatment with lurasidone on weight in patients with schizophrenia. Post-hoc, observed-case analysis included pooled data from six studies on 40-160 mg/day lurasidone; two studies included active comparators (2-6 mg/day risperidone or 200-800 mg/day quetiapine XR). Overall, 593 patients completed 12 months of treatment (N=471 lurasidone, N = 89 risperidone, N = 33 quetiapine XR). The mean baseline weight was 72.8, 80.8, and 72.4 kg in the lurasidone, risperidone, and quetiapine XR groups, respectively. The mean weight change at month 12 was -0.4 kg with lurasidone, +2.6 kg with risperidone, and +1.2 kg with quetiapine XR. Weight gain of at least 7% from study baseline was observed in 16.0, 25.8, and 15.2% of patients, and weight loss of at least 7% was seen in 18.5, 6.7, and 9.1% of patients treated with lurasidone, risperidone, and quetiapine XR, respectively. A shift from normal/underweight baseline BMI status to overweight/obese at month 12 occurred in 10.2, 27.6, and 15.0% of patients in the lurasidone, risperidone, and quetiapine XR groups, respectively. Conversely, 14.3, 1.7, and 7.7% of patients, respectively, shifted from overweight/obese to normal/underweight. In summary, a low potential for clinically significant weight gain was observed in patients with schizophrenia treated continuously with lurasidone for 12 months.

  8. Investigation of the effect of solubility increase at the main absorption site on bioavailability of BCS class II drug (risperidone) using liquisolid technique.

    Science.gov (United States)

    Khames, Ahmed

    2017-11-01

    BCS class II drugs usually suffer inadequate bioavailability as dissolution step is the absorption rate limiting step. In this work, the effect of solubility increase at the main absorption site for these drugs was investigated using risperidone as a drug model. Liquisolid technique was applied to prepare risperidone per-oral tablets of high dissolution rate at intestinal pH (6.8) using versatile nonionic surfactants of high solubilizing ability [Transcutol HP, Labrasol and Labrasol/Labrafil (1:1) mixture] as liquid vehicles at different drug concentrations (10-30%) and fixed (R). The prepared liquisolid tablets were fully evaluated and the dissolution rate at pH 6.8 was investigated. The formulae that showed significantly different release rate were selected and subjected to mathematical modeling using DE 25 , MDT and similarity factor (f2). Depending on mathematical modeling results, formula of higher dissolution rate was subjected to solid state characterization using differential scanning calorimetric (DSC), infrared spectroscopy (IR) and X-ray diffraction (XRD). Finally, the drug bioavailability was studied in comparison to conventional tablets in rabbits. Results showed that liquisolid tablet prepared using Labrasol/Labrafil (1:1) mixture as liquid vehicle containing 10% risperidone is a compatible formula with law drug crystallinity and higher dissolution rate (100% in 25 min). The drug bioavailability was significantly increased in comparison to the conventional tablets (1441.711 μg h/mL and 137.518 μg/mL in comparison to 321.011 μg h/mL and 38.673 μg/mL for AUC and Cp max , respectively). This led to the conclusion that liquisolid technique was efficiently improved drug solubility and solubility increase of BCS class II drugs at their main absorption site significantly increases their bioavailability.

  9. Risperidone-Induced Weight Gain in Referred Children with Autism Spectrum Disorders Is Associated with a Common Polymorphism in the 5-Hydroxytryptamine 2C Receptor Gene

    NARCIS (Netherlands)

    Hoekstra, Pieter J.; Troost, Pieter W.; Lahuis, Bertine E.; Mulder, Hans; Mulder, Erik J.; Franke, Barbara; Buitelaar, Jan K.; Anderson, George M.; Scahill, Lawrence; Minderaa, Ruud B.

    2010-01-01

    Weight gain is an important adverse effect of risperidone, but predictors of significant weight gain have yet to be identified in pediatric patients. Here, we investigated differences between age-and gender-normed body mass index-standardized z scores at baseline and after 8 weeks of open-label,

  10. A comparison of the effect of short-acting and long-acting cloxacillin-based dry-cow therapy on somatic cell counts after calving in cows also given internal teat sealants.

    Science.gov (United States)

    Whitfield, L K; Laven, R A

    2018-01-01

    To compare, in cows treated with an internal teat sealant, the effect of short-acting and long-acting cloxacillin-based dry-cow therapy on somatic cell counts (SCC) after calving. Cows from a spring-calving, pasture-based dairy farm in the Manawatu-Whanganui region of New Zealand were randomly allocated to receive either a short-acting cloxacillin and ampicillin dry-cow therapy and internal teat sealant (n=291) or a long-acting cloxacillin and ampicillin dry-cow therapy and internal teat sealant (n=288) at the end of lactation. Cows were managed on-farm with routine husbandry procedures through the dry period and following calving. A multivariable logistic regression model was used to determine the association between length of action of dry-cow therapy and the proportion of cows with a SCC >150,000 cells/mL at the first herd test after calving. Age of cow, mean SCC for the preceding season and interval from calving to the first post-calving herd test were all associated with the proportion of cows with an individual SCC >150,000 cells/mL at the first herd test (pcow therapy was not associated with decreased odds of cows having a SCC >150,000 cells/mL at the first herd test compared with treatment with long-acting dry-cow therapy (OR=0.724; 95% CI=0.40-1.30). In this herd, which routinely used internal teat sealants, the use of short-acting cloxacillin-based dry-cow therapy did not result in an increased proportion of cows with elevated SSC post-calving. This was a single farm, single year study but indicates that in this herd, changing from a long-acting to a short-acting antimicrobial may have no impact on the prevalence of subclinical mastitis.

  11. Proportion of long-term injection drug users as an indicator to characterize the state and prognosis of HIV-epidemic within a certain territory

    Directory of Open Access Journals (Sweden)

    Andreeva, Tatiana

    2012-07-01

    Full Text Available BACKGROUND: Epidemics of drug use and thus the spread of HIV have different duration in different regions, and, therefore, the prognosis of these epidemics may differ. We aimed to assess indicators measuring the peculiarities of injection drug use epidemics by region, informative for prevention activities among vulnerable to HIV groups. METHODS: Data from cross-sectional survey of 4026 injection drug users (IDUs conducted in 2007 in Ukraine were analyzed. The outcome measure was a binary variable depicting whether a respondent injects drugs for 20 years and over. Binary Logistic Regression in SPSS software was used to test associations with socio-demographic characteristics. RESULTS: More respondents from Odessa, Mykolayiv, Dnipropetrovsk, Cherkassy, Poltava, and Crimea regions inject over 20 years. Older respondents were more likely to belong to the group of long-term users. Men were more likely to inject over 20 years than women. Those respondents who were married, but did not live with their spouse or other sexual partner were more likely to inject longer than 20 years compared to those single or in a stable marriage. Those respondents who use opiates or combine them with stimulants were more likely to inject over 20 years and those who use only stimulants were more likely to inject less than 20 years. CONCLUSION: Injection drug use in Ukraine started earlier among men, on certain territories and was associated with opiate use. Percentage of IDUs who inject for more than 20 years was found to be a good indicator to distinguish territories with long-lasting epidemics.

  12. Treatment Patterns and Antipsychotic Medication Adherence Among Commercially Insured Patients With Schizoaffective Disorder in the United States

    Science.gov (United States)

    Joshi, Kruti; Lin, Jay; Lingohr-Smith, Melissa; Fu, Dong-Jing; Muser, Erik

    2016-01-01

    Abstract This study assessed real-world treatment patterns and antipsychotic (AP) medication adherence among commercially insured US patients with schizoaffective disorder (SCA). Continuously insured adults aged 18 years or older with a diagnosis of SCA from January 1, 2009, to December 31, 2012, were identified from the Clinformatics Data Mart database. Patients were categorized into 2 cohorts: incident or prevalent SCA. Demographics and clinical characteristics were evaluated during the baseline period. Use of psychiatric medications and adherence to AP medications were evaluated during a 12-month follow-up period after index diagnosis of SCA. Of the overall study population (N = 2713; mean age, 40.2 y; 52.7% female), 1961 patients (72.3%) (mean age, 38.7 y; 51.3% female) had incident SCA, and 752 patients (27.7%) (mean age, 43.9 y; 56.5% female) had prevalent SCA. Antipsychotics were used by 74.8% of patients in the overall study population during the follow-up period. The most commonly prescribed oral AP was risperidone (23.9%), followed by quetiapine (21.4%) and aripiprazole (20.4%). Use of any long-acting injectable APs in the overall study population during the follow-up period was less than 3%. A total of 49.0% and 38.0% of the overall study population had medication possession ratios and proportion of days covered for APs of 80% or greater, respectively. Overall use of long-acting injectable APs for the treatment of SCA is low, and adherence to AP medications, measured by both medication possession ratio and proportion of days covered, is suboptimal among patients with SCA in the real-world setting. PMID:27525965

  13. Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis

    DEFF Research Database (Denmark)

    Hetland, Merete Lund; Østergaard, Mikkel; Ejbjerg, Bo

    2012-01-01

    To investigate the short-term and long-term efficacy of intra-articular betamethasone injections, and the impact of joint area, repeated injections, MRI pathology, anticyclic citrullinated peptide (CCP) and immunoglobulin M rheumatoid factor (IgM-RF) status in patients with early rheumatoid arthr...

  14. Demand for long acting contraceptive methods and associated factors among family planning service users, Northwest Ethiopia: a health facility based cross sectional study.

    Science.gov (United States)

    Yalew, Saleamlak Adbaru; Zeleke, Berihun Megabiaw; Teferra, Alemayehu Shimeka

    2015-02-04

    Demand for long acting contraceptive methods is one of the key factors for total fertility rate and reproductive health issues. Increased demand for these methods can decline fertility rate through spacing and limiting family size in turn improving maternal and family health and socioeconomic development of a country. The aim of this study was to assess demand for long acting contraceptives and associated factors among family planning users in Debre-Tabor Town, Northwest Ethiopia. Facility based cross-sectional study was conducted from July to August 2013. Data was collected on 487 current family planning users through face to face interview using structured questionnaire. Study participants were selected by systematic sampling method. Data were entered in to Epi Info and analyzed by using SPSS version 20. Bi-variable and multi-variable regression analyses were done to identify factors associated with demand for long acting contraceptive methods. Odds ratio with 95% CI was used to assess the association between the independent variables and demand for long acting family planning methods. The study showed that, demand for long acting contraceptives was 17%. Only 9.2% of the women were using long acting contraceptive methods (met need). About 7.8% of women were using short acting methods while they actually want to use long acting methods (unmet need). Demand for LACMs was positively associated 3 with being a daily labour (AOR = 3.87, 95% CI = [1.06, 14.20]), being a student (AOR = 2.64, 95% CI = [1.27, 5.47]), no future birth intensions (AOR = 2.17, 95% CI = [1.12, 4.23]), having five or more children (AOR = 1.67, 95% CI = [1.58, 4.83]), deciding together with husbands for using the methods (AOR = 2.73, 95% CI = [1.40, 5.32]) and often having discussion with husband (AOR = 3.89, 95% CI = [1.98, 7.65]). Clients treated poorly by the health care providers during taking the services was negatively associated with demand for LACMs (AOR = 0.42, 95% CI = [0.24, 0

  15. Labeling of hepatic glycogen after short- and long-term stimulation of glycogen synthesis in rats injected with 3H-galactose

    International Nuclear Information System (INIS)

    Michaels, J.E.; Garfield, S.A.; Hung, J.T.; Cardell, R.R. Jr.

    1990-01-01

    The effects of short- and long-term stimulation of glycogen synthesis elicited by dexamethasone were studied by light (LM) and electron (EM) microscopic radioautography (RAG) and biochemical analysis. Adrenalectomized rats were fasted overnight and pretreated for short- (3 hr) or long-term (14 hr) periods with dexamethasone prior to intravenous injection of tracer doses of 3H-galactose. Analysis of LM-RAGs from short-term rats revealed that about equal percentages (44%) of hepatocytes became heavily or lightly labeled 1 hr after labeling. The percentage of heavily labeled cells increased slightly 6 hr after labeling, and unlabeled glycogen became apparent in some hepatocytes. The percentage of heavily labeled cells had decreased somewhat 12 hr after labeling, and more unlabeled glycogen was evident. In the long-term rats 1 hr after labeling, a higher percentage of heavily labeled cells (76%) was observed compared to short-term rats, and most glycogen was labeled. In spite of the high amount of labeling seen initially, the percentage of heavily labeled hepatocytes had decreased considerably to 55% by 12 hr after injection; and sparsely labeled and unlabeled glycogen was prevalent. The EM-RAGs of both short- and long-term rats were similar. Silver grains were associated with glycogen patches 1 hr after labeling; 12 hr after labeling, the glycogen patches had enlarged; and label, where present, was dispersed over the enlarged glycogen clumps. Analysis of DPM/mg tissue corroborated the observed decrease in label 12 hr after administration in the long-term animals. The loss of label observed 12 hr after injection in the long-term pretreated rats suggests that turnover of glycogen occurred during this interval despite the net accumulation of glycogen that was visible morphologically and evident from biochemical measurement

  16. Sex work involvement among women with long-term opioid injection drug dependence who enter opioid agonist treatment.

    Science.gov (United States)

    Marchand, Kirsten; Oviedo-Joekes, Eugenia; Guh, Daphne; Marsh, David C; Brissette, Suzanne; Schechter, Martin T

    2012-01-25

    Substitution with opioid-agonists (e.g., methadone) has shown to be an effective treatment for chronic long-term opioid dependency. Survival sex work, very common among injection drug users, has been associated with poor Opioid Agonist Treatment (OAT) engagement, retention and response. Therefore, this study was undertaken to determine factors associated with engaging in sex work among long-term opioid dependent women receiving OAT. Data from a randomized controlled trial, the North American Opiate Medication Initiative (NAOMI), conducted in Vancouver and Montreal (Canada) between 2005-2008, was analyzed. The NAOMI study compared the effectiveness of oral methadone to injectable diacetylmorphine or injectable hydromorphone, the last two on a double blind basis, over 12 months. A research team, independent of the clinic services, obtained outcome evaluations at baseline and follow-up (3, 6, 9, 12, 18 and 24 months). A total 53.6% of women reported engaging in sex work in at least one of the research visits. At treatment initiation, women who were younger and had fewer years of education were more likely to be engaged in sex work. The multivariate logistic generalized estimating equation regression analysis determined that psychological symptoms, and high illicit heroin and cocaine use correlated with women's involvement in sex work during the study period. After entering OAT, women using injection drugs and engaging in sex work represent a particularly vulnerable group showing poorer psychological health and a higher use of heroin and cocaine compared to women not engaging in sex work. These factors must be taken into consideration in the planning and provision of OAT in order to improve treatment outcomes. NCT00175357.

  17. Sex work involvement among women with long-term opioid injection drug dependence who enter opioid agonist treatment

    Directory of Open Access Journals (Sweden)

    Marchand Kirsten

    2012-01-01

    Full Text Available Abstract Background Substitution with opioid-agonists (e.g., methadone has shown to be an effective treatment for chronic long-term opioid dependency. Survival sex work, very common among injection drug users, has been associated with poor Opioid Agonist Treatment (OAT engagement, retention and response. Therefore, this study was undertaken to determine factors associated with engaging in sex work among long-term opioid dependent women receiving OAT. Methods Data from a randomized controlled trial, the North American Opiate Medication Initiative (NAOMI, conducted in Vancouver and Montreal (Canada between 2005-2008, was analyzed. The NAOMI study compared the effectiveness of oral methadone to injectable diacetylmorphine or injectable hydromorphone, the last two on a double blind basis, over 12 months. A research team, independent of the clinic services, obtained outcome evaluations at baseline and follow-up (3, 6, 9, 12, 18 and 24 months. Results A total 53.6% of women reported engaging in sex work in at least one of the research visits. At treatment initiation, women who were younger and had fewer years of education were more likely to be engaged in sex work. The multivariate logistic generalized estimating equation regression analysis determined that psychological symptoms, and high illicit heroin and cocaine use correlated with women's involvement in sex work during the study period. Conclusions After entering OAT, women using injection drugs and engaging in sex work represent a particularly vulnerable group showing poorer psychological health and a higher use of heroin and cocaine compared to women not engaging in sex work. These factors must be taken into consideration in the planning and provision of OAT in order to improve treatment outcomes. Trial Registration NCT00175357.

  18. Plasma characteristics of long-pulse discharges heated by neutral beam injection in the Large Helical Device

    Science.gov (United States)

    Takeiri, Y.; Nakamura, Y.; Noda, N.; Osakabe, M.; Kawahata, K.; Oka, Y.; Kaneko, O.; Tsumori, K.; Sato, M.; Mutoh, T.; Shimozuma, T.; Goto, M.; Ida, K.; Inagaki, S.; Kado, S.; Masuzaki, S.; Morita, S.; Nagayama, Y.; Narihara, K.; Peterson, B. J.; Sakakibara, S.; Sato, K.; Shoji, M.; Tanaka, K.; de Vries, P. C.; Sudo, S.; Ohyabu, N.; Motojima, O.

    2000-02-01

    Long-pulse neutral beam injection heating has been achieved in the large helical device (LHD). Two different confinement states are observed for different averaged densities in the long-pulse plasmas. A quasi-steady-state plasma was sustained for 21 s with an injection power of 0.6 MW, where the central plasma temperature was around 1 keV with a line-averaged electron density of 0.3 × 1019 m-3 . The discharge duration can be so extended as to keep the plasma properties in the short-pulse discharge. The energy confinement time is nearly the same as that of the short-pulse discharge, which is 1.3 times as long as the international stellarator scaling ISS95. At higher densities, a relaxation oscillation phenomenon, observed as if the plasma would breathe, lasted for 20 s with a period of 1-2 s. The phenomenon is characterized with profile expansion and contraction of the electron temperature. The density oscillation is out of phase with the temperature oscillation and is related to the density clamping phenomenon. The observed plasma properties are shown in detail for the `breathing' oscillation phenomenon. Possible mechanisms for the breathing oscillation are also discussed, with a view of the screening effect near the last closed magnetic surface and the power balance between the heating and the radiation powers. The long-pulse heating results indicate unique characteristics of the LHD where no special feedback stabilization is required due to absence of disruption and no need for current drive.

  19. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes.

    Science.gov (United States)

    Heise, T; Nosek, L; Bøttcher, S G; Hastrup, H; Haahr, H

    2012-10-01

    Insulin degludec (IDeg) is a new-generation, ultra-long-acting basal insulin that forms soluble multihexamers upon subcutaneous injection, resulting in a depot from which IDeg is absorbed slowly and continuously into circulation. This double-blind, two-period, incomplete block cross-over trial investigated the pharmacodynamic and pharmacokinetic properties of IDeg at steady state (SS) in people with type 2 diabetes. Forty-nine subjects treated with insulin without concomitant oral anti-diabetic drugs were given IDeg (0.4, 0.6 and/or 0.8 U/kg) once daily for two 6-day periods, separated by an interval of 13-21 days. Following dosing on Day 6, subjects underwent a 26-h euglycaemic glucose clamp (Biostator®; clamp blood glucose level: 90 mg/dl; 5.0 mmol/l). Pharmacokinetic samples were taken until 120 h after last dosing. For all dose levels, the mean glucose infusion rate (GIR) profiles were flat and stable. The glucose-lowering effect of IDeg was evenly distributed over the dosing interval τ, with area under the curve (AUC) for each of the four 6-h intervals being approximately 25% of the total AUC (AUC(GIR) (,τ,) (SS) ). Total glucose-lowering effect increased linearly with increasing dose. The blood glucose levels of all subjects stayed very close to the clamp target until end of clamp. The terminal half-life of IDeg was approximately 25 h at steady state. IDeg was well tolerated and no safety concerns were identified. No injection site reactions were reported. IDeg has a flat and consistent glucose-lowering effect in people with type 2 diabetes. © 2012 Blackwell Publishing Ltd.

  20. [Long-acting insulins in the treatment of type 2 diabetes and their position in the current treatment algorithm].

    Science.gov (United States)

    Haluzík, Martin

    Insulin therapy has been for many years an inseparable part of the treatment of patients with type 2 diabetes, in particular those with longer diabetes duration. Current national and international guidelines list insulin treatment as a possible second choice therapy in patient with unsatisfactory glucose control on monotherapy with metformin. In reality, insulin therapy is often initiated later than it optimally should be. The reasons include among others the fear of patients and sometimes also of physicians from the side effects of insulin. Even though the options of antidiabetic treatment has been diversified by the addition of novel groups of antidiabetics with good efficacy and low risk of hypoglycemia, long acting insulin therapy still remains the most effective way of decreasing fasting hyperglycemia with the effect lasting further throughout the day. In this paper we summarize the current knowledge concerning long-acting insulins available on the Czech market or the ones that should be available in the near future. We discuss the differences among available long-acting insulins and their clinical consequences with respect to the selection of particular insulin for particular patient.Key words: biosimilar insulins - body weight - diabetes mellitus - hypoglycemia - long acting insulin.

  1. Long-acting beta-agonists in the management of chronic obstructive pulmonary disease: current and future agents

    Directory of Open Access Journals (Sweden)

    Fabbri Leonardo M

    2010-10-01

    Full Text Available Abstract Chronic obstructive pulmonary disease (COPD is characterized by progressive airflow limitation and debilitating symptoms. For patients with moderate-to-severe COPD, long-acting bronchodilators are the mainstay of therapy; as symptoms progress, guidelines recommend combining bronchodilators from different classes to improve efficacy. Inhaled long-acting β2-agonists (LABAs have been licensed for the treatment of COPD since the late 1990s and include formoterol and salmeterol. They improve lung function, symptoms of breathlessness and exercise limitation, health-related quality of life, and may reduce the rate of exacerbations, although not all patients achieve clinically meaningful improvements in symptoms or health related quality of life. In addition, LABAs have an acceptable safety profile, and are not associated with an increased risk of respiratory mortality, although adverse effects such as palpitations and tremor may limit the dose that can be tolerated. Formoterol and salmeterol have 12-hour durations of action; however, sustained bronchodilation is desirable in COPD. A LABA with a 24-hour duration of action could provide improvements in efficacy, compared with twice-daily LABAs, and the once-daily dosing regimen could help improve compliance. It is also desirable that a new LABA should demonstrate fast onset of action, and a safety profile at least comparable to existing LABAs. A number of novel LABAs with once-daily profiles are in development which may be judged against these criteria. Indacaterol, a LABA with a 24-hour duration of bronchodilation and fast onset of action, is the most advanced of these. Preliminary results from large clinical trials suggest indacaterol improves lung function compared with placebo and other long-acting bronchodilators. Other LABAs with a 24-hour duration of bronchodilation include carmoterol, vilanterol trifenatate and oldaterol, with early results indicating potential for once-daily dosing in

  2. The effects of increasing doses of 2 preparations of long-acting insulin on short-term plasma profiles of glucose and insulin in lactating dairy cows.

    Science.gov (United States)

    Winkelman, L A; Overton, T R

    2012-12-01

    Two experiments were conducted to investigate effects of administering increasing doses of 2 different preparations of long-acting insulin on the 24-h profiles of plasma glucose and insulin concentrations in mid lactation dairy cows. The 2 separately analyzed experiments investigated the effects administering either Humulin N (H), a neutral protamine Hagedorn insulin, or insulin glargine (Lantus, L), an insulin analog, at doses of 0 (control), 0.1, 0.2, and 0.4 IU/kg of body weight in a randomized complete block design. Sixteen cows (237±11 d in milk for H; 213±10 d in milk for L; mean ± SD) were used for each insulin preparation, resulting in n=4 for each dose within insulin preparation. Cows were fitted with a single jugular catheter on the day before the study. On the day of the study, cows were given treatments by subcutaneous injection of either sterile water or the designated insulin type and dose. Blood samples were taken hourly from the jugular catheter. Subcutaneous injection of both H and L resulted in linear decreases in plasma glucose concentrations, increased area under the curve, and decreased nadir for plasma glucose following administration of the insulin preparations. Plasma insulin concentration linearly increased with increasing dose of H. Though elevated concentrations of insulin were measurable in cows treated with H, they were not measurable in cows treated with L. Attempts to measure overall insulin concentrations and metabolites of L by a commercially available ELISA and a commercially available RIA kit were not successful and did not retrieve values that we felt truly represented the amount of insulin activity exhibited during this treatment. Both long-acting insulin preparations elicited insulin-like activity in lactating dairy cows, as evidenced by reduced plasma glucose concentrations. Given these results, the potential exists to use both H and L to study the effects of insulin in mid lactation dairy cows without the confounding

  3. Predicting Long-Term College Success through Degree Completion Using ACT[R] Composite Score, ACT Benchmarks, and High School Grade Point Average. ACT Research Report Series, 2012 (5)

    Science.gov (United States)

    Radunzel, Justine; Noble, Julie

    2012-01-01

    This study compared the effectiveness of ACT[R] Composite score and high school grade point average (HSGPA) for predicting long-term college success. Outcomes included annual progress towards a degree (based on cumulative credit-bearing hours earned), degree completion, and cumulative grade point average (GPA) at 150% of normal time to degree…

  4. Long-term Results of Intravitreal Anti-VEGF Injections in Wet AMD: A Meta-Analysis.

    Science.gov (United States)

    Gerding, H

    2016-04-01

    Although intravitreal anti-VEGF medications are widely used in age-related macular degeneration, no systematic data analysis is available on the long-term prognosis of this relatively new therapeutic approach. A meta-analysis was performed on available Medline literature. 13 relevant clinical studies (14 case series) could be identified, covering 10 247 treated eyes. The majority of available reports originate from single centre retrospective real-life environments. The mean improvement in average visual gain was 0.9 ± 0.5 (mean ± 1 standard deviation, median; 0.8 lines) at year 1, 1.2 ± 1.1 (median: 1.1) letters at year 2, 0.7 ± 1.0 (median: 0.7) letters at year 3, and 0.2 ± 0.8 (median: 0.5), 0.4 ± 0.4 (median: 0.5) at years 4 and 5. The drop-out rates in these studies was relatively high. At the end of year 3, the average percentage of observed eyes was 44.3 ± 18.4 % (mean ± 1 standard deviation), at the end of year 4 23.5 ± 23.9 % and after years 6 and 7 below 10 % (8.2 and 7.9 %). The mean treatment frequency of injections in all available studies was highest in year 1 (6.4 ± 1.2, 6.1 - mean ± SD; median), followed by relatively consistent mean values of 4.1 and 5.1 (year (Y)2: 4.4, Y3: 4.3, Y4: 4.7, Y5: 4.1, Y6: 5.1, Y7: 4.7) injections per year. The results of this meta-analysis clearly indicate that intravitreal anti-VEGF injection therapy is capable of maintaining visual acuity on a long-term basis of at least 4-5 years. Georg Thieme Verlag KG Stuttgart · New York.

  5. Correction of sleep disorders in EMERCOM employees: The results of using long-acting melatonin

    Directory of Open Access Journals (Sweden)

    Yu. B. Slizkova

    2017-01-01

    Full Text Available Objective: to evaluate the efficacy of long-acting melatonin in EMERCOM employees with sleep disorders (insomnia associated with desynchronosis.Patients and methods. 30 patients (EMERCOM employees having manifestations of desynchronosis-associated insomnia were examined using the following tests and questionnaires: the short-term verbal memory test (five words test; the modified point subjective sleep characteristics scale; the Hospital Anxiety and Depression Scale; the Screening Dysfunctional Beliefs and Attitudes Scale; the symbolic-digital coding test; individual sleep diaries.Results. According to the tests and questionnaires, the treatment resulted in a statistically significant improvement in sleep quality and indicators of short-term memory and cognitive functions (attention concentration and a reduction in anxiety and depression.Conclusion. Long-acting melatonin has a good safety profile and can be recommended as a first-line drug to treat desynchronosis-associated sleep disorders.

  6. Use of long-acting reversible contraceptives to reduce the rate of teen pregnancy.

    Science.gov (United States)

    Rome, Ellen

    2015-11-01

    Long-acting reversible contraceptives (LARCs) are safe for use in adolescents and do not rely on compliance or adherence for effectiveness. Continuation rates are higher and pregnancy rates are lower for adolescent users of LARCs compared with short-acting methods such as oral contraceptives. Similarly, repeat pregnancy rates are lower when LARCs are used compared with other forms of contraception. Myths and misconceptions about LARCs and other contraceptives remain a barrier to their use. Health care providers are in a unique position to provide confidential care to adolescents, and should provide education to them about the various contraceptive options, especially LARCs. Copyright © 2015 Cleveland Clinic.

  7. 76 FR 68766 - Draft Blueprint for Prescriber Education for Long-Acting/Extended-Release Opioid Class-Wide Risk...

    Science.gov (United States)

    2011-11-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0771] Draft Blueprint for Prescriber Education for Long-Acting/ Extended-Release Opioid Class-Wide Risk... announcing the availability of a draft document entitled ``Blueprint for Prescriber Education for the Long...

  8. Effect of long-acting beta2 agonists on exacerbation rates of asthma in children

    DEFF Research Database (Denmark)

    Bisgaard, Hans

    2003-01-01

    The purpose of this analysis was to examine the effect of long-acting beta(2)-adrenoceptor agonists (LABAs) on the asthma exacerbation rate in pediatric patients. Randomized controlled trials (RCT) that included the use of LABAs to treat symptoms of pediatric asthma in children on inhaled cortico...

  9. Rapid colorimetric assay for gentamicin injection.

    Science.gov (United States)

    Tarbutton, P

    1987-01-01

    A rapid colorimetric method for determining gentamicin concentration in commercial preparations of gentamicin sulfate injection was developed. Methods currently available for measuring gentamicin concentration via its colored complex with cupric ions in alkaline solution were modified to reduce the time required for a single analysis. The alkaline copper tartrate (ACT) reagent solution was prepared such that each milliliter contained 100 mumol cupric sulfate, 210 mumol potassium sodium tartrate, and 1.25 mmol sodium hydroxide. The assay involves mixing 0.3 mL gentamicin sulfate injection 40 mg/mL (of gentamicin), 1.0 mL ACT reagent, and 0.7 mL water; the absorbance of the resulting solution at 560 nm was used to calculate the gentamicin concentration in the sample. For injections containing 10 mg/mL of gentamicin, the amount of the injection was increased to 0.5 mL and water decreased to 0.5 mL. The concentration of gentamicin in samples representing 11 lots of gentamicin sulfate injection 40 mg/mL and 8 lots of gentamicin sulfate injection 10 mg/mL was determined. The specificity, reproducibility, and accuracy of the assay were assessed. The colored complex was stable for at least two hours. Gentamicin concentration ranged from 93.7 to 108% and from 95 to 109% of the stated label value of the 40 mg/mL and the 10 mg/mL injections, respectively. No components of the preservative system present in the injections interfered with the assay. Since other aminoglycosides produced a colored complex, the assay is not specific for gentamicin. The assay was accurate and reproducible over the range of 4-20 mg of gentamicin. This rapid and accurate assay can be easily applied in the hospital pharmacy setting.

  10. Comparison Review of Short-Acting and Long-Acting Glucagon-like Peptide-1 Receptor Agonists.

    Science.gov (United States)

    Uccellatore, Annachiara; Genovese, Stefano; Dicembrini, Ilaria; Mannucci, Edoardo; Ceriello, Antonio

    2015-09-01

    Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1 RAs) are useful tools for treating type 2 diabetes mellitus. In their recent position statement, the American Diabetes Association and European Association for the Study of Diabetes recommend GLP1-RAs as add-on to metformin when therapeutic goals are not achieved with monotherapy, particularly for patients who wish to avoid weight gain or hypoglycemia. GLP1-RAs differ substantially in their duration of action, frequency of administration and clinical profile. Members of this class approved for clinical use include exenatide twice-daily, exenatide once-weekly, liraglutide and lixisenatide once-daily. Recently, two new once-weekly GLP1-RAs have been approved: dulaglutide and albiglutide. This article summarizes properties of short- and long-acting GLP-1 analogs, and provides useful information to help choose the most appropriate compound for individual patients.

  11. The affordable care act and long-term care: comprehensive reform or just tinkering around the edges?

    Science.gov (United States)

    Miller, Edward Alan

    2012-01-01

    The Patient Protection and Affordable Care Act (ACA) includes several provisions that aim to improve prevailing deficiencies in the nation's long-term care system. But just how effective is the ACA likely to be in addressing these challenges? Will it result in meaningful or marginal reform? This special issue of Journal of Aging & Social Policy seeks to answer these questions. The most prominent long-term care provision is the now-suspended Community Living Assistance Services and Supports Act. Others include incentives and options for expanding home- and community-based care, a number of research and demonstration projects in the areas of chronic care coordination and the dually eligible, and nursing home quality reforms. There are also elements that seek to improve workforce recruitment and retention, in addition to benefit improvements and spending reductions under Medicare. This article reviews the basic problems plaguing the long-term care sector and the provisions within the ACA meant to address them. It also includes a brief overview of issue content.

  12. Assessment of the Pharmacokinetics, Pharmacodynamics, and Safety of Single Doses of TV-1106, a Long-Acting Growth Hormone, in Healthy Japanese and Caucasian Subjects.

    Science.gov (United States)

    Cohen-Barak, Orit; Barkay, Hadas; Rasamoelisolo, Michele; Butler, Kathleen; Yamada, Kazumasa; Bassan, Merav; Yoon, Esther; Spiegelstein, Ofer

    2017-07-01

    TV-1106 is a human serum albumin genetically fused to recombinant human growth hormone, designed to provide a long-acting alternative to daily growth hormone (GH) injections in patients with GH deficiency. This study investigated the pharmacokinetics, pharmacodynamics, and safety of single subcutaneous doses of TV-1106 (7.5, 15, 50, and 100 mg) in Japanese (n = 44) and caucasian (n = 44) healthy subjects. TV-1106 pharmacokinetics and pharmacodynamics were comparable in Japanese and caucasian populations. TV-1106 demonstrated relatively slow absorption (median t max , 10-30 hours) and a mean elimination half-life of 26-36 hours. Apparent clearance and volume of distribution decreased with increasing TV-1106 doses in both populations and appeared to increase more than dose proportionality across the tested doses. Insulin-like growth factor-1 (IGF-1) and IGF binding protein-3 (IGFBP-3) increased in a dose-related manner, with maximum responses observed at 33-96 and 42-109 hours, respectively. IGF-1 and IGFBP-3 returned to baseline values at 168 hours following 7.5 and 15 mg of TV-1106, and 336 hours following 50 and 100 mg of TV-1106. TV-1106 appeared safe in both populations. There was no evidence of differences in pharmacokinetics, pharmacodynamics, or safety of TV-1106 between Japanese and caucasian populations. The data also demonstrate long-acting growth hormone properties of TV-1106 and support its potential for once-weekly dosing. © 2016, The Authors. Clinical Pharmacology in Drug Development Published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.

  13. Preferences for Long-Acting Pre-exposure Prophylaxis (PrEP), Daily Oral PrEP, or Condoms for HIV Prevention Among U.S. Men Who Have Sex with Men.

    Science.gov (United States)

    Greene, George J; Swann, Greg; Fought, Angela J; Carballo-Diéguez, Alex; Hope, Thomas J; Kiser, Patrick F; Mustanski, Brian; D'Aquila, Richard T

    2017-05-01

    HIV prevention method preferences were evaluated among 512 U.S. men who have sex with men (MSM; median age: 22 years). Approximately 90 % consistently preferred one option across pairwise comparisons of condoms, daily oral pre-exposure prophylaxis (PrEP), and long-acting PrEP delivered via either an injectable or one of two types of PrEP implants differing in visibility. Condoms were most frequently preferred (33.8 %), followed by non-visible implants (21.5 %), and oral PrEP (17.0 %); HIV risk was reported by more choosing implants. In a follow-up question comparing the four PrEP options only, daily oral pills and non-visible implants were most frequently preferred (35.5 and 34.3 %, respectively), followed by injections (25.2 %) and visible implants (4.3 %). An inductive, open-coding approach determined that convenience, duration of protection, and privacy were the most commonly cited reasons for a PrEP method choice, and associated with self-report of HIV risk. Tailoring PrEP product development to privacy and other concerns important to those at highest HIV risk may improve HIV prevention.

  14. Does Prolonged Therapy with a Long-Acting Stimulant Suppress Growth in Children with ADHD?

    Science.gov (United States)

    Spencer, Thomas J.; Faraone, Stephen V.; Biederman, Joseph; Lerner, Marc; Cooper, Kimberly M.; Zimmerman, Brenda

    2006-01-01

    Objective: To investigate whether prolonged therapy with a long-acting stimulant affects growth in children with attention-deficit/hyperactivity disorder (ADHD). Method: One hundred seventy-eight children ages 6 to 13 years received OROS methylphenidate (OROS MPH, CONCERTA) for at least 21 months. Height and weight were measured monthly during the…

  15. Effects of MDMA Injections on the Behavior of Socially-Housed Long-Tailed Macaques (Macaca fascicularis).

    Science.gov (United States)

    Ballesta, Sébastien; Reymond, Gilles; Pozzobon, Matthieu; Duhamel, Jean-René

    2016-01-01

    3,4-methylenedioxy-N-methyl amphetamine (MDMA) is one of the few known molecules to increase human and rodent prosocial behaviors. However, this effect has never been assessed on the social behavior of non-human primates. In our study, we subcutaneously injected three different doses of MDMA (1.0, 1.5 or 2.0mg/kg) to a group of three, socially housed, young male long-tailed macaques. More than 200 hours of behavioral data were recorded, during 68 behavioral sessions, by an automatic color-based video device that tracked the 3D positions of each animal and of a toy. This data was then categorized into 5 exclusive behaviors (resting, locomotion, foraging, social contact and object play). In addition, received and given social grooming was manually scored. Results show several significant dose-dependent behavioral effects. At 1.5mg/kg only, MDMA induces a significant increase in social grooming behavior, thus confirming the prosocial effect of MDMA in macaques. Additionally, at 1.5 and 2.0 mg/kg MDMA injection substantially decreases foraging behavior, which is consistent with the known anorexigenic effect of this compound. Furthermore, at 2.0 mg/kg MDMA injection induces an increase in locomotor behavior, which is also in accordance with its known stimulant property. Interestingly, MDMA injected at 1.0mg/kg increases the rate of object play, which might be interpreted as a decrease of the inhibition to manipulate a unique object in presence of others, or, as an increase of the intrinsic motivation to manipulate this object. Together, our results support the effectiveness of MDMA to study the complex neurobiology of primates' social behaviors.

  16. Effects of MDMA Injections on the Behavior of Socially-Housed Long-Tailed Macaques (Macaca fascicularis.

    Directory of Open Access Journals (Sweden)

    Sébastien Ballesta

    Full Text Available 3,4-methylenedioxy-N-methyl amphetamine (MDMA is one of the few known molecules to increase human and rodent prosocial behaviors. However, this effect has never been assessed on the social behavior of non-human primates. In our study, we subcutaneously injected three different doses of MDMA (1.0, 1.5 or 2.0mg/kg to a group of three, socially housed, young male long-tailed macaques. More than 200 hours of behavioral data were recorded, during 68 behavioral sessions, by an automatic color-based video device that tracked the 3D positions of each animal and of a toy. This data was then categorized into 5 exclusive behaviors (resting, locomotion, foraging, social contact and object play. In addition, received and given social grooming was manually scored. Results show several significant dose-dependent behavioral effects. At 1.5mg/kg only, MDMA induces a significant increase in social grooming behavior, thus confirming the prosocial effect of MDMA in macaques. Additionally, at 1.5 and 2.0 mg/kg MDMA injection substantially decreases foraging behavior, which is consistent with the known anorexigenic effect of this compound. Furthermore, at 2.0 mg/kg MDMA injection induces an increase in locomotor behavior, which is also in accordance with its known stimulant property. Interestingly, MDMA injected at 1.0mg/kg increases the rate of object play, which might be interpreted as a decrease of the inhibition to manipulate a unique object in presence of others, or, as an increase of the intrinsic motivation to manipulate this object. Together, our results support the effectiveness of MDMA to study the complex neurobiology of primates' social behaviors.

  17. Choice of Postpartum Contraception: Factors Predisposing Pregnant Adolescents to Choose Less Effective Methods Over Long-Acting Reversible Contraception.

    Science.gov (United States)

    Chacko, Mariam R; Wiemann, Constance M; Buzi, Ruth S; Kozinetz, Claudia A; Peskin, Melissa; Smith, Peggy B

    2016-06-01

    The purposes were to determine contraceptive methods pregnant adolescents intend to use postpartum and to understand factors that predispose intention to use less effective birth control than long-acting reversible contraception (LARC). Participants were 247 pregnant minority adolescents in a prenatal program. Intention was assessed by asking "Which of the following methods of preventing pregnancy do you intend to use after you deliver?" Multinomial logistic regression analysis was used to determine factors associated with intent to use nonhormonal (NH) contraception (male/female condoms, abstinence, withdrawal and no method) or short-/medium-acting hormonal (SMH) contraception (birth control pill, patch, vaginal ring, injectable medroxyprogesterone acetate) compared with LARC (implant and intrauterine device) postpartum. Twenty-three percent intended to use LARC, 53% an SMH method, and 24% an NH method. Participants who intended to use NH or SMH contraceptive methods over LARC were significantly more likely to believe that LARC is not effective at preventing pregnancy, to report that they do not make decisions to help reach their goals and that partners are not important when making contraceptive decisions. Other important factors were having a mother who was aged >19 years at first birth and had not graduated from high school, not having experienced a prior pregnancy or talked with parents about birth control options, and the perception of having limited financial resources. Distinct profiles of factors associated with intending to use NH or SMH contraceptive methods over LARC postpartum were identified and may inform future interventions to promote the use of LARC to prevent repeat pregnancy. Copyright © 2015 The Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  18. A study of the methods for the production and confinement of high energy plasmas. [injection of dense plasma into long magnetic field

    Science.gov (United States)

    Cheng, D. Y.; Wang, P.

    1972-01-01

    The injection of dense plasmas into a B sub z long magnetic field from both ends of the field coil was investigated. Deflagration plasma guns and continuous flow Z-pinch are discussed along with the possibility of a continuous flow Z-pinch fusion reactor. The injection experiments are described with emphasis on the synchronization of the two plasma deflagration guns, the collision of the two plasma beams, and the determination of plasma density.

  19. Client satisfaction among participants in a randomized trial comparing oral methadone and injectable diacetylmorphine for long-term opioid-dependency

    Directory of Open Access Journals (Sweden)

    Brissette Suzanne

    2011-07-01

    Full Text Available Abstract Background Substitution with opioid-agonists (e.g., methadone has shown to be an effective treatment for chronic long-term opioid dependency. Patient satisfaction with treatment has been associated with improved addiction treatment outcomes. However, there is a paucity of studies evaluating patients' satisfaction with Opioid Substitution Treatment (OST. In the present study, participants' satisfaction with OST was evaluated at 3 and 12 months. We sought to test the relationship between satisfaction and patients' characteristics, the treatment modality received and treatment outcomes. Methods Data from a randomized controlled trial, the North American Opiate Medication Initiative (NAOMI, conducted in Vancouver and Montreal (Canada between 2005-2008, was analyzed. The NAOMI study compared the effectiveness of oral methadone vs. injectable diacetylmorphine over 12 months. A small sub-group of patients received injectable hydromorphone on a double blind basis with diacetylmorphine. The Client Satisfaction Questionnaire (CSQ-8 was used to measure satisfaction with treatment. CSQ-8 scores, as well as retention and response to treatment, did not differ between those receiving hydromorphone and diacetylmorphine at 3 or 12 months assessments; therefore, these two groups were analyzed together as the 'injectable' treatment group. Results A total of 232 (92% and 237 (94% participants completed the CSQ-8 at 3 and 12 months, respectively. Participants in both groups were highly satisfied with treatment. Independent of treatment group, participants satisfied with treatment at 3 months were more likely to be retained at 12 months. Multivariate analysis indicated that satisfaction was greater among those randomized to the injection group after controlling for treatment effectiveness. Participants who were retained, responded to treatment, and had fewer psychological symptoms were more satisfied with treatment. Finally, open-ended comments were made by

  20. Pathophysiological Role of Transient Receptor Potential Ankyrin 1 in a Mouse Long-Lasting Cystitis Model Induced by an Intravesical Injection of Hydrogen Peroxide

    Directory of Open Access Journals (Sweden)

    Shohei Oyama

    2017-11-01

    Full Text Available Chronic inflammatory bladder disorders, such as interstitial cystitis/bladder pain syndrome, are associated with poor quality of life. The exact pathological processes remain unclear, but accumulating evidence suggests that reactive oxidative species (ROS are involved in urinary bladder disorders. Transient receptor potential ankyrin 1 (TRPA1, the most sensitive TRP channel to ROS, was shown to be responsible for urinary bladder abnormalities and hyperalgesia in an acute cystitis model. However, the roles of TRPA1 in chronic inflammatory bladder are not fully understood. We previously established a novel mouse cystitis model induced by intravesical injection of hydrogen peroxide (H2O2, resulting in long-lasting frequent urination, bladder inflammation, pain-related behavior, and histopathological changes. In the present study, we investigated the pathophysiological role of TRPA1 in the H2O2-induced long-lasting cystitis mouse model. Under anesthesia, 1.5% H2O2 solution was introduced transurethrally into the bladder of female wild-type (WT and TRPA1-knockout mice and maintained for 30 min. This increased the number of voids in WT mice at 1 and 7 days after injection, but reduced the number in TRPA1-knockout mice at 1 day but not 7 days after injection. Spontaneous locomotor activities (increase in freezing time and decrease in distance moved were reduced at 3 h after injection in WT mice, whereas the spontaneous visceral pain-related behaviors were attenuated in TRPA1-knockout mice. Furthermore, upregulation of c-fos mRNA in the spinal cord at 1 day after injection was observed in WT but not TRPA1-knockout mice. However, there was no difference in histopathological changes in the urinary bladder, such as edematous thickening in the submucosa, between WT and TRPA1-knockout mice at 1 or 7 days after injection. Finally, Trpa1 mRNA levels in the L5-S1 dorsal root ganglion were not altered, but levels in the urinary bladder were drastically increased

  1. Do cervical epidural injections provide long-term relief in neck and upper extremity pain? A systematic review.

    Science.gov (United States)

    Manchikanti, Laxmaiah; Nampiaparampil, Devi E; Candido, Kenneth D; Bakshi, Sanjay; Grider, Jay S; Falco, Frank J E; Sehgal, Nalini; Hirsch, Joshua A

    2015-01-01

    The high prevalence of chronic persistent neck pain not only leads to disability but also has a significant economic, societal, and health impact. Among multiple modalities of treatments prescribed in the management of neck and upper extremity pain, surgical, interventional and conservative modalities have been described. Cervical epidural injections are also common modalities of treatments provided in managing neck and upper extremity pain. They are administered by either an interlaminar approach or transforaminal approach. To determine the long-term efficacy of cervical interlaminar and transforaminal epidural injections in the treatment of cervical disc herniation, spinal stenosis, discogenic pain without facet joint pain, and post surgery syndrome. The literature search was performed from 1966 to October 2014 utilizing data from PubMed, Cochrane Library, US National Guideline Clearinghouse, previous systematic reviews, and cross-references. The evidence was assessed based on best evidence synthesis with Level I to Level V. There were 7 manuscripts meeting inclusion criteria. Of these, 4 assessed the role of interlaminar epidural injections for managing disc herniation or radiculitis, and 3 assessed these injections for managing central spinal stenosis, discogenic pain without facet joint pain, and post surgery syndrome. There were 4 high quality manuscripts. A qualitative synthesis of evidence showed there is Level II evidence for each etiology category. The evidence is based on one relevant, high quality trial supporting the efficacy of cervical interlaminar epidural injections for each particular etiology. There were no randomized trials available assessing the efficacy of cervical transforaminal epidural injections. Paucity of available literature, specifically conditions other than disc herniation. This systematic review with qualitative best evidence synthesis shows Level II evidence for the efficacy of cervical interlaminar epidural injections with local

  2. Multi-shot type pellet injection device

    International Nuclear Information System (INIS)

    Onozuka, Masaki; Uchikawa, Takashi; Kuribayashi, Shitomi.

    1988-01-01

    Purpose: To inject pellets at high speed without melting or sublimating not-injected pellets even at a long pellet injection interval. Constitution: In the conventional multi-shot pellet injection device, the pellet injection interval is set depending on the plasma retention time. However, as the pellet injection interval is increased, not-injected pellets are melted or sublimated due to the introduced heat of acceleration gases supplied from an acceleration gas introduction pipe to give an effect on the dimensional shape of the pellets. In view of the above, a plurality of pellet forming and injection portions each comprising a carrier, an injection pipe and a holder are disposed independently of each other and pellets are formed and injected independently to thereby prevent the thermal effects of the acceleration gases. (Kamimura, M.)

  3. Multi-shot type pellet injection device

    Energy Technology Data Exchange (ETDEWEB)

    Onozuka, Masaki; Uchikawa, Takashi; Kuribayashi, Shitomi.

    1988-07-27

    Purpose: To inject pellets at high speed without melting or sublimating not-injected pellets even at a long pellet injection interval. Constitution: In the conventional multi-shot pellet injection device, the pellet injection interval is set depending on the plasma retention time. However, as the pellet injection interval is increased, not-injected pellets are melted or sublimated due to the introduced heat of acceleration gases supplied from an acceleration gas introduction pipe to give an effect on the dimensional shape of the pellets. In view of the above, a plurality of pellet forming and injection portions each comprising a carrier, an injection pipe and a holder are disposed independently of each other and pellets are formed and injected independently to thereby prevent the thermal effects of the acceleration gases. (Kamimura, M.).

  4. Onset of effect of aclidinium, a novel, long-acting muscarinic antagonist, in patients with COPD

    DEFF Research Database (Denmark)

    Vestbo, Jørgen; Vogelmeier, Claus; Creemers, Jacques

    2010-01-01

    ABSTRACT Aclidinium bromide is a novel, long-acting, inhaled muscarinic antagonist in development for the treatment of chronic obstructive pulmonary disease (COPD). The aim of this study was to assess the rate of onset of bronchodilation with aclidinium compared with placebo and tiotropium. This ...

  5. Different antipsychotics elicit different effects on magnocellular oxytocinergic and vasopressinergic neurons as revealed by Fos immunohistochemistry

    DEFF Research Database (Denmark)

    Kiss, A; Bundzikova, J; Pirnik, Z

    2010-01-01

    rats were injected intraperitoneally with haloperidol (1 mg/kg), clozapine (30 mg/kg), olanzapine (30 mg/kg), risperidone (2mg/kg), and vehicle (5% chremophor) and were sacrificed 60 min later by a fixative. Fos, Fos/OXY, and Fos/AVP labelings were visualized by immunohistochemistry in the SON, 5...... accessory (ACS) cell groups, and 4 distinct PVN subdivisions using a computerized light microscope. Most apparent activation of single Fos, Fos/OXY, and Fos/AVP cells was induced by clozapine and olanzapine; effects of risperidone and haloperidol were substantially lower; no colocalizations were revealed...... of risperidone and haloperidol. Variabilities in Fos distribution in the PVN, SON, and ACS induced by antipsychotics may be helpful to understand more precisely the extent of their extra-forebrain actions with possible presumption of their functional impact and side effect consequences....

  6. Novel GLP-1 fusion chimera as potent long acting GLP-1 receptor agonist.

    Directory of Open Access Journals (Sweden)

    Qinghua Wang

    2010-09-01

    Full Text Available GLP-1 has a variety of anti-diabetic effects. However, native GLP-1 is not suitable for therapy of diabetes due to its short half-life (t1/2168 h. Intraperitoneal glucose tolerance test (IPGTT in mice showed that GLP-1/hIgG2 significantly decreased glucose excursion. Furthermore, IPGTT performed on mice one week after a single drug-injection also displayed significantly reduced glucose excursion, indicating that GLP-1/hIgG2 fusion protein has long-lasting effects on the modulation of glucose homeostasis. GLP-1/hIgG2 was found to be effective in reducing the incidence of diabetes in multiple-low-dose streptozotocin-induced type 1 diabetes in mice. Together, the long-lasting bioactive GLP-1/hIgG2 retains native GLP-1 activities and thus may serve as a potent GLP-1 receptor agonist.

  7. Effect of subcutaneous injection of a long-acting analogue of somatostatin (SMS 201-995) on plasma thyroid-stimulating hormone in normal human subjects

    Energy Technology Data Exchange (ETDEWEB)

    Itoh, S.; Tanaka, K.; Kumagae, M.; Takeda, F.; Morio, K.; Kogure, M.; Hasegawa, M.; Horiuchi, T.; Watabe, T.; Miyabe, S.

    1988-01-01

    SMS 201-995 (SMS), a synthetic analogue of somatostatin (SRIF) has been shown to be effective in the treatment of the hypersecretion of hormones such as in acromegaly. However, little is known about the effects of SMS on the secretion of thyroid-stimulating hormone (TSH) in normal subjects. In this study, plasma TSH was determined with a highly sensitive immunoradiometric assay, in addition to the concentration of SMS in plasma and urine with a radioimmunoassay, following subcutaneous injection of 25, 50, 100 ..mu..g of SMS or a placebo to normal male subjects, at 0900 h after an overnight fast. The plasma concentrations of SMS were dose-responsive and the peak levels were 1.61 +/- 0.09, 4.91 +/- 0.30 and 8.52 +/- 1.18 ng/ml, which were observed at 30, 15 and 45 min after the injection of 25, 50, and 100 ..mu..g of SMS, respectively. Mean plasma disappearance half-time of SMS was estimated to be 110 +/- 3 min. Plasma TSH was suppressed in a dose dependent manner and the suppression lasted for at least 8 hours. At 8 hours after the injection of 25, 50, and 100 ..mu..g of SMS, the plasma TSH levels were 43.8 +/- 19.4, 33.9 +/- 9.4 and 24.9 +/- 3.2%, respectively, of the basal values.

  8. Long-Acting Diclofenac Ester Prodrugs for Joint Injection: Kinetics, Mechanism of Degradation, and In Vitro Release From Prodrug Suspension.

    Science.gov (United States)

    Mertz, Nina; Larsen, Susan Weng; Kristensen, Jesper; Østergaard, Jesper; Larsen, Claus

    2016-10-01

    A prodrug approach for local and sustained diclofenac action after injection into joints based on ester prodrugs having a pH-dependent solubility is presented. Inherent ester prodrug properties influencing the duration of action include their pH-dependent solubility and charge state, as well as susceptibility to undergo esterase facilitated hydrolysis. In this study, physicochemical properties and pH rate profiles of 3 diclofenac ester prodrugs differing with respect to the spacer carbon chain length between the drug and the imidazole-based promoiety were determined and a rate equation for prodrug degradation in aqueous solution in the pH range 1-10 was derived. In the pH range 6-10, the prodrugs were subject to parallel degradation to yield diclofenac and an indolinone derivative. The prodrug degradation was found to be about 6-fold faster in 80% (vol/vol) human plasma as compared to 80% (vol/vol) human synovial fluid with 2-(1-methyl-1H-imidazol-2-yl)ethyl 2-(2-(2,6 dichlorophenyl)amino)phenylacetate being the poorest substrate toward enzymatic cleavage. The conversion and release of parent diclofenac from prodrug suspensions in vitro were studied using the rotating dialysis model. The results suggest that it is possible to alter and control dissolution and reconversion behavior of the diclofenac prodrugs, thus making the prodrug approach feasible for local and sustained diclofenac action after joint injection. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  9. Factors impacting knowledge and use of long acting and permanent contraceptive methods by postpartum HIV positive and negative women in Cape Town, South Africa: a cross-sectional study.

    Science.gov (United States)

    Credé, Sarah; Hoke, Theresa; Constant, Deborah; Green, Mackenzie S; Moodley, Jennifer; Harries, Jane

    2012-03-16

    The prevention of unintended pregnancies among HIV positive women is a neglected strategy in the fight against HIV/AIDS. Women who want to avoid unintended pregnancies can do this by using a modern contraceptive method. Contraceptive choice, in particular the use of long acting and permanent methods (LAPMs), is poorly understood among HIV-positive women. This study aimed to compare factors that influence women's choice in contraception and women's knowledge and attitudes towards the IUD and female sterilization by HIV-status in a high HIV prevalence setting, Cape Town, South Africa. A quantitative cross-sectional survey was conducted using an interviewer-administered questionnaire amongst 265 HIV positive and 273 HIV-negative postpartum women in Cape Town. Contraceptive use, reproductive history and the future fertility intentions of postpartum women were compared using chi-squared tests, Wilcoxon rank-sum and Fisher's exact tests where appropriate. Women's knowledge and attitudes towards long acting and permanent methods as well as factors that influence women's choice in contraception were examined. The majority of women reported that their most recent pregnancy was unplanned (61.6% HIV positive and 63.2% HIV negative). Current use of contraception was high with no difference by HIV status (89.8% HIV positive and 89% HIV negative). Most women were using short acting methods, primarily the 3-monthly injectable (Depo Provera). Method convenience and health care provider recommendations were found to most commonly influence method choice. A small percentage of women (6.44%) were using long acting and permanent methods, all of whom were using sterilization; however, it was found that poor knowledge regarding LAPMs is likely to be contributing to the poor uptake of these methods. Improving contraceptive counselling to include LAPM and strengthening services for these methods are warranted in this setting for all women regardless of HIV status. These study results

  10. Steroid injections in the treatment of humeral unicameral bone cysts: long-term follow-up and review of the literature.

    Science.gov (United States)

    Pavone, V; Caff, G; Di Silvestri, C; Avondo, S; Sessa, G

    2014-05-01

    Retrospective evaluation of long-term effectiveness of the steroid injections treatment in patients with unicameral bone cysts (UBC). From January 1993 to April 2005, 23 children affected by proximal humeral UBC were evaluated according to the Neer-Cole classification system and treated with serial methylprednisolone acetate's injections. The patients were followed up at 1, 3, 6 and 12 months and then every year until the adolescence. After treatment, in 15 out of 23 patients (65.2%), the humeral cysts were referred, respectively, as Grade 1 and in four as Grade 2. In 4 patients, a refracture occurred. Statistical analysis showed an overall good response in 82.6% of patients at the end of the follow-up. Minor complication including skin discoloration accounted for 13.04%. The steroid injections showed to be an alternative excellent treatment for UBC, with complete healing of the lesions in the majority of cases. This procedure is not expensive, mini-invasive, with low surgical risk and short hospitalization.

  11. MK-801-induced deficits in social recognition in rats: reversal by aripiprazole, but not olanzapine, risperidone, or cannabidiol.

    Science.gov (United States)

    Deiana, Serena; Watanabe, Akihito; Yamasaki, Yuki; Amada, Naoki; Kikuchi, Tetsuro; Stott, Colin; Riedel, Gernot

    2015-12-01

    Deficiencies in social activities are hallmarks of numerous brain disorders. With respect to schizophrenia, social withdrawal belongs to the category of negative symptoms and is associated with deficits in the cognitive domain. Here, we used the N-methyl-D-aspartate receptor antagonist dizocilpine (MK-801) for induction of social withdrawal in rats and assessed the efficacy of several atypical antipsychotics with different pharmacological profiles as putative treatment. In addition, we reasoned that the marijuana constituent cannabidiol (CBD) may provide benefit or could be proposed as an adjunct treatment in combination with antipsychotics. Hooded Lister rats were tested in the three-chamber version for social interaction, with an initial novelty phase, followed after 3 min by a short-term recognition memory phase. No drug treatment affected sociability. However, distinct effects on social recognition were revealed. MK-801 reduced social recognition memory at all doses (>0.03 mg/kg). Predosing with aripiprazole dose-dependently (2 or 10 mg/kg) prevented the memory decline, but doses of 0.1 mg/kg risperidone or 1 mg/kg olanzapine did not. Intriguingly, CBD impaired social recognition memory (12 and 30 mg/kg) but did not rescue the MK-801-induced deficits. When CBD was combined with protective doses of aripiprazole (CBD-aripiprazole at 12 :  or 5 : 2 mg/kg) the benefit of the antipsychotic was lost. At the same time, activity-related changes in behaviour were excluded as underlying reasons for these pharmacological effects. Collectively, the combined activity of aripiprazole on dopamine D2 and serotonin 5HT1A receptors appears to provide a significant advantage over risperidone and olanzapine with respect to the rescue of cognitive deficits reminiscent of schizophrenia. The differential pharmacological properties of CBD, which are seemingly beneficial in human patients, did not back-translate and rescue the MK-801-induced social memory deficit.

  12. Minocycline as Adjunctive Treatment to Risperidone in Children with Autistic Disorder: A Randomized, Double-Blind Placebo-Controlled Trial.

    Science.gov (United States)

    Ghaleiha, Ali; Alikhani, Rosa; Kazemi, Mohammad-Reza; Mohammadi, Mohammad-Reza; Mohammadinejad, Payam; Zeinoddini, Atefeh; Hamedi, Mehdi; Shahriari, Mona; Keshavarzi, Zahra; Akhondzadeh, Shahin

    2016-11-01

    This is an investigation of minocycline efficacy and safety as an adjuvant to risperidone in management of children with autism. Forty-six children with diagnosis of autistic disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) criteria and a score of ≥12 on the Aberrant Behavior Checklist-Community (ABC-C) irritability subscale, who were already drug-free for at least 6 months participated in a randomized controlled trial and underwent 10 weeks of treatment with either minocycline (50 mg twice per day) or placebo in addition to risperidone titrated up to 2 mg/day (based on bodyweight). Patients were evaluated using ABC-C at baseline and at weeks 5 and 10. General linear model repeated measures showed significant effect for time × treatment interaction on the irritability [F(2, 88) = 3.94, p = 0.02] and hyperactivity/noncompliance [F(1.50, 66.05) = 7.92, p = 0.002], but not for lethargy/social withdrawal [F(1.61, 71.02) = 0.98, p = 0.36], stereotypic behavior [F(1.34, 58.80) = 1.55, p = 0.22], and inappropriate speech subscale scores [F(1.52, 66.88) = 1.15, p = 0.31]. By week 10, 21 (91.3%) patients in the minocycline group and 15 (65.5%) patients in the placebo group achieved at least partial response (p = 0.03). Frequencies of adverse events were not significantly different between groups. Minocycline seems to be a safe and effective adjuvant in management of patients with autistic disorder. Future studies with larger sample sizes, longer follow-ups, and inflammatory cytokine measurements are warranted to confirm these findings and provide insight into minocycline mechanism of action in autistic disorder.

  13. Injection and lessons for 2012

    International Nuclear Information System (INIS)

    Bracco, C.; Barnes, M.J.; Bartmann, W.; Cornelis, K.; Drosdal, L.N.; Goddard, B.; Kain, V.; Meddahi, M.; Mertens, V.; Uythoven, J.

    2012-01-01

    Injection of 144 bunches into the LHC became fully operational during the 2011 run and one nominal injection of 288 bunches was accomplished. Several mitigation solutions were put in place to minimise losses from the Transfer Line (TL) collimators and losses from kicking de-bunched beam during injection. Nevertheless, shot-by- shot and bunch-by-bunch trajectory variations, as well as long terms drifts, were observed and required a regular re-steering of the TL implying a non negligible amount of time spent for injection setup. Likely sources of instability have been identified (i.e. MKE and MSE ripples) and possible cures to optimise 2012 operation are presented. Well defined references for TL steering will be defined in a more rigorous way in order to allow a more straightforward and faster injection setup. Encountered and potential issues of the injection system, in particular the injection kickers MKI, are discussed also in view of injections with a higher number of bunches. (authors)

  14. Injection and lessons for 2012

    CERN Document Server

    Bracco, C; Bartmann, W; Cornelis, K; Drosdal, L N; Goddard, B; Kain, V; Meddahi, M; Mertens, V; Uythoven, J

    2012-01-01

    Injection of 144 bunches into the LHC became fully operational during the 2011 run and a nominal injection of 288 bunches was accomplished during MD time. Several mitigation solutions were put in place to minimise losses from the transfer line (TL) collimators and losses from kicking debunched beam during injection. Nevertheless, shot-by-shot and bunch-by-bunch trajectory variations, as well as long terms drifts, were observed and required a regular resteering of the TL implying a non negligible amount of time spent for injection setup. Likely sources of instability have been identified (i.e. MKE and MSE ripples) and possible cures to optimise 2012 operation are presented. Well defined references for TL steering will be defined in a more rigorous way in order to allow a more straightforward and faster injection setup. Encountered and potential issues of the injection system, in particular the injection kickers MKI, are discussed also in view of injections with a higher number of bunches.

  15. Beta-Adrenergic Receptors and Mechanisms in Asthma: The New Long-Acting Beta-Agonists

    Directory of Open Access Journals (Sweden)

    Robert G Townley

    1996-01-01

    Full Text Available The objective is to review β-adrenergic receptors and mechanisms in the immediate and late bronchial reaction in asthma and the new long-acting β-agonist. This will be discussed in light of the controversy of the potential adverse effect of regular use of long-acting β-agonists. We studied the effect of formoterol on the late asthmatic response (LAR and airway inflammation in guinea-pigs. Formoterol suppressed the LAR, antigen-induced airway inflammation and hyperresponsiveness, although isoproterenol failed to inhibit these parameters. β-Adrenergic hyporesponsiveness, and cholinergic and a- adrenergic hyperresponsiveness have been implicated in the pathogenesis of asthma. A decrease in β-adrenoreceptor function can result either from exogenously administered β-agonist or from exposure to allergens resulting in a late bronchial reaction. There is increasing evidence that eosinophils, macrophages, and lymphocytes which are of primary importance in the late bronchial reaction are also modulated by β2- adrenoreceptors. In functional studies of guinea-pig or human isolated trachea and lung parenchyma, PAF and certain cytokines significantly reduced the potency of isoproterenol to reverse methacholine- or histamine-induced contraction. The effect of glucocorticoids on pulmonary β-adrenergic receptors and responses suggests an important role for glucocorticoids to increase β-adrenergic receptors and responsiveness.

  16. How Much Volume of Local Anesthesia and How Long Should You Wait After Injection for an Effective Wrist Median Nerve Block?

    Science.gov (United States)

    Lovely, Lyndsay M; Chishti, Yasmin Z; Woodland, Jennifer L; Lalonde, Donald H

    2018-05-01

    Many surgeons and emergentologists use non-ultrasound-guided wrist nerve blocks. There is little evidence to guide the ideal volume of local anesthesia or how long we should wait after injection before performing pain-free procedures. This pilot study examined time to maximal anesthesia to painful needle stick in 14 volunteer participants receiving bilateral wrist blocks of 6 versus 11 mL of local. One surgeon performed all 14 bilateral wrist median nerve blocks in participants who remained blinded until after bandages were applied to their wrist. No one could see which wrist received the larger 11-mL volume injection versus the 6-mL block. Blinded sensory assessors then measured perceived maximal numbness time and numbness to needle stick pain in the fingertips of the median nerve distribution. Failure to get a complete median nerve block occurred in seven of fourteen 6-mL wrist blocks versus failure in only one of fourteen 11-mL blocks. Perceived maximal numbness occurred at roughly 40 minutes after injection, but actual numbness to painful needle stick took around 100 minutes. Incomplete median nerve numbness occurred with both 6- and 11-mL non-ultrasound-guided blocks at the wrist. In those with complete blocks, it took a surprisingly long time of 100 minutes for maximal anesthesia to occur to painful needle stick stimuli to the fingertips of the median nerve distribution. Non-ultrasound-guided median nerve blocks at the wrist as described in this article lack reliability and take too long to work.

  17. Determinants of long acting and permanent contraceptive methods utilization among married women of reproductive age groups in western Ethiopia: a cross-sectional study.

    Science.gov (United States)

    Melka, Alemu Sufa; Tekelab, Tesfalidet; Wirtu, Desalegn

    2015-01-01

    In Ethiopia information on the level of utilization of the long term and permanent contraceptive methods and associated factorsis lacking. The aim of this study was to understand the determinant factors of long acting and permanent contraceptive methods use among married women of reproductive age in Western Ethiopia. A community based cross-sectional study design was employed. Multi stage sampling was used to select 1003 study participants. Data was collected from April 10 to April 25,2014 using a pre- tested structured questionnaire. The data were entered using Epi-info version 3.5.1 and exported to SPSS version 20 for analysis. Multivariate logistic regression analysis was done to identify predictors of long acting and permanent contraceptive methods at 95% CL. Use of long acting and permanent contraceptive methods in this study was found to be 20%. Survey results showed a significant positive association between utilization of long acting and permanent contraceptive methods and women's education (AOR=1.72, 95%CI=1.02-3.05), women's occupation (AOR=2.01, 95% CI=1.11-3.58), number of live children (AOR=2.42, 95% CI: 1.46-4.02), joint fertility related decision (AOR=6.11, 95% CI: 2.29-16.30), having radio/TV (AOR=2.31, 95% CI: 1.40-3.80), and discussion with health care provider about long acting and permanent contraceptive methods (AOR=13.72, 95% CI: 8.37-22.47). Efforts need to be aimed at women empowerment, health education, and encouraging open discussion of family planning by couples.

  18. The effect of the Taq1A variant in the dopamine D2 receptor gene and common CYP2D6 alleles on prolactin levels in risperidone-treated boys

    NARCIS (Netherlands)

    Roke, Y.; Harten, P.N. van; Franke, B.; Galesloot, T.E.; Boot, A.M.; Buitelaar, J.K.

    2013-01-01

    OBJECTIVE: To investigate the effect of the Taq1A variant in the Dopamine D2 receptor gene (DRD2) and common functional genetic variants in the cytochrome P450 2D6 gene (CYP2D6) on prolactin levels in risperidone-treated boys with autism spectrum disorders and disruptive behavior disorders. METHODS:

  19. The effect of the Taq1A variant in the dopamine D-2 receptor gene and common CYP2D6 alleles on prolactin levels in risperidone-treated boys

    NARCIS (Netherlands)

    Roke, Yvette; van Harten, Peter N.; Franke, Barbara; Galesloot, Tessel E.; Boot, Annemieke M.; Buitelaar, Jan K.

    Objective To investigate the effect of the Taq1A variant in the Dopamine D2 receptor gene (DRD2) and common functional genetic variants in the cytochrome P450 2D6 gene (CYP2D6) on prolactin levels in risperidone-treated boys with autism spectrum disorders and disruptive behavior disorders.Methods

  20. Factors associated with utilization of long-acting and permanent contraceptive methods among women who have decided not to have more children in Gondar city.

    Science.gov (United States)

    Zenebe, Chernet Baye; Adefris, Mulat; Yenit, Melaku Kindie; Gelaw, Yalemzewod Assefa

    2017-09-06

    Despite the fact that long acting family planning methods reduce population growth and improve maternal health, their utilization remains poor. Therefore, this study assessed the prevalence of long acting and permanent family planning method utilization and associated factors among women in reproductive age groups who have decided not to have more children in Gondar city, northwest Ethiopia. An institution based cross-sectional study was conducted from August to October, 2015. Three hundred seventeen women who have decided not to have more children were selected consecutively into the study. A structured and pretested questionnaire was used to collect data. Both bivariate and multi-variable logistic regressions analyses were used to identify factors associated with utilization of long acting and permanent family planning methods. The multi-variable logistic regression analysis was used to investigate factors associated with the utilization of long acting and permanent family planning methods. The Adjusted Odds Ratio (AOR) with the corresponding 95% Confidence Interval (CI) was used to show the strength of associations, and variables with a P-value of <0.05 were considered statistically significant. In this study, the overall prevalence of long acting and permanent contraceptive (LAPCM) method utilization was 34.7% (95% CI: 29.5-39.9). According to the multi-variable logistic regression analysis, utilization of long acting and permanent contraceptive methods was significantly associated with women who had secondary school, (AOR: 2279, 95% CI: 1.17, 4.44), college, and above education (AOR: 2.91, 95% CI: 1.36, 6.24), history of previous utilization (AOR: 3.02, 95% CI: 1.69, 5.38), and information about LAPCM (AOR: 8.85, 95% CI: 2.04, 38.41). In this study the prevalence of long acting and permanent family planning method utilization among women who have decided not to have more children was high compared with previous studies conducted elsewhere. Advanced educational

  1. Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Fu Dong-Jing

    2011-05-01

    Full Text Available Abstract Background Paliperidone palmitate is a long-acting injectable atypical antipsychotic for the acute and maintenance treatment of adults with schizophrenia. The recommended initiation dosing regimen is 234 mg on Day 1 and 156 mg on Day 8 via intramuscular (deltoid injection; followed by 39 to 234 mg once-monthly thereafter (deltoid or gluteal. These post-hoc analyses addressed two commonly encountered clinical issues regarding the initiation dosing: the time to onset of efficacy and the associated tolerability. Methods In a 13-week double-blind trial, 652 subjects with schizophrenia were randomized to paliperidone palmitate 39, 156, or 234 mg (corresponding to 25, 100, or 150 mg equivalents of paliperidone, respectively or placebo (NCT#00590577. Subjects randomized to paliperidone palmitate received 234 mg on Day 1, followed by their randomized fixed dose on Day 8, and monthly thereafter, with no oral antipsychotic supplementation. The onset of efficacy was defined as the first timepoint where the paliperidone palmitate group showed significant improvement in the Positive and Negative Syndrome Scale (PANSS score compared to placebo (Analysis of Covariance [ANCOVA] models and Last Observation Carried Forward [LOCF] methodology without adjusting for multiplicity using data from the Days 4, 8, 22, and 36 assessments. Adverse event (AE rates and relative risks (RR with 95% confidence intervals (CI versus placebo were determined. Results Paliperidone palmitate 234 mg on Day 1 was associated with greater improvement than placebo on Least Squares (LS mean PANSS total score at Day 8 (p = 0.037. After the Day 8 injection of 156 mg, there was continued PANSS improvement at Day 22 (p ≤ 0.007 vs. placebo and Day 36 (p Conclusions Significantly greater symptom improvement was observed by Day 8 with paliperidone palmitate (234 mg on Day 1 compared to placebo; this effect was maintained after the 156 mg Day 8 injection, with a trend towards a dose

  2. Long-lasting solar energetic electron injection during the 26 Dec 2013 widespread SEP event

    Science.gov (United States)

    Dresing, N.; Klassen, A.; Temmer, M.; Gomez-Herrero, R.; Heber, B.; Veronig, A.

    2017-12-01

    The solar energetic particle (SEP) event on 26 Dec 2013 was detected all around the Sun by the two STEREO spacecraft and close-to-Earth observers. While the two STEREOs were separated by 59 degrees and situated at the front side of the associated large coronal event, it was a backside-event for Earth. Nevertheless, significant and long-lasting solar energetic electron anisotropies together with long rise times were observed at all three viewpoints, pointing to an extended electron injection. Although the CME-driven shock appears to account for the SEP event at a first glance a more detailed view reveals a more complex scenario: A CME-CME interaction takes place during the very early phase of the SEP event. Furthermore, four hours after the onset of the event, a second component is measured at all three viewpoints on top of the first SEP increase, mainly consisting of high energy particles. We find that the CME-driven shock alone can hardly account for the observed SEP event in total but a trapping scenario together with ongoing particle acceleration is more likely.

  3. Reverse-Tangent Injection in a Centrifugal Compressor

    Science.gov (United States)

    Skoch, Gary J.

    2007-01-01

    Injection of working fluid into a centrifugal compressor in the reverse tangent direction has been invented as a way of preventing flow instabilities (stall and surge) or restoring stability when stall or surge has already commenced. The invention applies, in particular, to a centrifugal compressor, the diffuser of which contains vanes that divide the flow into channels oriented partly radially and partly tangentially. In reverse-tangent injection, a stream or jet of the working fluid (the fluid that is compressed) is injected into the vaneless annular region between the blades of the impeller and the vanes of the diffuser. As used here, "reverse" signifies that the injected flow opposes (and thereby reduces) the tangential component of the velocity of the impeller discharge. At the same time, the injected jet acts to increase the radial component of the velocity of the impeller discharge.

  4. Anisomycin Injection in Area CA3 of the Hippocampus Impairs Both Short-Term and Long-Term Memories of Contextual Fear

    Science.gov (United States)

    Remaud, Jessica; Ceccom, Johnatan; Carponcy, Julien; Dugué, Laura; Menchon, Gregory; Pech, Stéphane; Halley, Helene; Francés, Bernard; Dahan, Lionel

    2014-01-01

    Protein synthesis is involved in the consolidation of short-term memory into long-term memory. Previous electrophysiological data concerning LTP in CA3 suggest that protein synthesis in that region might also be necessary for short-term memory. We tested this hypothesis by locally injecting the protein synthesis inhibitor anisomycin in hippocampal…

  5. Long-Acting Composite Systems Based on Powdered Medicinal Plants and Nanosilica

    Directory of Open Access Journals (Sweden)

    Turov, V.V.

    2017-03-01

    Full Text Available The state of water in the powdered plant materials (calendula, hibiscus and their composite systems with A-300 nanosilicas having different bulk density has been studied by low-temperature 1H NMR spectroscopy method. The change in bulk density has been found to significantly affect the radius of inner cavities in fibrillar space of plant components. The composite systems based on wetting-drying compaction of nanosilica and plant powder have been showed to form a mix with high interaction energy of heterogeneous particles. This results in the effective retention of plant bioactive complex by composite, which enables the development of long-acting herbal drugs.

  6. Post-stroke psychosis: how long should we treat?

    Directory of Open Access Journals (Sweden)

    Maria do Céu Ferreira

    2017-06-01

    Full Text Available Abstract Objective: To describe a rare case of a patient who developed psychotic symptoms after a right stroke that disappeared with antipsychotic treatment, but appears to need low-dose maintenance antipsychotic therapy. Case description: A 65-year-old man presented at the psychiatric emergency service with a history of persistent delusional jealousy, visual illusions and agitation with onset about 1 month after a right posterior cerebral artery ischemic stroke. These symptoms only disappeared with therapeutic dosages of an antipsychotic drug (3 mg/day of risperidone. At 2-year follow-up, he no longer had delusional activity and the antipsychotic treatment was gradually discontinued over the following year. However, 1 week after full cessation, the patient once more became agitated and suspicious and was put back on risperidone at 0.25 mg/day, resulting in rapid clinical remission. One year after the return to low-dose risperidone, the patient's psychopathology is still under control and he is free from psychotic symptoms. Comments: Psychosis is a relatively rare complication after stroke. To our knowledge, no cases of post-stroke psychosis that apparently require continuous low-dose antipsychotic treatment have been reported to date. Our case suggests that low-dose maintenance antipsychotic therapy may be needed for certain patients with post-stroke psychosis, especially for those with risk factors and non-acute onset.

  7. A Long-Acting BMP-2 Release System Based on Poly(3-hydroxybutyrate) Nanoparticles Modified by Amphiphilic Phospholipid for Osteogenic Differentiation

    Science.gov (United States)

    Peng, Xiaochun; Chen, Yunsu; Li, Yamin; Wang, Yiming

    2016-01-01

    We explored a novel poly(3-hydroxybutyrate) (PHB) nanoparticle loaded with hydrophilic recombinant human BMP-2 with amphiphilic phospholipid (BPC-PHB NP) for a rapid-acting and long-acting delivery system of BMP-2 for osteogenic differentiation. The BPC-PHB NPs were prepared by a solvent evaporation method and showed a spherical particle with a mean particle size of 253.4 nm, mean zeta potential of −22.42 mV, and high entrapment efficiency of 77.18%, respectively. For BPC-PHB NPs, a short initial burst release of BMP-2 from NPs in 24 h was found and it has steadily risen to reach about 80% in 20 days for in vitro test. BPC-PHB NPs significantly reduced the burst release of BMP-2, as compared to that of PHB NPs loading BMP-2 without PL (B-PHB NPs). BPC-PHB NPs maintained the content of BMP-2 for a long-term osteogenic differentiation. The OCT-1 cells with BPC-PHB NPs have high ALP activity in comparison with others. The gene markers for osteogenic differentiation were significantly upregulated for sample with BPC-PHB NPs, implying that BPC-PHB NPs can be used as a rapid-acting and long-acting BMP-2 delivery system for osteogenic differentiation. PMID:27379249

  8. Long-lasting injection of solar energetic electrons into the heliosphere

    Science.gov (United States)

    Dresing, N.; Gómez-Herrero, R.; Heber, B.; Klassen, A.; Temmer, M.; Veronig, A.

    2018-05-01

    Context. The main sources of solar energetic particle (SEP) events are solar flares and shocks driven by coronal mass ejections (CMEs). While it is generally accepted that energetic protons can be accelerated by shocks, whether or not these shocks can also efficiently accelerate solar energetic electrons is still debated. In this study we present observations of the extremely widespread SEP event of 26 Dec 2013 To the knowledge of the authors, this is the widest longitudinal SEP distribution ever observed together with unusually long-lasting energetic electron anisotropies at all observer positions. Further striking features of the event are long-lasting SEP intensity increases, two distinct SEP components with the second component mainly consisting of high-energy particles, a complex associated coronal activity including a pronounced signature of a shock in radio type-II observations, and the interaction of two CMEs early in the event. Aims: The observations require a prolonged injection scenario not only for protons but also for electrons. We therefore analyze the data comprehensively to characterize the possible role of the shock for the electron event. Methods: Remote-sensing observations of the complex solar activity are combined with in situ measurements of the particle event. We also apply a graduated cylindrical shell (GCS) model to the coronagraph observations of the two associated CMEs to analyze their interaction. Results: We find that the shock alone is likely not responsible for this extremely wide SEP event. Therefore we propose a scenario of trapped energetic particles inside the CME-CME interaction region which undergo further acceleration due to the shock propagating through this region, stochastic acceleration, or ongoing reconnection processes inside the interaction region. The origin of the second component of the SEP event is likely caused by a sudden opening of the particle trap.

  9. A novel role for dopamine signaling in the pathogenesis of bone loss from the atypical antipsychotic drug risperidone in female mice.

    Science.gov (United States)

    Motyl, Katherine J; Beauchemin, Megan; Barlow, Deborah; Le, Phuong T; Nagano, Kenichi; Treyball, Annika; Contractor, Anisha; Baron, Roland; Rosen, Clifford J; Houseknecht, Karen L

    2017-10-01

    Atypical antipsychotic (AA) drugs, including risperidone (RIS), are used to treat schizophrenia, bipolar disorder, and autism, and are prescribed off-label for other mental health issues. AA drugs are associated with severe metabolic side effects of obesity and type 2 diabetes. Cross-sectional and longitudinal data also show that risperidone causes bone loss and increases fracture risk in both men and women. There are several potential mechanisms of bone loss from RIS. One is hypogonadism due to hyperprolactinemia from dopamine receptor antagonism. However, many patients have normal prolactin levels; moreover we demonstrated that bone loss from RIS in mice can be blocked by inhibition of β-adrenergic receptor activation with propranolol, suggesting the sympathetic nervous system (SNS) plays a pathological role. Further, when, we treated ovariectomized (OVX) and sham operated mice daily for 8weeks with RIS or vehicle we demonstrated that RIS causes significant trabecular bone loss in both sham operated and OVX mice. RIS directly suppressed osteoblast number in both sham and OVX mice, but increased osteoclast number and surface in OVX mice alone, potentially accounting for the augmented bone loss. Thus, hypogonadism alone cannot explain RIS induced bone loss. In the current study, we show that dopamine and RIS are present in the bone marrow compartment and that RIS can exert its effects directly on bone cells via dopamine receptors. Our findings of both direct and indirect effects of AA drugs on bone are relevant for current and future clinical and translational studies investigating the mechanism of skeletal changes from AA drugs. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Characteristics of a long-pulse (30-s), high-power (4-MW) ion source for neutral beam injection

    International Nuclear Information System (INIS)

    Menon, M.M.; Barber, G.C.; Combs, S.K.

    1983-01-01

    A quasi-steady-state ion source has been developed for neutral beam injection applications. It is of the duoPIGatron type designed for delivering 50 A of hydrogen ions at 80 keV for 30-s-long pulses. Ion beams of 40 A at 75 keV were extracted for pulse lengths up to 30 s, maintaining excellent optical quality in the beam for the entire pulse duration. The design features and operational characteristics of the ion source are elaborated

  11. Adaptive upstream rate adjustment by RSOA-ONU depending on different injection power of seeding light in standard-reach and long-reach PON systems

    Science.gov (United States)

    Yeh, C. H.; Chow, C. W.; Shih, F. Y.; Pan, C. L.

    2012-08-01

    The wavelength division multiplexing-time division multiplexing (WDM-TDM) passive optical network (PON) using reflective semiconductor optical amplifier (RSOA)-based colorless optical networking units (ONUs) is considered as a promising candidate for the realization of fiber-to-the-home (FTTH). And this architecture is actively considered by Industrial Technology Research Institute (ITRI) for the realization of FTTH in Taiwan. However, different fiber distances and optical components would introduce different power budgets to different ONUs in the PON. Besides, due to the aging of optical transmitter (Tx), the power decay of the distributed optical carrier from the central office (CO) could also reduce the injection power into each ONU. The situation will be more severe in the long-reach (LR) PON, which is considered as an option for the future access. In this work, we investigate a WDM-TDM PON using RSOA-based ONU for upstream data rate adjustment depending on different continuous wave (CW) injection powers. Both standard-reach (25 km) and LR (100 km) transmissions are evaluated. Moreover, a detail analysis of the upstream signal bit-error rate (BER) performances at different injection powers, upstream data rates, PON split-ratios under stand-reach and long-reach is presented.

  12. Long-acting reversible contraception in the pediatric emergency department: clinical implications and common challenges.

    Science.gov (United States)

    Koyama, Atsuko; Dorfman, David H; Forcier, Michelle M

    2015-04-01

    Long-acting reversible contraception (LARC) is recommended as first-line contraception for adolescents and young adults. As the use of LARC increases, pediatric emergency medicine clinicians should be able to recognize different types of LARC and address their common adverse effects, adverse reactions, and complications. This continuing medical education activity provides an overview of LARC and will assist clinicians in the evaluation and management of patients with LARC-associated complaints.

  13. 300 Area Uranium Stabilization Through Polyphosphate Injection: Final Report

    Energy Technology Data Exchange (ETDEWEB)

    Vermeul, Vincent R.; Bjornstad, Bruce N.; Fritz, Brad G.; Fruchter, Jonathan S.; Mackley, Rob D.; Newcomer, Darrell R.; Mendoza, Donaldo P.; Rockhold, Mark L.; Wellman, Dawn M.; Williams, Mark D.

    2009-06-30

    amendment arrival response data indicate some degree of overlap between the reactive species and thus potential for the formation of calcium-phosphate mineral phases (i.e., apatite formation), the efficiency of this treatment approach was relatively poor. In general, uranium performance monitoring results support the hypothesis that limited long-term treatment capacity (i.e., apatite formation) was established during the injection test. Two separate overarching issues affect the efficacy of apatite remediation for uranium sequestration within the 300 Area: 1) the efficacy of apatite for sequestering uranium under the present geochemical and hydrodynamic conditions, and 2) the formation and emplacement of apatite via polyphosphate technology. In addition, the long-term stability of uranium sequestered via apatite is dependent on the chemical speciation of uranium, surface speciation of apatite, and the mechanism of retention, which is highly susceptible to dynamic geochemical conditions. It was expected that uranium sequestration in the presence of hydroxyapatite would occur by sorption and/or surface complexation until all surface sites have been depleted, but that the high carbonate concentrations in the 300 Area would act to inhibit the transformation of sorbed uranium to chernikovite and/or autunite. Adsorption of uranium by apatite was never considered a viable approach for in situ uranium sequestration in and of itself, because by definition, this is a reversible reaction. The efficacy of uranium sequestration by apatite assumes that the adsorbed uranium would subsequently convert to autunite, or other stable uranium phases. Because this appears to not be the case in the 300 Area aquifer, even in locations near the river, apatite may have limited efficacy for the retention and long-term immobilization of uranium at the 300 Area site..

  14. Treatment and prevention of HIV infection with long-acting antiretrovirals.

    Science.gov (United States)

    Benítez-Gutiérrez, Laura; Soriano, Vicente; Requena, Silvia; Arias, Ana; Barreiro, Pablo; de Mendoza, Carmen

    2018-05-01

    Current antiretroviral therapy allows to achieve and sustain maximal suppression of HIV replication in most treated patients. As result, the life expectancy of HIV-infected persons has improved dramatically and is nowadays similar to that of the HIV-negative population. However, oral antiretrovirals have to be taken daily and indefinitely to avoid resumption of HIV replication and selection of drug resistance. Unfortunately, drug adherence is often suboptimal and tends to decline over time. Areas covered: New drugs, formulations and delivery systems are being developed for extended-release of antiretrovirals. At this time, intramuscular cabotegravir and rilpivirine, dapivirine vaginal rings and tenofovir alafenamide subdermal implants are the products in more advanced stages of clinical development. Their pharmacokinetics/dynamics and safety/efficacy are reviewed. Expert commentary: In the absence of eradicative therapy for individuals with HIV infection and protective vaccines for persons at risk, long-term antiretroviral therapy is the best approach for preventing disease progression in patients and halting transmissions, either as result of 'treatment as prevention' for HIV carriers or 'pre-exposure prophylaxis' for uninfected individuals at risk. In all these scenarios, the advent of long-acting antiretrovirals will expand options for overcoming the challenge of suboptimal drug adherence and reduce the burden of HIV infection.

  15. In-situ combustion with solvent injection

    Energy Technology Data Exchange (ETDEWEB)

    D' Silva, J.; Kakade, G. [Society of Petroleum Engineers, Kuala Lumpur (Malaysia)]|[Maharashtra Inst. of Technology, Pune (India)

    2008-10-15

    The effects of combining in situ combustion and heavy hydrocarbon naphtha vapor injection techniques in a heavy oil reservoir were investigated. Oil production rates and steam injection efficiencies were considered. The technique was also combined with toe-to-heel air injection (THAI) processes. The study showed that the modified THAI process achieved high rates of recovery for both primary production and as a follow-up technique in partially depleted reservoirs after cyclic steam and cold production. Oil produced using the modified THAI technique was also partially upgraded by the process. Results of the vapour chamber pressure calculations showed that the volume of oil produced by naphtha assisted gravity drainage was between 1 to 3 times higher than amounts of oil produced by SAGD processes during the same amount of time. The naphtha injection process produced more oil than the steam only process. However, high amounts of naphtha were needed to produce oil. Injection and production rates during the naphtha injection process were higher. Naphtha vapor was injected near the heel of a horizontal producer well. The vapor acted as a thermal and diluent mechanism in order to reduce the viscosity of the heavy oil . 9 refs., 4 tabs., 6 figs.

  16. Long-term complications of polyethylene glycol injection to the face.

    Science.gov (United States)

    Altintas, Hande; Odemis, Mustafa; Bilgi, Selcuk; Cakmak, Ozcan

    2012-04-01

    Currently, filling, smoothing, or recontouring the face through the use of injectable fillers is one of the most popular forms of cosmetic surgery. Because these materials promise a more youthful appearance without anesthesia in a noninvasive way, various fillers have been used widely in different parts of the world. However, most of these fillers have not been approved by the Food and Drug Administration, and their applications might cause unpleasant disfiguring complications. This report describes a case of foreign body granuloma in the cheeks secondary to polyethylene glycol injection and shows the possible complications associated with the use of facial fillers.

  17. Successful use of long acting octreotide in two cases with Beckwith-Wiedemann syndrome and severe hypoglycemia.

    Science.gov (United States)

    Al-Zubeidi, Hiba; Gottschalk, Michael E; Newfield, Ron S

    2014-01-01

    Hyperinsulinism associated with Beckwith-Wiedemann syndrome (BWS) can occur in about 50% of cases, causing hypoglycemia of variable severity. Parenteral use of octreotide may be indicated if unresponsive to diazoxide. There is limited data on use of octreotide in BWS. Chart review describing 2 cases with BWS and hypoglycemia treated with long acting Octreotide as a monthly injection. We describe two unrelated females born large for gestational age found to have clinical features consistent with BWS, who developed severe hypoglycemia. Genetic diagnosis of BWS was confirmed. The first patient was born at 37 weeks and developed hypoglycemia shortly after birth. She was initially started on diazoxide but developed pulmonary congestion and was therefore switched to depot octreotide (LAR). She maintained euglycemia with LAR. In the second patient (born at 26-4/7 weeks), onset of hypoglycemia was delayed till 11 weeks of age due to hydrocortisone (indicated hemodynamically) and continuous feeding, and was partially responsive to diazoxide. She was switched to octreotide 4 times daily, treated till at age 18 months. Despite frequent feeds, she required treatment again between ages 4-6.5 years, initially with diazoxide but due to severe hypertrichosis she was switched to LAR with an excellent response. Both patients treated with LAR for over two years achieved euglycemia above 70 mg/dl and had normal height gain, without side effects. Successful treatment of hypoglycemia can be achieved and maintained with LAR in infants and children with BWS who are either resistant or cannot tolerate diazoxide.

  18. Long-acting family planning method switching among revisit clients of public health facilities in Dire Dawa, Ethiopia.

    Science.gov (United States)

    Atnafe, Meselu; Assefa, Nega; Alemayehu, Tadesse

    2016-01-01

    "Contraceptive switching" from one method to another is a common phenomenon. Switching from a more effective long-acting method to a less effective method exposes women for unplanned pregnancy. The aim of this study was to assess the level and factors associated with long-acting family planning method switching to other methods. A facility-based cross-sectional study was conducted from January to March 2013 on 634 women attending public health facilities in Dire Dawa City Administration, Ethiopia. Participants of the study were revisit clients of family planning service and were interviewed as they appear in the clinics. Data were analyzed using crude and adjusted logistic regression, and results were reported using OR and corresponding 95 % CI. Long-acting family planning method switching among revisit clients was 40.4 %; switching from implant was 29.8 % and from IUCD, it was 10.6 %. The main reasons for methods switching were side effects of the methods such as bleeding, weight loss, and feeling of arm numbness. The tendency of switching was less among married women (AOR = 2.41, 95 % CI: 1.01, 5.74), women who had 2-4 and 5 and more children (AOR 3.00, 95 % CI: 1.59, 5.67) and (AOR 2.07, 95 % CI: 1.17, 3.66), respectively. It was also less among women who want to stop birth (AOR 5.11, 95 % CI: 1.15, 24.8), among those who mentioned health care providers as source of information for family planning (AOR 1.88, 95 % CI: 1.18, 3.01), and among women whose husbands were aware of their use of the methods (AOR 3.05, 95 % CI: 1.88, 4.94). Method switching from long-acting contraceptives to less effective methods is high. Method switching was significant among unmarried women, who had one child, plan to postpone fertility, and whose husbands were not aware of their wive's use of the method. In the provision of family planning service, the health care providers should give adequate information about each method and risks of method switching. Appropriate family

  19. Factors impacting knowledge and use of long acting and permanent contraceptive methods by postpartum HIV positive and negative women in Cape Town, South Africa: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Credé Sarah

    2012-03-01

    Full Text Available Abstract Background The prevention of unintended pregnancies among HIV positive women is a neglected strategy in the fight against HIV/AIDS. Women who want to avoid unintended pregnancies can do this by using a modern contraceptive method. Contraceptive choice, in particular the use of long acting and permanent methods (LAPMs, is poorly understood among HIV-positive women. This study aimed to compare factors that influence women's choice in contraception and women's knowledge and attitudes towards the IUD and female sterilization by HIV-status in a high HIV prevalence setting, Cape Town, South Africa. Methods A quantitative cross-sectional survey was conducted using an interviewer-administered questionnaire amongst 265 HIV positive and 273 HIV-negative postpartum women in Cape Town. Contraceptive use, reproductive history and the future fertility intentions of postpartum women were compared using chi-squared tests, Wilcoxon rank-sum and Fisher's exact tests where appropriate. Women's knowledge and attitudes towards long acting and permanent methods as well as factors that influence women's choice in contraception were examined. Results The majority of women reported that their most recent pregnancy was unplanned (61.6% HIV positive and 63.2% HIV negative. Current use of contraception was high with no difference by HIV status (89.8% HIV positive and 89% HIV negative. Most women were using short acting methods, primarily the 3-monthly injectable (Depo Provera. Method convenience and health care provider recommendations were found to most commonly influence method choice. A small percentage of women (6.44% were using long acting and permanent methods, all of whom were using sterilization; however, it was found that poor knowledge regarding LAPMs is likely to be contributing to the poor uptake of these methods. Conclusions Improving contraceptive counselling to include LAPM and strengthening services for these methods are warranted in this setting

  20. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials.

    Science.gov (United States)

    Coombes, Brooke K; Bisset, Leanne; Vicenzino, Bill

    2010-11-20

    Few evidence-based treatment guidelines for tendinopathy exist. We undertook a systematic review of randomised trials to establish clinical efficacy and risk of adverse events for treatment by injection. We searched eight databases without language, publication, or date restrictions. We included randomised trials assessing efficacy of one or more peritendinous injections with placebo or non-surgical interventions for tendinopathy, scoring more than 50% on the modified physiotherapy evidence database scale. We undertook meta-analyses with a random-effects model, and estimated relative risk and standardised mean differences (SMDs). The primary outcome of clinical efficacy was protocol-defined pain score in the short term (4 weeks, range 0-12), intermediate term (26 weeks, 13-26), or long term (52 weeks, ≥52). Adverse events were also reported. 3824 trials were identified and 41 met inclusion criteria, providing data for 2672 participants. We showed consistent findings between many high-quality randomised controlled trials that corticosteroid injections reduced pain in the short term compared with other interventions, but this effect was reversed at intermediate and long terms. For example, in pooled analysis of treatment for lateral epicondylalgia, corticosteroid injection had a large effect (defined as SMD>0·8) on reduction of pain compared with no intervention in the short term (SMD 1·44, 95% CI 1·17-1·71, ptendon rupture). By comparison with placebo, reductions in pain were reported after injections of sodium hyaluronate (short [3·91, 3·54-4·28, peffective than was eccentric exercise. Despite the effectiveness of corticosteroid injections in the short term, non-corticosteroid injections might be of benefit for long-term treatment of lateral epicondylalgia. However, response to injection should not be generalised because of variation in effect between sites of tendinopathy. None. Copyright © 2010 Elsevier Ltd. All rights reserved.

  1. Effects of single injection of local anesthetic agents on intervertebral disc degeneration: ex vivo and long-term in vivo experimental study.

    Directory of Open Access Journals (Sweden)

    Koji Iwasaki

    Full Text Available Analgesic discography (discoblock can be used to diagnose or treat discogenic low back pain by injecting a small amount of local anesthetics. However, recent in vitro studies have revealed cytotoxic effects of local anesthetics on intervertebral disc (IVD cells. Here we aimed to investigate the deteriorative effects of lidocaine and bupivacaine on rabbit IVDs using an organotypic culture model and an in vivo long-term follow-up model.For the organotypic culture model, rabbit IVDs were harvested and cultured for 3 or 7 days after intradiscal injection of local anesthetics (1% lidocaine or 0.5% bupivacaine. Nucleus pulposus (NP cell death was measured using confocal microscopy. Histological and TUNEL assays were performed. For in vivo study, each local anesthetic was injected into rabbit lumbar IVDs under a fluoroscope. Six or 12 months after the injection, each IVD was prepared for magnetic resonance imaging (MRI and histological analysis.In the organotypic culture model, both anesthetic agents induced time-dependent NP cell death; when compared with injected saline solution, significant effects were detected within 7 days. Compared with the saline group, TUNEL-positive NP cells were significantly increased in the bupivacaine group. In the in vivo study, MRI analysis did not show any significant difference. Histological analysis revealed that IVD degeneration occurred to a significantly level in the saline- and local anesthetics-injected groups compared with the untreated control or puncture-only groups. However, there was no significant difference between the saline and anesthetic agents groups.In the in vivo model using healthy IVDs, there was no strong evidence to suggest that discoblock with local anesthetics has the potential of inducing IVD degeneration other than the initial mechanical damage of the pressurized injection. Further studies should be performed to investigate the deteriorative effects of the local injection of analgesic agents

  2. Injectable biomaterials for adipose tissue engineering

    International Nuclear Information System (INIS)

    Young, D A; Christman, K L

    2012-01-01

    Adipose tissue engineering has recently gained significant attention from materials scientists as a result of the exponential growth of soft tissue filler procedures being performed within the clinic. While several injectable materials are currently being marketed for filling subcutaneous voids, they often face limited longevity due to rapid resorption. Their inability to encourage natural adipose formation or ingrowth necessitates repeated injections for a prolonged effect and thus classifies them as temporary fillers. As a result, a significant need for injectable materials that not only act as fillers but also promote in vivo adipogenesis is beginning to be realized. This paper will discuss the advantages and disadvantages of commercially available soft tissue fillers. It will then summarize the current state of research using injectable synthetic materials, biopolymers and extracellular matrix-derived materials for adipose tissue engineering. Furthermore, the successful attributes observed across each of these materials will be outlined along with a discussion of the current difficulties and future directions for adipose tissue engineering. (paper)

  3. Methylphenidate-risperidone combination in child psychiatry: A retrospective analysis of 44 cases.

    Science.gov (United States)

    Javelot, H; Glay-Ribau, C; Ligier, F; Weiner, L; Didelot, N; Messaoudi, M; Socha, M; Body-Lawson, F; Kabuth, B

    2014-05-01

    Psychotimulant-antipyschotic combinations are frequently used in child psychiatry, but have been rarely described in the literature. We propose here a retrospective study of 44 children who received the combination methylphenidate (MPH)-risperidone (RIS). The sample is composed of children who received either MPH (n=28) or RIS (n=16) as primary treatment. A vast majority of the children had a comorbid attention deficit hyperactivity disorder (ADHD) diagnosis. For over 60% of patients, regardless of their initial monotherapy, bitherapy decreased the symptoms of ADHD and conduct disorder, sleep disorders and anxiety. Concerning the safety of the bitherapy, a compensation effect on weight gain and appetite was respectively observed in 70% and 50% of patients. Even though iatrogenic tachycardia can be encountered with both drugs, it has never been reported when they are associated and we have reported a total of 3 cases in our study. We have also observed a case of dyskinesia resolved with the discontinuation of the treatment. MPH-RIS bitherapy appears to be particularly effective in ADHD with conduct disorder symptoms. Although tolerance may limit its use, the benefit/risk ratio seems favourable for a number of children. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  4. Conversion of daily pegvisomant to weekly pegvisomant combined with long-acting somatostatin analogs, in controlled acromegaly patients

    NARCIS (Netherlands)

    S.J.C.M.M. Neggers (Bas); W.W. de Herder (Wouter); R.A. Feelders (Richard); A-J. van der Lely (Aart-Jan)

    2011-01-01

    textabstractThe efficacy of combined treatment in active acromegaly with both long-acting somatostatin analogs (SRIF) and pegvisomant (PEG-V) has been well established. The aim was to describe the PEG-V dose reductions after the conversion from daily PEG-V to combination treatment. To clarify the

  5. MRI diagnosis of the complications of polyamide hydrogel injection for augmentation mammoplasty

    International Nuclear Information System (INIS)

    Chen Xueqiang; Chen Pingyou; Zhang Yunshu; Luo Qinghua; Xu Rong

    2005-01-01

    Objective: To analyze MRI findings and its clinical significance in complications of polyamide hydrogel injection for augmentation mammoplasty. Methods: The complication findings of MR imaging in 20 cases with polyamide hydrogel injection for augmentation mammoplasty were retrospectively reviewed and analyzed. Results: In 20 patients, 26 breasts suffered from complications, including infection (n=5) with pieces of long T 1 and long T 2 signals, aseptic inflammation (n=2) with pieces of slight long T 1 and moderate T 2 signals, hard nodule (n=10) with long T 1 and long T 2 signals, and rupture (n=5) with pieces and nodes of long T 1 and long T 2 signals on MR images. Conclusion: MRI has the great diagnostic value in the detection of complications after polyamide hydrogel injection for augmentation mammoplasty, and it should be taken as the first diagnostic choice. (authors)

  6. Serial follow-up of presurgical treatment using pasireotide long-acting release with or without octreotide long-acting release for naïve active acromegaly

    Directory of Open Access Journals (Sweden)

    Jan-Shun Chang

    2016-06-01

    Full Text Available The aim of the present study was to evaluate the serial changes of GH and IGF-1 in seven patients with naïve, active acromegaly following presurgical treatment of the somatostatin analog pasireotide long-acting release (LAR and octreotide LAR. The patients were treated with pasireotide LAR with or without octreotide LAR for two years and underwent transsphenoidal adenomectomy. After treatment with the somatostatin analogs, the surgical cure rate was similar to that in patients who underwent transsphenoidal surgery alone. Diabetes insipidus was not identified in any patients after the operation. Pasireotide LAR was effective on GH as well as IGF-1 suppression and tumor size decreasing when used as the primary therapy. Future large-population studies to investigate the surgical curative rate after presurgical treatment with somatostatin analogs in patients with acromegaly and macroadenomas close to the cavernous sinus are warranted. However, that hyperglycemia developed following pre-surgical treatment with pasireotide should take into consideration.

  7. New pellet production and acceleration technologies for high speed pellet injection system 'HIPEL' in large helical device

    International Nuclear Information System (INIS)

    Viniar, I.; Sudo, S.

    1994-12-01

    New technologies of pellet production and acceleration for fueling and diagnostics purposes in large thermonuclear reactors are proposed. The technologies are intended to apply to the multiple-pellet injection system 'HIPEL' for Large Helical Device of NIFS in Japan. The pellet production technology has already been tested in a pipe-gun type pellet injector. It will realize the repeating pellet injection by means of decreasing of the pellet formation time into the pipe-gun barrel. The acceleration technology is based upon a new pump tube operation in two-stage gas gun and also upon a new conception of the allowable pressure acting on a pellet into a barrel. Some preliminary estimations have been made, and principles of a pump tube construction providing for a reliable long term operation in the repeating mode without any troubles from a piston are proposed. (author)

  8. Long-acting beneficial effect of percutaneously intramyocardially delivered secretome of apoptotic peripheral blood cells on porcine chronic ischemic left ventricular dysfunction.

    Science.gov (United States)

    Pavo, Noemi; Zimmermann, Matthias; Pils, Dietmar; Mildner, Michael; Petrási, Zsolt; Petneházy, Örs; Fuzik, János; Jakab, András; Gabriel, Christian; Sipos, Wolfgang; Maurer, Gerald; Gyöngyösi, Mariann; Ankersmit, Hendrik Jan

    2014-04-01

    The quantity of cells with paracrine effects for use in myocardial regeneration therapy is limited. This study investigated the effects of catheter-based endomyocardial delivery of secretome of 2.5 × 10(9) apoptotic peripheral blood mononuclear cells (APOSEC) on porcine chronic post-myocardial infarction (MI) left ventricular (LV) dysfunction and on gene expression. Closed-chest reperfused MI was induced in pigs by 90-min occlusion followed by reperfusion of the mid-LAD (day 0). At day 30, animals were randomized to receive porcine APOSEC (n = 8) or medium solution (control; n = 8) injected intramyocardially into the MI border zone using 3D NOGA guidance. At day 60, cardiac MRI with late enhancement and diagnostic NOGA (myocardial viability) were performed. Gene expression profiling of the infarct core, border zone, and normal myocardium was performed using microarray analysis and confirmed by quantitative real-time PCR. Injection of APOSEC significantly decreased infarct size (p < 0.05) and improved cardiac index and myocardial viability compared to controls. A trend towards higher LV ejection fraction was observed in APOSEC vs. controls (45.4 ± 5.9% vs. 37.4 ± 8.9%, p = 0.052). Transcriptome analysis revealed significant downregulation of caspase-1, tumor necrosis factor and other inflammatory genes in APOSEC-affected areas. rtPCR showed higher expression of myogenic factor Mefc2 (p < 0.05) and downregulated caspase genes (p < 0.05) in APOSEC-treated pigs. In conclusion, overexpression of MEF2c and repression of caspase was related to decreased infarct size and improved cardiac function in secretome-treated animals. Altered gene expression 1-month post-APOSEC treatment proved the long-acting effects of cell-free therapy with paracrine factors. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  9. A European multicentre survey of impulse control behaviours in Parkinson's disease patients treated with short- and long-acting dopamine agonists.

    Science.gov (United States)

    Rizos, A; Sauerbier, A; Antonini, A; Weintraub, D; Martinez-Martin, P; Kessel, B; Henriksen, T; Falup-Pecurariu, C; Silverdale, M; Durner, G; Røkenes Karlsen, K; Grilo, M; Odin, P; Chaudhuri, K Ray

    2016-08-01

    Impulse control disorders (ICDs) in Parkinson's disease (PD) are associated primarily with dopamine agonist (DA) use. Comparative surveys of clinical occurrence of impulse control behaviours on longer acting/transdermal DA therapy across age ranges are lacking. The aim of this study was to assess the occurrence of ICDs in PD patients across several European centres treated with short- or long-acting [ropinirole (ROP); pramipexole (PPX)] and transdermal [rotigotine skin patch (RTG)] DAs, based on clinical survey as part of routine clinical care. A survey based on medical records and clinical interviews of patients initiating or initiated on DA treatment (both short- and long-acting, and transdermal) across a broad range of disease stages and age groups was performed. Four hundred and twenty-five cases were included [mean age 68.3 years (range 37-90), mean duration of disease 7.5 years (range 0-37)]. ICD frequencies (as assessed by clinical interview) were significantly lower with RTG (4.9%; P controlling for possible confounding factors. © 2016 EAN.

  10. Injectable barriers for waste isolation

    International Nuclear Information System (INIS)

    Persoff, P.; Finsterle, S.; Moridis, G.J.; Apps, J.; Pruess, K.; Muller, S.J.

    1995-03-01

    In this paper the authors report laboratory work and numerical simulation done in support of development and demonstration of injectable barriers formed from either of two fluids: colloidal silica or polysiloxane. Two principal problems addressed here are control of gel time and control of plume emplacement in the vadose zone. Gel time must be controlled so that the viscosity of the barrier fluid remains low long enough to inject the barrier, but increases soon enough to gel the barrier in place. During injection, the viscosity must be low enough to avoid high injection pressures which could uplift or fracture the formation. To test the grout gel time in the soil, the injection pressure was monitored as grouts were injected into sandpacks. When grout is injected into the vadose zone, it slumps under the influence of gravity, and redistributes due to capillary forces as it gels. The authors have developed a new module for the reservoir simulator TOUGH2 to model grout injection into the vadose zone, taking into account the increase of liquid viscosity as a function of gel concentration and time. They have also developed a model to calculate soil properties after complete solidification of the grout. The numerical model has been used to design and analyze laboratory experiments and field pilot tests. The authors present the results of computer simulations of grout injection, redistribution, and solidification

  11. Comparing the Cost of Treatment with Octreotide Long-Acting Release versus Lanreotide in Patients with Metastatic Gastrointestinal Neuroendocrine Tumors.

    Science.gov (United States)

    Ayyagari, Rajeev; Neary, Maureen; Li, Shang; Rokito, Ariel; Yang, Hongbo; Xie, Jipan; Benson, Al B

    2017-11-01

    The 2 somatostatin analogs currently recommended by the National Comprehensive Cancer Network for the treatment of gastrointestinal (GI) neuroendocrine tumors (NETs) include octreotide long-acting release (Sandostatin LAR) for injectable suspension and lanreotide (Somatuline Depot) injection for subcutaneous use. To estimate the costs to payers associated with 30-mg octreotide LAR and 120-mg lanreotide treatment among patients with metastatic GI-NETs. The costs to payers associated with the 2 drugs were estimated by including the costs of each drug, drug administration, and adverse events. The unit drug costs for octreotide LAR and for lanreotide were obtained from ReadyPrice Wholesale Acquisition Cost; the doses were obtained from published studies. The adverse event rates were obtained from 2 phase 3 clinical trials, PROMID and CLARINET. Deterministic one-way sensitivity analyses were used to assess the impact of modifying assumptions and inputs on the results, including the 2017 Average Sales Price (ASP). All costs were estimated in 2016 US dollars, with a constant discount of 3%. The costs to payers associated with the treatment of GI-NETs during 1-, 3-, and 5-year horizons were $74,566, $180,082, and $262,344, respectively, for octreotide LAR and $84,856, $205,562, and $299,667, respectively, for lanreotide. Thus, octreotide LAR was associated with lower costs by $10,290 (1 year), $25,480 (3 years), and $37,323 (5 years) compared with lanreotide. Over a 5-year horizon, the costs of adverse events and administration accounted for 0.72% of the total cost for octreotide LAR and 0.51% of the total cost for lanreotide. Sensitivity analyses confirmed that the main factor affecting the cost difference was the price of the drugs; analyses using the ASP yielded similar results. For the management of metastatic GI-NETs, the cost to payers of treatment with 30-mg octreotide LAR is considerably lower than with 120-mg lanreotide over 1-, 3-, and 5-year horizons. In the

  12. Inhibition of pituitary-gonadal axis in mice by long-term administration of D-Trp-6-LHRH microcapsules.

    Science.gov (United States)

    Bokser, L; Zalatnai, A; Schally, A V

    1989-03-01

    Female mice were injected, every 30 days for 5 months, with a long-acting formulation of microcapsules liberating 2.5 micrograms D-Trp-6-LHRH/day. The control group was injected with vehicle only. At 30 days after the last injection mice were killed, ovaries, uteri and adrenals were weighed and fixed in formalin for histological studies. LH and oestradiol concentrations were measured by RIA. In the D-Trp-6-LHRH-treated group, the weights of the ovaries and uterus (P less than 0.01 and P less than 0.05, respectively), and LH and oestradiol values (P less than 0.02 and P less than 0.01, respectively) were reduced compared to controls. Histologically, the ovaries contained a large number of degenerated, atretic follicles, and corpora lutea had almost completely disappeared. These results indicate, contrary to the prevailing opinion, that mice are sensitive to inhibitory effects of LHRH agonists and that a suppression of the pituitary-gonadal axis can be obtained with long-term administration of D-Trp-6-LHRH microcapsules.

  13. A rapid-acting, long-acting insulin formulation based on a phospholipid complex loaded PHBHHx nanoparticles.

    Science.gov (United States)

    Peng, Qiang; Zhang, Zhi-Rong; Gong, Tao; Chen, Guo-Qiang; Sun, Xun

    2012-02-01

    The application of poly(hydroxybutyrate-co-hydroxyhexanoate) (PHBHHx) for sustained and controlled delivery of hydrophilic insulin was made possible by preparing insulin phospholipid complex loaded biodegradable PHBHHx nanoparticles (INS-PLC-NPs). The INS-PLC-NPs produced by a solvent evaporation method showed a spherical shape with a mean particle size, zeta potential and entrapment efficiency of 186.2 nm, -38.4 mv and 89.73%, respectively. In vitro studies demonstrated that only 20% of insulin was released within 31 days with a burst release of 5.42% in the first 8 h. The hypoglycaemic effect in STZ induced diabetic rats lasted for more than 3 days after the subcutaneous injection of INS-PLC-NPs, which significantly prolonged the therapeutic effect compared with the administration of insulin solution. The pharmacological bioavailability (PA) of INS-PLC-NPs relative to insulin solution was over 350%, indicating that the bioavailability of insulin was significantly enhanced by INS-PLC-NPs. Therefore, the INS-PLC-NPs system is promising to serve as a long lasting insulin release formulation, by which the patient compliance can be enhanced significantly. This study also showed that phospholipid complex loaded biodegradable nanoparticles (PLC-NPs) have a great potential to be used as a sustained delivery system for hydrophilic proteins to be encapsulated in hydrophobic polymers. Copyright © 2011 Elsevier Ltd. All rights reserved.

  14. Endoscopic Injection of Dextranomer/Hyaluronic Acid as First-Line Treatment in 851 Consecutive Children with High-Grade Vesicoureteral Reflux: Efficacy and Long-Term Results.

    Science.gov (United States)

    Friedmacher, Florian; Colhoun, Eric; Puri, Prem

    2018-03-15

    Endoscopic injection of dextranomer/hyaluronic is widely acknowledged as first-line treatment of lower grade vesicoureteral reflux. Our objective was to demonstrate its long-term efficacy and safety in eradicating high-grade reflux. Eight-hundred-fifty-one children (518 girls, 333 boys), median age 2.3 years (2 months-13.7 years), underwent endoscopic correction of high-grade vesicoureteral reflux using dextranomer/hyaluronic acid. Reflux was unilateral in 415 cases and bilateral in 436, comprising 1,287 refluxing units: grade IV in 1,153 (89.6%) and grade V in 134 (10.4%). 99m technetium-dimercaptosuccinic acid imaging identified renal scarring in 317 (37.3%) patients. Follow-up ultrasound and voiding cystourethrogram were performed 3 months post intervention and renal ultrasound annually thereafter. Median follow-up was 8.5 years (6 months-16 years). Overall resolution rate after the first endoscopic injection was 895/1,287 (69.5%): 70.4% in grade IV and 61.9% in grade V, respectively. Reflux resolved after a second injection in 259 (20.1%) and after a third in 133 (10.4%). Persistent reflux after initial treatment was significantly more common in infants reflux resolution, 43 (5.1%) children developed febrile urinary tract infections: 24 (55.8%) in the first, 15 (34.9%) in the second and 4 (9.3%) after ≥3 years. Of these, 6 had reflux recurrence and 8 demonstrated neocontralateral grade III reflux, which was successfully treated with single endoscopic injection of dextranomer/hyaluronic acid. Endoscopic injection of dextranomer/hyaluronic acid is an efficient and safe long-term treatment for grade IV and V vesicoureteral reflux, which can be easily repeated in cases of failure with a high subsequent resolution rate. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  15. Long-term correction of obesity and diabetes in genetically obese mice by a single intramuscular injection of recombinant adeno-associated virus encoding mouse leptin

    Science.gov (United States)

    Murphy, John E.; Zhou, Shangzhen; Giese, Klaus; Williams, Lewis T.; Escobedo, Jaime A.; Dwarki, Varavani J.

    1997-01-01

    The ob/ob mouse is genetically deficient in leptin and exhibits a phenotype that includes obesity and non-insulin-dependent diabetes melitus. This phenotype closely resembles the morbid obesity seen in humans. In this study, we demonstrate that a single intramuscular injection of a recombinant adeno-associated virus (AAV) vector encoding mouse leptin (rAAV-leptin) in ob/ob mice leads to prevention of obesity and diabetes. The treated animals show normalization of metabolic abnormalities including hyperglycemia, insulin resistance, impaired glucose tolerance, and lethargy. The effects of a single injection have lasted through the 6-month course of the study. At all time points measured the circulating levels of leptin in the serum were similar to age-matched control C57 mice. These results demonstrate that maintenance of normal levels of leptin (2–5 ng/ml) in the circulation can prevent both the onset of obesity and associated non-insulin-dependent diabetes. Thus a single injection of a rAAV vector expressing a therapeutic gene can lead to complete and long-term correction of a genetic disorder. Our study demonstrates the long-term correction of a disease caused by a genetic defect and proves the feasibility of using rAAV-based vectors for the treatment of chronic disorders like obesity. PMID:9391128

  16. Closure of shallow underground injection wells

    International Nuclear Information System (INIS)

    Veil, J.A.; Grunewald, B.

    1993-01-01

    Shallow injection wells have long been used for disposing liquid wastes. Some of these wells have received hazardous or radioactive wastes. According to US Environmental Protection Agency (EPA) regulations, Class IV wells are those injection wells through which hazardous or radioactive wastes are injected into or above an underground source of drinking water (USDW). These wells must be closed. Generally Class V wells are injection wells through which fluids that do not contain hazardous or radioactive wastes are injected into or above a USDW. Class V wells that are responsible for violations of drinking water regulations or that pose a threat to human health must also be closed. Although EPA regulations require closure of certain types of shallow injection wells, they do not provide specific details on the closure process. This paper describes the regulatory background, DOE requirements, and the steps in a shallow injection well closure process: Identification of wells needing closure; monitoring and disposal of accumulated substances; filling and sealing of wells; and remediation. In addition, the paper describes a major national EPA shallow injection well enforcement initiative, including closure plan guidance for wells used to dispose of wastes from service station operations

  17. Comparison of efficacy of long-acting bronchodilators in emphysema dominant and emphysema nondominant chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Fujimoto K

    2011-04-01

    Full Text Available Keisaku Fujimoto1, Yoshiaki Kitaguchi2, Shintaro Kanda2, Kazuhisa Urushihata2, Masayuki Hanaoka2, Keishi Kubo21Department of Biomedical Laboratory Sciences, 2First Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Nagano, JapanBackground: The purpose of this study was to clarify the association between morphological phenotypes according to the predominance of emphysema and efficacy of long-acting muscarinic antagonist and β2 agonist bronchodilators in patients with chronic obstructive pulmonary disease (COPD.Methods: Seventy-two patients with stable COPD treated with tiotropium (n = 41 or salmeterol (n = 31 were evaluated for pulmonary function, dynamic hyperinflation following metronome-paced incremental hyperventilation, six-minute walking distance, and St George’s Respiratory Questionnaire (SGRQ before and 2–3 months following treatment with tiotropium or salmeterol. They were then visually divided into an emphysema dominant phenotype (n = 25 in the tiotropium-treated group and n = 22 in the salmeterol-treated group and an emphysema nondominant phenotype on high-resolution computed tomography, and the efficacy of the two drugs in each phenotype was retrospectively analyzed.Results: Tiotropium significantly improved airflow limitation, oxygenation, and respiratory impedance in both the emphysema dominant and emphysema nondominant phenotypes, and improved dynamic hyperinflation, exercise capacity, and SGRQ in the emphysema dominant phenotype but not in the emphysema nondominant phenotype. Salmeterol significantly improved total score for SGRQ in the emphysema phenotype, but no significant effects on other parameters were found for either of the phenotypes.Conclusion: These findings suggest that tiotropium is more effective than salmeterol for airflow limitation regardless of emphysema dominance, and also can improve dynamic hyperinflation in the emphysema dominant phenotype, which results in further

  18. Insulin degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine

    NARCIS (Netherlands)

    Birkeland, Kåre I.; Home, Philip D.; Wendisch, Ulrich; Ratner, Robert E.; Johansen, Thue; Endahl, Lars A.; Lyby, Karsten; Jendle, Johan H.; Roberts, Anthony P.; DeVries, J. Hans; Meneghini, Luigi F.

    2011-01-01

    Insulin degludec (IDeg) is a basal insulin that forms soluble multihexamers after subcutaneous injection, resulting in an ultra-long action profile. We assessed the efficacy and safety of IDeg formulations administered once daily in combination with mealtime insulin aspart in people with type 1

  19. Increasing Doses of Inhaled Corticosteroids Compared to Adding Long-Acting Inhaled beta(2)-Agonists in Achieving Asthma Control

    NARCIS (Netherlands)

    O'Byrne, Paul M.; Naya, Ian P.; Kallen, Anders; Postma, Dirkje S.; Barnes, Peter J.

    2008-01-01

    Background: Combination therapy with inhaled corticosteroids (ICSs) and long-acting beta(2)-agonists (LABAs), or treatment with high doses of ICSs alone improves asthma control when therapy with low-dose ICSs is not sufficient. However, it is not known which of these treatment options is more

  20. Long-term Results of Percutaneous Ethanol Injection for the Treatment of Hepatocellular Carcinoma in Korea

    International Nuclear Information System (INIS)

    Sung, Yon Mi; Choi, Don Gil; Lim, Hyo K.

    2006-01-01

    To evaluate the long-term follow-up results of percutaneous ethanol injection (PEI) for the treatment of hepatocellular carcinoma (HCC) in Korea. Sixty-eight nodular HCCs initially detected in 64 patients, were subjected to US-guided PEI as a first-line treatment. Long-term survival rates, local tumor progression rates, and complications were evaluated, as were the influences of tumor size and Child-Pugh class on these variables. No major complications occurred. The overall survival rates of the 64 patients at three and five years were 71% and 39%, and their cancer-free survival rates were 22% and 15%, respectively. The overall survival rate of patients with a small HCC (≤ 2 cm) was significantly higher (p = 0.014) than that of patients with a medium-sized HCC (≤ 2 cm). The overall survival rate of patients with Child- Pugh class A was significantly higher (p = 0.049) than that of patients with Child- Pugh class B. Of 59 cases with no residual tumor, local tumor progression was observed in ablation zones in 18, and this was not found to be significantly influenced by tumor size or Child-Pugh class. The results of our investigation of the long-term survival rates of PEI in HCC patients in Korea (a hepatitis B virus-endemic area) were consistent with those reported previously in hepatitis C endemic areas. Patients with a smaller tumor or a better liver function exhibited superior survival rates

  1. Novel Double-Needle System That Can Prevent Intravascular Injection of Any Filler

    Directory of Open Access Journals (Sweden)

    Hsiang Huang, MD

    2017-09-01

    Full Text Available Summary:. A new type of needle system combines 2 parts, an inner needle and an outer needle. The inner needle is used for filler injection and the outer needle acts as a guiding needle that can observe blood reflow when inserting into the vessel lumen during injection process. This new needle system can be used for all kinds of filler, providing real time monitoring for physician and preventing intravascular injection of any filler.

  2. Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations

    DEFF Research Database (Denmark)

    Christiansen, Jens Sandahl; Backeljauw, Philippe F; Bidlingmaier, Martin

    2016-01-01

    OBJECTIVE: The Growth Hormone (GH) Research Society (GRS) convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting growth hormone preparations (LAGH). PARTICIPANTS: A closed meeting of 55 international scientists with expertise in GH, including...... and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final...

  3. Lanreotide depot deep subcutaneous injection: a new method of delivery and its associated benefits

    Directory of Open Access Journals (Sweden)

    Carmichael JD

    2012-01-01

    Full Text Available John D CarmichaelDepartment of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USAAbstract: Acromegaly is a rare disease characterized by excessive growth hormone secretion, usually from a pituitary tumor. Treatment options include surgery, medical therapy, and in some cases, radiation therapy. Current medical therapy consists of treatment with somatostatin analog medications or a growth hormone receptor antagonist. There are two somatostatin analogs currently in use, octreotide and lanreotide. Both are supplied in long-acting formulations and are of comparable biochemical efficacy. Lanreotide is supplied in a prefilled syringe and is injected into deep subcutaneous tissue. Studies have been conducted to assess the efficacy of self- or partner administration, and have demonstrated that injection of lanreotide can be accomplished reliably and safely outside a physician's office. For patients who have achieved biochemical control with lanreotide, the FDA has recently approved an extended dosing interval. Selected patients may be able to receive the medication less frequently with injections of 120 mg administered every 6 or 8 weeks. This review focuses on the use of lanreotide in the treatment of acromegaly, the safety and efficacy of the drug, and the benefits afforded to patients because of unique aspects of the delivery of lanreotide.Keywords: acromegaly, treatment, lanreotide, somatostatin analog, pituitary tumor

  4. Riluzole as an adjunctive therapy to risperidone for the treatment of irritability in children with autistic disorder: a double-blind, placebo-controlled, randomized trial.

    Science.gov (United States)

    Ghaleiha, Ali; Mohammadi, Effat; Mohammadi, Mohammad-Reza; Farokhnia, Mehdi; Modabbernia, Amirhossein; Yekehtaz, Habibeh; Ashrafi, Mandana; Hassanzadeh, Elmira; Akhondzadeh, Shahin

    2013-12-01

    A hyperglutamatergic state has been shown to play a possible role in the pathophysiology of autistic disorders. Riluzole is a glutamate-modulating agent with neuroprotective properties, which has been shown to have positive effects in many neuropsychiatric disorders. The aim of this study was to assess the efficacy and tolerability of riluzole as an adjunctive to risperidone in the treatment of irritability in autistic children who were not optimally responding to previous medications. This was a 10-week, randomized, double-blind, parallel-group, placebo-controlled trial. The study enrolled male and female outpatients aged 5-12 years with a diagnosis of autistic disorder based on the DSM-IV-TR criteria and a score of ≥12 on the Aberrant Behavior Checklist-Community (ABC-C) irritability subscale who had discontinued other medications because of a lack of efficacy. Subjects received riluzole (titrated to 50 or 100 mg/day based on bodyweight) or placebo in addition to risperidone (titrated up to 2 or 3 mg/day based on bodyweight) for 10 weeks. Patients were assessed at baseline, week 5, and week 10. The primary outcome measure was the difference in the change in the ABC-C irritability subscale score from baseline to week 10 between the two groups. We also compared changes in other ABC-C subscale scores and Clinical Global Impressions-Improvement (CGI-I) scale scores between the two groups. Forty-nine patients were enrolled in the study, and forty children completed the trial (dropouts: placebo = 4, riluzole = 5). A significantly greater improvement in the study primary outcome (the ABC-C irritability subscale score) was achieved by the riluzole-treated children compared with the placebo group (P = 0.03). Patients in the riluzole group also showed significantly greater improvement on the lethargy/social withdrawal (P = 0.02), stereotypic behavior (P = 0.03), and hyperactivity/non-compliance subscales (P = 0.005), but not on the inappropriate speech

  5. Predictive Engineering Tools for Injection-Molded Long-Carbon-Fiber Thermoplastic Composites. Topical Report

    Energy Technology Data Exchange (ETDEWEB)

    Nguyen, Ba Nghiep [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Fifield, Leonard S. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Wang, Jin [Autodesk, Inc., Ithaca, NY (United States); Costa, Franco [Autodesk, Inc., Ithaca, NY (United States); Lambert, Gregory [Virginia Polytechnic Inst. and State Univ. (Virginia Tech), Blacksburg, VA (United States); Baird, Donald G. [Virginia Polytechnic Inst. and State Univ. (Virginia Tech), Blacksburg, VA (United States); Sharma, Bhisham A. [Purdue Univ., West Lafayette, IN (United States); Kijewski, Seth A. [Purdue Univ., West Lafayette, IN (United States); Sangid, Michael D. [Purdue Univ., West Lafayette, IN (United States); Gandhi, Umesh N. [Toyota Research Inst. North America, Ann Arbor, MI (United States); Wollan, Eric J. [PlastiComp, Inc., Winona, MN (United States); Roland, Dale [PlastiComp, Inc., Winona, MN (United States); Mori, Steven [Magna Exteriors and Interiors Corporation, Aurora, ON (Canada); Tucker, III, Charles L. [Univ. of Illinois, Urbana-Champaign, IL (United States)

    2016-06-01

    This project aimed to integrate, optimize, and validate the fiber orientation and length distribution models previously developed and implemented in the Autodesk® Simulation Moldflow® Insight (ASMI) software package for injection-molded long-carbon-fiber (LCF) thermoplastic composite structures. The project was organized into two phases. Phase 1 demonstrated the ability of the advanced ASMI package to predict fiber orientation and length distributions in LCF/polypropylene (PP) and LCF/polyamide-6, 6 (PA66) plaques within 15% of experimental results. Phase 2 validated the advanced ASMI package by predicting fiber orientation and length distributions within 15% of experimental results for a complex three-dimensional (3D) Toyota automotive part injection-molded from LCF/PP and LCF/PA66 materials. Work under Phase 2 also included estimate of weight savings and cost impacts for a vehicle system using ASMI and structural analyses of the complex part. The present report summarizes the completion of Phases 1 and 2 work activities and accomplishments achieved by the team comprising Pacific Northwest National Laboratory (PNNL); Purdue University (Purdue); Virginia Polytechnic Institute and State University (Virginia Tech); Autodesk, Inc. (Autodesk); PlastiComp, Inc. (PlastiComp); Toyota Research Institute North America (Toyota); Magna Exteriors and Interiors Corp. (Magna); and University of Illinois. Figure 1 illustrates the technical approach adopted in this project that progressed from compounding LCF/PP and LCF/PA66 materials, to process model improvement and implementation, to molding and modeling LCF/PP and LCF/PA66 plaques. The lessons learned from the plaque study and the successful validation of improved process models for fiber orientation and length distributions for these plaques enabled the project to go to Phase 2 to mold, model, and optimize the 3D complex part.

  6. Establishment and maintenance of donkey-in-mule pregnancy after embryo transfer in a non-cycling mule treated with oestradiol benzoate and long-acting progesterone

    Energy Technology Data Exchange (ETDEWEB)

    Bottrel, M.; Fortes, T.; Ortiz, I.; Hidalgo, M.; Dorado, J.

    2017-07-01

    Female mules are considered as infertile; however, they could be used as recipients in interspecific embryo transfer. This study reports for the first time how it is possible to obtain the birth of a live Andalusian donkey foal after transfer a donkey embryo to a non-cycling mule. Two non-cycling mules were used as recipients, oestradiol benzoate was administered when donors showed oestrus and long-acting progesterone after ovulation. The mules also received long-acting progesterone every 7 days until 120 days of gestation. One embryo was collected from the two donor jennies and transferred to one of the mules after 5 days of progesterone treatment. Pregnancy was established and maintained after embryo transfer. The pregnant mule carried to term and delivered a live donkey foal after 375 days of pregnancy. In conclusion, non-cycling mules treated with oestradiol benzoate and long-acting progesterone can be successfully used as recipients of donkey embryos, which open new ways for the conservation of endangered donkey species.

  7. Establishment and maintenance of donkey-in-mule pregnancy after embryo transfer in a non-cycling mule treated with oestradiol benzoate and long-acting progesterone

    International Nuclear Information System (INIS)

    Bottrel, M.; Fortes, T.; Ortiz, I.; Hidalgo, M.; Dorado, J.

    2017-01-01

    Female mules are considered as infertile; however, they could be used as recipients in interspecific embryo transfer. This study reports for the first time how it is possible to obtain the birth of a live Andalusian donkey foal after transfer a donkey embryo to a non-cycling mule. Two non-cycling mules were used as recipients, oestradiol benzoate was administered when donors showed oestrus and long-acting progesterone after ovulation. The mules also received long-acting progesterone every 7 days until 120 days of gestation. One embryo was collected from the two donor jennies and transferred to one of the mules after 5 days of progesterone treatment. Pregnancy was established and maintained after embryo transfer. The pregnant mule carried to term and delivered a live donkey foal after 375 days of pregnancy. In conclusion, non-cycling mules treated with oestradiol benzoate and long-acting progesterone can be successfully used as recipients of donkey embryos, which open new ways for the conservation of endangered donkey species.

  8. Injection Protection Upgrade for the HL-LHC

    CERN Document Server

    AUTHOR|(CDS)2067108; Biancacci, Nicolo; Bracco, Chiara; Frasciello, Oscar; Gentini, Luca; Goddard, Brennan; Lechner, Anton; Maciariello, Fausto; Perillo Marcone, Antonio; Salvant, Benoit; Shetty, Nikhil Vittal; Steele, Genevieve; Velotti, Francesco; Zobov, Mikhail

    2015-01-01

    The injector complex of the LHC is undergoing important changes in the light of the LIU project to provide brighter beams to the LHC. For this reason and as part of the High Luminosity LHC project the injection protection system of the LHC will be upgraded in the Long Shutdown 2 (2018 - 2019) to be able to protect downstream elements against injection failures with the high brightness, high intensity HL-LHC beams. The upgraded LHC injection protection system will consist of a segmented injection protection absorber TDIS, and auxiliary collimators and masks. The layout modifications are described, and the machine element protection and absorber jaw robustness studies are presented for the new systems.

  9. l-Carnosine As an Adjunctive Therapy to Risperidone in Children with Autistic Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Hajizadeh-Zaker, Reihaneh; Ghajar, Alireza; Mesgarpour, Bita; Afarideh, Mohsen; Mohammadi, Mohammad-Reza; Akhondzadeh, Shahin

    2018-02-01

    This study aimed at investigating the efficacy and tolerability of l-carnosine as an add-on to risperidone in the management of children with autism. This was a 10-week, randomized, double-blind, placebo-controlled study. Seventy drug-free children aged 4-12 years old with a diagnosis of autism spectrum disorder (ASD), according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition. (DSM-5) who had an Aberrant Behavior Checklist-Community (ABC-C) scale irritability subscale score of ≥12, entered the study. The patients were randomly assigned to l-carnosine (800 mg/day in 2 divided doses) or placebo in addition to risperidone titrated up to 2 mg/day (based on body weight) for 10 weeks. The children were assessed by using ABC-C at baseline and weeks 5 and 10 post-baseline. The primary outcome measure was the mean change in the ABC-C irritability subscale score, and other subscale scores were defined as secondary outcomes. Using the general linear model repeated measures, no significant effect was observed for time × treatment interaction on the irritability subscale scores. However, significant effect was detected on the hyperactivity/noncompliance subscale [F (1.62, 64.96) = 3.53, p-value = 0.044]. No significant improvements were obtained on the lethargy/social withdrawal, stereotypic behavior, and inappropriate speech subscale scores. Significantly greater score reduction in the hyperactivity/noncompliance subscale occurred in the l-carnosine group compared with the placebo group at the end of the trial. Extrapyramidal Symptom Rating Scale Scores and its changes did not differ between the two groups. The frequency of other side effects was not significantly different between the two groups. Although no significant difference was detected on the irritability subscale scores, l-carnosine add-on can improve hyperactivity/noncompliance subscales of the ABC-C rating scale in patients with ASD.

  10. Pharmacokinetic drug evaluation of paliperidone in the treatment of schizoaffective disorder.

    Science.gov (United States)

    Macaluso, Matthew; Oliver, Hannah; Sohail, Zohaib

    2017-08-01

    This paper reviews the pharmacokinetics, receptor binding, clinical efficacy and safety of paliperidone in the treatment of patients with schizoaffective disorder. Areas covered: We reviewed the literature using keywords 'paliperidone', 'schizoaffective disorder' and 'clinical trials' with a focus on seminal data papers and information that is clinically relevant to the treatment of schizoaffective disorder. The purpose of this paper is to provide a clinically oriented review of the pharmacokinetic and pharmacodynamic properties of paliperidone including receptor binding, clinical efficacy, safety and tolerability. Expert opinion: Paliperidone is currently the only medication FDA approved specifically for the treatment of schizoaffective disorder. Paliperidone is an active metabolite of risperidone, is minimally metabolized in the liver and is primarily known to be cleared through the kidneys. For this reason, paliperidone could be considered for some patients with schizoaffective disorder who also have hepatic impairment. After correcting for the reduced protein binding that is characteristic of hepatically impaired patients, the Cmax was 12% lower than in healthy subjects while the AUC and CL/F were comparable [14]. In addition, the availability of long acting injectable formulations may be useful for patients who are non-adherent with oral medications. The cost of paliperidone may be a disadvantage.

  11. Barriers and Facilitators to Adolescents' Use of Long-Acting Reversible Contraceptives.

    Science.gov (United States)

    Pritt, Nicole M; Norris, Alison H; Berlan, Elise D

    2017-02-01

    Most pregnancies among teenagers are unintended and many can be attributed to contraception misuse or nonuse. The etonogestrel implant and intrauterine devices, referred to as long-acting reversible contraceptives, or LARCs, are the most effective reversible contraceptive methods. These methods are safe for use by adolescents, yet the number of LARC users remains low among adolescents in the United States. In this review we examine recent literature about barriers and facilitators to LARC use among adolescent women. Factors that influence decision-making and provision are organized into 4 categories: (1) cost and clinical operations; (2) adolescent awareness and attitudes; (3) confidentiality, consent, and parental attitudes; and (4) health care provider knowledge, attitudes, and counseling. Knowledge deficits and misconceptions among adolescents and their health care providers are key barriers to adolescent LARC use. Copyright © 2016 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

  12. Advocacy for Gender Affirming Care: Learning from the Injectable Estrogen Shortage.

    Science.gov (United States)

    Geffen, Sophia; Horn, Tim; Smith, Kimberleigh Joy; Cahill, Sean

    2018-01-01

    Hormone therapy is medically necessary for many transgender individuals. The U.S. Food and Drug Administration (FDA) and pharmaceutical companies' failure to guarantee a supply of injectable estrogen in 2016 and 2017 for transgender individuals is a violation of their right to comprehensive medical treatment, free of discrimination. A series of advocacy actions eventually led to all formulations of injectable estrogen being restored to market; however, long-term solutions to supply interruptions of injectable estrogen are needed. Long-term solutions should address the lack of federally funded research and, consequently, evidence-based practice on hormone therapy for gender affirmation.

  13. Bladder base/trigone injection is safe and as effective as bladder body injection of onabotulinumtoxinA for idiopathic detrusor overactivity refractory to antimuscarinics.

    Science.gov (United States)

    Kuo, Hann-Chorng

    2011-09-01

    The purpose of this study was to evaluate the efficacy and safety of onabotulinumtoxinA injections at bladder base/trigone and compare with injections at bladder body or bladder body/trigone for the treatment of idiopathic detrusor overactivity (IDO) refractory to antimuscarinics. A single blind, randomized, paralleled, actively controlled trial was performed in patients with urodynamically proven IDO who failed antimuscarinic therapy. Patients were randomly assigned to receive intravesical injections of 100 U of onabotulinumtoxinA into three different bladder sites. All treatments were evaluated by voiding diary variables, urgency severity score, urodynamic studies, and patient perception of bladder condition. Long-term success rates over 12 months were also determined. Among the patients, 37 were randomized to injections in the bladder body, 35 into the bladder body/trigone, and 33 into the bladder base/trigone. Successful results were reported in 76 (72%) patients at 3 months: 26 (70%) in the bladder body group, 26 (74%) in the bladder body/trigone group, and 24 (73%) in the bladder base/trigone group. There were no significant differences in success rates, changes in urgency and urgency incontinence episodes, urodynamic variables, or long-term success rates among the three subgroups. The incidence of adverse events was similar among three groups. No vesicoureteral reflux was noted in all patients with or without involving trigone injection. Intravesical onabotulinumtoxinA injection is an effective treatment for IDO regardless of the bladder injection site. Bladder base/trigone injection is as safe and effective as bladder body injections with or without trigone involvement. Copyright © 2011 Wiley-Liss, Inc.

  14. Groundwater monitoring for deep-well injection

    International Nuclear Information System (INIS)

    Chia, Y.; Chiu, J.

    1994-01-01

    A groundwater monitoring system for detecting waste migration would not only enhance confidence in the long-term containment of injected waste, but would also provide early warnings of contamination for prompt responses to protect underground sources of drinking water (USDWs). Field experiences in Florida have demonstrated monitoring water quality and fluid pressure changes in overlying formations is useful in detecting the upward migration of injected waste. Analytical and numerical solutions indicate changes in these two monitoring parameters can vary on the basis of hydrogeologic characteristics, operation conditions, and the distances from the injection well to the monitoring wells and to the preferential hydrologic conduits. To detect waste migration through defects around the wellbore or the leaky containment interval, groundwater monitoring wells should be placed as close as possible to an injection well. In the vertical direction, a monitoring well completed in a permeable interbed within the containment interval is expected to have the highest potential for detecting upward migration. Another acceptable horizon for groundwater monitoring is the lower portion of the buffer brine aquifer immediately above the containment interval. Monitoring wells in USDWs may be needed when waste has been detected in deeper formations or when leakage out of well casings poses a concern. A monitoring well open to the injection interval is of little value in alleviating the concerns of long-term upward migration. Moreover, the installation of the well could create additional preferential pathways. Complications in groundwater monitoring may arise at existing injection sites, especially with prior releases. It is also important to recognize that monitoring in the vicinity of the wellbore may not be effective for detecting waste migration through unidentified unplugged wells or undetected transmissive fractures

  15. Safety and tolerability of pasireotide long-acting release in acromegaly-results from the acromegaly, open-label, multicenter, safety monitoring program for treating patients who have a need to receive medical therapy (ACCESS) study.

    Science.gov (United States)

    Fleseriu, Maria; Rusch, Elisha; Geer, Eliza B

    2017-01-01

    Pasireotide long-acting release is a somatostatin analog that is indicated for treatment of patients with acromegaly. This analysis documents the safety of pasireotide long-acting release in patients with acromegaly enrolled in the ACCESS trial (ClinicalTrials.gov identifier: NCT01995734). ACCESS is an open-label, multicenter, single-arm, expanded-treatment protocol designed to provide patients access to pasireotide long-acting release pending regulatory approval. Patients received pasireotide long-acting release 40 mg administered intramuscularly every 28 days. The primary outcome was the proportion of patients having a treatment-emergent grade ≥3 or serious adverse event. Efficacy data were not collected. Forty-four adult patients with active acromegaly were enrolled in the study for an average of 37.6 weeks (range, 4-70 weeks). Twenty-five grade ≥3 treatment-emergent adverse events were reported in 11 patients (25.0 %), 3 of whom (27.3 %) experienced grade ≥3 hyperglycemia. In patients treated with pasireotide long-acting release for ≥3 months (n = 42), mean glycated hemoglobin and fasting plasma glucose levels increased significantly from 5.9 % and 100.4 mg/dL at baseline to 6.8 % and 135.9 mg/dL at 3 months, respectively. Ten patients (22.7 %) were treated with pasireotide long-acting release for ≥15 months, after which mean glycated hemoglobin and fasting plasma glucose levels were 6.3 % and 123 mg/dL, respectively. Twenty-one patients (48 %) initiated antidiabetic medication. Grade ≥3 adverse events (primary outcome) were reported in 25.0 % of acromegaly patients treated with pasireotide long-acting release in a clinical setting. Hyperglycemia-related adverse events were reported in 45.5 % of patients, but were typically manageable, supporting the role of pasireotide long-acting release as a safe treatment option for acromegaly patients.

  16. Fault reactivation by fluid injection considering permeability evolution in fault-bordering damage zones

    Science.gov (United States)

    Yang, Z.; Yehya, A.; Rice, J. R.; Yin, J.

    2017-12-01

    Earthquakes can be induced by human activity involving fluid injection, e.g., as wastewater disposal from hydrocarbon production. The occurrence of such events is thought to be, mainly, due to the increase in pore pressure, which reduces the effective normal stress and hence the strength of a nearby fault. Change in subsurface stress around suitably oriented faults at near-critical stress states may also contribute. We focus on improving the modeling and prediction of the hydro-mechanical response due to fluid injection, considering the full poroelastic effects and not solely changes in pore pressure in a rigid host. Thus we address the changes in porosity and permeability of the medium due to the changes in the local volumetric strains. Our results also focus on including effects of the fault architecture (low permeability fault core and higher permeability bordering damage zones) on the pressure diffusion and the fault poroelastic response. Field studies of faults have provided a generally common description for the size of their bordering damage zones and how they evolve along their direction of propagation. Empirical laws, from a large number of such observations, describe their fracture density, width, permeability, etc. We use those laws and related data to construct our study cases. We show that the existence of high permeability damage zones facilitates pore-pressure diffusion and, in some cases, results in a sharp increase in pore-pressure at levels much deeper than the injection wells, because these regions act as conduits for fluid pressure changes. This eventually results in higher seismicity rates. By better understanding the mechanisms of nucleation of injection-induced seismicity, and better predicting the hydro-mechanical response of faults, we can assess methodologies and injection strategies to avoid risks of high magnitude seismic events. Microseismic events occurring after the start of injection are very important indications of when injection

  17. Mesoporous hydroxyapatite as a carrier of olanzapine for long-acting antidepression treatment in rats with induced depression.

    Science.gov (United States)

    Shyong, Yan-Jye; Wang, Mao-Hsien; Kuo, Li-Wei; Su, Chang-Fu; Kuo, Wei-Ting; Chang, Kuo-Chi; Lin, Feng-Huei

    2017-06-10

    An antidepressant carrier, mesoporous hydroxyapatite olanzapine (mesoHAP-OLZ), was designed to maintain 3weeks of constant medication release. The carrier was intramuscularly (IM) injected, where cellular activity played a role in achieving the goal of constant release. The efficiency of the treatment was evaluated from 3 perspectives in in vivo studies: locomotor activities, biomarkers, and learning and memory ability. MesoHAP-OLZ can increase the locomotor activity in rats with induced depression determined by open field test (OFT) and forced swim test (FST). Serotonin (5-HT), one of the most important biomarker in depression can also be increased by mesoHAP-OLZ, leading to increased hippocampus activity as measured by functional magnetic resonance imaging (fMRI). MesoHAP-OLZ can also improve learning and memory ability in rats with induced depression during Morris water maze (MWM) test. Our findings further show that mesoHAP-OLZ can provide long-term drug release with a single IM injection, helping to solve the problem of non-adherent medication intake that often occurs in antidepressant therapy. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Nanofibrous yet injectable polycaprolactone-collagen bone tissue scaffold with osteoprogenitor cells and controlled release of bone morphogenetic protein-2

    Energy Technology Data Exchange (ETDEWEB)

    Subramanian, Gayathri; Bialorucki, Callan [Department of Bioengineering, College of Engineering, University of Toledo, Toledo, OH 43606 (United States); Yildirim-Ayan, Eda, E-mail: eda.yildirimayan@utoledo.edu [Department of Bioengineering, College of Engineering, University of Toledo, Toledo, OH 43606 (United States); Department of Orthopaedic Surgery, University of Toledo Medical Center, Toledo, OH 43614 (United States)

    2015-06-01

    In this work, we developed a nanofibrous, yet injectable orthobiologic tissue scaffold that is capable of hosting osteoprogenitor cells and controlling kinetic release profile of the encapsulated pro-osteogenic factor without diminishing its bioactivity over 21 days. This innovative injectable scaffold was synthesized by incorporating electrospun and subsequently O{sub 2} plasma-functionalized polycaprolactone (PCL) nanofibers within the collagen type-I solution along with MC3T3-E1 cells (pre-osteoblasts) and bone morphogenetic protein-2 (BMP2). Through changing the PCL nanofiber concentration within the injectable scaffolds, we were able to tailor the mechanical strength, protein retention capacity, bioactivity preservation, and osteoinductive potential of the scaffolds. The nanofibrous internal structure of the scaffold allowed us to use a low dose of BMP2 (200 ng/ml) to achieve osteoblastic differentiation in in vitro culture. The osteogenesis capacity of the injectable scaffolds were evaluated though measuring MC3T3-E1 cell proliferation, ALP activity, matrix mineralization, and early- and late-osteoblast specific gene expression profiles over 21 days. The results demonstrated that the nanofibrous injectable scaffold provides not only an osteoinductive environment for osteoprogenitor cells to differentiate, but also a suitable biomechanical and biochemical environment to act as a reservoir for osteogenic factors with controlled release profile. - Highlights: • Injectable nanofibrous scaffold with osteoprogenitor cells and BMP2 was synthesized. • PCL nanofiber concentration within collagen scaffold affected the BMP2 retention and bioactivity. • Optimal PCL concentration was identified for mechanical stability, injectability, and osteogenic activity. • Scaffolds exhibited long-term osteoinductive capacity for bone repair and regeneration.

  19. Safe and successful endoscopic initial treatment and long-term eradication of gastric varices by endoscopic ultrasound-guided Histoacryl (N-butyl-2-cyanoacrylate) injection.

    Science.gov (United States)

    Gubler, Christoph; Bauerfeind, Peter

    2014-09-01

    Optimal endoscopic treatment of gastric varices is still not standardized nowadays. Actively bleeding varices may prohibit a successful endoscopic injection therapy of Histoacryl® (N-butyl-2-cyanoacrylate). Since 2006, we have treated gastric varices by standardized endoscopic ultrasound (EUS) guided Histoacryl injection therapy without severe adverse events. We present a large single-center cohort over 7 years with a standardized EUS-guided sclerotherapy of all patients with gastric varices. Application was controlled by fluoroscopy to immediately detect any glue embolization. Only perforating veins located within the gastric wall were treated. In the follow up, we repeated this treatment until varices were eradicated. Utmost patients (36 of 40) were treated during or within 24 h of active bleeding. About 32.5% of patients were treated while visible bleeding. Histoacryl injection was always technically successful and only two patients suffered a minor complication. Acute bleeding was stopped in all patients. About 15% (6 of 40) of patients needed an alternative rescue treatment in the longer course. Three patients got a transjugular portosystemic shunt and another three underwent an orthotopic liver transplantation. Mean long-term survival of 60 months was excellent. Active bleeding of gastric varices can be treated successfully without the necessity of gastric rinsing with EUS-guided injection of Histoacryl.

  20. MHD simulation study of compact toroid injection into magnetized plasmas

    International Nuclear Information System (INIS)

    Suzuki, Yoshio; Kishimoto, Yasuaki

    2000-01-01

    To understand the fuelling process in a fusion device by a compact toroid (CT) plasmoid injection method, we have carried out MHD numerical simulations where a spheromak-like CT (SCT) is injected into a magnetized target plasma region. So far, we revealed that the penetration depth of the SCT plasma becomes shorter than that estimated from the conducting sphere (CS) model, because in the simulation the Lorentz force of the target magnetic field sequentially decelerates the injected SCT while in the CS model only the magnetic pressure force acts as the deceleration mechanism. In this study, we represent the new theoretical model where the injected SCT is decelerated by both the magnetic pressure force and the magnetic tension force (we call it the non-slipping sphere (NS) model) and investigate in detail the deceleration mechanism of the SCT by comparison with simulation results. As a result, it is found that the decrease of the SCT kinetic energy in the simulation coincides with that in the NS model more than in the CS model. It means that not only the magnetic pressure force but also the magnetic tension force acts as the deceleration mechanism of the SCT. Furthermore, it is revealed that magnetic reconnection between the SCT magnetic field and the target magnetic field plays a role to relax the SCT deceleration. (author)

  1. Single-use autoinjector for once-weekly intramuscular injection of IFNβ-1a.

    Science.gov (United States)

    Limmroth, Volker; Gerbershagen, Kathrin

    2014-12-01

    IFNβ products and glatiramer acetate are established treatment first-line options in long-term disease-modifying therapy of multiple sclerosis (MS). These self-injectable medications are used once weekly to once daily. Injection-related issues are common patient-cited reasons for nonadherence. Autoinjectors have been shown to support long-term adherence to injectable medications. The ability to self-inject in MS patients has been associated with a reduced risk of missed injections and drug discontinuation, and a beneficial effect on patient independence. The recently introduced easy-to-use prefilled once-weekly pen is a safe and effective device for intramuscular (IM) IFNβ-1a application and provides a convenient method for self-injection. We reviewed the available published evidence on the characteristics of this device. The once-weekly pen facilitates self-injection and was preferred over prefilled syringes by patients in a prospective open-label, multicenter Phase IIIb trial in MS patients who had been using IM IFNβ-1a in prefilled syringes. The simple and safe handling, shielded short needle, single-use disposable design and virtually painless injection by the device may contribute to adherence, quality of life and independence in patients using IM IFNβ-1a.

  2. [Treatment of Adult Schizophrenic Patients With Depot Antipsychotics].

    Science.gov (United States)

    Jaramillo González, Luis Eduardo; Gómez Restrepo, Carlos; García Valencia, Jenny; de la Hoz Bradford, Ana María; Ávila-Guerra, Mauricio; Bohórquez Peñaranda, Adriana

    2014-01-01

    To determine the indications of long-acting antipsychotic injection and what its effectiveness and safety in adult patients with schizophrenia during the treatment maintenance phase. A clinical practice guideline was elaborated under the parameters of the Methodological Guide of the Ministerio de Salud y Protección Social to identify, synthesize and evaluate the evidence and make recommendations about the treatment and follow-up of adult patients with schizophrenia. The evidence of NICE guide 82 was adopted and updated. The evidence was presented to the Guideline Developing Group and recommendations, employing the GRADE system, were produced. The literature review shows that the evidence has moderate to low quality. 8 articles were used. The risk of relapse was lower with depot risperidone and paliperidone palmitate when compared with placebo. For the risk of hospitalizations comparing depot antipsychotics (APD) versus oral AP, the result is inconclusive. Globally the second-generation APD had a lower risk of discontinuation when compared with placebo. The second generation AP had higher risk of extrapyramidal syndromes than placebo, as in the use of antiparkinsonian. The comparison of second-generation AP injections versus placebo showed an increased risk of early weight gain. The use of depot antipsychotics in the maintenance phase of adult patients diagnosed with schizophrenia is recommended if there is no adherence to oral antipsychotics as the patient's preference. It is not recommended depot antipsychotics in the acute phase of schizophrenia in adults. Copyright © 2014 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

  3. Percutaneous ethanol injection of hyperfunctioning thyroid nodules: long-term follow-up in 125 patients.

    Science.gov (United States)

    Tarantino, Luciano; Francica, Giampiero; Sordelli, Ignazio; Sperlongano, Pasquale; Parmeggiani, Domenico; Ripa, Carmine; Parmeggiani, Umberto

    2008-03-01

    The purpose of this study was to assess the long-term efficacy of percutaneous ethanol injection (PEI) for the treatment of hyperfunctioning thyroid nodules. One hundred twenty-five patients (88 women, 37 men; age range, 17-76 years; mean age, 53 years) with 127 hyperfunctioning thyroid nodules (volume, 1.2-90 mL; mean, 10.3 mL) were treated with PEI. There were 1-11 PEI sessions per patient (average, 3.9) performed, with injection of