Simulating real world functioning in schizophrenia using a naturalistic city environment and single-trial, goal-directed navigation

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John A Zawadzki

2013-11-01

Full Text Available Objective: To develop a virtual reality platform that would serve as a functionally meaningful measure of cognition in schizophrenia that would complement standard batteries of cognitive tests during clinical trials for cognitive treatments in schizophrenia, be amenable to human neuroimaging research, yet lend itself to neurobiological comparison with rodent analogues.Method: Thirty-three patients with schizophrenia and 33 healthy controls matched for age, sex, video gaming experience and education completed eight rapid, single-trial virtual navigation tasks within a naturalistic virtual city. Four trials tested their ability to find different targets seen during the passive viewing of a closed path that led them around different city blocks. Four subsequent trials tested their ability to return to four different starting points after viewing a path that took them several blocks away from the starting position. Results: Individuals with schizophrenia had difficulties in way-finding, measured as distance travelled to find targets previously encountered within the virtual city. They were also more likely not to notice the target during passive viewing, less likely to find novel shortcuts to targets and more likely to become lost and fail completely in finding the target. Total travel distances across all eight trials strongly correlated (negatively with neurocognitive measures and, for 49 participants who completed the Quality of Life Scale, psychosocial functioning. Conclusion: Single-trial, goal-directed navigation in a naturalistic virtual environment is a functionally meaningful measure of cognitive functioning in schizophrenia.

Topiramate's effectiveness on weight reduction in overweight/obese persons with schizophrenia: study protocol for a randomized controlled trial.

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Chandradasa, Miyuru; Champika, Layani; de Silva, Silumini; Kuruppuarachchi, K A L A

2017-09-20

Schizophrenia is a psychiatric disorder with a higher mortality than that of the general population. Most of the deaths are due to cardiovascular causes and are related to metabolic risks. This risk is due not only to antipsychotics but also to inherent factors of the disorder. Studies in the West have shown topiramate to be effective in schizophrenia to reduce weight gain and for symptomatic control. Whether this is effective for South Asians is not known. It is important because South Asians have a higher risk of metabolic syndrome. We aim to conduct a double-blind, randomized controlled trial comparing topiramate add-on therapy with treatment as usual with antipsychotics in patients with schizophrenia in an outpatient setting in Sri Lanka. Ninety patients with schizophrenia presenting to the Colombo North Teaching Hospital will be randomized to intervention and control groups equally using permuted block randomization. Patients with comorbid metabolic disorders and taking prescribed weight-controlling medications will be excluded. The intervention group will be prescribed topiramate in addition to their antipsychotics in a predefined dosing regimen targeting a dose of 100 mg per day. The control subjects are to receive a placebo. As the primary outcome, anthropometric measurements including weight, waist circumference, skinfold thickness, and body mass index will be recorded at baseline and monthly during the study period of 3 months. The secondary outcome is the change in symptoms according to the clinician-administered Brief Psychiatric Rating Scale. Assessment of capacity will be performed and informed consent obtained from all subjects. Ethics approval has been obtained from the ethical review committee of the Faculty of Medicine, University of Kelaniya, and the trial has been registered in the Sri Lanka Clinical Trials Registry. In this double-blind, randomized controlled trial, we will attempt to assess the effectiveness of topiramate as an add

Factors associated with poor satisfaction with treatment and trial discontinuation in chronic schizophrenia.

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Schoemaker, Joep H; Vingerhoets, Ad J J M; Emsley, Robin A

2018-06-05

IntroductionDespite consistently high discontinuation rates due to withdrawal of consent (WOC) and insufficient therapeutic effect (ITE) in schizophrenia trials, insight into the underlying factors contributing to poor satisfaction with treatment and dropout is limited. A better understanding of these factors could help to improve trial design and completion rates. Using data from 1,136 trial participants with schizophrenia or schizoaffective disorder, we explored associations between predictor variables with (1) dropout due to WOC and ITE and (2) satisfaction with treatment among patients and investigators by means of hierarchic multiple regression analyses. ITE was associated with poor clinical improvement, poor investigator satisfaction with treatment, and poor patient insight into their own disease, whereas WOC only showed a meaningful association with poor patient satisfaction with treatment. Investigator satisfaction with treatment appeared most strongly associated with Positive and Negative Syndrome Scale (PANSS) positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor. The occurrence of severe side effects showed no meaningful association to satisfaction with treatment among investigators and patients, and neither did a patient's experienced psychopathology, nor their self-rating of functional impairment. Whereas trial discontinuation due to ITE is associated with poor treatment effectiveness, a patient's decision to withdraw from an antipsychotic trial remains unpredictable and may occur even when the investigator observes a global clinical improvement and is satisfied with the treatment.

The optimization of treatment and management of schizophrenia in Europe (OPTiMiSE) trial

DEFF Research Database (Denmark)

Leucht, Stefan; Winter-van Rossum, Inge; Heres, Stephan

2015-01-01

Commission sponsored "Optimization of Treatment and Management of Schizophrenia in Europe" (OPTiMiSE) trial which aims to provide a treatment algorithm for patients with a first episode of schizophrenia. METHODS: We searched Pubmed (October 29, 2014) for randomized controlled trials (RCTs) that examined...... switching the drug in nonresponders to another antipsychotic. We described important methodological choices of the OPTiMiSE trial. RESULTS: We found 10 RCTs on switching antipsychotic drugs. No trial was conclusive and none was concerned with first-episode schizophrenia. In OPTiMiSE, 500 first episode...

Antipsychotic polypharmacy in clozapine resistant schizophrenia: a randomized controlled trial of tapering antipsychotic co-treatment

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Jari Tiihonen

2012-01-01

Full Text Available There is a considerable disparity between clinical practice and recommendations based on meta-analyses of antipsychotic polypharmacy in clozapine resistant schizophrenia. For this reason, we investigated the clinical response to reducing the use olanzapine that had been previously added on clozapine treatment among seriously ill hospitalized patients. In a randomized controlled trial with crossover design, we studied volunteer patients (N = 15 who had olanzapine added on to clozapine in a state mental hospital. Clozapine monotherapy was just as effective as clozapine-olanzapine therapy, according to results from Clinical Global Impression Scale and Global Assessment of Functioning as primary outcome measures. Polypharmacy is widely used in treating schizophrenia, and usually, add-on medications are started because of worsening of the clinical state. A major confounding feature of these add-ons is whether observed improvements are caused by the medication or explained by the natural fluctuating course of the disorder. The present study, in spite of its small size, indicates the necessity of reconsidering the value of polypharmacy in treating schizophrenia.

Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial.

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Chatterjee, Sudipto; Leese, Morven; Koschorke, Mirja; McCrone, Paul; Naik, Smita; John, Sujit; Dabholkar, Hamid; Goldsmith, Kimberley; Balaji, Madhumitha; Varghese, Mathew; Thara, Rangaswamy; Patel, Vikram; Thornicroft, Graham

2011-01-13

There is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR), involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC) intervention, combined with usual Facility Based Care (FBC), is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India. This trial is a multi-site, parallel group randomised controlled trial design in India.The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2:1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs) working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines. If the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries. The trial is registered with the International Society for the Registration of Clinical Trials and the allocated unique ID number is ISRCTN

Effects on cognitive and clinical insight with the use of Guided Self-Determination in outpatients with schizophrenia: A randomized open trial.

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Jørgensen, R; Licht, R W; Lysaker, P H; Munk-Jørgensen, P; Buck, K D; Jensen, S O W; Hansson, L; Zoffmann, V

2015-07-01

Poor insight has a negative impact on the outcome in schizophrenia; consequently, poor insight is a logical target for treatment. However, neither medication nor psychosocial interventions have been demonstrated to improve poor insight. A method originally designed for diabetes patients to improve their illness management, Guided Self-Determination (GSD), has been adapted for use in patients with schizophrenia (GSD-SZ). The purpose of this study was to investigate the effect on insight of GSD-SZ as a supplement to treatment as usual (TAU) as compared to TAU alone in outpatients diagnosed with schizophrenia. The design was an open randomized trial. The primary hypothesis was cognitive insight would improve in those patients who received GSD-SZ+TAU as assessed by the BCIS. We additionally explored whether the intervention led to changes in clinical insight, self-perceived recovery, self-esteem, social functioning and symptom severity. Assessments were conducted at baseline, and at 3-, 6- and 12-month follow-up. Analysis was based on the principles of intention to treat and potential confounders were taken into account through applying a multivariate approach. A total of 101 participants were randomized to GSD-SZ+TAU (n=50) or to TAU alone (n=51). No statistically significant differences were found on the cognitive insight. However, at 12-month follow-up, clinical insight (measured by G12 from the Positive and Negative Syndrome Scale), symptom severity, and social functioning had statistically significantly improved in the intervention group as compared to the control group. "Improving insight in patients diagnosed with schizophrenia", NCT01282307, http://clinicaltrials.gov/. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Moderating factors for the effectiveness of group art therapy for schizophrenia: secondary analysis of data from the MATISSE randomised controlled trial.

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Leurent, Baptiste; Killaspy, Helen; Osborn, David P; Crawford, Mike J; Hoadley, Angela; Waller, Diane; King, Michael

2014-11-01

Although some studies suggest that art therapy may be useful in the treatment of negative symptoms of schizophrenia, a recent large trial of group art therapy found no clinical advantage over standard care, but the study population was heterogeneous and uptake of the intervention was poor. This study aimed to investigate whether art therapy was more effective for specific subgroups of patients. Secondary analysis of data from a randomised controlled trial of group art therapy as an adjunctive treatment for schizophrenia (n = 140) versus standard care alone (n = 137). Positive and Negative Syndrome Scale scores at 12 months were compared between trial arms. Interaction between intervention effect and different subgroups, including those with more severe negative symptoms of schizophrenia, and those who expressed a preference for art therapy prior to randomisation, was tested using a linear mixed model. The clinical effectiveness of group art therapy did not significantly differ between participants with more or less severe negative symptoms [interaction for difference in PANSS = 1.7, 95 % CI (-8.6 to 12.1), P = 0.741], or between those who did and did not express a preference for art therapy [interaction = 3.9, 95 % CI (-6.7 to 14.5), P = 0.473]. None of the other exploratory subgroups suggested differences in intervention effect. There was no evidence of greater improvement in clinical symptoms of schizophrenia for those with more severe negative symptoms or those with a preference for art therapy. Identification of patients with schizophrenia who may benefit most from group art therapy remains elusive.

Resveratrol supplementation did not improves cognition in patients with schizophrenia: results from a randomized clinical trial

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KARINE ZORTEA

2016-09-01

Full Text Available Background: Schizophrenia is associated with psychotic experiences and cognitive deficits. Therefore, cognitive function is one of the most critical determinants of quality of life in this pathology. Resveratrol has been related with neuroprotective action but there are no studies evaluating resveratrol in schizophrenia. The objective of this study was to determine the efficacy of resveratrol supplementation on cognition in individuals with schizophrenia. Methods: This is a 1-month randomized, double-blind controlled trial (NCT 02062190, in which 19 men with diagnosis of schizophrenia, aged 18 to 65 years, were assigned to a resveratrol supplement group (200mg or placebo group (200mg, with a 1-month follow-up. Applying a series of cognitive tests assessed neuropsychology performance (Hopkins Verbal Learning Test, Stroop Color and Word Test, Weschler Adult Intelligence Scale and Brief Psychiatric Rating Scale assessed psychopathology severity. Results: There were no significant improvement in neuropsychology performance (episodic memory, working memory, attention and concentration capacity, inhibitory control, interference measures, selective attention and mental flexibility and psychopathology severity after 1-month of resveratrol supplementation (p>0.05. Conclusion: In conclusion, we have shown that 1-month of a resveratrol supplementation (200 mg/day did not improve episodic memory, working memory, attention and concentration capacity, inhibitory control, interference measures, selective attention and mental flexibility as compared with placebo in patients with schizophrenia.

Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia: a randomized clinical trial - the SMART trial protocol

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Baandrup, Lone; Fagerlund, Birgitte; Jennum, Poul

2011-01-01

Treatment of schizophrenia frequently includes prolonged benzodiazepine administration despite a lack of evidence of its use. It is often difficult to discontinue benzodiazepines because of the development of dependence. We aim to assess if melatonin can facilitate the withdrawal of prolonged...... benzodiazepine administration in patients with schizophrenia. Furthermore, we aim to investigate the association of benzodiazepine dose reduction with the following clinically important variables: sleep, psychophysiology, cognition, social function, and quality of life....

An algorithm-based approach to first-episode schizophrenia: response rates over 3 prospective antipsychotic trials with a retrospective data analysis.

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Agid, Ofer; Arenovich, Tamara; Sajeev, Gautam; Zipursky, Robert B; Kapur, Shitij; Foussias, George; Remington, Gary

2011-11-01

Early, effective treatment in first-episode schizophrenia is advocated, although evidence based on a systematic approach over multiple antipsychotic trials is lacking. Employing a naturalistic design, we examined response rates over 3 circumscribed antipsychotic trials. Between June 2003 and December 2008, 244 individuals with first-episode schizophrenia or schizoaffective disorder according to DSM-IV criteria were treated at the Centre for Addiction and Mental Health, Toronto, Ontario, Canada, following an algorithm that moved them through 2 antipsychotic trials, followed by a trial with clozapine. For the first 2 trials, treatment consisted of risperidone followed by olanzapine, or vice versa; each trial consisted of 3 stages (low-, full-, or high-dose) lasting up to 4 weeks at each level and adjusted according to response/tolerability. Clinical response was defined as a Clinical Global Impressions-Improvement score of 2 (much improved) or 1 (very much improved) and/or a Brief Psychiatric Rating Scale Thought Disorder subscale score ≤ 6. Data were analyzed retrospectively, and publication of anonymized clinical data was approved by the Research Ethics Board of the Centre for Addiction and Mental Health in May 2003. In trial 1, 74.5% of individuals responded, with rates significantly higher for olanzapine (82.1%, 115/140) versus risperidone (66.3%, 69/104; P = .005). With trial 2, response rate dropped dramatically to 16.6% but again was significantly higher for olanzapine (25.7%, 9/35) compared to risperidone (4.0%, 1/25; P = .04). Response rate climbed above 70% once more, specifically 75.0% (21/28), in those individuals who agreed to a third trial with clozapine. Results confirm a high response rate (75%) to initial antipsychotic treatment in first-episode schizophrenia. A considerably lower response rate (algorithm. © Copyright 2011 Physicians Postgraduate Press, Inc.

Efficacy of antipsychotic drugs against hostility in the European First-Episode Schizophrenia Trial (EUFEST)

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Volavka, Jan; Czobor, Pal; Derks, Eske M.; Bitter, Istvan; Libiger, Jan; Kahn, René S.; Fleischhacker, W. Wolfgang; Kahn, R. S.; Fleischhacker, W. W.; Boter, H.; Keet, I. P. M.; Brugman, C.; Davidson, M.; Dollfus, S.; Gaebel, W.; Galderisi, S.; Gheorghe, M.; Gonen, I.; Grobbee, D. E.; Hranov, L. G.; Hummer, M.; Libiger, J.; Králové, Hradec; Lindefors, N.; López-Ibor, J. J.; Nijssen, K.; Peuskens, J.; Prelipceanu, D.; Riecher-Rössler, A.; Rybakowski, J. K.; Sedvall, G.; von Wilmsdorff, M.

2011-01-01

To compare the effects of haloperidol, amisulpride, olanzapine, quetiapine, and ziprasidone on hostility in first-episode schizophrenia, schizoaffective disorder, or schizophreniform disorder. We used the data acquired in the European First-Episode Schizophrenia Trial, an open, randomized trial

Genome-wide association study of clinical dimensions of schizophrenia

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Fanous, Ayman H; Zhou, Baiyu; Aggen, Steven H

2012-01-01

Multiple sources of evidence suggest that genetic factors influence variation in clinical features of schizophrenia. The authors present the first genome-wide association study (GWAS) of dimensional symptom scores among individuals with schizophrenia.......Multiple sources of evidence suggest that genetic factors influence variation in clinical features of schizophrenia. The authors present the first genome-wide association study (GWAS) of dimensional symptom scores among individuals with schizophrenia....

Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial

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Dabholkar Hamid

2011-01-01

Full Text Available Abstract Background There is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR, involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC intervention, combined with usual Facility Based Care (FBC, is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India. Methods/Design This trial is a multi-site, parallel group randomised controlled trial design in India. The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2:1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines. Discussion If the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries. Trial registration The trial is registered with the International Society

Differential sensory fMRI signatures in autism and schizophrenia: Analysis of amplitude and trial-to-trial variability.

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Haigh, Sarah M; Gupta, Akshat; Barb, Scott M; Glass, Summer A F; Minshew, Nancy J; Dinstein, Ilan; Heeger, David J; Eack, Shaun M; Behrmann, Marlene

2016-08-01

Autism and schizophrenia share multiple phenotypic and genotypic markers, and there is ongoing debate regarding the relationship of these two disorders. To examine whether cortical dynamics are similar across these disorders, we directly compared fMRI responses to visual, somatosensory and auditory stimuli in adults with autism (N=15), with schizophrenia (N=15), and matched controls (N=15). All participants completed a one-back letter detection task presented at fixation (to control attention) while task-irrelevant sensory stimulation was delivered to the different modalities. We focused specifically on the response amplitudes and the variability in sensory fMRI responses of the two groups, given the evidence of greater trial-to-trial variability in adults with autism. Both autism and schizophrenia individuals showed weaker signal-to-noise ratios (SNR) in sensory-evoked responses compared to controls (d>0.42), but for different reasons. For the autism group, the fMRI response amplitudes were indistinguishable from controls but were more variable trial-to-trial (d=0.47). For the schizophrenia group, response amplitudes were smaller compared to autism (d=0.44) and control groups (d=0.74), but were not significantly more variable (dautism and is not a defining characteristic of schizophrenia, and (2) that blunted response amplitudes may be characteristic of schizophrenia. The relationship between the amplitude and the variability of cortical activity might serve as a specific signature differentiating these neurodevelopmental disorders. Identifying the neural basis of these responses and their relationship to the underlying genetic bases may substantially enlighten the understanding of both disorders. Copyright © 2016 Elsevier B.V. All rights reserved.

Patient compliance with drug therapy in schizophrenia. Economic and clinical issues.

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Lindström, E; Bingefors, K

2000-08-01

The effectiveness of drug treatment in clinical practice is considerably lower than the efficacy shown in controlled studies. The lower effectiveness in practice presumably leads to lower cost effectiveness of drug treatment in real-life situations compared with that demonstrated by studies based on results from controlled trials. Improved cost effectiveness in routine clinical practice would be a significant advantage in the treatment of schizophrenia, one of the most costly diseases in society. The aetiology of schizophrenia is unknown, and there is no cure. The main aims of therapy with antipsychotic medication include the effective relief of symptoms without the introduction of adverse effects or serious adverse events, improved quality of life, cost effectiveness and a positive long term outcome. The older classical antipsychotic drugs do not always meet these requirements because of their well-known limitations, such as a lack of response in a subgroup of individuals with schizophrenia and intolerable adverse effects. There has long been a need for new antipsychotics that can ameliorate more symptoms and have no or few adverse effects. Some of the recently introduced antipsychotics have been shown to be more effective in certain clinical situations and to have a more favourable adverse effect profile than the classical antipsychotics. A major factor contributing to the lower effectiveness of drug treatment is noncompliance, which may be very high in schizophrenia. There are several factors influencing compliance, including drug type and formulation, patient, disease status, physician, health care system, community care and family. There have been very few studies of compliance improvement strategies in schizophrenia or, indeed, in medicine in general. Current methods are relatively complex and there are differing opinions on their effectiveness. There are several ways to increase compliance in schizophrenia--the evidence is strongest for psychoeducative

Add-on treatment of benzoate for schizophrenia: a randomized, double-blind, placebo-controlled trial of D-amino acid oxidase inhibitor.

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Lane, Hsien-Yuan; Lin, Ching-Hua; Green, Michael F; Hellemann, Gerhard; Huang, Chih-Chia; Chen, Po-Wei; Tun, Rene; Chang, Yue-Cung; Tsai, Guochuan E

2013-12-01

In addition to dopaminergic hyperactivity, hypofunction of the N-methyl-d-aspartate receptor (NMDAR) has an important role in the pathophysiology of schizophrenia. Enhancing NMDAR-mediated neurotransmission is considered a novel treatment approach. To date, several trials on adjuvant NMDA-enhancing agents have revealed beneficial, but limited, efficacy for positive and negative symptoms and cognition. Another method to enhance NMDA function is to raise the levels of d-amino acids by blocking their metabolism. Sodium benzoate is a d-amino acid oxidase inhibitor. To examine the clinical and cognitive efficacy and safety of add-on treatment of sodium benzoate for schizophrenia. A randomized, double-blind, placebo-controlled trial in 2 major medical centers in Taiwan composed of 52 patients with chronic schizophrenia who had been stabilized with antipsychotic medications for 3 months or longer. Six weeks of add-on treatment of 1 g/d of sodium benzoate or placebo. The primary outcome measure was the Positive and Negative Syndrome Scale (PANSS) total score. Clinical efficacy and adverse effects were assessed biweekly. Cognitive functions were measured before and after the add-on treatment. Benzoate produced a 21% improvement in PANSS total score and large effect sizes (range, 1.16-1.69) in the PANSS total and subscales, Scales for the Assessment of Negative Symptoms-20 items, Global Assessment of Function, Quality of Life Scale and Clinical Global Impression and improvement in the neurocognition subtests as recommended by the National Institute of Mental Health's Measurement and Treatment Research to Improve Cognition in Schizophrenia initiative, including the domains of processing speed and visual learning. Benzoate was well tolerated without significant adverse effects. Benzoate adjunctive therapy significantly improved a variety of symptom domains and neurocognition in patients with chronic schizophrenia. The preliminary results show promise for d-amino acid oxidase

Vitamin D Supplementation in Chronic Schizophrenia Patients Treated with Clozapine: A Randomized, Double-Blind, Placebo-controlled Clinical Trial.

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Krivoy, Amir; Onn, Roy; Vilner, Yael; Hochman, Eldar; Weizman, Shira; Paz, Amir; Hess, Shmuel; Sagy, Roi; Kimhi-Nesher, Shiri; Kalter, Ehud; Friedman, Tal; Friedman, Zvi; Bormant, Gil; Trommer, Sharon; Valevski, Avi; Weizman, Abraham

2017-12-01

While accumulating evidence suggests that vitamin D deficiency may be involved in the risk to develop schizophrenia and its outcome, there are no studies on vitamin D supplementation in this context. We sought to assess the effect of vitamin D supplementation on psychiatric, cognitive and metabolic parameters in chronic clozapine-treated schizophrenia patients. This eight-week, randomized, double-blind, placebo-controlled clinical trial, recruited schizophrenia patients who had been maintained on clozapine treatment for at least 18weeks and had low levels of vitamin D (70 (to ascertain the presence of residual symptoms). Patients were randomly allocated to either weekly oral drops of vitamin D (14,000IU) or placebo and subsequently assessed at two-week intervals for psychosis severity, mood, cognition and metabolic profile. Twenty four patients were randomly assigned to vitamin D (aged 39.4±9.6years, 75% males) and the other 23 patients to the placebo arm (aged 42.5±11.2years, 60.9% males). After eight weeks, the vitamin D group exhibited a significant increase in vitamin D levels (31.4 vs -0.4nmol/l, pvitamin D on psychotic, depressive or metabolic parameters. However, in the vitamin D group, there was a trend towards improved cognition (effect size=0.17, significance lost following Bonferroni correction). Vitamin D supplementation was associated with a trend towards improved cognition, but did not affect psychosis, mood or metabolic status. It is possible that the robust decrease in the PANSS scores in both groups may have obscured an effect of vitamin D supplementation. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Omega-3 fatty acids in schizophrenia Part II: Clinical applications

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Róg Joanna

2016-12-01

Full Text Available Ω-3 unsaturated fatty acids are compounds belonging to the group of essential fatty acids (EFAs. The history of the discovery of EFAs dates back to the 1930s of the twentieth century, however, growing interest in ω-3 EFAs in the context of mental health has been observed since the year 2000. In view of their multidirectional action, these compounds are a promising form of adjunctive therapy of many illnesses, including psychiatric disorders. The present article aims to review the literature on the clinical applicability of ω-3 EFAs in treating schizophrenia. We present the results of preclinical studies in this area and the mechanisms of ω-3 EFAs action discussed by the authors. The randomized controlled trials (RCTs evaluating the possibility of using ω-3 EFAs in schizophrenia are characterized in detail. The results of the tests are not clear, which may result from the methodological diversity of interventions made. Ω-3 EFAs seem to be a promising form of adjunctive therapy of schizophrenia. Further research is needed, which will allow for defining groups of patients in which intervention will bring the expected results.

Clinical determinants of life satisfaction in chronic schizophrenia: data from the CATIE study.

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Fervaha, Gagan; Agid, Ofer; Takeuchi, Hiroyoshi; Foussias, George; Remington, Gary

2013-12-01

Quality of life is seen as an important outcome variable for patients with schizophrenia. However, the precise definition of this construct varies and has often been used to define health-related domains. The present study sought to focus on global life satisfaction as a key subjective domain and determine its relationship with clinical variables. The study sample included 1437 patients with chronic schizophrenia who participated in the Clinical Antipsychotic Trial of Intervention Effectiveness (CATIE) study. Patients were evaluated with a comprehensive battery of assessments capturing symptoms, cognition and medication side effects, among other variables. Life satisfaction was evaluated with a global self-report item. Greater depressive symptoms were the most robust indicator of worse life satisfaction. Lower life satisfaction was also associated with poorer psychosocial functioning, greater symptoms of anxiety, apathy and more negative attitudes toward medication. Taken together, these variables explained 20% of the variance in life satisfaction scores. Positive symptoms and other medication side effects also negatively influenced life satisfaction scores. These results affirm that clinical variables have an adverse effect on the overall subjective well-being of patients with schizophrenia. The relatively small amount of variance explained, though, argues for a better understanding of those other variables that contribute to life satisfaction. © 2013 Elsevier B.V. All rights reserved.

Problem solving skills for schizophrenia.

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Xia, J; Li, Chunbo

2007-04-18

The severe and long-lasting symptoms of schizophrenia are often the cause of severe disability. Environmental stress such as life events and the practical problems people face in their daily can worsen the symptoms of schizophrenia. Deficits in problem solving skills in people with schizophrenia affect their independent and interpersonal functioning and impair their quality of life. As a result, therapies such as problem solving therapy have been developed to improve problem solving skills for people with schizophrenia. To review the effectiveness of problem solving therapy compared with other comparable therapies or routine care for those with schizophrenia. We searched the Cochrane Schizophrenia Group's Register (September 2006), which is based on regular searches of BIOSIS, CENTRAL, CINAHL, EMBASE, MEDLINE and PsycINFO. We inspected references of all identified studies for further trials. We included all clinical randomised trials comparing problem solving therapy with other comparable therapies or routine care. We extracted data independently. For homogenous dichotomous data we calculated random effects, relative risk (RR), 95% confidence intervals (CI) and, where appropriate, numbers needed to treat (NNT) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD) using a random effects statistical model. We included only three small trials (n=52) that evaluated problem solving versus routine care, coping skills training or non-specific interaction. Inadequate reporting of data rendered many outcomes unusable. We were unable to undertake meta-analysis. Overall results were limited and inconclusive with no significant differences between treatment groups for hospital admission, mental state, behaviour, social skills or leaving the study early. No data were presented for global state, quality of life or satisfaction. We found insufficient evidence to confirm or refute the benefits of problem solving therapy as an additional

A Multisite, Randomized Controlled Clinical Trial of Computerized Cognitive Remediation Therapy for Schizophrenia.

Science.gov (United States)

Gomar, Jesús J; Valls, Elia; Radua, Joaquim; Mareca, Celia; Tristany, Josep; del Olmo, Francisco; Rebolleda-Gil, Carlos; Jañez-Álvarez, María; de Álvaro, Francisco J; Ovejero, María R; Llorente, Ana; Teixidó, Cristina; Donaire, Ana M; García-Laredo, Eduardo; Lazcanoiturburu, Andrea; Granell, Luis; Mozo, Cristina de Pablo; Pérez-Hernández, Mónica; Moreno-Alcázar, Ana; Pomarol-Clotet, Edith; McKenna, Peter J

2015-11-01

The effectiveness of cognitive remediation therapy (CRT) for the neuropsychological deficits seen in schizophrenia is supported by meta-analysis. However, a recent methodologically rigorous trial had negative findings. In this study, 130 chronic schizophrenic patients were randomly assigned to computerized CRT, an active computerized control condition (CC) or treatment as usual (TAU). Primary outcome measures were 2 ecologically valid batteries of executive function and memory, rated under blind conditions; other executive and memory tests and a measure of overall cognitive function were also employed. Carer ratings of executive and memory failures in daily life were obtained before and after treatment. Computerized CRT was found to produce improvement on the training tasks, but this did not transfer to gains on the primary outcome measures and most other neuropsychological tests in comparison to either CC or TAU conditions. Nor did the intervention result in benefits on carer ratings of daily life cognitive failures. According to this study, computerized CRT is not effective in schizophrenia. The use of both active and passive CCs suggests that nature of the control group is not an important factor influencing results. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

Telomerase level increase is related to n-3 polyunsaturated fatty acid efficacy in first episode schizophrenia: Secondary outcome analysis of the OFFER randomized clinical trial.

Science.gov (United States)

Pawełczyk, Tomasz; Grancow-Grabka, Marta; Trafalska, Elżbieta; Szemraj, Janusz; Żurner, Natalia; Pawełczyk, Agnieszka

2018-04-20

Schizophrenia is associated with shortening of the lifespan mainly due to cardiovascular events, cancer and chronic obstructive pulmonary disease. Both telomere attrition and decrease of telomerase levels were observed in schizophrenia. Polyunsaturated fatty acids (PUFA) influence multiple biochemical mechanisms which are postulated to accelerate telomere shortening and limit the longevity of patients with schizophrenia. Intervention studies based on add-on therapy with n-3 polyunsaturated fatty acids (n-3 PUFA) in patients with schizophrenia did not assess the changes in telomerase levels. A randomized placebo-controlled trial named OFFER was designed to compare the efficacy of a 26-week intervention composed of either 2.2g/day of n-3 PUFA or olive oil placebo with regard to symptom severity in first-episode schizophrenia patients. The secondary outcome measure of the study was to describe the association between the clinical effect of n-3 PUFA and changes in telomerase levels. Seventy-one patients aged 16-35 were enrolled in the study and randomly assigned to the study arms. The Positive and Negative Syndrome Scale (PANSS) was used to assess the change in symptom severity. Telomerase levels of peripheral blood mononuclear cells (PBMC) were assessed at three points: at baseline and at weeks 8 and 26 of the intervention. A significantly greater increase in PBMC telomerase levels in the intervention group compared to placebo was observed (p<0.001). Changes in telomerase levels significantly and inversely correlated with improvement in depressive symptoms and severity of the illness. The efficacy of a six-month intervention with n-3 PUFA observed in first-episode schizophrenia may be related to an increase in telomerase levels. Copyright © 2017 Elsevier Inc. All rights reserved.

Associations between purine metabolites and clinical symptoms in schizophrenia.

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Jeffrey K Yao

Full Text Available The antioxidant defense system, which is known to be dysregulated in schizophrenia, is closely linked to the dynamics of purine pathway. Thus, alterations in the homeostatic balance in the purine pathway may be involved in the pathophysiology of schizophrenia.Breakdown products in purine pathway were measured using high-pressure liquid chromatography coupled with a coulometric multi-electrode array system for 25 first-episode neuroleptic-naïve patients with schizophrenia at baseline and at 4-weeks following initiation of treatment with antipsychotic medication. Associations between these metabolites and clinical and neurological symptoms were examined at both time points. The ratio of uric acid and guanine measured at baseline predicted clinical improvement following four weeks of treatment with antipsychotic medication. Baseline levels of purine metabolites also predicted clinical and neurological symtpoms recorded at baseline; level of guanosine was associated with degree of clinical thought disturbance, and the ratio of xanthosine to guanosine at baseline predicted degree of impairment in the repetition and sequencing of actions.Findings suggest an association between optimal levels of purine byproducts and dynamics in clinical symptoms and adjustment, as well as in the integrity of sensory and motor processing. Taken together, alterations in purine catabolism may have clinical relevance in schizophrenia pathology.

Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 2—External Validity and Correlates.

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Horan, William P; Reddy, L Felice; Barch, Deanna M; Buchanan, Robert W; Dunayevich, Eduardo; Gold, James M; Marder, Steven R; Wynn, Jonathan K; Young, Jared W; Green, Michael F

2015-09-01

Effort-based decision making has strong conceptual links to the motivational disturbances that define a key subdomain of negative symptoms. However, the extent to which effort-based decision-making performance relates to negative symptoms, and other clinical and functionally important variables has yet to be systematically investigated. In 94 clinically stable outpatients with schizophrenia, we examined the external validity of 5 effort-based paradigms, including the Effort Expenditure for Rewards, Balloon Effort, Grip Strength Effort, Deck Choice Effort, and Perceptual Effort tasks. These tasks covered 3 types of effort: physical, cognitive, and perceptual. Correlations between effort related performance and 6 classes of variables were examined, including: (1) negative symptoms, (2) clinically rated motivation and community role functioning, (3) self-reported motivational traits, (4) neurocognition, (5) other psychiatric symptoms and clinical/demographic characteristics, and (6) subjective valuation of monetary rewards. Effort paradigms showed small to medium relationships to clinical ratings of negative symptoms, motivation, and functioning, with the pattern more consistent for some measures than others. They also showed small to medium relations with neurocognitive functioning, but were generally unrelated to other psychiatric symptoms, self-reported traits, antipsychotic medications, side effects, and subjective valuation of money. There were relatively strong interrelationships among the effort measures. In conjunction with findings from a companion psychometric article, all the paradigms warrant further consideration and development, and 2 show the strongest potential for clinical trial use at this juncture. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Glutamate in schizophrenia: clinical and research implications.

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Goff, D C; Wine, L

1997-10-30

The excitatory amino acids, glutamate and aspartate, are of interest to schizophrenia research because of their roles in neurodevelopment, neurotoxicity and neurotransmission. Recent evidence suggests that densities of glutamatergic receptors and the ratios of subunits composing these receptors may be altered in schizophrenia, although it is unclear whether these changes are primary or compensatory. Agents acting at the phencyclidine binding site of the NMDA receptor produce symptoms of schizophrenia in normal subjects, and precipitate relapse in patients with schizophrenia. The improvement of negative symptoms with agents acting at the glycine modulatory site of the NMDA receptor, as well as preliminary evidence that clozapine may differ from conventional neuroleptic agents in its effects on glutamatergic systems, suggest that clinical implications may follow from this model. While geriatric patients may be at increased risk for glutamate-mediated neurotoxicity, very little is known about the specific relevance of this model to geriatric patients with schizophrenia.

A review of schizophrenia research in malaysia.

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Chee, K Y; Salina, A A

2014-08-01

Research in schizophrenia has advanced tremendously. One hundred and seventy five articles related to Schizophrenia were found from a search through a database dedicated to indexing all original data relevant to medicine published in Malaysia between the years 2000-2013. This project aims to examine published research articles, in local and international journals in order to provide a glimpse of the research interest in Malaysia with regards to schizophrenia. Single case study, case series report, reviews and registry reports were not included in this review. Medication trial, unless it concerned a wider scope of psychopharmacology was also excluded from this review. A total of 105 articles were included in this review. Despite numerous genetics studies conducted and published, a definitive conclusion on the aetiology or mechanism underlying schizophrenia remains elusive. The National Mental Health - Schizophrenia Registry (NMHR) proved to be an important platform for many studies and publications. Studies stemmed from NMHR have provided significant insight into the baseline characteristic of patients with schizophrenia, pathway to care, and outcomes of the illness. International and regional collaborations have also encouraged important work involving stigma and discrimination in schizophrenia. Ministry of Health's hospitals (MOH) are the main research sites in the country with regards to schizophrenia research. Numbers of schizophrenia research are still low in relation to the number of universities and hospitals in the country. Some of the weaknesses include duplication of studies, over-emphasising clinical trials and ignoring basic clinical research, and the lack of publications in international and regional journals.

Effects on cognitive and clinical insight with the use of Guided Self-Determination in outpatients with schizophrenia

DEFF Research Database (Denmark)

Jørgensen, Rikke; Licht, R W; Lysaker, P H

2015-01-01

with schizophrenia. The design was an open randomized trial. The primary hypothesis was cognitive insight would improve in those patients who received GSD-SZ+TAU as assessed by the BCIS. We additionally explored whether the intervention led to changes in clinical insight, self-perceived recovery, self-esteem, social...... their illness management, Guided Self-Determination (GSD), has been adapted for use in patients with schizophrenia (GSD-SZ). The purpose of this study was to investigate the effect on insight of GSD-SZ as a supplement to treatment as usual (TAU) as compared to TAU alone in outpatients diagnosed...

Effect of Liraglutide Treatment on Prediabetes and Overweight or Obesity in Clozapine- or Olanzapine-Treated Patients With Schizophrenia Spectrum Disorder: A Randomized Clinical Trial.

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Larsen, Julie R; Vedtofte, Louise; Jakobsen, Mathilde S L; Jespersen, Hans R; Jakobsen, Michelle I; Svensson, Camilla K; Koyuncu, Kamuran; Schjerning, Ole; Oturai, Peter S; Kjaer, Andreas; Nielsen, Jimmi; Holst, Jens J; Ekstrøm, Claus T; Correll, Christoph U; Vilsbøll, Tina; Fink-Jensen, Anders

2017-07-01

Compared with the general population, patients with schizophrenia have a 2- to 3-fold higher mortality rate primarily caused by cardiovascular disease. Previous interventions designed to counteract antipsychotic-induced weight gain and cardiometabolic disturbances reported limited effects. To determine the effects of the glucagon-like peptide-1 receptor agonist liraglutide added to clozapine or olanzapine treatment of schizophrenia spectrum disorders. This randomized clinical double-blind trial enrolled participants at 2 clinical sites in Denmark. Of 214 eligible participants with a schizophrenia spectrum disorder, 103 were randomized to liraglutide or placebo. Participants received stable treatment with clozapine or olanzapine, were overweight or obese, and had prediabetes. Data were collected from May 1, 2013, through February 25, 2016. Treatment for 16 weeks with once-daily subcutaneous injection of liraglutide or placebo. Trial drug therapy was titrated during the first 2 weeks of the study. The primary end point was change in glucose tolerance estimated by a 75-g oral glucose tolerance test result. Secondary end points included change in body weight and cardiometabolic parameters. Of the 103 patients undergoing randomization (60 men [58.3%] and 43 women [41.7%]), 97 were included in the efficacy analysis, with a mean (SD) age of 42.5 (10.5) years and mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) of 33.8 (5.9). The liraglutide and placebo groups had comparable characteristics (mean [SD] age, 42.1 [10.7] vs 43.0 [10.5] years; 30 men in each group; mean [SD] body mass index, 33.7 [5.1] vs 33.9 [6.6]). A total of 96 randomized participants (93.2%) completed the trial. Glucose tolerance improved in the liraglutide group compared with the placebo group (P < .001). Altogether, 30 liraglutide-treated participants (63.8%) developed normal glucose tolerance compared with 8 placebo-treated participants (16.0%) (P�

Group art therapy as an adjunctive treatment for people with schizophrenia: a randomised controlled trial (MATISSE).

OpenAIRE

Crawford, MJ; Killaspy, H; Barnes, TR; Barrett, B; Byford, S; Clayton, K; Dinsmore, J; Floyd, S; Hoadley, A; Johnson, T; Kalaitzaki, E; King, M; Leurent, B; Maratos, A; O'Neill, FA

2012-01-01

OBJECTIVE To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia. DESIGN A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre. SETTING Study partic...

Clinical implication of smoking among patients with schizophrenia at ...

African Journals Online (AJOL)

Objective: The aim of this study was to determine if cigarette smoking in schizophrenia is associated with increased disability ... Cite as: Aguocha C, Uwakwe R, Olose E, Amadi K, Onyeama G, Duru C. Clinical ..... addiction and schizophrenia.

Relationships between brain-derived neurotrophic factor, clinical symptoms and decision-making in chronic schizophrenia: data from the Iowa Gambling Task

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Hikaru eHori

2014-12-01

Full Text Available The levels of brain-derived neurotrophic factor (BDNF are significantly decreased in patients with schizophrenia and correlate with impairments in cognitive function. However, no study has investigated the relationship between the serum BDNF levels and decision-making. We compared patients with schizophrenia to healthy controls with respect to their decision-making ability and serum BDNF levels. Eighty-six chronic schizophrenia patients and 51 healthy controls participated in this study. We controlled for gender, age, and estimated intelligence quotient (IQ, and we investigated the differences in decision-making performance on the Iowa Gambling Task (IGT between the schizophrenia patient and control groups. We also compared the IGT scores, the serum BDNF levels, and the clinical symptoms between the groups. The IGT scores of the schizophrenia patients were lower than those of the controls. A negative correlation was detected between the mean net scores on the trials in the final two blocks and the serum BDNF levels（p<0.05）. Multiple regression analysis revealed that depressive symptoms and the serum BDNF levels were significantly associated with the mean net scores on the trials in the final two blocks. Based on these results, impaired sensitivity to both reward and punishment is associated with depressive symptoms and reduced serum BDNF levels in chronic schizophrenia patients and may be related to their poor performance on the IGT.

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.

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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

Effect of transcranial direct current stimulation (tDCS over the prefrontal cortex combined with cognitive training for treating schizophrenia: a sham-controlled randomized clinical trial

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Pedro Shiozawa

Full Text Available Abstract Introduction: We report a transcranial direct current stimulation (tDCS protocol over the dorsolateral prefrontal cortex (DLPFC combined with cognitive training in schizophrenia. Method: We assessed psychotic symptoms in nine patients using the Positive and Negative Syndrome Scale (PANSS. All evaluations were scored at baseline, at the end of the intervention protocol, and during a 4-week follow-up. The tDCS protocol consisted of 10 consecutive sessions over 5-day periods. We placed the cathode over the right and the anode over the left DLPFC. For sham stimulation, we turned the device off after 60 seconds. Cognitive training consisted of the administration of N-back and sequence learning tasks. Results: We performed an analysis of covariance (ANCOVA to adjust for the dependent variable PANSS, considering the interaction with baseline severity scores (p = 0.619. Mixed analysis of variance (ANOVA showed no statistical significance between the groups regarding final PANSS scores. Conclusion: The results failed to demonstrate that the concomitant use of tDCS and cognitive training is effective to improve clinical outcomes in patients with schizophrenia. The present findings should be analyzed with care, considering the small sample size. Larger controlled trials on electric/cognitive stimulation should be produced in order to enhance therapeutic strategies in schizophrenia.

Cognitive Remediation in Middle-Aged or Older Inpatients with Chronic Schizophrenia: A Randomized Controlled Trial in Korea

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Kee-Hong Choi

2018-02-01

Full Text Available Background: Accumulating evidence indicates that cognitive remediation (CR is effective for improving various cognitive deficits in adult patients with schizophrenia. Although reports of brain plasticity in older adults and the service needs for chronic patients with schizophrenia are increasing, very few randomized controlled trials of CR have been conducted in middle-aged or older inpatients with chronic schizophrenia. We investigated the efficacy of individualized CR on the cognitive impairments of middle-aged or older inpatients with chronic schizophrenia within the context of comprehensive psychiatric rehabilitation (PR by comparing the results obtained with PR only and treatment as usual (TAU.Method: Fifty-seven middle-aged and older individuals with chronic schizophrenia and mild to moderate cognitive deficits were enrolled. Thirty-eight who were undergoing PR were randomly assigned to CR + PR (N = 19 or PR-only (N = 19 groups. Nineteen participants who were undergoing TAU without CR or PR were evaluated pre- and post-treatment.Results: CR was easily provided and well received (drop-out rates = 5.3% by middle-aged or older psychiatric inpatients. Compared to the PR-Only or TAU patients, patients in the CR + PR group showed greater improvement in executive functioning. Compared to TAU patients, CR + PR and PR-only patients showed greater improvement in logical memory. More patients in the CR + PR group improved clinically significantly in executive functioning and logical memory, compared with the PR-only and TAU patients.Conclusions: These results suggested that CR improved some cognitive deficits in middle-aged or older inpatients with chronic schizophrenia and that it was effective as an adjunctive treatment to the usual PR services provided in inpatient settings.Clinical Registration: KCT0002609

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

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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

Role of 108 schizophrenia-associated loci in modulating psychopathological dimensions in schizophrenia and bipolar disorder.

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Fabbri, Chiara; Serretti, Alessandro

2017-10-01

The Schizophrenia Working Group of the Psychiatric Genomics Consortium (PGC) identified 108 loci associated with schizophrenia, but their role in modulating specific psychopathological dimensions of the disease is unknown. This study investigated which symptom dimensions may be affected by these loci in schizophrenia, and bipolar disorder. Positive, negative and depressive symptoms, suicidal ideation, cognition, violent behaviors, quality of life, and early onset were investigated in schizophrenia and bipolar disorder using the clinical antipsychotic trials of intervention effectiveness (CATIE) and systematic treatment enhancement program for bipolar disorder (STEP-BD) studies. Individual loci were investigated, then genes within 50 Kbp from polymorphisms with p schizophrenia-associated variant (rs75059851) may modulate negative symptoms. Multi-locus models may provide interesting insights about the biological mechanisms that mediate psychopathological dimensions. © 2017 Wiley Periodicals, Inc.

Design and validation of standardized clinical and functional remission criteria in schizophrenia

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Mosolov, Sergey N; Potapov, Andrey V; Ushakov, Uriy V; Shafarenko, Aleksey A; Kostyukova, Anastasiya B

2014-01-01

Background International Remission Criteria (IRC) for schizophrenia were developed recently by a group of internationally known experts. The IRC detect only 10%–30% of cases and do not cover the diversity of forms and social functioning. Our aim was to design a more applicable tool and validate its use – the Standardized Clinical and Functional Remission Criteria (SCFRC). Methods We used a 6-month follow-up study of 203 outpatients from two Moscow centers and another further sample of stable patients from a 1-year controlled trial of atypical versus typical medication. Diagnosis was confirmed by International Classification of Diseases Version 10 (ICD10) criteria and the Mini-International Neuropsychiatric Interview (MINI). Patients were assessed by the Positive and Negative Syndrome Scale, including intensity threshold, and further classified using the Russian domestic remission criteria and the level of social and personal functioning, according to the Personal and Social Performance Scale (PSP). The SCFRC were formulated and were validated by a data reanalysis on the first population sample and on a second independent sample (104 patients) and in an open-label prospective randomized 12-month comparative study of risperidone long-acting injectable (RLAI) versus olanzapine. Results Only 64 of the 203 outpatients (31.5%) initially met the IRC, and 53 patients (26.1%) met the IRC after 6 months, without a change in treatment. Patients who were in remission had episodic and progressive deficit (39.6%), or remittent (15%) paranoid schizophrenia, or schizoaffective disorder (17%). In addition, 105 patients of 139 (51.7%), who did not meet symptomatic IRC, remained stable within the period. Reanalysis of data revealed that 65.5% of the patients met the SCFRC. In the controlled trial, 70% of patients in the RLAI group met the SCFRC and only 19% the IRC. In the routine treatment group, 55.9% met the SCFRC and only 5.7% the IRC. Results of the further independent

Joint modelling of longitudinal outcome and interval-censored competing risk dropout in a schizophrenia clinical trial

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Gueorguieva, Ralitza; Rosenheck, Robert; Lin, Haiqun

2011-01-01

Summary The ‘Clinical antipsychotic trials in intervention effectiveness’ study, was designed to evaluate whether there were significant differences between several antipsychotic medications in effectiveness, tolerability, cost and quality of life of subjects with schizophrenia. Overall, 74 % of patients discontinued the study medication for various reasons before the end of 18 months in phase I of the study. When such a large percentage of study participants fail to complete the study schedule, it is not clear whether the apparent profile in effectiveness reflects genuine changes over time or is influenced by selection bias, with participants with worse (or better) outcome values being more likely to drop out or to discontinue. To assess the effect of dropouts for different reasons on inferences, we construct a joint model for the longitudinal outcome and cause-specific dropouts that allows for interval-censored dropout times. Incorporating the information regarding the cause of dropout improves inferences and provides better understanding of the association between cause-specific dropout and the outcome process. We use simulations to demonstrate the advantages of the joint modelling approach in terms of bias and efficiency. PMID:22468033

Tolerability and efficacy of paliperidone ER compared to olanzapine in the treatment of schizophrenia: A randomized, double-blind, multicentric trial

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Sandip Shah

2011-01-01

Full Text Available Background: Paliperidone is an active metabolite of risperidone and actss through a combination of central dopamine Type 2 (D2 and serotonin Type 2 (5HT2A receptor antagonism. Aim: The present randomized, double-blind, multicentric trial was designed to determine the safety and efficacy of paliperidone extended release (ER compared to olanzapine in the treatment of acute schizophrenia. Materials and Methods: A total of 214 patients with diagnosis of schizophrenia were randomized to paliperidone ER (n=109 and olanzapine (n=106 treatment groups. Totally 206 patients were evaluated for efficacy parameters using Positive and negative syndrome scale (PANSS score and Clinical Global Impression-severity of illness (CGI-S and Clinical Global Impression-improvement of illness (CGI-I scales. Safety was assessed by treatment-emergent adverse events and movement disorders. Results: All patients showed significant reduction in PANSS scores at the end of treatment. However, the results were comparable and there was no significant difference at the end of the trial between paliperidone ER group and olanzapine group. Both the treatment groups showed decrease in the severity of illness and improvement in symptomatology. The most common adverse events reported in paliperidone ER versus olanzapine group were Extra Pyramidal Syndrome (EPS (13.7% vs. 15.6%, headache (12.7% vs. 8.9%, increased appetite (8.8% vs. 10.0% and drowsiness (4.9% vs. 303%. There was no clinically relevant difference in change from baseline to the end of the trial in abnormal involuntary movement scale (AIMS and barnes akathisia rating scale (BARS total scores between both the groups. Conclusion: Paliperidone ER is effective in controlling schizophrenic symptoms as well as exhibits comparable tolerability profile. Thus, paliperidone ER has the potential to be a useful new treatment option for patients with schizophrenia.

Vitamin D in schizophrenia: a clinical review.

Science.gov (United States)

Chiang, Mathew; Natarajan, Radhika; Fan, Xiaoduo

2016-02-01

Vitamin D (vitD) is known for its essential role in calcium homeostasis and bone health. VitD is made endogenously in the skin from UVB radiation from sunlight. VitD is now considered as a potent neurosteroid hormone, critical to brain development and normal brain function, and is known for its anti-inflammatory property affecting various aspects of human health. VitD ligand-receptor, a receptor that mediates much of vitD's biological actions, has been found throughout the body including the central nervous system. VitD deficiency is common in patients with severe mental illness such as schizophrenia. Schizophrenia is a debilitating chronic mental illness characterised by positive symptoms, such as hallucinations and delusions, and negative symptoms including flat affect and lack of motivation. Several environmental risk factors for schizophrenia, such as season of birth, latitude and migration, have been linked to vitD deficiency. Recent studies have suggested a potential role of vitD in the development of schizophrenia. For example, neonatal vitD status is associated with the risk of developing schizophrenia in later life obesity, insulin resistance, diabetes, hyperlipidaemia and cardiovascular disease, which are commonly seen in patients with schizophrenia. It has been well established that vitD deficiency is related to these metabolic problems. The biological mechanism is most likely related to vitD's action on the regulation of inflammatory and immunological processes, consequently affecting the manifestation of clinical symptoms and treatment response of schizophrenia. Potential benefits of vitD supplementation to improve schizophrenia symptoms as well as physical health in patients with schizophrenia should be further explored in future studies. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A 20-week program of resistance or concurrent exercise improves symptoms of schizophrenia: results of a blind, randomized controlled trial

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Bruna Andrade e Silva

2015-01-01

Full Text Available Objective:To evaluate the effects of 20 weeks of resistance and concurrent training on psychotic and depressive symptoms, quality of life outcomes, and serum IGF-1, IGFBP-3, and brain-derived neurotrophic factor (BDNF concentrations in patients with schizophrenia.Methods:In this blind, randomized controlled clinical trial, 34 patients with schizophrenia were assigned to one of three groups: control (CTRL, n=13, resistance exercise (RESEX, n=12, or concurrent exercise (CONCEX, n=9. Symptoms, quality of life, strength, and other variables were assessed.Results:A significant time-by-group interaction was found for the RESEX and CONCEX groups on the Positive and Negative Syndrome Scale (PANSS total score for disease symptoms (p = 0.007, positive symptoms (p = 0.003, and on the arm extension one-repetition maximum (1RM test (p = 0.016. In addition, significant improvements on negative symptoms (p = 0.027, on the role-physical domain of the Short Form-36 Health Survey (p = 0.019, and on the chest press 1RM test (p = 0.040 were observed in the RESEX group. No changes were observed for the other variables investigated.Conclusions:In this sample of patients with schizophrenia, 20 weeks of resistance or concurrent exercise program improved disease symptoms, strength, and quality of life. ClinicalTrials.gov: NCT01674543.

Design and validation of standardized clinical and functional remission criteria in schizophrenia

Directory of Open Access Journals (Sweden)

Mosolov SN

2014-01-01

Full Text Available Sergey N Mosolov,1 Andrey V Potapov,1 Uriy V Ushakov,2 Aleksey A Shafarenko,1 Anastasiya B Kostyukova11Department of Mental Disorders Therapy, Moscow Research Institute of Psychiatry, Moscow, Russia; 2Moscow Psychiatric Outpatient Services #21, Moscow, RussiaBackground: International Remission Criteria (IRC for schizophrenia were developed recently by a group of internationally known experts. The IRC detect only 10%–30% of cases and do not cover the diversity of forms and social functioning. Our aim was to design a more applicable tool and validate its use – the Standardized Clinical and Functional Remission Criteria (SCFRC.Methods: We used a 6-month follow-up study of 203 outpatients from two Moscow centers and another further sample of stable patients from a 1-year controlled trial of atypical versus typical medication. Diagnosis was confirmed by International Classification of Diseases Version 10 (ICD10 criteria and the Mini-International Neuropsychiatric Interview (MINI. Patients were assessed by the Positive and Negative Syndrome Scale, including intensity threshold, and further classified using the Russian domestic remission criteria and the level of social and personal functioning, according to the Personal and Social Performance Scale (PSP. The SCFRC were formulated and were validated by a data reanalysis on the first population sample and on a second independent sample (104 patients and in an open-label prospective randomized 12-month comparative study of risperidone long-acting injectable (RLAI versus olanzapine.Results: Only 64 of the 203 outpatients (31.5% initially met the IRC, and 53 patients (26.1% met the IRC after 6 months, without a change in treatment. Patients who were in remission had episodic and progressive deficit (39.6%, or remittent (15% paranoid schizophrenia, or schizoaffective disorder (17%. In addition, 105 patients of 139 (51.7%, who did not meet symptomatic IRC, remained stable within the period. Reanalysis of

[Eppendorf Schizophrenia Inventory (ESI) vs. Frankfurt Complaint Questionnaire (FCQ). Direct comparison in a clinical trial].

Science.gov (United States)

Mass, R

2005-09-01

This study is the first to directly compare two clinical questionnaires which are both aimed at self-experienced cognitive dysfunctions of schizophrenia: Eppendorf Schizophrenia Inventory (ESI) and Frankfurt Complaint Questionnaire (FCQ). Evaluated were (a) diagnostic validity, (b) psychometric properties, (c) scale intercorrelations, and (d) factor analytic stability. Ad (a): schizophrenic subjects (n=36) show highly significant increases in the ESI scales and sum score when compared to other clinical groups (patients with depression, alcohol dependence, or obsessive-compulsive disorder, n>30, respectively); on the other hand, the FCQ yields no systematic group differences. Ad (b): mean of reliability coefficients (Cronbach alpha) of the ESI scales is r(tt)=0.86, mean of reliability coefficients of the FCQ scales is significantly lower. Ad (c): the mean intercorrelation between ESI and FCQ scales amounts to r(xy)=0.56 (minimum 0.29, maximum 0.73), corresponding to an average shared variance of about 31%. Ad (d): factor analysis yielded an ESI factor and a FBF factor; one-way ANOVA with the factor scores confirms the diagnostic validity of the ESI. ESI and FCQ measure essentially different aspects of schizophrenic psychopathology. Regarding reliability and diagnostic validity, the ESI is superior to the FCQ.

Moderating factors for the effectiveness of group art therapy for schizophrenia: secondary analysis of data from the MATISSE randomised controlled trial

OpenAIRE

Leurent, Baptiste; Killaspy, Helen; Osborn, David P.; Crawford, Mike J.; Hoadley, Angela; Waller, Diane; King, Michael

2014-01-01

PURPOSE Although some studies suggest that art therapy may be useful in the treatment of negative symptoms of schizophrenia, a recent large trial of group art therapy found no clinical advantage over standard care, but the study population was heterogeneous and uptake of the intervention was poor. This study aimed to investigate whether art therapy was more effective for specific subgroups of patients. METHODS Secondary analysis of data from a randomised controlled trial of group art therapy ...

Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia

Science.gov (United States)

2017-01-01

Background Accurately monitoring and collecting drug adherence data can allow for better understanding and interpretation of the outcomes of clinical trials. Most clinical trials use a combination of pill counts and self-reported data to measure drug adherence, despite the drawbacks of relying on these types of indirect measures. It is assumed that doses are taken, but the exact timing of these events is often incomplete and imprecise. Objective The objective of this pilot study was to evaluate the use of a novel artificial intelligence (AI) platform (AiCure) on mobile devices for measuring medication adherence, compared with modified directly observed therapy (mDOT) in a substudy of a Phase 2 trial of the α7 nicotinic receptor agonist (ABT-126) in subjects with schizophrenia. Methods AI platform generated adherence measures were compared with adherence inferred from drug concentration measurements. Results The mean cumulative pharmacokinetic adherence over 24 weeks was 89.7% (standard deviation [SD] 24.92) for subjects receiving ABT-126 who were monitored using the AI platform, compared with 71.9% (SD 39.81) for subjects receiving ABT-126 who were monitored by mDOT. The difference was 17.9% (95% CI -2 to 37.7; P=.08). Conclusions Using drug levels, this substudy demonstrates the potential of AI platforms to increase adherence, rapidly detect nonadherence, and predict future nonadherence. Subjects monitored using the AI platform demonstrated a percentage change in adherence of 25% over the mDOT group. Subjects were able to use the technology successfully for up to 6 months in an ambulatory setting with early termination rates that are comparable to subjects outside of the substudy. Trial Registration ClinicalTrials.gov NCT01655680 https://clinicaltrials.gov/ct2/show/NCT01655680?term=NCT01655680 PMID:28223265

Amotivation in schizophrenia: integrated assessment with behavioral, clinical, and imaging measures.

Science.gov (United States)

Wolf, Daniel H; Satterthwaite, Theodore D; Kantrowitz, Jacob J; Katchmar, Natalie; Vandekar, Lillie; Elliott, Mark A; Ruparel, Kosha

2014-11-01

Motivational deficits play a central role in disability caused by schizophrenia and constitute a major unmet therapeutic need. Negative symptoms have previously been linked to hypofunction in ventral striatum (VS), a core component of brain motivation circuitry. However, it remains unclear to what extent this relationship holds for specific negative symptoms such as amotivation, and this question has not been addressed with integrated behavioral, clinical, and imaging measures. Here, 41 individuals with schizophrenia and 37 controls performed a brief, computerized progressive ratio task (PRT) that quantifies effort exerted in pursuit of monetary reward. Clinical amotivation was assessed using the recently validated Clinical Assessment Interview for Negative Symptoms (CAINS). VS function was probed during functional magnetic resonance imaging using a monetary guessing paradigm. We found that individuals with schizophrenia had diminished motivation as measured by the PRT, which significantly and selectively related to clinical amotivation as measured by the CAINS. Critically, lower PRT motivation in schizophrenia was also dimensionally related to VS hypofunction. Our results demonstrate robust dimensional associations between behavioral amotivation, clinical amotivation, and VS hypofunction in schizophrenia. Integrating behavioral measures such as the PRT will facilitate translational efforts to identify biomarkers of amotivation and to assess response to novel therapeutic interventions. © The Author 2014. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Aripiprazole in schizophrenia and schizoaffective disorder: A review.

Science.gov (United States)

Stip, Emmanuel; Tourjman, Valérie

2010-01-01

During the past decade, there has been some progress in the pharmacotherapy of schizophrenia and schizoaffective disorder. Current evidence supports the use of various second-generation, or atypical, antipsychotic medications, although few of these agents have been associated with long-term efficacy and tolerability. Aripiprazole is an atypical antipsychotic that has been found to improve positive and negative symptoms of schizophrenia with a favorable adverse-effect profile. This article reviews the efficacy and tolerability of aripiprazole in the context of recommended management strategies for schizophrenia and schizoaffective disorder, and in comparison with first-generation and other second-generation antipsychotics. A search of MEDLINE (1999-May 2009) was conducted for reports of short- and long-term clinical studies of atypical antipsychotics (including aripiprazole) and meta-analyses of randomized controlled trials comparing first- and second-generation antipsychotics (including aripiprazole) in the treatment of schizophrenia or schizoaffective disorder. The search terms were schizophrenia; schizoaffective disorder; pharmacogenetics; adverse effects; tardive dyskinesia AND atypical antipsychotics; aripiprazole; aripiprazole, schizophrenia, AND double-blind studies; and atypical antipsychotics AND adverse effects. The reference lists of identified articles were reviewed for additional relevant publications. Only full study publications were included. Based on the clinical evidence, including data from short-term (4-8 weeks) and long-term (26-52 weeks) randomized, double-blind clinical trials, aripiprazole has been associated with improvements in positive, negative, cognitive, and affective symptoms of schizophrenia and schizoaffective disorder. It has been associated with long-term (up to 52 weeks) symptom control in schizophrenia, as well as with efficacy in treatment-resistant schizophrenia. Common adverse effects associated with aripiprazole were nausea

Clinical Trials

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Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

Disorganization at the stage of schizophrenia clinical outcome: Clinical-biological study.

Science.gov (United States)

Nestsiarovich, A; Obyedkov, V; Kandratsenka, H; Siniauskaya, M; Goloenko, I; Waszkiewicz, N

2017-05-01

According to the multidimensional model of schizophrenia, three basic psychopathological dimensions constitute its clinical structure: positive symptoms, negative symptoms and disorganization. The latter one is the newest and the least studied. Our aim was to discriminate disorganization in schizophrenia clinical picture and to identify its distinctive biological and socio-psychological particularities and associated genetic and environmental factors. We used SAPS/SANS psychometrical scales, scales for the assessment of patient's compliance, insight, social functioning, life quality. Neuropsychological tests included Wisconsin Card Sorting Test (WCST), Stroop Color-Word test. Neurophysiological examination included registration of P300 wave of the evoked cognitive auditory potentials. Environmental factors related to patient's education, family, surrounding and nicotine use, as well as subjectively significant traumatic events in childhood and adolescence were assessed. Using PCR we detected SNP of genes related to the systems of neurotransmission (COMT, SLC6A4 and DRD2), inflammatory response (IL6, TNF), cellular detoxification (GSTM1, GSTT1), DNA methylation (MTHFR, DNMT3b, DNMT1). Disorganization is associated with early schizophrenia onset and history of psychosis in family, low level of insight and compliance, high risk of committing delicts, distraction errors in WCST, lengthened P300 latency of evoked cognitive auditory potentials, low-functional alleles of genes MTHFR (rs1801133) and DNMT3b (rs2424913), high level of urbanicity and psychotraumatic events at early age. Severe disorganization at the stage of schizophrenia clinical outcome is associated with the set of specific biological and social-psychological characteristics that indicate its epigenetic nature and maladaptive social significance. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.

Science.gov (United States)

Asher, Laura; De Silva, Mary; Hanlon, Charlotte; Weiss, Helen A; Birhane, Rahel; Ejigu, Dawit A; Medhin, Girmay; Patel, Vikram; Fekadu, Abebaw

2016-06-24

Care for most people with schizophrenia is best delivered in the community and evidence-based guidelines recommend combining both medication and a psychosocial intervention, such as community-based rehabilitation. There is emerging evidence that community-based rehabilitation for schizophrenia is effective at reducing disability in middle-income country settings, yet there is no published evidence on the effectiveness in settings with fewer mental health resources. This paper describes the protocol of a study that aims to evaluate the effectiveness of community-based rehabilitation as an adjunct to health facility-based care in rural Ethiopia. This is a cluster randomised trial set in a rural district in Ethiopia, with sub-district as the unit of randomisation. Participants will be recruited from an existing cohort of people with schizophrenia receiving treatment in primary care. Fifty-four sub-districts will be randomly allocated in a 1:1 ratio to facility-based care plus community-based rehabilitation (intervention arm) or facility-based care alone (control arm). Facility-based care consists of treatment by a nurse or health officer in primary care (antipsychotic medication, basic psychoeducation and follow-up) with referral to a psychiatric nurse-led outpatient clinic or psychiatric hospital when required. Trained community-based rehabilitation workers will deliver a manualised community-based rehabilitation intervention, with regular individual and group supervision. We aim to recruit 182 people with schizophrenia and their caregivers. Potential participants will be screened for eligibility, including enduring or disabling illness. Participants will be recruited after providing informed consent or, for participants without decision-making capacity, after the primary caregiver gives permission on behalf of the participant. The primary outcome is disability measured with the 36-item WHO Disability Assessment Schedule (WHODAS) version 2.0 at 12 months. The sample

Schizophrenia-like symptoms in narcolepsy type 1: shared and distinctive clinical characteristics.

Science.gov (United States)

Plazzi, Giuseppe; Fabbri, Chiara; Pizza, Fabio; Serretti, Alessandro

2015-01-01

The occurrence of psychotic symptoms in narcolepsy type 1 (NT1) has been reported as responsible for delayed diagnosis due to the misdiagnosis of schizophrenia. This study aimed to identify shared and distinctive clinical characteristics between NT1 and schizophrenia, with the focus on psychotic symptoms. A total of 28 NT1 and 21 schizophrenia patients were included. Hallucination characteristics and PANSS (Positive and Negative Syndrome Scale), HRSD (Hamilton Rating Scale for Depression), DES (Dissociative Experiences Scale), and STAI (State-Trait Anxiety Inventory) scores were collected. Symptom overlap was investigated by χ(2), Fisher's or t tests and multiple logistic regression models. Hallucinations and illusions frequently occurred in both diseases. Unimodal hallucinations were more common in schizophrenia (p = 6.30e-07) and multimodal hallucinations in NT1, but no clear difference was identified in their sensory modality. Hypnagogic/hypnopompic hallucinations were typical of NT1 (p = 5.22e-07), and 25% of NT1 patients exhibited some degree of insight deficit. Hypnagogic/hypnopompic hallucinations, unimodal hallucinations and PANSS score were the most distinctive clinical characteristics. Clinical overlap was found in the dissociative and anxiety domains, while higher depressive scores were observed in schizophrenia. The overlap between NT1 and schizophrenia should be further investigated under a clinical and pathogenetic point of view to improve diagnostic and therapeutic approaches. © 2015 S. Karger AG, Basel.

Adapting social neuroscience measures for schizophrenia clinical trials, part 3: fathoming external validity.

Science.gov (United States)

Olbert, Charles M; Penn, David L; Kern, Robert S; Lee, Junghee; Horan, William P; Reise, Steven P; Ochsner, Kevin N; Marder, Stephen R; Green, Michael F

2013-11-01

It is unknown whether measures adapted from social neuroscience linked to specific neural systems will demonstrate relationships to external variables. Four paradigms adapted from social neuroscience were administered to 173 clinically stable outpatients with schizophrenia to determine their relationships to functionally meaningful variables and to investigate their incremental validity beyond standard measures of social and nonsocial cognition. The 4 paradigms included 2 that assess perception of nonverbal social and action cues (basic biological motion and emotion in biological motion) and 2 that involve higher level inferences about self and others' mental states (self-referential memory and empathic accuracy). Overall, social neuroscience paradigms showed significant relationships to functional capacity but weak relationships to community functioning; the paradigms also showed weak correlations to clinical symptoms. Evidence for incremental validity beyond standard measures of social and nonsocial cognition was mixed with additional predictive power shown for functional capacity but not community functioning. Of the newly adapted paradigms, the empathic accuracy task had the broadest external validity. These results underscore the difficulty of translating developments from neuroscience into clinically useful tasks with functional significance.

Clinical Trials

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Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

Predictors of discontinuation of antipsychotic medication and subsequent outcomes in the European First Episode Schizophrenia Trial (EUFEST)

NARCIS (Netherlands)

Landolt, Karin; Rössler, Wulf; Ajdacic-Gross, Vladeta; Derks, Eske M.; Libiger, Jan; Kahn, René S.; Fleischhacker, W. Wolfgang

2016-01-01

This study had two aims: to describe patients suffering from first-episode schizophrenia who had stopped taking any antipsychotic medication, and to gain information on the predictors of successful discontinuation. We investigated data from the European First Episode Schizophrenia Trial (EUFEST).

Risk factors for suicide in schizophrenia: systematic review and clinical recommendations.

Science.gov (United States)

Popovic, D; Benabarre, A; Crespo, J M; Goikolea, J M; González-Pinto, A; Gutiérrez-Rojas, L; Montes, J M; Vieta, E

2014-12-01

To identify risk factors associated with suicide of patients with schizophrenia and provide clinical recommendations, which integrate research findings into a consensus based on clinical experience and evidence. A task force formed of experts and clinicians iteratively developed consensus through serial revisions using the Delphi method. Initial survey items were based on systematic literature review published up to June 2013. Various risk factors were reported to be implicated in suicide in schizophrenia. Our findings indicate that suicide risk in schizophrenia is mainly related to affective symptoms, history of a suicide attempt and number of psychiatric admissions. Other risk factors identified are given by younger age, closeness to illness onset, older age at illness onset, male sex, substance abuse and period during or following psychiatric discharge. Integrating the evidence and the experience of the task force members, a consensus was reached on 14 clinical recommendations. Identification of risk factors for suicide in individuals diagnosed with schizophrenia is imperative to improve clinical management and develop strategies to reduce the incidence of suicide in this population. This study provides the critical overview of available data and clinical recommendations on recognition and management of the above-mentioned risk factors. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Cognitive and clinical predictors of functional capacity in patients with first episode schizophrenia

DEFF Research Database (Denmark)

Vesterager, Lone; Christensen, Torben Ø; Olsen, Birthe B

2012-01-01

The predictors of functional capacity in first episode schizophrenia among seven separable cognitive domains and clinical variables are unknown.......The predictors of functional capacity in first episode schizophrenia among seven separable cognitive domains and clinical variables are unknown....

Social skills programmes for schizophrenia.

Science.gov (United States)

Almerie, Muhammad Qutayba; Okba Al Marhi, Muhammad; Jawoosh, Muhammad; Alsabbagh, Mohamad; Matar, Hosam E; Maayan, Nicola; Bergman, Hanna

2015-06-09

Social skills programmes (SSP) are treatment strategies aimed at enhancing the social performance and reducing the distress and difficulty experienced by people with a diagnosis of schizophrenia and can be incorporated as part of the rehabilitation package for people with schizophrenia. The primary objective is to investigate the effects of social skills training programmes, compared to standard care, for people with schizophrenia. We searched the Cochrane Schizophrenia Group's Trials Register (November 2006 and December 2011) which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. We inspected references of all identified studies for further trials.A further search for studies has been conducted by the Cochrane Schizophrenia Group in 2015, 37 citations have been found and are currently being assessed by review authors. We included all relevant randomised controlled trials for social skills programmes versus standard care involving people with serious mental illnesses. We extracted data independently. For dichotomous data we calculated risk ratios (RRs) and their 95% confidence intervals (CI) on an intention-to-treat basis. For continuous data, we calculated mean differences (MD) and 95% CIs. We included 13 randomised trials (975 participants). These evaluated social skills programmes versus standard care, or discussion group. We found evidence in favour of social skills programmes compared to standard care on all measures of social functioning. We also found that rates of relapse and rehospitalisation were lower for social skills compared to standard care (relapse: 2 RCTs, n = 263, RR 0.52 CI 0.34 to 0.79, very low quality evidence), (rehospitalisation: 1 RCT, n = 143, RR 0.53 CI 0.30 to 0.93, very low quality evidence) and participants' mental state results (1 RCT, n = 91, MD -4.01 CI -7.52 to -0.50, very low quality evidence) were better in the group receiving social skill programmes

Moving from Efficacy to Effectiveness in Cognitive Behavioral Therapy for Psychosis: A Randomized Clinical Practice Trial

Science.gov (United States)

Lincoln, Tania M.; Ziegler, Michael; Mehl, Stephanie; Kesting, Marie-Luise; Lullmann, Eva; Westermann, Stefan; Rief, Winfried

2012-01-01

Objective: Randomized controlled trials have attested the efficacy of cognitive behavioral therapy (CBT) in reducing psychotic symptoms. Now, studies are needed to investigate its effectiveness in routine clinical practice settings. Method: Eighty patients with schizophrenia spectrum disorders who were seeking outpatient treatment were randomized…

Clinical Trials

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Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

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Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... will be done during the clinical trial and why. Each medical center that does the study uses ...

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Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

Clinical writing and the documentary construction of schizophrenia.

Science.gov (United States)

Barrett, R J

1988-09-01

Psychiatric practice involves writing as much as it involves talking. This study examines the interpretive processes of reading, writing and interviewing which are central to the clinical interaction. It is part of a broader ethnographic study of an Australian psychiatric hospital (which specializes in the treatment of patients with a diagnosis of schizophrenia). The paper examines two major types of written assessment of patients--the admission assessment and the 'complete work-up.' Writing is analyzed as performance, thereby focusing on the transformations that are effected in patients, their perceptions of their schizophrenia, and their total identity. One crucial transformation is from 'person suffering from schizophrenia' to 'schizophrenic.' The paper aims to show that as much as psychiatry is a 'talking cure' it is also a 'writing cure.'

Sustained and "sleeper" effects of group metacognitive training for schizophrenia: a randomized clinical trial.

Science.gov (United States)

Moritz, Steffen; Veckenstedt, Ruth; Andreou, Christina; Bohn, Francesca; Hottenrott, Birgit; Leighton, Lucy; Köther, Ulf; Woodward, Todd S; Treszl, András; Menon, Mahesh; Schneider, Brooke C; Pfueller, Ute; Roesch-Ely, Daniela

2014-10-01

Cognitive interventions increasingly complement psychopharmacological treatment to enhance symptomatic and functional outcome in schizophrenia. Metacognitive training (MCT) is targeted at cognitive biases involved in the pathogenesis of delusions. To examine the long-term efficacy of group MCT for schizophrenia in order to explore whether previously established effects were sustained. A 2-center, randomized, controlled, assessor-blind, parallel group trial was conducted. A total of 150 inpatients or outpatients with DSM-IV diagnoses of schizophrenia spectrum disorders were enrolled. All patients were prescribed antipsychotic medication. The second follow-up assessment took place 3 years later after the intervention phase was terminated. Group MCT targeting cognitive biases vs neuropsychological training (COGPACK). Patients received a maximum of 16 sessions. The primary outcome measure was a delusion score derived from the Positive and Negative Syndrome Scale (PANSS). The PANSS positive syndrome and total scores, the Psychotic Symptom Rating Scales, the jumping to conclusions bias, self-esteem, and quality of life served as secondary outcome measures. The intention-to-treat analyses demonstrated that patients in the MCT group had significantly greater reductions in the core PANSS delusion score, after 3 years compared with the control group (η2partial = .037; P = .05). Among the secondary outcomes, the intention-to-treat analyses also demonstrated that patients in the MCT group had significantly greater reductions in the PANSS positive syndrome score (η2partial = .055; P = .02) and the Psychotic Symptom Rating Scales delusion score (η2partial = .109; P = .001). Significant group differences at the 3-year follow-up were also found on measures of self-esteem and quality of life, which did not distinguish groups at earlier assessment points. Attention was improved in the neuropsychological training group relative to the MCT group. The

Differential effects of antipsychotic drugs on insight in first episode schizophrenia: Data from the European First-Episode Schizophrenia Trial (EUFEST).

Science.gov (United States)

Pijnenborg, G H M; Timmerman, M E; Derks, E M; Fleischhacker, W W; Kahn, R S; Aleman, A

2015-06-01

Although antipsychotics are widely prescribed, their effect of on improving poor illness insight in schizophrenia has seldom been investigated and therefore remains uncertain. This paper examines the effects of low dose haloperidol, amisulpride, olanzapine, quetiapine, and ziprasidone on insight in first-episode schizophrenia, schizoaffective disorder, or schizophreniform disorder. The effects of five antipsychotic drugs in first episode psychosis on insight were compared in a large scale open randomized controlled trial conducted in 14 European countries: the European First-Episode Schizophrenia Trial (EUFEST). Patients with at least minimal impairments in insight were included in the present study (n=455). Insight was assessed with item G12 of the Positive and Negative Syndrome Scale (PANSS), administered at baseline and at 1, 3, 6, 9, and 12 months after randomization. The use of antipsychotics was associated with clear improvements in insight over and above improvements in other symptoms. This effect was most pronounced in the first three months of treatment, with quetiapine being significantly less effective than other drugs. Effects of spontaneous improvement cannot be ruled out due to the lack of a placebo control group, although such a large spontaneous improvement of insight would seem unlikely. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.

Can exercise increase fitness and reduce weight in patients with schizophrenia and depression?

DEFF Research Database (Denmark)

Krogh, Jesper; Speyer, Helene; Nørgaard, Hans Christian Brix

2014-01-01

in this patient group and low levels of physical activity is associated with increased risk of cardiovascular disease, diabetes, and all-cause mortality. This study aimed to review trials allocating patients with either schizophrenia or depression to exercise interventions for effect on cardiovascular fitness......, strength, and weight. METHODS: We searched PubMed, Embase, and PsycINFO including randomized clinical trial allocating patients with either schizophrenia or depression to isolated exercise interventions. RESULTS: We identified five trials including patients with schizophrenia (n = 94) and found little...... evidence that exercise could increase cardiovascular fitness or decrease weight. Nine exercise trials for patients with depression (n = 892) were identified increasing cardiovascular fitness by 11-30% and strength by 33-37%. No evidence in favor of exercise for weight reduction was found. CONCLUSION: Based...

Clinical Trials

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Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key ... Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

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Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

Reliability, validity and treatment sensitivity of the Schizophrenia Cognition Rating Scale.

Science.gov (United States)

Keefe, Richard S E; Davis, Vicki G; Spagnola, Nathan B; Hilt, Dana; Dgetluck, Nancy; Ruse, Stacy; Patterson, Thomas D; Narasimhan, Meera; Harvey, Philip D

2015-02-01

Cognitive functioning can be assessed with performance-based assessments such as neuropsychological tests and with interview-based assessments. Both assessment methods have the potential to assess whether treatments for schizophrenia improve clinically relevant aspects of cognitive impairment. However, little is known about the reliability, validity and treatment responsiveness of interview-based measures, especially in the context of clinical trials. Data from two studies were utilized to assess these features of the Schizophrenia Cognition Rating Scale (SCoRS). One of the studies was a validation study involving 79 patients with schizophrenia assessed at 3 academic research centers in the US. The other study was a 32-site clinical trial conducted in the US and Europe comparing the effects of encenicline, an alpha-7 nicotine agonist, to placebo in 319 patients with schizophrenia. The SCoRS interviewer ratings demonstrated excellent test-retest reliability in several different circumstances, including those that did not involve treatment (ICC> 0.90), and during treatment (ICC>0.80). SCoRS interviewer ratings were related to cognitive performance as measured by the MCCB (r=-0.35), and demonstrated significant sensitivity to treatment with encenicline compared to placebo (Pcognition in schizophrenia, and may be useful for clinical practice. The weaknesses of the SCoRS include its reliance on informant information, which is not available for some patients, and reduced validity when patient's self-report is the sole information source. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

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Full Text Available ... take part in a clinical trial. When researchers think that a trial's potential risks are greater than ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

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Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are ... earlier than they would be in general medical practice. This is because late-phase trials have large ...

Reconsidering Clinical Staging Model: A Case of Genetic High Risk for Schizophrenia

OpenAIRE

Lee, Tae Young; Kim, Minah; Kim, Sung Nyun; Kwon, Jun Soo

2016-01-01

The clinical staging model is considered a useful and practical method not only in dealing with the early stage of psychosis overcoming the debate about diagnostic boundaries but also in emerging mood disorder. However, its one limitation is that it cannot discriminate the heterogeneity of individuals at clinical high risk for psychosis, but lumps them all together. Even a healthy offspring of schizophrenia can eventually show clinical symptoms and progress to schizophrenia under the influenc...

Z-drug for schizophrenia: A systematic review and meta-analysis.

Science.gov (United States)

Kishi, Taro; Inada, Ken; Matsui, Yuki; Iwata, Nakao

2017-10-01

No systematic reviews and meta-analyses on the use of Z-drug for schizophrenia are available. Randomized, placebo-controlled, or non-pharmacological intervention-controlled trials published before 03/20/2017 were retrieved from major healthcare databases and clinical trial registries. A meta-analysis including only randomized, placebo-controlled trials was performed. Efficacy outcomes were measured as improvement in overall schizophrenia symptoms, total sleep time, and wake after sleep onset. Safety/acceptability outcomes were discontinuation rate and individual adverse events. Four trials [1 alpidem placebo-controlled study (n=66), 2 eszopiclone placebo-controlled studies (n=60), and 1 eszopiclone, shallow needling-controlled study (n=96)] were identified. The meta-analysis showed no significant differences in any outcome between pooled Z-drug and placebo treatment groups. For individual studies, alpidem was superior to placebo in improving the overall schizophrenia symptoms. One of the eszopiclone studies showed that eszopiclone was superior to placebo in improving the Insomnia Severity Index scores. Another eszopiclone study showed that eszopiclone did not differ from shallow needling therapy in improving both schizophrenia- and insomnia-related symptoms. Although this study failed to show significant benefits for the use of Z-drug in the treatment of schizophrenia, it showed that short-term use of eszopiclone is an acceptable method for treating persistent insomnia among these patients. Copyright © 2017 Elsevier B.V. All rights reserved.

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Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...

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Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

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.

Study protocol: a randomised controlled trial of cognitive remediation for a national cohort of forensic mental health patients with schizophrenia or schizoaffective disorder.

Science.gov (United States)

O'Reilly, Ken; Donohoe, Gary; O'Sullivan, Danny; Coyle, Ciaran; Mullaney, Ronan; O'Connell, Paul; Maddock, Catherine; Nulty, Andrea; O'Flynn, Padraic; O'Connell, Carina; Kennedy, Harry G

2016-01-13

Evidence is accumulating that cognitive remediation therapy (CRT) is an effective intervention for patients with schizophrenia or schizoaffective disorder. To date there has been no randomised controlled trial (RCT) cohort study of cognitive remediation within a forensic hospital. The goal of this study is to examine the effectiveness of a trial of cognitive remediation for forensic mental health patients with schizophrenia or schizoaffective disorder. An estimated sixty patients will be enrolled in the study. Participants will be randomised to one of two conditions: CRT with treatment as usual (TAU), or TAU. CRT will consist of 42 individual sessions and 14 group sessions. The primary outcome measure for this study is change in cognitive functioning using the MATRICS Consensus Cognitive Battery (MCCB). Secondary outcomes include change in social and occupational functioning, disorganised symptoms, negative symptoms, violence, participation in psychosocial treatment and recovery. In addition to these effectiveness measures, we will examine patient satisfaction. Cognitive difficulties experienced by schizophrenia spectrum patients are associated with general functioning, ability to benefit from psychosocial interventions and quality of life. Research into the treatment of cognitive difficulties within a forensic setting is therefore an important priority. The results of the proposed study will help answer the question whether cognitive remediation improves functional outcomes in forensic mental health patients with schizophrenia or schizoaffective disorder. Forensic mental health patients are detained for the dual purpose of receiving treatment and for public protection. There can be conflict between these two roles perhaps causing forensic services to have an increased length of stay compared to general psychiatric admissions. Ultimately a focus on emphasising cognition and general functioning over symptoms may decrease tension between the core responsibilities of

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Full Text Available ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ...

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Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

Overcoming Disembodiment: The Effect of Movement Therapy on Negative Symptoms in Schizophrenia- A Multicenter Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Lily Anna Lina Martin

2016-03-01

Full Text Available AbstractObjective. Negative symptoms of patients with Schizophrenia are resistant to medical treatment or conventional group therapy. Understanding schizophrenia as a form of disembodiment of the self, a number of scientists have argued that the approach of embodiment and associated embodied therapies, such as Dance and Movement Therapy (DMT or Body Psychotherapy (BPT, may be more suitable to explain the psychopathology underlying the mental illness and to address its symptoms. Hence the present randomized controlled trial (DRKS00009828, http://apps.who.int/trialsearch/ aimed to examine the effectiveness of manualized movement therapy (BPT/DMT on the negative symptoms of patients with schizophrenia.Method. A total of 68 out-patients with a diagnosis of a schizophrenia spectrum disorder were randomly allocated to either the treatment (n = 44, 20 sessions of BPT/DMT or the control condition (n = 24, treatment as usual (TAU. Changes in negative symptom scores on the Scale for the Assessment of Negative Symptoms (SANS were analyzed using Analysis of Covariance (ANCOVA with Simpson-Angus Scale (SAS scores as covariates in order to control for side effects of antipsychotic medication.Results. After twenty sessions of treatment (BPT/DMT or TAU, patients receiving movement therapy had significantly lower negative symptom scores (SANS total score, blunted affect, attention. Effect sizes were moderate and mean symptom reduction in the treatment group was 20.65%.Conclusion. The study demonstrates that embodied therapies, such as BPT/DMT, are highly effective in the treatment of patients with schizophrenia. Results strongly suggest that BPT/DMT should be embedded in the daily clinical routine.

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[Relevance of drug use in clinical manifestations of schizophrenia].

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Arias Horcajadas, F; Sánchez Romero, S; Padín Calo, J J

2002-01-01

To study the association between drugs use with schizophrenia clinical manifestations. The sample consists of 82 out-patients with schizophrenia, between 18 and 45 years old. They were evaluated with Addiction Severity Index (ASI) and with Positive and Negative Syndrome Scale (PANSS). A 6 months follow up was carried out. 37,8% patients had lifetime drug dependence (including alcohol and others drugs except for tobacco). The prevalence of dependence for the different drugs were: opioids 9,8%, cocaine 11%, alcohol 29,3%, cannabis 24,4%, tobacco 68,3%, caffeine 15,9%. Drug dependent had more family and legal problems. At the multiple regression analysis it was observed that cannabis and tobacco dependence was associated with a decrease in the PANSS negative symptoms subscale, and on the contrary, alcohol dependence produces a similar intensity increase at that scoring. We don't detect any clinical relevance effects over positive symptoms. Cannabis and tobacco may improve schizophrenia negative symptoms or neuroleptic secondary effects or patients with few negative symptoms may have more predisposition to the use, on the contrary alcohol use can impairment those symptoms.

Clinical factors related to schizophrenia relapse.

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Porcelli, Stefano; Bianchini, Oriana; De Girolamo, Giovanni; Aguglia, Eugenio; Crea, Luciana; Serretti, Alessandro

2016-01-01

Relapses represent one of the main problems of schizophrenia management. This article reviews the clinical factors associated with schizophrenia relapse. A research of the last 22 years of literature data was performed. Two-hundred nineteen studies have been included. Three main groups of factors are related to relapse: factors associated with pharmacological treatment, add-on psychotherapeutic treatments and general risk factors. Overall, the absence of a maintenance therapy and treatment with first generation antipsychotics has been associated with higher risk of relapse. Further, psychotherapy add-on, particularly with cognitive behaviour therapy and psycho-education for both patients and relatives, has shown a good efficacy for reducing the relapse rate. Among general risk factors, some could be modified, such as the duration of untreated psychosis or the substance misuse, while others could not be modified as male gender or low pre-morbid level of functioning. Several classes of risk factors have been proved to be relevant in the risk of relapse. Thus, a careful assessment of the risk factors here identified should be performed in daily clinical practice in order to individualise the relapse risk for each patient and to provide a targeted treatment in high-risk subjects.

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Neurological soft signs in the clinical course of schizophrenia

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Silke eBachmann

2014-12-01

Full Text Available Neurological soft signs (NSS comprise subtle deficits in sensory integration, motor coordination, and sequencing of complex motor acts which are typically observed in the majority of schizophrenia patients, including chronic cases and neuroleptic-naïve first-episode patients. However, recent studies clearly demonstrate that NSS are not a static feature of schizophrenia but vary in the clinical course of the disorder. This effect was investigated in a meta-analysis based on 17 longitudinal studies published between 1992 and 2012. Studies included between 10 and 93 patients with schizophrenia spectrum disorders (total number 787 with follow-up periods between 2 and 208 weeks. Beside the Neurological Examination Scale, the Cambridge Neurological Inventory and the Heidelberg NSS Scale were used to assess NSS. All but three studies found NSS to decrease in parallel with remission of psychopathological symptoms. This effect was more pronounced in patients with a remitting compared to a non-remitting, chronic course (Cohen´s d 0.81 vs. 0.15 and was significantly correlated with length of the follow-up period (r=-0.64 but not with age (r=0.28. NSS scores did not decrease to the level typically observed in healthy controls. From a clinical perspective, NSS may therefore be used to identify subjects at risk to develop schizophrenia and to monitor disease progression.

Determinants of patient-rated and clinician-rated illness severity in schizophrenia.

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Fervaha, Gagan; Takeuchi, Hiroyoshi; Agid, Ofer; Lee, Jimmy; Foussias, George; Remington, Gary

2015-07-01

The contribution of specific symptoms on ratings of global illness severity in patients with schizophrenia is not well understood. The present study examined the clinical determinants of clinician and patient ratings of overall illness severity. This study included 1,010 patients with a DSM-IV diagnosis of schizophrenia who participated in the baseline visit of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study conducted between January 2001 and December 2004 and who had available symptom severity, side effect burden, cognition, and community functioning data. Both clinicians and patients completed the 7-point Clinical Global Impressions-Severity of Illness scale (CGI-S), the primary measure of interest in the present study. Symptoms were rated using the Positive and Negative Syndrome Scale and the Calgary Depression Scale for Schizophrenia, and functional status with the Quality of Life Scale. Neurocognition, insight, and medication-related side effects were also evaluated. Clinicians rated illness severity significantly higher than patients (P negative, disorganized, and depressive symptoms, as well as functional outcome (all P values enhance patient engagement in care and improve outcomes. ClinicalTrials.gov identifier: NCT00014001. © Copyright 2014 Physicians Postgraduate Press, Inc.

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Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...

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Psychoeducation for schizophrenia

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Xia, Jun; Merinder, Lars Bertil; Belgamwar, Madhvi R

2014-01-01

Background Schizophrenia can be a severe and chronic illness characterised by lack of insight and poor compliance with treatment. Psychoeducational approaches have been developed to increase patients’ knowledge of, and insight into, their illness and its treatment. It is supposed that this increased knowledge and insight will enable people with schizophrenia to cope in a more effective way with their illness, thereby improving prognosis. Objectives To assess the effects of psychoeducational interventions compared with standard levels of knowledge provision. Search methods We searched the Cochrane Schizophrenia Group Trials Register (February 2010). We updated this search November 2012 and added 27 new trials to the awaiting assessment section. Selection criteria All relevant randomised controlled trials focusing on psychoeducation for schizophrenia and/or related serious mental illnesses involving individuals or groups. We excluded quasi-randomised trials. Data collection and analysis At least two review authors extracted data independently from included papers. We contacted authors of trials for additional and missing data. We calculated risk ratios (RR) and 95% confidence intervals (CI) of homogeneous dichotomous data. We used a fixed-effects model for heterogeneous dichotomous data. Where possible we also calculated the numbers needed to treat (NNT), as well as weighted means for continuous data. Main results This review includes a total of 5142 participants (mostly inpatients) from 44 trials conducted between 1988 and 2009 (median study duration ~ 12 weeks, risk of bias - moderate). We found that incidences of non-compliance were lower in the psychoeducation group in the short term (n = 1400, RR 0.52 CI 0.40 to 0.67, NNT 11 CI 9 to 16). This finding holds for the medium and long term. Relapse appeared to be lower in psychoeducation group (n = 1214, RR 0.70 CI 0.61 to 0.81, NNT 9 CI 7 to 14) and this also applied to readmission (n = 206, RR 0.71 CI 0.56 to 0

NMDA receptor antagonists interventions in schizophrenia: Meta-analysis of randomized, placebo-controlled trials.

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Kishi, Taro; Iwata, Nakao

2013-09-01

We examined whether N-methyl d-aspartate (NMDA) receptor antagonists as adjunctive therapy have therapeutic potential for schizophrenia treatment. Systematic review of PubMed, Cochrane Library, PsycINFO and Google Scholar up until October 2012 and meta-analysis of randomized placebo-controlled trials were performed. Risk ratio (RR), 95% confidence intervals (CI), numbers-needed-to-harm (NNH), and standardized mean difference (SMD) were calculated. Results were across 8 studies and 406 patients (85.5% schizophrenia related disorder and 14.5% bipolar disorder) were included (amantadine: 5 trials and 220 patients, memantine: 3 trials and 186 patients). NMDA receptor antagonists (NMDAR-ANTs) as adjunctive therapy were not superior to placebo in overall (SMD = -0.25, CI = -0.72, 0.23, p = 0.31, N = 6, n = 347), positive symptoms (SMD = -0.20, CI = -0.70, 0.31, p = 0.44, N = 4, n = 205), and negative symptoms (SMD = -0.69, CI = -1.65, 0.27, p = 0.16, N = 4, n = 205), and Clinical Global Impression Severity scale (SMD = -0.27, CI = -1.20, 0.65, p = 0.56, N = 3, n = 177). There was also no significant difference in discontinuation rate between NMDAR-ANTs and placebo treatments (all cause: RR = 1.23, CI = 0.89-1.70, p = 0.20, N = 8, n = 396, side effects: RR = 1.86, CI = 0.84-4.13, p = 0.13, N = 6, n = 359, inefficacy/worsening psychosis: RR = 0.70, CI = 0.20-2.38, p = 0.56, N = 7, n = 380). However, memantine was favorable compared with placebo in Mini-Mental State Examination in schizophrenia (SMD = -0.77, CI = -1.27, -0.28, p = 0.002, N = 3, n = 71). While NMDAR-ANTs caused weight loss compared with placebo (SMD = -0.42, CI = -0.73, -0.11, p = 0.008, N = 3, n = 165), amantadine caused more frequent insomnia than placebo (RR = 3.83, CI = 1.41-10.38, p = 0.008, NNH = 9, p = 0.002, N = 2, n = 147). Our results indicate that NMDAR-ANTs as adjunctive therapy may improve

Magnetic Seizure Therapy in Treatment-Resistant Schizophrenia: A Pilot Study

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Victor M. Tang

2018-01-01

Full Text Available ObjectiveElectroconvulsive therapy is effective in treatment-resistant schizophrenia (TRS but use is limited due to stigma and concerns around cognitive adverse effects. Magnetic seizure therapy (MST is a promising new neuromodulation technique that uses transcranial magnetic stimulation to induce therapeutic seizures. Studies of MST in depression have shown clinical improvement with a favorable adverse effect profile. No studies have examined the clinical utility of MST in schizophrenia.MethodsWe conducted an open-label pilot clinical trial of MST in eight TRS patients. Up to 24 MST treatments were delivered depending on treatment response. We assessed clinical outcome through the Brief Psychiatric Rating Scale (BPRS and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q. Cognitive testing included a neuropsychological test battery, the Autobiographical Memory Inventory (AMI, Montreal Cognitive Assessment (MoCA, and reorientation time.ResultsFour patients completed the trial as per protocol. For all patients and for trial completers alone, there was a significant clinical and quality of life improvement. Three met pre-determined criteria for remission (total score ≤25 on the BPRS and one met criteria for response (i.e., ≥25% BPRS improvement from baseline for two consecutive assessments. Pre and post neurocognitive data showed no significant cognitive adverse effects apart from a decrease in AMI scores.ConclusionIn this pilot study, MST demonstrated evidence for feasibility in patients with TRS, with promise for clinical efficacy and negligible cognitive side effects. Further study in larger clinical populations is needed.Clinical Trial Registrationwww.ClinicalTrials.gov, Identifier NCT01596608.

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

Village doctor-assisted case management of rural patients with schizophrenia: protocol for a cluster randomized control trial.

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Gong, Wenjie; Xu, Dong; Zhou, Liang; Brown, Henry Shelton; Smith, Kirk L; Xiao, Shuiyuan

2014-01-16

Strict compliance with prescribed medication is the key to reducing relapses in schizophrenia. As villagers in China lack regular access to psychiatrists to supervise compliance, we propose to train village 'doctors' (i.e., villagers with basic medical training and currently operating in villages across China delivering basic clinical and preventive care) to manage rural patients with schizophrenia with respect to compliance and monitoring symptoms. We hypothesize that with the necessary training and proper oversight, village doctors can significantly improve drug compliance of villagers with schizophrenia. We will conduct a cluster randomized controlled trial in 40 villages in Liuyang, Hunan Province, China, home to approximately 400 patients with schizophrenia. Half of the villages will be randomized into the treatment group (village doctor, or VD model) wherein village doctors who have received training in a schizophrenia case management protocol will manage case records, supervise drug taking, educate patients and families on schizophrenia and its treatment, and monitor patients for signs of relapse in order to arrange prompt referral. The other 20 villages will be assigned to the control group (case as usual, or CAU model) wherein patients will be visited by psychiatrists every two months and receive free antipsychotic medications under an on-going government program, Project 686. These control patients will receive no other management or follow up from health workers. A baseline survey will be conducted before the intervention to gather data on patient's socio-economic status, drug compliance history, and clinical and health outcome measures. Data will be re-collected 6 and 12 months into the intervention. A difference-in-difference regression model will be used to detect the program effect on drug compliance and other outcome measures. A cost-effectiveness analysis will also be conducted to compare the value of the VD model to that of the CAU group. Lack of

Use of a Novel Artificial Intelligence Platform on Mobile Devices to Assess Dosing Compliance in a Phase 2 Clinical Trial in Subjects With Schizophrenia.

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Bain, Earle E; Shafner, Laura; Walling, David P; Othman, Ahmed A; Chuang-Stein, Christy; Hinkle, John; Hanina, Adam

2017-02-21

Accurately monitoring and collecting drug adherence data can allow for better understanding and interpretation of the outcomes of clinical trials. Most clinical trials use a combination of pill counts and self-reported data to measure drug adherence, despite the drawbacks of relying on these types of indirect measures. It is assumed that doses are taken, but the exact timing of these events is often incomplete and imprecise. The objective of this pilot study was to evaluate the use of a novel artificial intelligence (AI) platform (AiCure) on mobile devices for measuring medication adherence, compared with modified directly observed therapy (mDOT) in a substudy of a Phase 2 trial of the α7 nicotinic receptor agonist (ABT-126) in subjects with schizophrenia. AI platform generated adherence measures were compared with adherence inferred from drug concentration measurements. The mean cumulative pharmacokinetic adherence over 24 weeks was 89.7% (standard deviation [SD] 24.92) for subjects receiving ABT-126 who were monitored using the AI platform, compared with 71.9% (SD 39.81) for subjects receiving ABT-126 who were monitored by mDOT. The difference was 17.9% (95% CI -2 to 37.7; P=.08). Using drug levels, this substudy demonstrates the potential of AI platforms to increase adherence, rapidly detect nonadherence, and predict future nonadherence. Subjects monitored using the AI platform demonstrated a percentage change in adherence of 25% over the mDOT group. Subjects were able to use the technology successfully for up to 6 months in an ambulatory setting with early termination rates that are comparable to subjects outside of the substudy. ClinicalTrials.gov NCT01655680 https://clinicaltrials.gov/ct2/show/NCT01655680?term=NCT01655680. ©Earle E Bain, Laura Shafner, David P Walling, Ahmed A Othman, Christy Chuang-Stein, John Hinkle, Adam Hanina. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 21.02.2017.

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Strategies for maximizing clinical effectiveness in the treatment of schizophrenia.

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Tandon, Rajiv; Targum, Steven D; Nasrallah, Henry A; Ross, Ruth

2006-11-01

The ultimate clinical objective in the treatment of schizophrenia is to enable affected individuals to lead maximally productive and personally meaningful lives. As with other chronic diseases that lack a definitive cure, the individual's service/recovery plan must include treatment interventions directed towards decreasing manifestations of the illness, rehabilitative services directed towards enhancing adaptive skills, and social support mobilization aimed at optimizing function and quality of life. In this review, we provide a conceptual framework for considering approaches for maximizing the effectiveness of the array of treatments and other services towards promoting recovery of persons with schizophrenia. We discuss pharmacological, psychological, and social strategies that decrease the burden of the disease of schizophrenia on affected individuals and their families while adding the least possible burden of treatment. In view of the multitude of treatments necessary to optimize outcomes for individuals with schizophrenia, effective coordination of these services is essential. In addition to providing best possible clinical assessment and pharmacological treatment, the psychiatrist must function as an effective leader of the treatment team. To do so, however, the psychiatrist must be knowledgeable about the range of available services, must have skills in clinical-administrative leadership, and must accept the responsibility of coordinating the planning and delivery of this multidimensional array of treatments and services. Finally, the effectiveness of providing optimal individualized treatment/rehabilitation is best gauged by measuring progress on multiple effectiveness domains. Approaches for efficient and reliable assessment are discussed.

Genetic correlates of insight in schizophrenia.

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Xavier, Rose Mary; Vorderstrasse, Allison; Keefe, Richard S E; Dungan, Jennifer R

2018-05-01

Insight in schizophrenia is clinically important as it is associated with several adverse outcomes. Genetic contributions to insight are unknown. We examined genetic contributions to insight by investigating if polygenic risk scores (PRS) and candidate regions were associated with insight. Schizophrenia case-only analysis of the Clinical Antipsychotics Trials of Intervention Effectiveness trial. Schizophrenia PRS was constructed using Psychiatric Genomics Consortium (PGC) leave-one out GWAS as discovery data set. For candidate regions, we selected 105 schizophrenia-associated autosomal loci and 11 schizophrenia-related oligodendrocyte genes. We used regressions to examine PRS associations and set-based testing for candidate analysis. We examined data from 730 subjects. Best-fit PRS at p-threshold of 1e-07 was associated with total insight (R 2 =0.005, P=0.05, empirical P=0.054) and treatment insight (R 2 =0.005, P=0.048, empirical P=0.048). For models that controlled for neurocognition, PRS significantly predicted treatment insight but at higher p-thresholds (0.1 to 0.5) but did not survive correction. Patients with highest polygenic burden had 5.9 times increased risk for poor insight compared to patients with lowest burden. PRS explained 3.2% (P=0.002, empirical P=0.011) of variance in poor insight. Set-based analyses identified two variants associated with poor insight- rs320703, an intergenic variant (within-set P=6e-04, FDR P=0.046) and rs1479165 in SOX2-OT (within-set P=9e-04, FDR P=0.046). To the best of our knowledge, this is the first study examining genetic basis of insight. We provide evidence for genetic contributions to impaired insight. Relevance of findings and necessity for replication are discussed. Copyright © 2017 Elsevier B.V. All rights reserved.

Incentive motivation deficits in schizophrenia reflect effort computation impairments during cost-benefit decision-making.

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Fervaha, Gagan; Graff-Guerrero, Ariel; Zakzanis, Konstantine K; Foussias, George; Agid, Ofer; Remington, Gary

2013-11-01

Motivational impairments are a core feature of schizophrenia and although there are numerous reports studying this feature using clinical rating scales, objective behavioural assessments are lacking. Here, we use a translational paradigm to measure incentive motivation in individuals with schizophrenia. Sixteen stable outpatients with schizophrenia and sixteen matched healthy controls completed a modified version of the Effort Expenditure for Rewards Task that accounts for differences in motoric ability. Briefly, subjects were presented with a series of trials where they may choose to expend a greater amount of effort for a larger monetary reward versus less effort for a smaller reward. Additionally, the probability of receiving money for a given trial was varied at 12%, 50% and 88%. Clinical and other reward-related variables were also evaluated. Patients opted to expend greater effort significantly less than controls for trials of high, but uncertain (i.e. 50% and 88% probability) incentive value, which was related to amotivation and neurocognitive deficits. Other abnormalities were also noted but were related to different clinical variables such as impulsivity (low reward and 12% probability). These motivational deficits were not due to group differences in reward learning, reward valuation or hedonic capacity. Our findings offer novel support for incentive motivation deficits in schizophrenia. Clinical amotivation is associated with impairments in the computation of effort during cost-benefit decision-making. This objective translational paradigm may guide future investigations of the neural circuitry underlying these motivational impairments. Copyright © 2013 Elsevier Ltd. All rights reserved.

Knowledge in schizophrenia: The Portuguese version of KAST (Knowledge About Schizophrenia Test) and analysis of social-demographic and clinical factors' influence.

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Daltio, C S; Attux, C; Ferraz, M B

2015-10-01

Schizophrenia is a complex disorder, and the knowledge about it can have a positive impact. The purpose of this study was to make the translation and cultural adaptation of the Knowledge About Schizophrenia Test (KAST) into Portuguese and determine the influence of clinical and socio-demographic factors on knowledge. The test was applied to 189 caregivers of patients enrolled in Schizophrenia Program of the Federal University of São Paulo, 30 caregivers of clinical patients of the General Outpatient Clinic of the same University, and 30 health professionals. The face and content validity of the test was established. The mean value (SD) obtained with the application of the final version to caregivers of schizophrenic patients was 12.96 (2.45) - maximum 17. Level of knowledge increased considering the following order: caregivers of clinical patients, caregivers of patients with schizophrenia and mental health professionals. The intraclass correlation coefficient (0.592) obtained in the test-retest was statistically significant. An influence of social class, race, gender and education of the caregiver on the test was observed, and the last two factors were more relevant. The KAST translated and adapted into Portuguese is a valid instrument and can be used as an evaluation tool on psychoeducational interventions. Copyright © 2015 Elsevier B.V. All rights reserved.

Interventions to reduce weight gain in schizophrenia.

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Faulkner, G; Cohn, T; Remington, G

2007-01-24

Weight gain is common for people with schizophrenia and this has serious implications for health and well being. To determine the effects of both pharmacological (excluding medication switching) and non pharmacological strategies for reducing or preventing weight gain in people with schizophrenia. We searched key databases and the Cochrane Schizophrenia Group's trials register (April 2006), reference sections within relevant papers, hand searched key journals, and contacted the first author of each relevant study and other experts to collect further information. We included all clinical randomised controlled trials comparing any pharmacological or non pharmacological intervention for weight gain (diet and exercise counselling) with standard care or other treatments for people with schizophrenia or schizophrenia-like illnesses. We reliably selected, quality assessed and extracted data from studies. As weight is a continuous outcome measurement, weighted mean differences (WMD) of the change from baseline were calculated. The primary outcome measure was weight loss. Twenty-three randomised controlled trials met the inclusion criteria for this review. Five trials assessed a cognitive/behavioural intervention and eighteen assessed a pharmacological adjunct. In terms of prevention, two cognitive/behavioural trials showed significant treatment effect (mean weight change) at end of treatment (n=104, 2 RCTs, WMD -3.38 kg CI -4.2 to -2.0). Pharmacological adjunct treatments were significant with a modest prevention of weight gain (n=274, 6 RCTs, WMD - 1.16 kg CI -1.9 to -0.4). In terms of treatments for weight loss, we found significantly greater weight reduction in the cognitive behavioural intervention group (n=129, 3 RCTs, WMD -1.69 kg CI -2.8 to -0.6) compared with standard care. Modest weight loss can be achieved with selective pharmacological and non pharmacological interventions. However, interpretation is limited by the small number of studies, small sample size

Socio-demographic and clinical profiles of paranoid and nonparanoid schizophrenia: a prospective, multicenter study in China.

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Xiang, Yu-Tao; Wang, Chuan-Yue; Chiu, Helen F K; Weng, Yong-Zhen; Bo, Qi-Jing; Chan, Sandra S M; Lee, Edwin H M; Ungvari, Gabor S

2011-07-01

This study aimed to explore the socio-demographic and clinical characteristics of paranoid and nonparanoid subtypes of schizophrenia. In a multicenter, randomized, controlled, longitudinal study, 374 clinically stable schizophrenia patients were interviewed at entry with standardized assessment instruments and followed for 12-26 months. In the multivariate analysis, male sex, married marital status, urban abode, and more frequent relapse over the study period were independently associated with paranoid schizophrenia. The socio-demographic and clinical characteristics of Chinese patients with the paranoid subtype of schizophrenia are different from those of their Caucasian counterparts who are more likely to be women and have a better outcome. © 2010 Wiley Periodicals, Inc.

Differences in Clinical Features of Methamphetamine Users with Persistent Psychosis and Patients with Schizophrenia.

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Wang, Liang-Jen; Lin, Shih-Ku; Chen, Yi-Chih; Huang, Ming-Chyi; Chen, Tzu-Ting; Ree, Shao-Chun; Chen, Chih-Ken

Methamphetamine exerts neurotoxic effects and elicits psychotic symptoms. This study attempted to compare clinical differences between methamphetamine users with persistent psychosis (MAP) and patients with schizophrenia. In addition, we examined the discrimination validity by using symptom clusters to differentiate between MAP and schizophrenia. We enrolled 53 MAP patients and 53 patients with schizophrenia. The psychopathology of participants was assessed using the Chinese version of the Diagnostic Interview for Genetic Studies and the 18-item Brief Psychiatric Rating Scale. Logistic regression was used to examine the predicted probability scores of different symptom combinations on discriminating between MAP and schizophrenia. The receiver operating characteristic (ROC) analyses and area under the curve (AUC) were further applied to examine the discrimination validity of the predicted probability scores on differentiating between MAP and schizophrenia. We found that MAP and schizophrenia demonstrated similar patterns of delusions. Compared to patients with schizophrenia, MAP experienced significantly higher proportions of visual hallucinations and of somatic or tactile hallucinations. However, MAP exhibited significantly lower severity in conceptual disorganization, mannerism/posturing, blunted affect, emotional withdrawal, and motor retardation compared to patients with schizophrenia. The ROC analysis showed that a predicted probability score combining the aforementioned 7 items of symptoms could significantly differentiate between MAP and schizophrenia (AUC = 0.77). Findings in the current study suggest that nuanced differences might exist in the clinical presentation of secondary psychosis (MAP) and primary psychosis (schizophrenia). Combining the symptoms as a whole may help with differential diagnosis for MAP and schizophrenia. © 2016 S. Karger AG, Basel.

Independent and Social Living Skills Training for People with Schizophrenia in Iran: a Randomized Controlled Trial

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Ashraf Karbalaee-Nouri

2015-09-01

Full Text Available Objectives: Schizophrenia is responsible for a significant proportion of burden of mental diseases in Iran. Lack of a follow-up system has resulted in the repeated hospitalizations. In this study it is hypothesized that standardized living skills training delivered to participants with schizophrenia in outpatient and inpatient centers can be effective compared to a  control group (with occupational therapy in reducing psychopathology severity and increasing quality of life. Methods: This is a multi-centered parallel group randomized controlled trial in Iran and it is single-blinded. Eligible participants are randomly allocated into two groups in a 1:1 ratio. Participants are assigned by stratified balanced block randomization method. The trial is conducted in the cities of Tehran and Mashhad. Its aim is to recruit 160 clients with schizophrenia. The intervention for the experimental group is social living skills training. The intervention for the control group is occupational therapy. The intervention for both groups is conducted in 90 to 120-minute group sessions. Results: The primary outcome of the study would be a decrease in  psychopathology severity, an improvement in participants' quality of life, and reduction in family burden will be followed for 6 months. Discussion: This paper presents a protocol for a randomized controlled trial of independent and social living skills training intervention delivered to participants with schizophrenia. If this intervention is effective, it could be scaled up to be developing for policymaking and improving outcomes for schizophrenic participants and their families in Iran.

Can exercise increase fitness and reduce weight in patients with schizophrenia and depression?

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Jesper eKrogh

2014-07-01

Full Text Available BackgroundPsychiatric patients have a reduced life expectancy of 15 to 20 years compared to the general population. Most years of lost life are due to excess mortality from somatic diseases. Sedentary lifestyle and medication is partly responsible for the high frequency of metabolic syndrome in this patient group and low levels of physical activity is associated with increased risk of cardiovascular disease, diabetes and all-cause mortality. This study aimed to review trials allocating patients with either schizophrenia or depression to exercise interventions for effect on cardiovascular fitness, strength and weight.MethodsWe searched Pubmed, Embase, and Psycinfo including randomized clinical trial allocating patients with either schizophrenia or depression to isolated exercise interventions.ResultsWe identified five trials including patients with schizophrenia and found little evidence that exercise could increase cardiovascular fitness or decrease weight. Nine exercise trials for patients with depression were identified increasing cardiovascular fitness by 11-30% and strength by 33-37%. No evidence in favor of exercise for weight reduction was found.ConclusionBased on the current evidence isolated exercise interventions are unlikely to improve cardiovascular fitness or induce weight loss in patients with schizophrenia. In patients with depression exercise interventions are likely to induce clinically relevant short term effects, however, due to lack of reporting little is known about the effect on cardiovascular fitness beyond the intervention and weight reduction. Future exercise trials regarding patients with mental illness should preferably measure changes in cardiovascular strength, repetition maximum and anthropometric outcomes. Ideally participants should be assessed beyond the intervention

Motivational deficits and cognitive test performance in schizophrenia.

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Fervaha, Gagan; Zakzanis, Konstantine K; Foussias, George; Graff-Guerrero, Ariel; Agid, Ofer; Remington, Gary

2014-09-01

Motivational and cognitive deficits are core features of schizophrenia, both closely linked with functional outcomes. Although poor effort and decreased motivation are known to affect performance on cognitive tests, the extent of this relationship is unclear in patients with schizophrenia. To evaluate the association between intrinsic motivation and cognitive test performance in patients with schizophrenia. Cross-sectional and 6-month prospective follow-up study performed at 57 sites in the United States, including academic and community medical treatment centers, participating in the Clinical Antipsychotic Trials of Intervention Effectiveness study. The primary sample included 431 stable patients with a DSM-IV diagnosis of schizophrenia currently receiving a stable medication regimen. Cognitive performance and intrinsic motivation were evaluated using a comprehensive neuropsychological test battery and a derived measure from the Heinrichs-Carpenter Quality of Life Scale, respectively. Symptom severity and functional status were also assessed. The primary outcome variable was global neurocognition. Individual domains of cognition were also evaluated for their association with motivation. Level of intrinsic motivation was significantly and positively correlated with global cognitive test performance, a relationship that held for each domain of cognition evaluated (correlation range, 0.20-0.34; P motivation and cognitive performance also remained significant after controlling for antipsychotic dose (P motivation during the 6-month follow-up was also found to be significantly related to improvement in global cognitive performance (P motivation and cognitive performance and suggest that test performance is not purely a measure of ability. Future studies assessing cognition in patients with schizophrenia should consider potential moderating variables such as effort and motivation. Implications for the assessment and interpretation of cognitive impairment based on

Clinical Trials

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Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... from a study at any time, for any reason. Also, during the trial, you have the right ...

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GWA study data mining and independent replication identify cardiomyopathy-associated 5 (CMYA5) as a risk gene for schizophrenia

NARCIS (Netherlands)

Chen, X.; Lee, G.; Maher, B. S.; Fanous, A. H.; Chen, J.; Zhao, Z.; Guo, A.; van den Oord, E.; Sullivan, P. F.; Shi, J.; Levinson, D. F.; Gejman, P. V.; Sanders, A.; Duan, J.; Owen, M. J.; Craddock, N. J.; O'Donovan, M. C.; Blackman, J.; Lewis, D.; Kirov, G. K.; Qin, W.; Schwab, S.; Wildenauer, D.; Chowdari, K.; Nimgaonkar, V.; Straub, R. E.; Weinberger, D. R.; O'Neill, F. A.; Walsh, D.; Bronstein, M.; Darvasi, A.; Lencz, T.; Malhotra, A. K.; Rujescu, D.; Giegling, I.; Werge, T.; Hansen, T.; Ingason, A.; Nöethen, M. M.; Rietschel, M.; Cichon, S.; Djurovic, S.; Andreassen, O. A.; Cantor, R. M.; Ophoff, R.; Corvin, A.; Morris, D. W.; Gill, M.; Pato, C. N.; Pato, M. T.; Macedo, A.; Gurling, H. M. D.; McQuillin, A.; Pimm, J.; Hultman, C.; Lichtenstein, P.; Sklar, P.; Purcell, S. M.; Scolnick, E.; St Clair, D.; Blackwood, D. H. R.; Kendler, K. S.; Kahn, René S.; Linszen, Don H.; van Os, Jim; Wiersma, Durk; Bruggeman, Richard; Cahn, Wiepke; de Haan, Lieuwe; Krabbendam, Lydia; Myin-Germeys, Inez; O'Donovan, Michael C.; Kirov, George K.; Craddock, Nick J.; Holmans, Peter A.; Williams, Nigel M.; Georgieva, Lyudmila; Nikolov, Ivan; Norton, N.; Williams, H.; Toncheva, Draga; Milanova, Vihra; Owen, Michael J.; Hultman, Christina M.; Lichtenstein, Paul; Thelander, Emma F.; Sullivan, Patrick; Morris, Derek W.; O'Dushlaine, Colm T.; Kenny, Elaine; Quinn, Emma M.; Gill, Michael; Corvin, Aiden; McQuillin, Andrew; Choudhury, Khalid; Datta, Susmita; Pimm, Jonathan; Thirumalai, Srinivasa; Puri, Vinay; Krasucki, Robert; Lawrence, Jacob; Quested, Digby; Bass, Nicholas; Gurling, Hugh; Crombie, Caroline; Fraser, Gillian; Kuan, Soh Leh; Walker, Nicholas; St Clair, David; Blackwood, Douglas H. R.; Muir, Walter J.; McGhee, Kevin A.; Pickard, Ben; Malloy, Pat; Maclean, Alan W.; van Beck, Margaret; Wray, Naomi R.; Macgregor, Stuart; Visscher, Peter M.; Pato, Michele T.; Medeiros, Helena; Middleton, Frank; Carvalho, Celia; Morley, Christopher; Fanous, Ayman; Conti, David; Knowles, James A.; Ferreira, Carlos Paz; Macedo, Antonio; Azevedo, M. Helena; Pato, Carlos N.; Stone, Jennifer L.; Ruderfer, Douglas M.; Kirby, Andrew N.; Ferreira, Manuel A. R.; Daly, Mark J.; Purcell, Shaun M.; Sklar, Pamela; Chambert, Kimberly; Kuruvilla, Finny; Gabriel, Stacey B.; Ardlie, Kristin; Moran, Jennifer L.; Scolnick, Edward M.

2011-01-01

We conducted data-mining analyses using the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and molecular genetics of schizophrenia genome-wide association study supported by the genetic association information network (MGS-GAIN) schizophrenia data sets and performed

The Texas medication algorithm project: clinical results for schizophrenia.

Science.gov (United States)

Miller, Alexander L; Crismon, M Lynn; Rush, A John; Chiles, John; Kashner, T Michael; Toprac, Marcia; Carmody, Thomas; Biggs, Melanie; Shores-Wilson, Kathy; Chiles, Judith; Witte, Brad; Bow-Thomas, Christine; Velligan, Dawn I; Trivedi, Madhukar; Suppes, Trisha; Shon, Steven

2004-01-01

In the Texas Medication Algorithm Project (TMAP), patients were given algorithm-guided treatment (ALGO) or treatment as usual (TAU). The ALGO intervention included a clinical coordinator to assist the physicians and administer a patient and family education program. The primary comparison in the schizophrenia module of TMAP was between patients seen in clinics in which ALGO was used (n = 165) and patients seen in clinics in which no algorithms were used (n = 144). A third group of patients, seen in clinics using an algorithm for bipolar or major depressive disorder but not for schizophrenia, was also studied (n = 156). The ALGO group had modestly greater improvement in symptoms (Brief Psychiatric Rating Scale) during the first quarter of treatment. The TAU group caught up by the end of 12 months. Cognitive functions were more improved in ALGO than in TAU at 3 months, and this difference was greater at 9 months (the final cognitive assessment). In secondary comparisons of ALGO with the second TAU group, the greater improvement in cognitive functioning was again noted, but the initial symptom difference was not significant.

Theory of mind correlates with clinical insight but not cognitive insight in patients with schizophrenia.

Science.gov (United States)

Zhang, Qi; Li, Xu; Parker, Giverny J; Hong, Xiao-Hong; Wang, Yi; Lui, Simon S Y; Neumann, David L; Cheung, Eric F C; Shum, David H K; Chan, Raymond C K

2016-03-30

Research on the relationship between insight and social cognition, in particular Theory of Mind (ToM), in schizophrenia has yielded mixed findings to date. Very few studies, however, have assessed both clinical insight and cognitive insight when examining their relationships with ToM in schizophrenia. The current study thus investigated the relationship between clinical insight, cognitive insight, and ToM in a sample of 56 patients with schizophrenia and 30 healthy controls. Twenty-seven patients were classified as low in clinical insight according to their scores on the 'insight' item (G12) of the Positive and Negative Syndrome Scale (PANSS). Moreover, cognitive insight and ToM were assessed with the Beck Cognitive Insight Scale (BCIS) and the Yoni task, respectively. The results indicated that patients with poor clinical insight performed worse on tasks of second-order cognitive and affective ToM, while the ToM performance of patients with high clinical insight was equivalent to that of healthy controls. Furthermore, while clinical insight was correlated with ToM and clinical symptoms, cognitive insight did not correlate with clinical insight, ToM, or clinical symptoms. Clinical insight thus appears to be an important factor related to ToM in schizophrenia. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Bridging the Measurement Gap Between Research and Clinical Care in Schizophrenia

DEFF Research Database (Denmark)

Østergaard, Søren D; Opler, Mark G A; Correll, Christoph U

2017-01-01

studies suggest that the much briefer PANSS-6 is a psychometrically valid measure of core positive and negative symptoms of schizophrenia and that the scale is sensitive to symptom improvement following pharmacological treatment. SNAPSI is a brief interview that yields the information needed to rate PANSS......There is currently a "measurement gap" between research and clinical care in schizophrenia. The main reason behind this gap is that the most widely used rating scale in schizophrenia research, the 30-item Positive and Negative Syndrome Scale (PANSS), takes so long to administer that it is rarely......-item PANSS in clinical practice; 2) how the brief, six-item version of the Positive and Negative Syndrome Scale (PANSS-6) was derived empirically from the full 30-item PANSS and what the initial results obtained with PANSS-6 entail; and 3) how PANSS-6 ratings, guided by the newly developed, 15...

Customising informed consent procedures for people with schizophrenia in India.

Science.gov (United States)

Chatterjee, Sudipto; Kieselbach, Berit; Naik, Smita; Kumar, Shuba; John, Sujit; Balaji, Madhumitha; Koschorke, Mirja; Dabholkar, Hamid; Varghese, Mathew; Patel, Vikram; Thornicroft, Graham; Thara, Rangaswamy

2015-10-01

There is little information on how the ethical and procedural challenges involved in the informed participation of people with schizophrenia in clinical trials are addressed in low- and middle-income countries (LMICs). The informed consent procedure used in the collaborative community care for people with schizophrenia in India (COPSI) RCT was developed keeping these challenges in mind. We describe the feasibility of conducting the procedure from the trial, researcher and participants perspectives and describe the reasons for people consenting to participate in the trial or refusing to do so. Three sources of information were used to describe the feasibility of the COPSI consent procedure: key process indicators for the trial perspective, data from a specially designed post-interview form for participant's observations and focus group discussion (FGD) with the research interviewers. Categorical data were analysed by calculating frequencies and proportions, while the qualitative data from the FGD, and the reasons for participation or refusal were analysed using a thematic content analysis approach. 434 people with schizophrenia and their primary caregiver(s) were approached for participation in the trial. Consent interviews were conducted with 332, of whom 303 (91%) agreed to participate in the trial. Expectation of improvement was the most common reason for agreeing to participate in the trial, while concerns related to the potential disclosure of the illness, especially for women, were an important reason for refusing consent. The COPSI consent procedure demonstrates preliminary, observational information about the feasibility of customising informed consent procedures for people with schizophrenia LMIC contexts. This and other similar innovations need to be refined and rigorously tested to develop evidence-based guidelines for informed consent procedures in such settings.

Therapeutic improvements expected in the near future for schizophrenia and schizoaffective disorder

DEFF Research Database (Denmark)

Garay, Ricardo P; Citrome, Leslie; Samalin, Ludovic

2016-01-01

INTRODUCTION: In this review, the authors describe medications in phase III of clinical development for schizophrenia and schizoaffective disorder, and provide an opinion on how current treatment can be improved in the near future. Areas covered: Recent (post 2013) phase III clinical trials...... and schizoaffective disorder. In addition to better-tolerated antipsychotics that treat positive symptoms, we could see the arrival of the first effective drug for negative symptoms and CIAS, which would strongly facilitate the ultimate goal of recovery in persons with schizophrenia....

Clinical Trials

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Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

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Full Text Available ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ... All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical ...

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Full Text Available ... more screening tests to see which test produces the best results. Some companies and groups sponsor clinical trials that test the ... and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

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[X-ray computed tomographic abnormalities in schizophrenia. Trial of relationship with clinical data].

Science.gov (United States)

D'Amato, T; Rochet, T; Dalery, J; Chauchat, J H; Terra, J L; Arteaga, C; Marie-Cardine, M

1992-01-01

Computerized tomography (CT-scan) studies in schizophrenia revealed that some patients have neuromorphological abnormalities. The structural changes consist mainly in lateral and third ventricle enlargement, and in cortical atrophy. The present study evaluates these three changes in 42 schizophrenics aged 18 to 50, compared to 24 healthy controls. Diagnosis were established from information gathered by personal interview with the SADS-LA. Clinical sub-types were evaluated according to the DSM III-R criteria. Moreover, detailed symptoms were rated according to the Positive And Negative Syndrome Scale (PANSS). CT scans were recorded in floppy disks and blindly analyzed. Schizophrenics shown significant higher mean size of lateral and third ventricles, and higher mean anterior cortical atrophy than healthy subjects. Significant differences were also found between subtypes, with more marked abnormalities in the disorganized group. The relationship between brain abnormalities and clinical symptoms recorded with the PANSS, were analysed using Pearson correlates. Positive correlations concerned mainly negative symptoms like blunted affect, emotional withdrawal, difficulties in abstract thinking, passive apathetic social withdrawal and lack of spontaneity of conversation. Positive correlations are also observed with some symptoms classified with the PANSS in the General Psychopathology scale such as mannerism and disorientation. Negative correlation concerned most of PANSS positive symptoms.

Normal-range verbal-declarative memory in schizophrenia.

Science.gov (United States)

Heinrichs, R Walter; Parlar, Melissa; Pinnock, Farena

2017-10-01

Cognitive impairment is prevalent and related to functional outcome in schizophrenia, but a significant minority of the patient population overlaps with healthy controls on many performance measures, including declarative-verbal-memory tasks. In this study, we assessed the validity, clinical, and functional implications of normal-range (NR), verbal-declarative memory in schizophrenia. Performance normality was defined using normative data for 8 basic California Verbal Learning Test (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000) recall and recognition trials. Schizophrenia patients (n = 155) and healthy control participants (n = 74) were assessed for performance normality, defined as scores within 1 SD of the normative mean on all 8 trials, and assigned to normal- and below-NR memory groups. NR schizophrenia patients (n = 26) and control participants (n = 51) did not differ in general verbal ability, on a reading-based estimate of premorbid ability, across all 8 CVLT-II-score comparisons or in terms of intrusion and false-positive errors and auditory working memory. NR memory patients did not differ from memory-impaired patients (n = 129) in symptom severity, and both patient groups were significantly and similarly disabled in terms of functional status in the community. These results confirm a subpopulation of schizophrenia patients with normal, verbal-declarative-memory performance and no evidence of decline from higher premorbid ability levels. However, NR patients did not experience less severe psychopathology, nor did they show advantage in community adjustment relative to impaired patients. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Oscillatory underpinnings of mismatch negativity and their relationship with cognitive function in patients with schizophrenia.

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Muzaffer Kaser

Full Text Available BACKGROUND: Impairments in mismatch negativity (MMN generation have been consistently reported in patients with schizophrenia. However, underlying oscillatory activity of MMN deficits in schizophrenia and the relationship with cognitive impairments have not been investigated in detail. Time-frequency power and phase analyses can provide more detailed measures of brain dynamics of MMN deficits in schizophrenia. METHOD: 21 patients with schizophrenia and 21 healthy controls were tested with a roving frequency paradigm to generate MMN. Time-frequency domain power and phase-locking (PL analysis was performed on all trials using short-time Fourier transforms with Hanning window tapering. A comprehensive battery (CANTAB was used to assess neurocognitive functioning. RESULTS: Mean MMN amplitude was significantly lower in patients with schizophrenia (95% CI 0.18 - 0.77. Patients showed significantly lower EEG power (95% CI -1.02 - -0.014 in the ~4-7 Hz frequency range (theta band between 170 and 210 ms. Patients with schizophrenia showed cognitive impairment in multiple domains of CANTAB. However, MMN impairments in amplitude and power were not correlated with clinical measures, medication dose, social functioning or neurocognitive performance. CONCLUSION: The findings from this study suggested that while MMN may be a useful marker to probe NMDA receptor mediated mechanisms and associated impairments in gain control and perceptual changes, it may not be a useful marker in association with clinical or cognitive changes. Trial-by-trial EEG power analysis can be used as a measure of brain dynamics underlying MMN deficits which also can have implications for the use of MMN as a biomarker for drug discovery.

Understanding Clinical Trials

Science.gov (United States)

Watch these videos to learn about some basic aspects of cancer clinical trials such as the different phases of clinical trials, methods used to protect patient safety, and how the costs of clinical trials are covered.

Clinico-Epidemiological Comparison of Delusion-Prominent and Hallucination-Prominent Clinical Subgroups of Paranoid Schizophrenia.

Science.gov (United States)

Kreinin, Anatoly; Krishtul, Vladimir; Kirsh, Zvi; Menuchin, Michael

2015-01-01

Though hallucinations and delusions are prominent basic impairments in schizophrenia, reports of the relationship between hallucinatory and delusional symptoms among schizophrenia patients are scant. To examine the epidemiological and clinical differences between mainly hallucinatory and mainly delusional subgroups of paranoid schizophrenia patients. One hundred schizophrenia patients, paranoid type, were recruited. In a cross-sectional study, participants were divided into Mainly Hallucinatory (H) and Mainly Delusional (D) subgroups. Demographic variables were compared and clinical characteristics were evaluated using the Scale for the Assessment of Positive Symptoms, the Scale for the Assessment of Negative Symptoms, and the Clinical Global Impression Scale. The Quality-of-Life Enjoyment and Satisfaction Questionnaire-18 was used to assess quality of life. Clinically, the H group was more heterogeneous as expressed by the broader range of scores that described the clinical picture of patients in that subgroup (in 43 of 78 variables, 55.13%) and similar ranges of scores (31 of 78 variables, 39.74%) for patients in the D group. Duration of hospitalization was significantly longer in group H than in group D (p=0.047). There was no statistically significant difference between the H and D subgroups in demographic characteristics. There are distinct epidemiological and clinical differences between the H and D subgroups, with more severe positive and negative symptoms and greater functional impairment in the H group. Paranoid schizophrenia patients with prominent hallucinations have poorer prognosis and need intensive therapeutic rehabilitation beginning with onset-of-illness. Further genetic studies and comparisons of fMRI and/or PET findings are warranted to investigate additional distinctive characteristics of these subgroups.

The prevalence, risk factors and clinical correlates of obesity in Chinese patients with schizophrenia.

Science.gov (United States)

Li, Qiongzhen; Du, Xiangdong; Zhang, Yingyang; Yin, Guangzhong; Zhang, Guangya; Walss-Bass, Consuelo; Quevedo, João; Soares, Jair C; Xia, Haishen; Li, Xiaosi; Zheng, Yingjun; Ning, Yuping; Zhang, Xiang Yang

2017-05-01

Obesity is a common comorbidity in schizophrenia. Few studies have addressed obesity in Chinese schizophrenia patients. The aims of this current study were to evaluate the prevalence, risk factors and clinical correlates of obesity in Chinese patients with schizophrenia. A total of 206 patients were recruited from a hospital in Beijing. Their clinical and anthropometric data together with plasma glucose and lipid parameters were collected. Positive and Negative Syndrome Scale (PANSS) was rated for all patients. Overall, 43 (20.9%) patients were obese and 67 (32.5%) were overweight. The obese patients had significantly higher glucose levels, triglyceride levels than non-obese patients. Females and patients with type 2 diabetes mellitus had increased risk for obesity. Correlation analysis showed that BMI was associated with sex, education levels, negative symptoms, total PANSS score, triglyceride levels and type 2 diabetes mellitus. Further stepwise regression analysis showed that sex, type 2 diabetes, education level, triglyceride and amount of smoking/day were significant predictors for obesity. Our study showed that the prevalence of obesity in Chinese patients with schizophrenia is higher than that in the general population. Some demographic and clinical variables are risk factors for obesity in schizophrenia. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Clinical Trials

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Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...

Sertindole versus other atypical antipsychotics for schizophrenia

Science.gov (United States)

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

2014-01-01

Background In many countries of the industrialised world second generation (atypical) antipsychotics 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 second generation antipsychotics differ is a matter of debate. Objectives To evaluate the effects of sertindole compared with other second generation antipsychotics for people with schizophrenia and schizophrenia-like psychosis. Search methods We searched the Cochrane Schizophrenia Group Trials Register (April 2007) and ClinicalTrials.gov (February 2009). Selection criteria We included all randomised trials comparing oral sertindole with oral forms of amisulpride, aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone or zotepine for people with schizophrenia or schizophrenia-like psychosis. Data collection and analysis We extracted data independently. For dichotomous data we calculated relative risks (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis based on a random-effects model. For continuous data, we calculated weighted mean differences (WMD) again based on a random-effects model. Main results The review currently includes two short-term low-quality randomised trials (total n=508) both comparing sertindole with risperidone. One third of participants left the studies early (2 RCTs, n=504, RR 1.23 CI 0.94 to 1.60). There was no difference in efficacy (2 RCTs, n=493, WMD PANSS total change from baseline 1.98 CI −8.24 to 12.20). Compared with relatively high doses of risperidone (between 4 and 12 mg/day), sertindole produced significantly less akathisia and parkinsonism (1 RCT, n=321, RR 0.24 CI 0.09 to 0.69, NNT 14, CI 8 to 100). Sertindole produced more cardiac effects (2 RCTs, n=508, RR QTc prolongation 4.86 CI 1.94 to 12.18), weight change (2 RCTs, n=328, WMD 0.99 CI 0.12 to 1.86) and male sexual dysfunction (2 RCTs, n=437, RR 2.90 CI 1.32 to 6.35, NNH 13 CI 8 to 33

Interventions to reduce weight gain in schizophrenia

Science.gov (United States)

Faulkner, Guy; Cohn, Tony; Remington, Gary

2014-01-01

Background Weight gain is common for people with schizophrenia and this has serious implications for health and well being. Objectives To determine the effects of both pharmacological (excluding medication switching) and non pharmacological strategies for reducing or preventing weight gain in people with schizophrenia. Search methods We searched key databases and the Cochrane Schizophrenia Group’s trials register (April 2006), reference sections within relevant papers, hand searched key journals, and contacted the first author of each relevant study and other experts to collect further information. Selection criteria We included all clinical randomised controlled trials comparing any pharmacological or non pharmacological intervention for weight gain (diet and exercise counselling) with standard care or other treatments for people with schizophrenia or schizophrenia-like illnesses. Data collection and analysis We reliably selected, quality assessed and extracted data from studies. As weight is a continuous outcome measurement, weighted mean differences (WMD) of the change from baseline were calculated. The primary outcome measure was weight loss. Main results Twenty-three randomised controlled trials met the inclusion criteria for this review. Five trials assessed a cognitive/behavioural intervention and eighteen assessed a pharmacological adjunct. In terms of prevention, two cognitive/behavioural trials showed significant treatment effect (mean weight change) at end of treatment (n=104, 2 RCTs, WMD −3.38 kg CI −4.2 to −2.0). Pharmacological adjunct treatments were significant with a modest prevention of weight gain (n=274, 6 RCTs, WMD − 1.16 kg CI −1.9 to −0.4). In terms of treatments for weight loss, we found significantly greater weight reduction in the cognitive behavioural intervention group (n=129, 3 RCTs, WMD −1.69 kg CI −2.8 to −0.6) compared with standard care. Authors’ conclusions Modest weight loss can be achieved with selective

Clinical Trials

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Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to ... as clinical trials for adults. For more information, go to "How Do Clinical ...

Outcome of first-episode schizophrenia and the new antipsychotics

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associated w~h poor outcome ard predictors of relapse, and the use ... Although a muttitude of clinical trials has been conducted, no ... negative symptoms and side-effects, are alienated from society ... development of chronic or secondary symptoms are .... psychotropic drugs on negative symptoms in schizophrenia. J Clin.

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Full Text Available ... to main content U.S. Department of Health & Human ... of people. Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ...

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Full Text Available ... risks that outweigh any possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These phases have different purposes and help researchers ...

Clinical and epidemiological aspects of suicide in patients with schizophrenia.

Science.gov (United States)

Gómez-Durán, Esperanza L; Martin-Fumadó, Carles; Hurtado-Ruíz, Gemma

2012-01-01

Suicide is a major cause of death among patients with schizophrenia. Suicide phenomenon's characterization is the best available approach for improved prediction and prevention of suicide. Patients at high risk for suicide need a more intensive monitoring and intervention. The aim of this review is to characterize, from a clinical-epidemiological point of view, the phenomenon of completed suicide in schizophrenia. We performed a systematic review to identify the most relevant studies published between 1994 and 2009, by searching on the international database Medline and among previous reviews references. Patients with schizophrenia experience higher mortality rates than the general population, especially due to the suicide. Most patients with schizophrenia who commit suicide are likely to be young and males, with a higher risk around illness onset and hospitalization periods. Previous suicide attempts are an important risk factor for completed suicide. Suicide risk is associated to psychotic positive symptoms, affective symptoms, depression and substance abuse. Treatment adherence is as protective factor. Patients with schizophrenia are likely to commit suicide by violent means. Suicide prevention should focus on treating affective symptoms and syndromes, improving treatment compliance and providing intensive monitoring to those patients at high risk of suicide, specially around hospitalization periods. Further studies are needed to clarify differential characteristics between suicide behaviour and completed suicide.

Cognitive deficit in patients with paranoid schizophrenia: Its clinical and laboratory correlates.

Science.gov (United States)

Dorofeikova, Mariia; Neznanov, Nikolay; Petrova, Nataliia

2018-04-01

The aim of this study was to search for correlates of cognitive impairment in patients with paranoid schizophrenia among clinical, demographic, anamnestic and biochemical markers (NSE, S100B protein, BDNF, hs-CRP). Patients with paranoid schizophrenia (n=125) were examined using the Brief Assessment of Cognitive Function in Schizophrenia, the Rey-Osterrieth Complex Figure task, and a number of clinical scales including the Positive and Negative Syndrome Scale. The majority of patients demonstrated cognitive impairment. The type of impairment was highly heterogeneous and individual. Relationships were found between the degree of executive functioning and family history of mental illness; working memory and age of onset of schizophrenia; and visual memory and psychopathological symptomatology. Negative and affective symptoms were not significantly associated with cognitive functioning. Treatment with first generation antipsychotics was associated with a more frequent impairment of motor skills, and concomitant anticholinergic drugs, with reduced accuracy. Use of second-generation antipsychotics only was associated with better accuracy, working memory and speech fluency. Among the patients, 21.4% had signs of a systemic inflammatory response, indicating a possible role of inflammatory response in the development of schizophrenia. CRP, S100B and NSE levels reflected features of the course of illness and therapeutic response. Patients with lower concentrations of BDNF were characterized by lower processing speeds. Copyright © 2017 Elsevier B.V. All rights reserved.

The association between weight change and symptom reduction in the CATIE schizophrenia trial.

Science.gov (United States)

Hermes, Eric; Nasrallah, Henry; Davis, Vicki; Meyer, Jonathan; McEvoy, Joseph; Goff, Donald; Davis, Sonia; Stroup, T Scott; Swartz, Marvin; Lieberman, Jeffrey; Rosenheck, Robert

2011-05-01

Weight gain and changes in metabolic indicators associated with some antipsychotics may be related to symptom improvement and thus an unavoidable correlate of clinical benefit. Data from the CATIE schizophrenia trial comparing the effectiveness of perphenazine, olanzapine, risperidone, quetiapine and ziprasidone in a randomized, double-blind, trial over 18 months were used to evaluate the relationship between percent change in body mass index (BMI) and change in total serum cholesterol and triglycerides with the Positive and Negative Syndrome Scale (PANSS) score. Analysis of covariance for observations at 3 months and a mixed effects model for all observations up to 18 months adjusted for potentially confounding variables were used to examine these associations. In both models, there was a significant association (p = 0.001) between change in PANSS total score and percent change in BMI, equating to a 0.28 and 0.21 point decrease in PANSS total score (range 30-210) per 1% increase in BMI respectively. Change in BMI accounted for 3% or less of variance for change in PANSS scores. There was no evidence that the association of symptoms and weight gain differed across medications in spite of substantial differences in weight gain and other metabolic measures. Neither total serum cholesterol nor triglyceride levels displayed a significant association with change in PANSS. The magnitude of the relationship between change in BMI and PANSS was too small to be clinically important, indicating that switching medications to one with less metabolic risk is unlikely to result in meaningful loss of clinical benefit. Copyright © 2011 Elsevier B.V. All rights reserved.

Towards an Immunophenotype of Schizophrenia: Progress, Potential Mechanisms, and Future Directions

Science.gov (United States)

Miller, Brian J; Goldsmith, David R

2017-01-01

The evidence to date, coupled with advances in immunology and genetics has afforded the field an unparalleled opportunity to investigate the hypothesis that a subset of patients with schizophrenia may manifest an immunophenotype, toward new potential diagnostics and therapeutics to reduce risk, alleviate symptoms, and improve quality of life in both at-risk populations and patients with established schizophrenia. In this paper, we will first summarize the findings on immune dysfunction in schizophrenia, including (1) genetic, prenatal, and premorbid immune risk factors and (2) immune markers across the clinical course of the disorder, including cytokines; C-reactive protein; immune cells; antibodies, autoantibodies and comorbid autoimmune disorders; complement; oxidative stress; imaging of neuroinflammation; infections; and clinical trials of anti-inflammatory agents and immunotherapy. We will then discuss a potential mechanistic framework toward increased understanding of a potential schizophrenia immunophenotype. We will then critically appraise the existing literature, and discuss suggestions for the future research agenda in this area that are needed to rigorously evaluate this hypothesis. PMID:27654215

Clinical Trials

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Full Text Available ... Some companies and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

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Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... medical strategy, treatment, or device is safe and effective for humans. These studies also may show which ...

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... include factors such as a patient's age and gender, the type and stage of disease, and whether ...

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Suicide attempt, clinical correlates, and BDNF Val66Met polymorphism in chronic patients with schizophrenia.

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Xia, Haisen; Zhang, Guangya; Du, Xiangdong; Zhang, Yingyang; Yin, Guangzhong; Dai, Jing; He, Man-Xi; Soares, Jair C; Li, Xiaosi; Zhang, Xiang Yang

2018-02-01

Recent evidence suggests the role of brain-derived neurotrophic factor (BDNF) in the pathophysiology of suicidal behavior. Because schizophrenia patients usually have high suicide rates and numerous studies have suggested that BDNF may contribute to the psychopathology of schizophrenia, we hypothesized that the functional polymorphism of BDNF (Val66Met) was associated with suicide attempts in patients with schizophrenia in a Chinese Han population. This polymorphism was genotyped in 825 chronic schizophrenia patients with (n = 123) and without (n = 702) suicide attempts and 445 healthy controls without a history of suicide attempts using a case-control design. The schizophrenia symptoms were assessed by the Positive and Negative Syndrome Scale. There were no significant differences in BDNF Val66Met genotype and allele distributions between the patients and healthy controls. However, we found the Val allele (p = .023) and the Val/Val genotypes (p = .058) to be associated with a history of suicide attempts. Moreover, some clinical characteristics, including age and cigarettes smoked each day, interacted with the BDNF gene variant and appeared to play an important role in suicide attempts among schizophrenia patients. The BDNF Val66Met polymorphism itself and its interaction with some clinical variables may influence suicide attempts among schizophrenia patients. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

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Persistent suicide risk in clinically improved schizophrenia patients: challenge of the suicidal dimension

Directory of Open Access Journals (Sweden)

Amresh Shrivastava

2010-09-01

Full Text Available Amresh Shrivastava1, Megan E Johnston2, Nilesh Shah3, Marco Innamorati4, Larry Stitt5, Meghana Thakar3, David Lester6, Maurizio Pompili4,71Silver Mind Hospital and Mental Health Foundation of India, Mumbai, India; 2Department of Psychology, University of Toronto, Toronto, ON, Canada; 3Lokmanya Tilak Municipal General Hospital, University of Mumbai, India; 4Department of Neurosciences, Mental Health and Sensory Functions, Suicide Prevention Center, Sant’Andrea Hospital, Sapienza University of Rome, Rome, Italy; 5Department of Biostatistics, The University of Western Ontario, London, ON, Canada; 6The Richard Stockton College of New Jersey, Pomona, NJ, USA; 7McLean Hospital, Harvard Medical School, Boston, MA, USABackground: Suicide is a major problem in schizophrenia, estimated to affect 9%–13% of patients. About 25% of schizophrenic patients make at least one suicide attempt in their lifetime. Current outcome measures do not address this problem, even though it affects quality of life and patient safety. The aim of this study was to assess suicidality in long-term clinically improved schizophrenia patients who were treated in a nongovernmental psychiatric treatment centre in Mumbai, India.Method: Participants were 61 patients out of 200 consecutive hospitalized first-episode patients with schizophrenia diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders who were much improved on the Clinical Global Impression Scale-Improvement (CGI-I scale at the endpoint of a 10-year follow-up. Clinical assessment tools included the Positive and Negative Syndrome Scale for Schizophrenia, CGI-I, Global Assessment of Functioning, and suicidality.Results: Many of the patients, although clinically improved, experienced emerging suicidality during the 10-year follow-up period. All of the patients reported significant suicidality (ie, suicide attempts, suicidal crises, or suicidal ideation at the end of the study, whereas only 83% had

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Levothyroxine Augmentation in Clozapine Resistant Schizophrenia: A Case Report and Review

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Ruohollah Seddigh

2015-01-01

Full Text Available There are many reports that show different thyroid abnormalities in schizophrenia without clear establishment of their role in etiology and treatment outcome of schizophrenia. Among these reports, there are only a few that consider a role for thyroid hormones as augmenting agents in the treatment with antipsychotic drugs. This case report outlines symptom subsidence of a patient with clozapine refractory paranoid schizophrenia and normal thyroid function who added levothyroxine to clozapine and found that symptoms of psychosis returned once levothyroxine was discontinued. Although this observation needs to be confirmed in controlled clinical trials, we aimed to discuss possible hypothesized mechanisms underlying this observation.

Treatment of substance use disorders in schizophrenia.

Science.gov (United States)

Bennett, Melanie E; Bradshaw, Kristen R; Catalano, Lauren T

2017-07-01

Substance use disorders (SUDs) represent a great barrier to functional recovery for individuals with schizophrenia. It is important to use research on treatment of SUDs in schizophrenia to guide treatment recommendations and program planning. We review studies of pharmacological and psychosocial interventions to treat SUDs in individuals with schizophrenia. The criteria used to select studies for inclusion are (1) the percentage of the sample with a schizophrenia spectrum diagnosis is at least 25%; (2) participants have a comorbid SUD or problem use of substances; (3) an intervention for SUD is provided; (4) a substance use-related outcome is measured; and (5) the study design enabled examination of pre-post outcome measures including open label trials, nonrandomized evaluations (quasi-experimental designs, nonrandom assignment to groups), or randomized controlled trials. There are few psychopharmacology outcomes studies. Most have examined use of antipsychotic medications to treat SUDs in schizophrenia. Several trials have yielded positive findings for naltrexone in reducing drinking compared to placebo in this population. Motivational and cognitive-behavioral interventions are associated with decreased substance use in several trials. Treatment for SUDs is feasible within a range of settings and acceptable to many individuals with schizophrenia. All individuals with schizophrenia should be offered brief or more extended psychosocial interventions that incorporate discussion of personal reasons to change and training in cognitive-behavioral strategies to reduce use, cope with cravings and stress, and avoid relapse. Future research must include larger samples, longitudinal designs, and similar outcome measures across studies.

Effort-based decision making as an objective paradigm for the assessment of motivational deficits in schizophrenia.

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Fervaha, Gagan; Duncan, Mark; Foussias, George; Agid, Ofer; Faulkner, Guy E; Remington, Gary

2015-10-01

Negative symptoms and motivational deficits are prevalent features of schizophrenia, and represent robust predictors of real-world functional outcomes. The standard for assessment of these symptoms is clinical interview and severity ratings on standardized rating scales. In the present study we examined the psychometric properties of a performance-based measure of motivational deficits in patients with schizophrenia. Ninety-seven patients with schizophrenia were included in this investigation. Patients' willingness to expend effort for reward (i.e., motivation) was evaluated using an effort-based decision making paradigm where participants chose over a series of trials whether to expend a greater amount of effort for a larger monetary reward versus less effort for a smaller reward. Effort performance was evaluated twice, separated by a two-week interval. Patients with schizophrenia opted to expend greater effort for trials with higher reward value and greater likelihood of reward receipt. Patients did not find the task overly difficult and reported being motivated to perform well, underscoring the tolerability of the task for patients. Test-retest consistency was good and there was only minimal change in scores over time. Effort performance was not related to sociodemographic or clinical variables (e.g., positive symptoms); however, deficit syndrome patients exerted effort for reward at a significantly lower rate than nondeficit patients. The effort-based decision making task used in the present study represents an objective paradigm that can be used to evaluate motivational impairments in patients with schizophrenia. Such performance-based measures of motivation may also serve as viable endpoints in clinical trials. Copyright © 2015 Elsevier B.V. All rights reserved.

Toxoplasma gondii and schizophrenia: a review of published RCTs.

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Chorlton, Sam D

2017-07-01

Over the last 60 years, accumulating evidence has suggested that acute, chronic, and maternal Toxoplasma gondii infections predispose to schizophrenia. More recent evidence suggests that chronically infected patients with schizophrenia present with more severe disease. After acute infection, parasites form walled cysts in the brain, leading to lifelong chronic infection and drug resistance to commonly used antiparasitics. Chronic infection is the most studied and closely linked with development and severity of schizophrenia. There are currently four published randomized controlled trials evaluating antiparasitic drugs, specifically azithromycin, trimethoprim, artemisinin, and artemether, in patients with schizophrenia. No trials have demonstrated a change in psychopathology with adjunctive treatment. Published trials have either selected drugs without evidence against chronic infection or used them at doses too low to reduce brain cyst burden. Furthermore, trials have failed to achieve sufficient power or account for confounders such as previous antipsychotic treatment, sex, age, or rhesus status on antiparasitic effect. There are currently no ongoing trials of anti-Toxoplasma therapy in schizophrenia despite ample evidence to justify further testing.

Schizophrenia and Metacognition

DEFF Research Database (Denmark)

Austin, Stephen F.; Mors, Ole; Nordentoft, Merete

2014-01-01

tested for relationships between course of illness and levels of specific metacognitions in schizophrenia spectrum disorders. A large cohort of people with first episode psychosis (n = 578) recruited as part the OPUS trial (1998–2000) were tested. Information about course of illness (remitted, episodic...... beliefs may also impact on positive symptoms and course of illness within schizophrenia....

Conducting clinical trials in Singapore.

Science.gov (United States)

Woo, K T

1999-04-01

All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

Quality of clinical trials for selected priority mental and neurological disorders in sub-Saharan Africa: a systematic review

Directory of Open Access Journals (Sweden)

Mulugeta A

2016-12-01

Full Text Available Anwar Mulugeta,1 Girmay Medhin,2 Getnet Yimer,1 Rahimush Jemal,3 Abebaw Fekadu,4,5 1Department of Pharmacology, School of Medicine, College of Health Sciences, Addis Ababa University, 2Aklilu Lemma Institute of Pathobiology, Addis Ababa University, 3Department of Pharmacy, Tikur Anbesa Hospital, 4Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; 5Department of Psychological Medicine, Centre for Affective Disorders, Institute of Psychiatry, King’s College London, London, UK Background: There is a developing consensus on the effectiveness of various interventions for mental disorders in low- and middle-income countries, and it has been proposed that the main task is to scale up these interventions. In this context, we aimed to review the quality and extent of intervention trials for selected priority mental and neurological disorders in sub-Saharan Africa.Methods: Medline and African Journals Online databases were used for searching relevant articles. Both randomized and nonrandomized clinical trials for the treatment of schizophrenia, depression, maternal depression, bipolar disorder, and epilepsy/seizure disorders that involve pharmacotherapy, psychotherapy, and physical therapy were included. An extensive list of search terms that identified locations, disorders, interventions, and study types were employed. The qualities of the trials were appraised using the single-component quality assessment of the consolidated standards of reporting trials (CONSORT statement and the Jadad scale.Results: From 1,136 studies identified, only 34 trials that fulfilled inclusion criteria were used for quality analysis. Most studies were clinical trials of treatments for epilepsy and were conducted after 2006. In terms of region, the majority of studies were conducted in South Africa (22 of the 34 studies. Approximately half of the trials (53% were conducted in single center and the majority

Effect of Olanzapine on Clinical and Polysomnography Profiles in Patients with Schizophrenia

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Mohammad Zia Ul Haq Katshu

2018-01-01

Full Text Available Acute and short-term administration of olanzapine has a favorable effect on sleep in schizophrenia patients. This study aimed to clarify the effect of olanzapine on polysomnographic profiles of schizophrenia patients during the acute phase of illness after controlling for previous drug exposure. Twenty-five drug-naïve or drug-free schizophrenia patients were assessed at baseline and after six weeks of olanzapine treatment on Brief Psychiatric Rating Scale (BPRS, Positive and Negative Syndrome Scale (PANSS, and Udvalg for Kliniske Undersogelser (UKU side-effect rating scale and a whole-night polysomnography; fifteen patients completed the study. There was a significant reduction in all psychopathological variables with maximum reduction in PANSS total, BPRS total, and PANSS positive scores. A significant increase in total sleep time (TST, sleep efficiency (SE, nonrapid eye movement (NREM stage 1 duration, stage 3 duration, stage 4 duration, and stage 4 percentage of TST, number of rapid eye movement (REM periods, REM duration, and REM percentage of TST was observed. REM latency at baseline inversely predicted the reduction in BPRS total and PANSS total and positive scores. In summary, short-term treatment with olanzapine produced significant improvement in clinical and polysomnography profiles of patients with schizophrenia with shorter REM latency predicting a good clinical response.

Clinical Trials

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Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, talk with your doctor. He or she may know about studies going on in your area. You can visit the following website to learn more about ...

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Full Text Available ... Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... phase II clinical trials. The risk of side effects might be even greater for ... treatments. Health insurance and health care providers don't always ...

Role of nitric oxide and related molecules in schizophrenia pathogenesis: biochemical, genetic and clinical aspects

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Regina F. Nasyrova

2015-05-01

Full Text Available Currently, schizophrenia is considered a multifactorial disease. Over the past 50 years, many investigators have considered the role of toxic free radicals in the etiology of schizophrenia. This is an area of active research which is still evolving. Here, we review the recent data and current concepts on the roles of nitric oxide (NO and related molecules in the pathogenesis of schizophrenia. NO is involved in storage, uptake and release of mediators and neurotransmitters, including glutamate, acetylcholine, noradrenaline, GABA, taurine and glycine. In addition, NO diffuses across cell membranes and activates its own extrasynaptic receptors. Further, NO is involved in peroxidation and reactive oxidative stress. Investigations reveal significant disturbances in NO levels in the brain structures (cerebellum, hypothalamus, hippocampus, striatum and fluids of subjects with schizophrenia. Given the roles of NO in central nervous system development, these changes may result in neurodevelopmental changes associated with schizophrenia. We describe here the recent literature on NOS gene polymorphisms on schizophrenia, which all point to consistent results. We also discuss how NO may be a new target for the therapy of mental disorders. Currently there have been 2 randomized double-blind placebo-controlled trials of L-lysine as an NOS inhibitor in the CNS.

Efficacy and safety of adjunctive topiramate for schizophrenia: a meta-analysis of randomized controlled trials.

Science.gov (United States)

Zheng, W; Xiang, Y-T; Xiang, Y-Q; Li, X-B; Ungvari, G S; Chiu, H F K; Correll, C U

2016-11-01

To systematically examine the randomized controlled trial (RCT) evidence regarding efficacy and tolerability of topiramate cotreatment with antipsychotics in schizophrenia-spectrum disorders. Random-effects meta-analysis of RCTs of topiramate cotreatment with antipsychotics vs. placebo/ongoing antipsychotic treatment in schizophrenia-spectrum disorders. Standardized or weighted mean difference (SMD/WMD), risk ratio (RR) ±95% confidence intervals (CIs), and number needed to harm (NNH) were calculated. Across 16 RCTs (n = 934, duration = 11.8 ± 5.6 weeks), topiramate outperformed the comparator regarding change/endpoint of total (SMD: -0.58, 95% CI: -0.82, -0.35, P weight loss was greater in prevention/co-initiation vs. intervention/augmentation RCTs (-4.11 kg, 95% CI: -6.70, -1.52 vs. -1.41 kg, 95% CI: -2.23, -0.59, P schizophrenia-spectrum disorders. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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Full Text Available ... products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ... cancer also increased. As a result, the U.S. Food and Drug Administration now recommends never using HT ... Clinical Trials Work If you take ...

Two patients walk into a clinic...a genomics perspective on the future of schizophrenia

Directory of Open Access Journals (Sweden)

Corvin Aiden P

2011-11-01

Full Text Available Abstract Progress is being made in schizophrenia genomics, suggesting that this complex brain disorder involves rare, moderate to high-risk mutations and the cumulative impact of small genetic effects, coupled with environmental factors. The genetic heterogeneity underlying schizophrenia and the overlap with other neurodevelopmental disorders suggest that it will not continue to be viewed as a single disease. This has radical implications for clinical practice, as diagnosis and treatment will be guided by molecular etiology rather than clinical diagnostic criteria.

Two patients walk into a clinic...a genomics perspective on the future of schizophrenia

LENUS (Irish Health Repository)

Corvin, Aiden P

2011-11-11

Abstract Progress is being made in schizophrenia genomics, suggesting that this complex brain disorder involves rare, moderate to high-risk mutations and the cumulative impact of small genetic effects, coupled with environmental factors. The genetic heterogeneity underlying schizophrenia and the overlap with other neurodevelopmental disorders suggest that it will not continue to be viewed as a single disease. This has radical implications for clinical practice, as diagnosis and treatment will be guided by molecular etiology rather than clinical diagnostic criteria.

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Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative ... safe a treatment is or how well it works. Children (aged 18 and younger) get ... legal consent for their child to take part in a clinical trial. When ...

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Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... clinical trials are vital to the process of improving medical care. Many people ... participants, it may not work for you. A new treatment may have side ...

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Full Text Available ... you agree to take part in the trial. Talk with your doctor about specific trials you're ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

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Full Text Available ... any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in. For a list of questions to ask your doctor and the ...

Hoarding behaviour in Xhosa patients with schizophrenia - prevalence and clinical presentation

Directory of Open Access Journals (Sweden)

T Ameer

2007-12-01

Full Text Available Objective:Hoarding is commonly defined as the acquisition ofand failure to discard possessions of little use or value, and isincluded as a symptom in the diagnostic criteria for obsessivecompulsive personality disorder (OCPD and obsessivecompulsive disorder (OCD. However, it has also beenobserved in other clinical syndromes including schizophrenia.This study was conducted to investigate the prevalence andclinical presentation of hoarding behaviour in schizophreniaamong Xhosa patients.Method:The sample consisted of 102 patients, recruited aspart of a larger genetic study in the Cape Town metropolebetween November 2004 and January 2005, diagnosed withschizophrenia or schizoaffective disorders according to theDiagnostic and Statistical Manual of Mental Disorders(DSM-IVcriteria. They were screened for clinically significant hoardingsymptoms. If these were present, additional information onthe phenomenology was obtained by means of a structuredquestionnaire. The Mini International Neuropsychiatric Interview(MINI (screen and full version, the Yale Brown ObsessiveCompulsive Scale (Y-BOCS Checklist, Y-BOCS, Clutter ImageRating Scale (CIRS and a structured questionnaire on hoardingwere administered.Results:Only four patients with schizophrenia were classifiedas hoarders. Although their clinical presentation resembled thatof hoarders described elsewhere in the literature, they had lowY-BOCS scores and did not report other obsessive-compulsivesymptoms.Conclusion:Our results suggest that hoarding behaviour isnot common in Xhosa patients with schizophrenia. Furtherinvestigation of protective factors for hoarding behaviour in theXhosa population is warranted.

Cognitive Training for Schizophrenia in Developing Countries: A Pilot Trial in Brazil

Directory of Open Access Journals (Sweden)

Livia M. M. Pontes

2013-01-01

Full Text Available Cognitive deficits in schizophrenia can massively impact functionality and quality of life, furthering the importance of cognitive training. Despite the development of the field in Europe and in the United States, no programmes have been developed and tested in developing countries. Different cultural backgrounds, budget restrictions, and other difficulties may render treatment packages created in high income countries difficult for adoption by developing nations. We performed a pilot double-blind, randomized, controlled trial in order to investigate the efficacy and feasibility of an attention and memory training programme specially created in a developing nation. The intervention used simple, widely available materials, required minimal infrastructure, and was conducted in groups. The sample included seventeen stable Brazilians with schizophrenia. Sessions were conducted weekly during five months. The cognitive training group showed significant improvements in inhibitory control and set-shifting over time. Both groups showed improvements in symptoms, processing speed, selective attention, executive function, and long-term visual memory. Improvements were found in the control group in long-term verbal memory and concentration. Our findings reinforce the idea that cognitive training in schizophrenia can be constructed using simple resources and infrastructure, facilitating its adoption by developing countries, and it may improve cognition.

Managing clinical trials

Directory of Open Access Journals (Sweden)

Kenyon Sara

2010-07-01

Full Text Available Abstract Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.

Memory deficit in patients with schizophrenia and posttraumatic stress disorder: relational vs item-specific memory

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Jung W

2016-05-01

Full Text Available Wookyoung Jung,1 Seung-Hwan Lee1,2 1Clinical Emotions and Cognition Research Laboratory, Department of Psychiatry, Inje University, Ilsan-Paik Hospital, 2Department of Psychiatry, Inje University, Ilsan-Paik Hospital, Goyang, Korea Abstract: It has been well established that patients with schizophrenia have impairments in cognitive functioning and also that patients who experienced traumatic events suffer from cognitive deficits. Of the cognitive deficits revealed in schizophrenia or posttraumatic stress disorder (PTSD patients, the current article provides a brief review of deficit in episodic memory, which is highly predictive of patients’ quality of life and global functioning. In particular, we have focused on studies that compared relational and item-specific memory performance in schizophrenia and PTSD, because measures of relational and item-specific memory are considered the most promising constructs for immediate tangible development of clinical trial paradigm. The behavioral findings of schizophrenia are based on the tasks developed by the Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia (CNTRICS initiative and the Cognitive Neuroscience Test Reliability and Clinical Applications for Schizophrenia (CNTRACS Consortium. The findings we reviewed consistently showed that schizophrenia and PTSD are closely associated with more severe impairments in relational memory compared to item-specific memory. Candidate brain regions involved in relational memory impairment in schizophrenia and PTSD are also discussed. Keywords: schizophrenia, posttraumatic stress disorder, episodic memory deficit, relational memory, item-specific memory, prefrontal cortex, hippocampus

[Association of Schizophrenia and its Clinical Implications with the NOS1AP Gene in the Colombian Population].

Science.gov (United States)

Valencia, Jenny García; Duarte, Ana Victoria Valencia; Vila, Ana Lucía Páez; Kremeyer, Bárbara; Montoya, María Patricia Arbeláez; Linares, Andrés Ruiz; Acosta, Carlos Alberto Palacio; Duque, Jorge Ospina; Berrío, Gabriel Bedoya

2012-06-01

The nitric oxide synthase 1 adaptor protein (NOS1AP) gene is possibly implicated in schizophrenia etiopathogenesis. To determine the association of NOS1AP gene variants with schizophrenia and the relationship of variants with the clinical dimensions of the disorder in the Colombian population. It is a case-control study with 255 subjects per group. Markers within the NOS1AP gene were typified as well as other informative material of genetic origin so as to adjust by population stratification. A factorial analysis of the main components for each item in the Scales for Evaluating Negative Symptoms (SENS) together with the Scales for Evaluating Positive Symptoms (SEPS) to determine clinical dimensions. Association between the C/C genotype of the rs945713 marker with schizophrenia (OR = 1.79, 95% CI: 1.13 - 2.84) was found. The C/C genotype of the rs945713 was related to higher scores in the "affective flattening and alogia" dimension; and the A/A genotype of the rs4657181 marker was associated to lower scores in the same dimension. Significant associations of markers inside the NOS1AP gene with schizophrenia and the "affective flattening and alogia" clinical dimension were found. These results are consistent with previous studies and support the possibility that NOS1AP influences schizophrenia susceptibility. Furthermore, NOS1AP might be a modifier of schizophrenia clinical characteristics. Copyright © 2012 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

A multicenter, randomized controlled trial of individualized occupational therapy for patients with schizophrenia in Japan

Science.gov (United States)

Ohori, Manami; Inagaki, Yusuke; Shimooka, Yuko; Sugimura, Naoya; Ishihara, Ikuyo; Yoshida, Tomotaka

2018-01-01

The individualized occupational therapy (IOT) program is a psychosocial program that we developed to facilitate proactive participation in treatment and improve cognitive functioning and other outcomes for inpatients with acute schizophrenia. The program consists of motivational interviewing, self-monitoring, individualized visits, handicraft activities, individualized psychoeducation, and discharge planning. This multicenter, open-labeled, blinded-endpoint, randomized controlled trial evaluated the impact of adding IOT to a group OT (GOT) program as usual for outcomes in recently hospitalized patients with schizophrenia in Japanese psychiatric hospitals setting compared with GOT alone. Patients with schizophrenia were randomly assigned to the GOT+IOT group or the GOT alone group. Among 136 randomized patients, 129 were included in the intent-to-treat population: 66 in the GOT+IOT and 63 in the GOT alone groups. Outcomes were administered at baseline and discharge or 3 months following hospitalization including the Brief Assessment of Cognition in Schizophrenia Japanese version (BACS-J), the Schizophrenia Cognition Rating Scale Japanese version, the Social Functioning Scale Japanese version, the Global Assessment of Functioning scale, the Intrinsic Motivation Inventory Japanese version (IMI-J), the Morisky Medication Adherence Scale-8 (MMAS-8), the Positive and Negative Syndrome Scale (PANSS), and the Japanese version of Client Satisfaction Questionnaire-8 (CSQ-8J). Results of linear mixed effects models indicated that the IOT+GOT showed significant improvements in verbal memory (p IOT demonstrated significant improvements on the CSQ-8J compared with the GOT alone (p IOT program and its effectiveness for improving cognitive impairment and other outcomes in patients with schizophrenia. PMID:29621261

Fundamentals of clinical trials

CERN Document Server

Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

2015-01-01

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

Electroconvulsive Therapy for Agitation in Schizophrenia: Metaanalysis of Randomized Controlled Trials.

Science.gov (United States)

Gu, Xiaojing; Zheng, Wei; Guo, Tong; Ungvari, Gabor S; Chiu, Helen F K; Cao, Xiaolan; D'Arcy, Carl; Meng, Xiangfei; Ning, Yuping; Xiang, Yutao

2017-02-25

Agitation poses a significant challenge in the treatment of schizophrenia. Electroconvulsive therapy (ECT) is a fast, effective and safe treatment for a variety of psychiatric disorders, but no meta-analysis of ECT treatment for agitation in schizophrenia has yet been reported. To systematically evaluate the efficacy and safety of ECT alone or ECT-antipsychotics (APs) combination for agitation in schizophrenia. Systematic literature search of randomized controlled trials (RCTs) was performed. Two independent evaluators selected studies, extracted data about outcomes and safety with available data, conducted quality assessment and data synthesis. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) was used to judge the level of the overall evidence of main outcomes. Seven RCTs from China, including ECT alone (4 RCTs with 5 treatment arms, n=240) and ECT-APs combination (3 RCTs, n=240), were identified. Participants in the studies were on average 34.3(4.5) years of age and lasted an average of 4.3(3.1) weeks of treatment duration. All 7 RCTs were non-blinded, and were rated as low quality based on Jadad scale. Meta-analysis of the pooled sample found no significant difference in the improvement of the agitation sub-score of the Positive and Negative Syndrome Scale (PANSS) when ECT alone (weighted mean difference=-0.90, (95% confidence interval (CI): -2.91, 1.11), p=0.38) or ECT-APs combination (WMD=-1.34, (95%CI: -4.07, 1.39), p=0.33) compared with APs monotherapy. However, ECT alone was superior to APs monotherapy regarding PANSS total score (WMD=-7.13, I 2 =0%, p =0.004) and its excitement sub-score (WMD=-1.97, p agitation related outcomes in schizophrenia patients. However, ECT alone or ECT-APs combination were associated with significant reduction in the PANSS total score. High-quality RCTs are needed to confirm the current interpretations.

Schizophrenia and the efficacy of qEEG-guided neurofeedback treatment: a clinical case series.

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Surmeli, Tanju; Ertem, Ayben; Eralp, Emin; Kos, Ismet H

2012-04-01

Schizophrenia is sometimes considered one of the most devastating of mental illnesses because its onset is early in a patient's life and its symptoms can be destructive to the patient, the family, and friends. Schizophrenia affects 1 in 100 people at some point during their lives, and while there is no cure, it is treatable with antipsychotic medications. According to the Clinical Antipsychotic Trials for Interventions Effectiveness (CATIE), about 74% of the patients who have discontinued the first medication prescribed within a year will have a relapse afterward. This shows an enormous need for developing better treatment methods and better ways to manage the disease, since current therapies do not have sufficient impact on negative symptoms, cognitive dysfunction, and compliance to treatment. In this clinical case series, we investigate the efficacy of quantitative electroencephalography (qEEG)-guided neurofeedback (NF) treatment in this population, and whether this method has an effect on concurrent medical treatment and on the patients. Fifty-one participants (25 males and 26 females) ranging from 17 to 54 years of age (mean: 28.82 years and SD: 7.94 years) were included. Signed consent was received from all patients. Most of the participants were previously diagnosed with chronic schizophrenia, and their symptoms did not improve with medication. All 51 patients were evaluated using qEEG, which was recorded at baseline and following treatment. Before recording the qEEG, participants were washed out for up to 7 half-lives of the medication. After Food and Drug Administration (FDA)-approved Nx-Link Neurometric analysis, qEEGs suggested a diagnosis of chronic schizophrenia for all participants. This was consistent with the clinical judgment of the authors. The participants' symptoms were assessed by means of the Positive and Negative Syndrome Scale (PANSS). Besides the PANSS, 33 out of 51 participants were also evaluated by the Minnesota Multiphasic Personality

Clinical trial methodology

National Research Council Canada - National Science Library

Peace, Karl E; Chen, Ding-Geng

2011-01-01

"Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...

[Negative symptoms in schizophrenia: psychotherapeutic approaches].

Science.gov (United States)

Azorin, J-M; Adida, M; Belzeaux, R; Pringuey, D; Micoulaud Franchi, J-A; Simon, N; Cermolacce, M; Kaladjian, A; Fakra, E

2015-12-01

Although negative symptoms are recognized as a central feature of schizophrenia, their definition as well as phenomenology have long been a vexing issue. During these last years, a major progress has been made with the delineation of two underlying subdomains of negative symptoms: diminished expression and anhedonia-avolition-apathy. As current guidelines are not always in accord on the efficacy of treatments on negative symptoms, it may be tempting to re-interpret the findings of clinical trials by looking at the effects of treatments on these two subdomains. This could concern both psychotropic treatments and psychotherapeutic interventions. Furthermore, neuroimaging as well as emotional response studies have permitted to better understand the mechanism which could be at the root of diminished expression and anhedonia in schizophrenia. On this basis, new psychotherapeutic methods have been devised which, by specifically targeting these two subdomains, are likely to be more efficient on negative symptoms. Further research is warranted to test their efficacy in randomized controlled trials. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Clinical global impression of cognition in schizophrenia (CGI-CogS): reliability and validity of a co-primary measure of cognition.

Science.gov (United States)

Ventura, Joseph; Cienfuegos, Angel; Boxer, Oren; Bilder, Robert

2008-11-01

Cognitive deficits are core features of schizophrenia that have been associated reliably with functional outcomes and now are a focus of treatment research. New rating scales are needed to complement current psychometric testing procedures, both to enable wider clinical use, and to serve as endpoints in clinical trials. Subjects were 35 schizophrenia patient-and-caregiver pairs recruited from the UCLA and West Los Angeles VA Outpatient Psychiatry Departments. Participants were assessed with the Clinical Global Impression of Cognition in Schizophrenia (CGI-CogS), an interview-based rating scale of cognitive functioning, on 3 occasions (baseline, 1 month, and 3 months). A computerized neurocognitive battery (Cogtest), an assessment of functioning, and symptom measures were administered at two occasions (baseline and one month). The CGI-CogS ratings generally showed a high level of internal consistency (Cronbach's alpha=.69 to .96), adequate levels of inter-rater reliability (ICC's=.71 to .80), and high test-retest stability (ICC's=.92 to .95). Correlations of caregiver and rater global (but not "patient only rating") CGI-CogS ratings with neurocognitive performance were in the moderate range (r's=-.27 to -.48), while most of the correlations with functional outcome were moderate to high (r's=-.41 to -.72). In fact, the CGI-CogS ratings were significantly more correlated with Social Functioning than were objective neurocognitive test scores (p=.02) and showed a trend in the same direction for predicting Instrumental Functioning (p=.06). We found moderate correlations between CGI-CogS global ratings and PANSS positive (r's=.36 to .49) and SANS negative symptoms (r=.41 to .61), but not with BPRS depression (r's=.11 to .13). An interview-based measure of cognition demonstrated high internal consistency, good inter-rater reliability, and high test-retest reliability. Caregiver ratings appear to add important clinical information over patient-only ratings. The CGI

Cigarette smoking in male patients with chronic schizophrenia in a Chinese population: prevalence and relationship to clinical phenotypes.

Directory of Open Access Journals (Sweden)

Xiang Yang Zhang

Full Text Available The high prevalence of smoking in schizophrenia of European background may be related to smoking's reducing clinical symptoms and medication side effects. Because smoking prevalence and its associations with clinical phenotypes are less well characterized in Chinese than European patients with schizophrenia, we assessed these smoking behaviors using clinician-administered questionnaires and the Fagerstrom Test for Nicotine Dependence (FTND in 776 Chinese male schizophrenia and 560 control subjects. Patients also were rated on the Positive and Negative Symptom Scale (PANSS, the Simpson and Angus Extrapyramidal Symptom Rating Scale (SAES, and the Abnormal Involuntary Movement Scale (AIMS. We found that the schizophrenia patients had a higher lifetime incidence of smoking (79% vs 63%, were more likely to be heavy smokers (61% vs 31%, and had lower smoking cessation rates (4% vs 9% (all p0.05 than the non-smoking patients. These results suggest that Chinese males with schizophrenia smoke more frequently than the general population. Further, smokers with schizophrenia may display fewer negative symptoms and possibly less parkinsonism than non-smokers with schizophrenia.

Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.

Science.gov (United States)

Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo

2017-12-01

The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.

First episode schizophrenia

African Journals Online (AJOL)

with schizophrenia present clinically with psychotic, negative and cognitive ... changes in their emotions, cognition or behaviour which may indicate a ... contribute 80% to the risk of schizophrenia developing. A number of .... Positive symptoms ... Depression ... treatment of first episode schizophrenia is of critical importance.

Association between forkhead-box P2 gene polymorphism and clinical symptoms in chronic schizophrenia in a Chinese population.

Science.gov (United States)

Rao, Wenwang; Du, Xiangdong; Zhang, Yingyang; Yu, Qiong; Hui, Li; Yu, Yaqin; Kou, Changgui; Yin, Guangzhong; Zhu, Xiaomin; Man, Lijuan; Soares, Jair C; Zhang, Xiang Yang

2017-07-01

The forkhead-box P2 (FOXP2) gene polymorphism has been reported to be involved in the susceptibility to schizophrenia; however, few studies have investigated the association between FOXP2 gene polymorphism and clinical symptoms in schizophrenia. This study investigated whether the FOXP2 gene was associated with the development and symptoms of schizophrenia in relatively genetically homogeneous Chinese population. The FOXP2 rs10447760 polymorphism was genotyped in 1069 schizophrenia inpatients and 410 healthy controls using a case-control design. The patients' psychopathology was assessed by the Positive and Negative Syndrome Scale (PANSS). We found no significant differences in the genotype and allele distributions between the patient and control groups. Interestingly, we found significant differences in PANSS total, positive symptom, and general psychopathology scores between genotypic subgroups in patients, with the higher score in patients with CC genotype than those with CT genotype (all p schizophrenia, but may contribute to the clinical symptoms of schizophrenia among Han Chinese.

Targeting Functional Biomarkers in Schizophrenia with Neuroimaging

OpenAIRE

Wylie, Korey P.; Smucny, Jason; Legget, Kristina T.; Tregellas, Jason R.

2016-01-01

Many of the most debilitating symptoms for psychiatric disorders such as schizophrenia remain poorly treated. As such, the development of novel treatments is urgently needed. Unfortunately, the costs associated with high failure rates for investigational compounds as they enter clinical trials has led to pharmaceutical companies downsizing or eliminating research programs needed to develop these drugs. One way of increasing the probability of success for investigational compounds is to incorp...

The MATISSE study: a randomised trial of group art therapy for people with schizophrenia

OpenAIRE

Crawford, M. J.; Killaspy, H.; Kalaitzaki, E.; Barrett, B.; Byford, S.; Patterson, S.; Soteriou, T.; O Neill, F. A.; Clayton, K.; Maratos, A.; Barnes, T. R.; Osborn, D.; Johnson, T.; King, M.; Tyrer, P.

2010-01-01

Background: Art Therapy has been promoted as a means of helping people who may find it difficult to express themselves verbally engage in psychological treatment. Group Art Therapy has been widely used as an adjunctive treatment for people with schizophrenia but there have been few attempts to examine its effects and cost effectiveness has not been examined. The MATISSE study aims to evaluate the clinical and cost effectiveness of group Art Therapy for people with schizophrenia.Method/Design:...

Symptom structure and severity: a comparison of responses to the positive and negative syndrome scale (PANSS) between patients with PTSD or schizophrenia.

Science.gov (United States)

Stefanovics, Elina A; Krystal, John H; Rosenheck, Robert A

2014-05-01

To describe and compare the structure and relative severity of symptoms in clinical trial patients diagnosed with Post Traumatic Stress Disorder (PTSD) or schizophrenia using the Positive and Negative Syndrome Scale (PANSS), developed originally to evaluate symptoms of schizophrenia. This secondary data analysis used baseline PANSS symptom ratings (n=267) from a six-month multicenter randomized placebo-controlled trial of adjunctive risperidone in patients with chronic military-related PTSD. First, using a split-half design, Exploratory Factor Analysis (EFA) was employed to identify independent factors which were then compared to published factor structures for schizophrenia. Next, Confirmatory Factor Analysis (CFA) was applied to the second half of the sample to compare the results of the EFA and published factor structures. Finally, T-tests were used to compare the severity of factor scores between the PTSD sample and the baseline PANSS ratings from the Clinical Antipsychotic Trial for Intervention Effectiveness (CATIE) schizophrenia sample (n=1460). EFA suggested five factors similar to those identified in a summary of 29 schizophrenia studies by Wallwork (Schizophrenia Research, 137:246-250). CFA showed that the five factor Wallwork model fit the data better than the EFA, although both had relatively high goodness of fit. T-tests showed that the PTSD sample had more severe symptoms on the Depressive factor, and the schizophrenia sample on the Positive, Negative, and Disorganized factors, with no significant difference on the Excited factor. Veterans with PTSD had similar symptom structure to patients with schizophrenia on the PANSS, but were less symptomatic on psychosis-related factors and more symptomatic on depression. Dimensional symptom factors can be virtually the same across diagnoses. Published by Elsevier Inc.

Clinical and neuropsychological features of violence in schizophrenia: A prospective cohort study.

Science.gov (United States)

Bulgari, Viola; Iozzino, Laura; Ferrari, Clarissa; Picchioni, Marco; Candini, Valentina; De Francesco, Alessandra; Maggi, Paolo; Segalini, Beatrice; de Girolamo, Giovanni

2017-03-01

The increased risk of violence in schizophrenia has been linked to several environmental, clinical and neuropsychological factors, including executive dysfunction. However, data about the nature of these effects are mixed and controversial. The main aim of this study was to investigate the relationship between clinical and neuropsychological factors with violence risk in patients with schizophrenia, taking into account current psychopathology and lifetime alcohol use. We compared a sample of patients living in Residential Facilities (RFs) with schizophrenia and a past history of interpersonal violence (vSZ, N=50) to patients with schizophrenia matched on age, gender and alcohol abuse/dependence but with no violence history (nvSZ, N=37). We then established the association between the clinical and neuropsychological factors that predicted violence over a 1year follow-up period. The results revealed that vSZ patients living in RFs were characterized by greater compulsory hospital admissions, higher anger and less negative symptoms as compared to nvSZ patients. vSZ patients performed better on executive and motor tasks than nvSZ; however, these differences appeared to be explained by the lower negative psychotic symptom in the vSZ group. Both groups were involved in episodes of violence during the follow-up period; among the two, the vSZ patients were more likely to be violent. Negative symptoms predicted less verbal aggression at 1year follow-up. Overall, these findings support a key role of negative rather than positive symptoms in driving violence risk among SZ patients living in RFs, in a manner that negative symptoms are linked to a lower risk of violence. Copyright © 2016 Elsevier B.V. All rights reserved.

Effects of nutritional education on weight change and metabolic abnormalities among patients with schizophrenia in Japan: A randomized controlled trial.

Science.gov (United States)

Sugawara, Norio; Sagae, Toyoaki; Yasui-Furukori, Norio; Yamazaki, Manabu; Shimoda, Kazutaka; Mori, Takao; Sugai, Takuro; Matsuda, Hiroshi; Suzuki, Yutaro; Ozeki, Yuji; Okamoto, Kurefu; Someya, Toshiyuki

2018-02-01

Patients with schizophrenia have a higher prevalence of metabolic syndrome (MetS) than the general population. Minimizing weight gain and metabolic abnormalities in a population with an already high prevalence of obesity is of clinical and social importance. This randomized controlled trial investigated the effect of monthly nutritional education on weight change and metabolic abnormalities among patients with schizophrenia in Japan. From July 2014 to December 2014, we recruited 265 obese patients who had a DSM-IV diagnosis of schizophrenia or schizoaffective disorder. Participants were randomly assigned to a standard care (A), doctor's weight loss advice (B), or an individual nutritional education group (C) for 12 months. The prevalence of MetS and body weight were measured at baseline and 12 months. After the 12-month treatment, 189 patients were evaluated, and the prevalence of MetS based on the ATP III-A definition in groups A, B, and C was 68.9%, 67.2%, and 47.5%, respectively. Group C showed increased weight loss (3.2 ± 4.5 kg) over the 12-month study period, and the change in weight differed significantly from that of group A; additionally, 26.2% of the participants in group C lost 7% or more of their initial weight, compared with 8.2% of those in group A. Individual nutrition education provided by a dietitian was highly successful in reducing obesity in patients with schizophrenia and could be the first choice to address both weight gain and metabolic abnormalities induced by antipsychotic medications. Copyright © 2017 Elsevier Ltd. All rights reserved.

Community-based comprehensive intervention for people with schizophrenia in Guangzhou, China: Effects on clinical symptoms, social functioning, internalized stigma and discrimination.

Science.gov (United States)

Li, Jie; Huang, Yuan-Guang; Ran, Mao-Sheng; Fan, Yu; Chen, Wen; Evans-Lacko, Sara; Thornicroft, Graham

2018-04-01

Comprehensive interventions including components of stigma and discrimination reduction in schizophrenia in low- and middle-income countries (LMICs) are lacking. We developed a community-based comprehensive intervention to evaluate its effects on clinical symptoms, social functioning, internalized stigma and discrimination among patients with schizophrenia. A randomized controlled trial including an intervention group (n = 169) and a control group (n = 158) was performed. The intervention group received comprehensive intervention (strategies against stigma and discrimination, psycho-education, social skills training and cognitive behavioral therapy) and the control group received face to face interview. Both lasted for nine months. Participants were measured at baseline, 6 months and 9 months using the Internalized Stigma of Mental Illness scale (ISMI), Discrimination and Stigma Scale (DISC-12), Global Assessment of Functioning (GAF), Schizophrenia Quality of Life Scale (SQLS), Self-Esteem Scale (SES), Brief Psychiatric Rating Scale (BPRS) and PANSS negative scale (PANSS-N). Insight and medication compliance were evaluated by senior psychiatrists. Data were analyzed by descriptive statistics, t-test, chi-square test or Fisher's exact test. Linear Mixed Models were used to show intervention effectiveness on scales. General Linear Mixed Models with multinomial logistic link function were used to assess the effectiveness on medication compliance and insight. We found a significant reduction on anticipated discrimination, BPRS and PANSS-N total scores, and an elevation on overcoming stigma and GAF in the intervention group after 9 months. These suggested the intervention may be effective in reducing anticipated discrimination, increasing skills overcoming stigma as well as improving clinical symptoms and social functioning in Chinese patients with schizophrenia. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Where Does Evidence from New Trials for Schizophrenia Fit with the Existing Evidence: A Case of the Emperor's New Clothes?

Directory of Open Access Journals (Sweden)

Mahesh Jayaram

2012-01-01

Full Text Available Advent of “atypical” antipsychotics has spawned new trials in the recent years and the number of such trial reports has been increasing exponentially. As clinicians we have been led to believe that “atypicals” are better than “typicals” despite the odd dissenting voice in academic and clinical circles. This has been largely ignored until the publication of two landmark, independent, pragmatic trials, Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE and Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS, which proved that thoughtfully chosen “typical” antipsychotics were as good as the newer “atypicals.” We pooled “leaving the study early data” from Cochrane Reviews that existed before CATIE and CUtLASS and added data from CATIE and CUtLASS to the pool for a “before and after” comparison. Addition of CATIE and CUtLASS data only led to narrowing of the already existing confidence intervals, merely increasing precision, and decreasing the risk of Type II error. Perhaps surprisingly, CATIE and CUtLASS when pooled with the already existing data showed us that we had chosen to turn a blind eye to findings that already existed. This leads clinicians to question as to whether, in future, we need to feel less guilty about crying out early on that the emperor has no clothes on.

[Basic symptoms in schizophrenia, their clinical study and relevance in research].

Science.gov (United States)

Miret, Salvador; Fatjó-Vilas, Mar; Peralta, Víctor; Fañanás, Lourdes

2016-01-01

Basic symptoms consist of subtle sub-clinical disturbances subjectively experienced by schizophrenia patients. These are mainly related to drive, affect, thinking and language, perception, memory, motor action, central vegetative functions, control of cognitive processes, and stress tolerance. Initially described by Huber, from a phenomenological approach, basic symptoms are part of the earliest features of schizophrenia, and they can evolve along the course of the disorder. Their assessment during the prodromal phase of the disease (together with ultra-high risk criteria) is one of the 2 main approaches that allow the definition of states of clinical risk for the development of psychosis. The present review provides an updated view of the concept of basic symptoms, highlighting its potential value in establishing neurobiological correlates of interest in aetiopathogenic research. Copyright © 2015 SEP y SEPB. Published by Elsevier España. All rights reserved.

[Clinical Practice Guidelines for Management of Schizophrenia: Evaluation Using AGREE II].

Science.gov (United States)

de la Hoz Bradford, Ana María; Ávila, Mauricio J; Bohórquez Peñaranda, Adriana Patricia; García Valencia, Jenny; Arenas Borrero, Álvaro Enrique; Vélez Traslaviña, Ángela; Jaramillo González, Luis Eduardo; Gómez-Restrepo, Carlos

2014-01-01

Colombia is developing multiple national practice guidelines from a range of diseases. Clinical practice guidelines represent a very useful tool to be able to take decision over a patient care that is widely available for the clinician. In psychiatry there are a good number of international clinical guidelines for the treatment of schizophrenia nevertheless there is no article that evaluate them scientifically In the settings of developing a Colombian schizophrenia practice guideline, a systematic search was performed in multiple databases and the results were then evaluated by two trained persons. We present the results globally and by domains. We found 164 matches for possible guidelines. After screening 7 guidelines were evaluated with the AGREE II instrument. Globally and by the different domains, the National Institute for Health and Care Excellence (NICE) was the guideline that got the best score. From the guidelines that were reviewed, 4 were from Europe and only 2 were from Latin America. None of the guidelines used GRADE methodology for the recommendations. The diversity of the schizophrenia treatment guidelines does not allow an easy adoption of the recommendation by a psychiatrist in Colombia. Copyright © 2014 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

PSYCHOMETRIC EVALUATION OF SYMPTOMS AND CLINICAL DYNAMICS OF SCHIZOPHRENIA IN DEPENDING ON CONSTITUTIONALLY-MORPHOLOGICAL TYPE OF THE PATIENTS

Directory of Open Access Journals (Sweden)

F. F. Mikilev

2016-01-01

Full Text Available The purpose of this study was to research the psychometrical parameters and the clinical-dynamic features of patients with schizophrenia in depending on their constitutionally-morphological type.Material and methods. The examination of 86 patients with schizophrenia who are hospitalized at Department of endogenous mental disorders of Mental Health Research Institute was conducted. The study included patients of age from 18 to 65 years old with prescription of catamnesis at least 1 year and whose state at the time of examination corresponded to the diagnostic criteria for schizophrenia from the ICD-10 (International Classification of Diseases 10th Revision. The examination included filling in a modified version of Basic Card of Standardized Description of the Patient with Schizophrenia and his Relative, Positive and Negative Syndrome Scale (PANSS, Clinical Global Impression Scale (CGI. In addition to that patients were examined using anthropometrical method by V.V. Bunak. Statistical significance of differences in the data was evaluated using the Kruskal – Wallis test by ranks, the Mann – Whitney U-test, and Pearson’s chi-squared test. The correlation analysis was performed by the Spearman’s rank correlation test. The K-Means Cluster Analysis was used to determine of the qualitative interrelation and conjugation between the clinical characteristics of the examined.The results of the study revealed that many parameters of the functioning in these patient groups have statistically significant differences. Use of the K-Means Cluster Analysis was allowed to reveal the internal structure of the data, to group the individual observations according to their degree of similarity.Conclusions. The obtained data leads to the assumption that the constitutionally-morphological type of patients has an impact on the clinical course of schizophrenia, as well as their adaptation abilities. Asthenic constitutionally-morphological type is a factor of

Clinical Trials

Medline Plus

Full Text Available ... well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

Statistical challenges in a regulatory review of cardiovascular and CNS clinical trials.

Science.gov (United States)

Hung, H M James; Wang, Sue-Jane; Yang, Peiling; Jin, Kun; Lawrence, John; Kordzakhia, George; Massie, Tristan

2016-01-01

There are several challenging statistical problems identified in the regulatory review of large cardiovascular (CV) clinical outcome trials and central nervous system (CNS) trials. The problems can be common or distinct due to disease characteristics and the differences in trial design elements such as endpoints, trial duration, and trial size. In schizophrenia trials, heavy missing data is a big problem. In Alzheimer trials, the endpoints for assessing symptoms and the endpoints for assessing disease progression are essentially the same; it is difficult to construct a good trial design to evaluate a test drug for its ability to slow the disease progression. In CV trials, reliance on a composite endpoint with low event rate makes the trial size so large that it is infeasible to study multiple doses necessary to find the right dose for study patients. These are just a few typical problems. In the past decade, adaptive designs were increasingly used in these disease areas and some challenges occur with respect to that use. Based on our review experiences, group sequential designs (GSDs) have borne many successful stories in CV trials and are also increasingly used for developing treatments targeting CNS diseases. There is also a growing trend of using more advanced unblinded adaptive designs for producing efficacy evidence. Many statistical challenges with these kinds of adaptive designs have been identified through our experiences with the review of regulatory applications and are shared in this article.

GABAergic Mechanisms in Schizophrenia

DEFF Research Database (Denmark)

de Jonge, Jeroen C; Vinkers, Christiaan H; Hulshoff Pol, Hilleke E

2017-01-01

Schizophrenia is a psychiatric disorder characterized by hallucinations, delusions, disorganized thinking, and impairments in cognitive functioning. Evidence from postmortem studies suggests that alterations in cortical γ-aminobutyric acid (GABAergic) neurons contribute to the clinical features...... of schizophrenia. In vivo measurement of brain GABA levels using magnetic resonance spectroscopy (MRS) offers the possibility to provide more insight into the relationship between problems in GABAergic neurotransmission and clinical symptoms of schizophrenia patients. This study reviews and links alterations...... in the GABA system in postmortem studies, animal models, and human studies in schizophrenia. Converging evidence implicates alterations in both presynaptic and postsynaptic components of GABAergic neurotransmission in schizophrenia, and GABA may thus play an important role in the pathophysiology...

Update on extended release quetiapine fumarate in schizophrenia and bipolar disorders

Directory of Open Access Journals (Sweden)

El-Khalili N

2012-11-01

Full Text Available Nizar El-KhaliliAlpine Clinic, Lafayette, IN, USAAbstract: The atypical antipsychotic quetiapine fumarate is available both as an immediate release (IR and as an extended release (XR formulation allowing flexibility of dosing for individual patients. Approved uses of quetiapine XR include the treatment of schizophrenia (including maintenance therapy for prevention of relapse, the treatment of bipolar disorder (manic and depressive episodes, and the prevention of recurrence in patients with bipolar disorder who respond to quetiapine XR. This narrative review provides an update on quetiapine XR in these indications. The pharmacological profile of quetiapine, including a moderate affinity for dopamine D2 receptors and higher affinity for serotonin 5-hydroxytryptophan (5-HT2A receptors, may explain its broad efficacy and low propensity for extrapyramidal symptoms (EPS. The XR formulation has similar bioavailability but prolonged plasma levels compared with the IR formulation, allowing for less frequent (once-daily dosing. Clinical studies have confirmed the efficacy of quetiapine XR in relieving the acute symptoms of schizophrenia during short-term trials, and reducing the risk for relapse in long-term studies. Direct switching from the IR formulation to the same dose of the XR formulation did not reveal any loss of efficacy or tolerability issues, and switching patients to quetiapine XR from conventional or other atypical antipsychotics (for reasons of insufficient efficacy or tolerability also proved to be beneficial and generally well tolerated. In bipolar disorder, quetiapine XR has also proven effective in relieving acute depressive and manic symptoms. Adverse events with quetiapine XR in patients with either schizophrenia or bipolar disorder are similar to those associated with the IR formulation, the most common being sedation, dry mouth, somnolence, dizziness, and headache. The low propensity for EPS is maintained with the XR formulation

Hopes and Expectations Regarding Genetic Testing for Schizophrenia Among Young Adults at Clinical High-Risk for Psychosis.

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Friesen, Phoebe; Lawrence, Ryan E; Brucato, Gary; Girgis, Ragy R; Dixon, Lisa

2016-11-01

Genetic tests for schizophrenia could introduce both risks and benefits. Little is known about the hopes and expectations of young adults at clinical high-risk for psychosis concerning genetic testing for schizophrenia, despite the fact that these youth could be among those highly affected by such tests. We conducted semistructured interviews with 15 young adults at clinical high-risk for psychosis to ask about their interest, expectations, and hopes regarding genetic testing for schizophrenia. Most participants reported a high level of interest in genetic testing for schizophrenia, and the majority said they would take such a test immediately if it were available. Some expressed far-reaching expectations for a genetic test, such as predicting symptom severity and the timing of symptom onset. Several assumed that genetic testing would be accompanied by interventions to prevent schizophrenia. Participants anticipated mixed reactions on finding out they had a genetic risk for schizophrenia, suggesting that they might feel both a sense of relief and a sense of hopelessness. We suggest that genetic counseling could play an important role in counteracting a culture of genetic over-optimism and helping young adults at clinical high-risk for psychosis understand the limitations of genetic testing. Counseling sessions could also invite individuals to explore how receiving genetic risk information might impact their well-being, as early evidence suggests that some psychological factors help individuals cope, whereas others heighten distress related to genetic test results.

Clinical Trials

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Full Text Available ... trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, Lung, and ...

Clinical Trials

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Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...

Clinical Trials

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Full Text Available ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ... DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs ...

Clinical Trials

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Full Text Available ... or strategies work best for certain illnesses or groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different ...

Clinical Trials

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Full Text Available ... including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored ... risks. Other examples of clinical trials that test principles or strategies include studies that explore whether surgery ...

Clinical Trials

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Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

Clinical Trials

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Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

Science.gov (United States)

Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

2013-11-01

To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

The current agonists and positive allosteric modulators of α7 nAChR for CNS indications in clinical trials

Directory of Open Access Journals (Sweden)

Taoyi Yang

2017-11-01

Full Text Available The alpha-7 nicotinic acetylcholine receptor (α7 nAChR, consisting of homomeric α7 subunits, is a ligand-gated Ca2+-permeable ion channel implicated in cognition and neuropsychiatric disorders. Enhancement of α7 nAChR function is considered to be a potential therapeutic strategy aiming at ameliorating cognitive deficits of neuropsychiatric disorders such as Alzheimer's disease (AD and schizophrenia. Currently, a number of α7 nAChR modulators have been reported and several of them have advanced into clinical trials. In this brief review, we outline recent progress made in understanding the role of the α7 nAChR in multiple neuropsychiatric disorders and the pharmacological effects of α7 nAChR modulators used in clinical trials.

Clinical Trials

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Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

Clinical Trials

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Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

Perceptual Measurement in Schizophrenia: Promising Electrophysiology and Neuroimaging Paradigms From CNTRICS

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Butler, Pamela D.; Chen, Yue; Ford, Judith M.; Geyer, Mark A.; Silverstein, Steven M.; Green, Michael F.

2012-01-01

The sixth meeting of the Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia (CNTRICS) focused on selecting promising imaging paradigms for each of the cognitive constructs selected in the first CNTRICS meeting. In the domain of perception, the 2 constructs of interest were “gain control” and “visual integration.” CNTRICS received 6 task nominations for imaging paradigms for gain control and 3 task nominations for integration. The breakout group for perception evaluated the degree to which each of these tasks met prespecified criteria. For gain control, the breakout group believed that one task (mismatch negativity) was already mature and was being incorporated into multisite clinical trials. The breakout group recommended that 1 visual task (steady-state visual evoked potentials to magnocellular- vs parvocellular-biased stimuli) and 2 auditory measures (an event-related potential (ERP) measure of corollary discharge and a functional magnetic resonance imaging (fMRI) version of prepulse inhibition of startle) be adapted for use in clinical trials in schizophrenia research. For visual integration, the breakout group recommended that fMRI and ERP versions of a contour integration test and an fMRI version of a coherent motion test be adapted for use in clinical trials. This manuscript describes the ways in which each of these tasks met the criteria used in the breakout group to evaluate and recommend tasks for further development. PMID:21890745

Is it me? Verbal self-monitoring neural network and clinical insight in schizophrenia.

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Sapara, Adegboyega; Ffytche, Dominic H; Cooke, Michael A; Williams, Steven C R; Kumari, Veena

2015-12-30

Self-monitoring, defined as the ability to distinguish between self-generated stimuli from other-generated ones, is known to be impaired in schizophrenia. This impairment has been theorised as the basis for many of the core psychotic symptoms, in particular, poor clinical insight. This study aimed to investigate verbal self-monitoring related neural substrates of preserved and poor clinical insight in schizophrenia. It involved 40 stable schizophrenia outpatients, 20 with preserved and 20 with poor insight, and 20 healthy participants. All participants underwent functional magnetic resonance imaging with brain coverage covering key areas in the self-monitoring network during a verbal self-monitoring task. Healthy participants showed higher performance accuracy and greater thalamic activity than both preserved and poor insight patient groups. Preserved insight patients showed higher activity in the putamen extending into the caudate, insula and inferior frontal gyrus, compared to poor insight patients, and in the anterior cingulate and medial frontal gyrus, compared to healthy participants. Poor insight patients did not show greater activity in any brain area compared to preserved insight patients or healthy participants. Future studies may pursue therapeutic avenues, such as meta-cognitive therapies to promote self-monitoring or targeted stimulation of relevant brain areas, as means of enhancing insight in schizophrenia. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Social media in clinical trials.

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Thompson, Michael A

2014-01-01

Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.

Clinical Trials

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Full Text Available ... identified earlier than they would be in general medical practice. This is because late-phase trials have large ... supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

Science.gov (United States)

Sivaramakrishnan, Gowri; Sridharan, Kannan

2016-06-01

Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be

World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of schizophrenia - a short version for primary care.

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Hasan, Alkomiet; Falkai, Peter; Wobrock, Thomas; Lieberman, Jeffrey; Glenthøj, Birte; Gattaz, Wagner F; Thibaut, Florence; Möller, Hans-Jürgen

2017-06-01

Schizophrenia is a severe mental disorder and many patients are treated in primary care settings. Apart from the pharmacological management of disease-associated symptoms, the detection and treatment of side effects is of the utmost importance in clinical practice. The purpose of this publication is to offer relevant evidence-based recommendations for the biological treatment of schizophrenia in primary care. This publication is a short and practice-oriented summary of Parts I-III of the World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Schizophrenia. The recommendations were developed by the authors and consented by a task force of international experts. Guideline recommendations are based on randomized-controlled trials and supplemented with non-randomized trials and meta-analyses where necessary. Antipsychotics of different chemical classes are the first-line pharmacological treatments for schizophrenia. Specific circumstances (e.g., suicidality, depression, substance dependence) may need additional treatment options. The pharmacological and non-pharmacological management of side effects is of crucial importance for the long-term treatment in all settings of the healthcare system. This summary of the three available evidence-based guidelines has the potential to support clinical decisions and can improve treatment of schizophrenia in primary care settings.

Clinical trials in dentistry in India: Analysis from trial registry.

Science.gov (United States)

Gowri, S; Kannan, Sridharan

2017-01-01

Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy

The emerging molecular architecture of schizophrenia, polygenic risk scores and the clinical implications for GxE research.

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Iyegbe, Conrad; Campbell, Desmond; Butler, Amy; Ajnakina, Olesya; Sham, Pak

2014-02-01

Schizophrenia is a devastating mental disorder. The level of risk in the general population is sustained by the persistence of social, environmental and biological factors, as well as their interactions. Socio-environmental risk factors for schizophrenia are well established and robust. The same can belatedly be said of genetic risk factors for the disorder. Recent progress in schizophrenia genetics is primarily fuelled by genome-wide association, which is able to leverage substantial proportions of additional explained variance previously classified as 'missing'. Here, we provide an outline of the emerging genetic landscape of schizophrenia and demonstrate how this knowledge can be turned into a simple empirical measure of genetic risk, known as a polygenic risk score. We highlight the statistical framework used to assess the clinical potential of the new score and finally, draw relevance to and discuss the clinical implications for the study of gene-environment interaction.

Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials.

Directory of Open Access Journals (Sweden)

Vojtech Huser

Full Text Available OBJECTIVE: In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world's largest clinical trial registry. MATERIALS AND METHODS: We considered two trial result artifacts: (1 existence of a trial result journal article that is formally linked to a registered trial or (2 the deposition of a trial's basic summary results within the registry. RESULTS: The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2% had no structured trial-article link present. A total of 2367 trials (26.6% deposited basic summary results within the registry. Of those, 969 trials (10.9% were classified as trials with extended results and 1398 trials (15.7% were classified as trials with only required basic results. The majority of the trials (54.8% had no evidence of results, based on either linked result articles or basic summary results (silent trials, while a minimal number (9.2% report results through both registry deposition and publication. DISCUSSION: Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the "trialome". Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. CONCLUSION: Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.

Clinical Trials

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Full Text Available ... other expenses (for example, travel and child care)? Who will be in charge of my care? What will happen after the trial? Taking part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

Zotepine versus other atypical antipsychotics for schizophrenia

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

2014-01-01

Background In many parts of the world, particularly in industrialised countries, second generation (atypical) antipsychotic drugs have become first line treatment for people suffering from schizophrenia. The question as to whether the effects of various second generation antipsychotic drugs differ is a matter of debate. Objectives To evaluate the effects of zotepine compared with other second generation antipsychotic drugs for people suffering from schizophrenia and schizophrenia-like psychoses. Search methods We searched the Cochrane Schizophrenia Group Trials Register (November 2009), inspected references of all identified studies for further trials and contacted authors of trials for additional information. Selection criteria We included only randomised clinical controlled trials that compared zotepine with any forms of amisulpride, aripiprazole, clozapine, olanzapine, risperidone, sertindole or ziprasidone in people suffering from only schizophrenia or schizophrenia-like psychoses. Data collection and analysis SS and KK extracted data independently. For dichotomous data we calculated relative risks (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis based on a random-effects model. For continuous data, we calculated weighted mean differences (MD) again based on a random-effects model. Main results We included three studies (total n=289; 2 RCTs zotepine vs clozapine; 1 RCT zotepine vs clozapine vs risperidone (at 4 mg, 8 mg doses) vs remoxipride. All studies were of limited methodological quality. When zotepine was compared with clozapine, it was clozapine that was found to be more effective in terms of global state (n=59, 1 RCT, RR No clinically significant response 8.23 CI 1.14 to 59.17). Mental state scores also favoured clozapine (n=59, 1 RCT, MD average score (BPRS total, high = poor) 6.00 CI 2.17 to 9.83) and there was less use of antiparkinson medication in the clozapine group (n=116, 2 RCTs, RR 20.96 CI 2.89 to 151.90). In the

Predicting severity of paranoid schizophrenia

OpenAIRE

Kolesnichenko Elena Vladimirovna

2015-01-01

Clinical symptoms, course and outcomes of paranoid schizophrenia are polymorphic. 206 cases of paranoid schizophrenia were investigated. Clinical predictors were collected from hospital records and interviews. Quantitative assessment of the severity of schizophrenia as special indexes was used. Schizoid, epileptoid, psychasthenic and conformal accentuation of personality in the premorbid, early onset of psychosis, paranoid and hallucinatory-paranoid variants of onset predicted more expressed ...

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.

Construction of ethics in clinical research: clinical trials registration

Directory of Open Access Journals (Sweden)

C. A. Caramori

2007-01-01

Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

A new generation of antipsychotics: pharmacology and clinical utility of cariprazine in schizophrenia

Directory of Open Access Journals (Sweden)

Caccia S

2013-08-01

Full Text Available Silvio Caccia, Roberto William Invernizzi, Alessandro Nobili, Luca Pasina IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy Abstract: Cariprazine is a potential antipsychotic awaiting approval from the US Food and Drug Administration. It is a dopamine D2- and D3-receptor partial agonist, with higher affinity for D3 receptors, as opposed to the D2 antagonism of most older antipsychotic agents. Like most lipophilic antipsychotics, it undergoes extensive hepatic metabolism by cytochrome P450 (CYP, mainly the highly variable 3A4, with the formation of active metabolites. However, the parent compound – particularly its active didesmethyl derivative – is cleared very slowly, with elimination half-lives in schizophrenic patients ranging from 2–5 days for cariprazine to 2–3 weeks for didesmethyl-cariprazine. Exposure to the latter was several times that for cariprazine, although didesmethyl-cariprazine did not reach steady state within the 3 weeks of 12.5 mg/day dosing. Preliminary information on its therapeutic role comes from press releases and a few abstracts presented at scientific meetings. In short-term controlled trials, it was more effective than placebo in reducing positive and negative symptoms of schizophrenia, with an effective dose range of 1.5–12 mg/day. Although cariprazine was associated with a higher incidence of akathisia and extrapyramidal side effects than placebo, it did not cause weight gain, metabolic abnormalities, prolactin increase, or corrected QT prolongation. Similarly, cariprazine's efficacy and tolerability for the treatment of bipolar disorder (manic/mixed and depressive episodes was established in the dose range of 3–12 mg/day, although again no long-term data are available. Well-designed clinical trials, mainly direct "head-to-head" comparisons with other second-generation antipsychotic agents, are needed to define the therapeutic role and safety profile of cariprazine in schizophrenia and

Research Areas - Clinical Trials

Science.gov (United States)

Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

Science.gov (United States)

Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

2015-05-01

A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

[Clinical trials in nursing journals].

Science.gov (United States)

Di Giulio, Paola; Campagna, Sara; Dimonte, Valerio

2014-01-01

Clinical trials are pivotal for the development of nursing knowledge. To describe the clinical trials published in nursing journals in the last two years and propose some general reflections on nursing research. A search with the key-word trial was done on PubMed (2009-2013) on Cancer Nursing, European Journal of Oncology Nursing, International Journal of Nursing Studies, Journal of Advanced Nursing, Journal of Clinical Nursing and Nursing Research. Of 228 trials identified, 104 (45.8%) were published in the last 2 years. Nurses from Asian countries published the larger number of trials. Educational and supportive interventions were the most studied (61/104 trials), followed by clinical interventions (33/104). Samples were limited and most trials are monocentric. A growing number of trials is published, on issues relevant for the nursing profession, however larger samples and multicentric studies would be necessary.

Neurocognitive function in clinically stable individuals with long-term bipolar I disorder: Comparisons with schizophrenia patients and controls

Directory of Open Access Journals (Sweden)

Pei-Yun Lin

2017-05-01

Full Text Available This study compared the levels of the five domains of neurocognitive function—executive function, attention, memory, verbal comprehension, and perceptual organization—among clinically stable individuals with long-term bipolar I disorder, individuals with long-term schizophrenia, and a group of controls. We recruited a total of 93 clinically stable individuals with bipolar I disorder, 94 individuals with schizophrenia, and 106 controls in this study. Their neurocognitive function was measured using a series of neurocognitive function tests: the Wechsler Adult Intelligence Scale—Third Edition (WAIS-III, Line Cancellation Test, Visual Form Discrimination, Controlled Oral Word Association Test, Wisconsin Card Sorting Test, Continuous Performance Task, and Wechsler Memory Scale—Third Edition. Neurocognitive function was compared among the three groups through a multivariate analysis of variance. The results indicated that when the effect of age was controlled, clinically stable individuals with bipolar I disorder and those with schizophrenia demonstrated poor neurocognitive function on all tests except for the WAIS-III Similarity and Information and the Line Cancellation Test. The individuals with bipolar I disorder had similar levels of neurocognitive function compared with the schizophrenia group, but higher levels of neurocognitive function on the WAIS-III Comprehension, Controlled Oral Word Association Test, and Wechsler Memory Scale—Third Edition Auditory Immediate and Delayed Index and Visual Immediate and Delayed Index. The conclusions of this study suggest that compared with controls, individuals with long-term bipolar I disorder and those with long-term schizophrenia have poorer neurocognitive function, even when clinically stable. Individuals with long-term bipolar I disorder and those with long-term schizophrenia have similar levels of deficits in several domains of neurocognitive function.

Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment.

Science.gov (United States)

Abbas, Ismail; Rovira, Joan; Casanovas, Josep

2007-05-01

The patient recruitment process of clinical trials is an essential element which needs to be designed properly. In this paper we describe different simulation models under continuous and discrete time assumptions for the design of recruitment in clinical trials. The results of hypothetical examples of clinical trial recruitments are presented. The recruitment time is calculated and the number of recruited patients is quantified for a given time and probability of recruitment. The expected delay and the effective recruitment durations are estimated using both continuous and discrete time modeling. The proposed type of Monte Carlo simulation Markov models will enable optimization of the recruitment process and the estimation and the calibration of its parameters to aid the proposed clinical trials. A continuous time simulation may minimize the duration of the recruitment and, consequently, the total duration of the trial.

Credentialing for participation in clinical trials

International Nuclear Information System (INIS)

Followill, David S.; Urie, Marcia; Galvin, James M.; Ulin, Kenneth; Xiao, Ying; FitzGerald, Thomas J.

2012-01-01

The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

Credentialing for participation in clinical trials

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Followill, David S. [Radiological Physics Center, Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Urie, Marcia [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); Ulin, Kenneth [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States); Xiao, Ying [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); FitzGerald, Thomas J., E-mail: dfollowi@mdanderson.org [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States)

2012-12-26

The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

Clinical Trials

Medline Plus

Full Text Available ... trial found that one of the combinations worked much better than the other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI ...

Effort-Based Decision Making: A Novel Approach for Assessing Motivation in Schizophrenia.

Science.gov (United States)

Green, Michael F; Horan, William P; Barch, Deanna M; Gold, James M

2015-09-01

Because negative symptoms, including motivational deficits, are a critical unmet need in schizophrenia, there are many ongoing efforts to develop new pharmacological and psychosocial interventions for these impairments. A common challenge of these studies involves how to evaluate and select optimal endpoints. Currently, all studies of negative symptoms in schizophrenia depend on ratings from clinician-conducted interviews. Effort-based decision-making tasks may provide a more objective, and perhaps more sensitive, endpoint for trials of motivational negative symptoms. These tasks assess how much effort a person is willing to exert for a given level of reward. This area has been well-studied with animal models of effort and motivation, and effort-based decision-making tasks have been adapted for use in humans. Very recently, several studies have examined physical and cognitive types of effort-based decision-making tasks in cross-sectional studies of schizophrenia, providing evidence for effort-related impairment in this illness. This article covers the theoretical background on effort-based decision-making tasks to provide a context for the subsequent articles in this theme section. In addition, we review the existing literature of studies using these tasks in schizophrenia, consider some practical challenges in adapting them for use in clinical trials in schizophrenia, and discuss interpretive challenges that are central to these types of tasks. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

An Update on the Epidemiology of Schizophrenia with a Special Reference to Clinically Important Risk Factors

Science.gov (United States)

El-Missiry, Ahmed; Aboraya, Ahmed Sayed; Manseur, Hader; Manchester, Johnna; France, Cheryl; Border, Katherine

2011-01-01

Schizophrenia is a chronic mental illness which poses a tremendous burden on the families, caregivers and the society. The purpose of this paper is to provide an updated review of the epidemiology of schizophrenia with a special attention to the clinically important risk factors such as drug abuse, hormonal factors and the new advances in genetic…

Clinical Manifestations of Self-disorders in Schizophrenia Spectrum Conditions

Directory of Open Access Journals (Sweden)

Henriksen Mads Gram

2017-09-01

Full Text Available This article explores the phenomenologically informed, theoretical and empirical research direction on self-disorders in the schizophrenia spectrum conditions. First, we describe the concept of ‘self’ that is operative in the concept of ‘self-disorders’ and we discuss how this self may be disordered or fragile in the schizophrenia spectrum. Second, we offer a detailed psychopathological presentation and discussion of 3 patients with schizophrenia. The vignettes provide paradigmatic examples of self-disorders in schizophrenia. Third, we summarize the main findings in the current empirical research on self-disorders. These findings consistently indicate that self-disorders constitute a crucial, trait phenotype of the schizophrenia spectrum.

First-episode schizophrenia: characterization and clinical correlates

Directory of Open Access Journals (Sweden)

Robert M. Bilder

2007-11-01

Full Text Available Neuropsychological impairments are well documented in schizophrenia and are important targets of treatment. Information about the severity and pattern of deficits after treatment for the first psychotic episode and about relationships between these deficits and syndromal characteristics remains limited. Comprehensive neuropsychological assessments including 41 individual tests were given to 94 patients with first-episode schizophrenia after initial stabilization of psychosis and to a comparison group of 36 healthy volunteers. Profiles of neuropsychological deficits and the relationship of deficits to sex and handedness were examined. Correlations of neuropsychological deficit with a broad range of historical and clinical characteristics, including outcome, were explored. Patients had a large generalized neuropsychological deficit. Patients also had, superimposed on the generalized deficit, subtle relative deficits in memory and executive functions. Learning/memory dysfunction best distinguished patients from healthy individuals; after accounting for this difference, only motor deficits further distinguished the groups. Patients with higher neuropsychological ability had only memory deficits, and patients with lower ability had both memory and executive deficits. Dextral patients had less severe generalized deficit. Severity of residual symptoms was associated with greater generalized deficit. Executive and attentional deficits were most linked to global functional impairment and poor outcome. The results document a large generalized deficit, and more subtle differential deficits, in clinically stabilized first-episode patients. Learning/memory deficits were observed even in patients with less severe generalized deficit, but the pattern was unlike the amnestic syndrome and probably reflects different mechanisms. Executive and attentional deficits marked the more severe ly disabled patients, and may portend relatively poor outcome. Failure to

Clinical Trials

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Full Text Available ... Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in ... Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain ...

Clinical Trials

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Full Text Available ... you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking ... people will need to travel or stay in hospitals to take part in clinical trials. For example, ...

Clinical trial methodology

National Research Council Canada - National Science Library

Peace, Karl E; Chen, Ding-Geng

2011-01-01

... in the pharmaceutical industry, Clinical trial methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research...

A randomized placebo-controlled trial of an omega-3 fatty acid and vitamins E+C in schizophrenia.

Science.gov (United States)

Bentsen, H; Osnes, K; Refsum, H; Solberg, D K; Bøhmer, T

2013-12-17

Membrane lipid metabolism and redox regulation may be disturbed in schizophrenia. We examined the clinical effect of adding an omega-3 fatty acid and/or vitamins E+C to antipsychotics. It was hypothesized that lower baseline levels of polyunsaturated fatty acids (PUFAs) would predict more benefit from the add-on treatment. The trial had a multicenter, randomized, double-blind, placebo-controlled 2 × 2 factorial design. Patients aged 18-39 years with schizophrenia or related psychoses were consecutively included at admission to psychiatric departments in Norway. They received active or placebo ethyl-eicosapentaenoate (EPA) 2 g day⁻¹ and active or placebo vitamin E 364 mg day⁻¹+vitamin C 1000 mg day⁻¹ (vitamins) for 16 weeks. The main outcome measures were Positive and Negative Syndrome Scale (PANSS) total and subscales scores, analyzed by linear mixed models. Ninety-nine patients were included. At baseline, erythrocyte PUFA were measured in 97 subjects. Given separately, EPA and vitamins increased drop-out rates, whereas when combined they did not differ from placebo. In low PUFA patients, EPA alone impaired the course of total PANSS (Cohen's d=0.29; P=0.03) and psychotic symptoms (d=0.40; P=0.003), especially persecutory delusions (d=0.48; P=0.0004). Vitamins alone impaired the course of psychotic symptoms (d= 0.37; P=0.005), especially persecutory delusions (d=0.47; P=0.0005). Adding vitamins to EPA neutralized the detrimental effect on psychosis (interaction d=0.31; P=0.02). In high PUFA patients, there were no significant effects of trial drugs on PANSS scales. In conclusion, given separately during an acute episode, EPA and vitamins E+C induce psychotic symptoms in patients with low levels of PUFA. Combined, these agents seem safe.

The effects of cannabidiol (CBD) on cognition and symptoms in outpatients with chronic schizophrenia a randomized placebo controlled trial.

Science.gov (United States)

Boggs, Douglas L; Surti, Toral; Gupta, Aarti; Gupta, Swapnil; Niciu, Mark; Pittman, Brian; Schnakenberg Martin, Ashley M; Thurnauer, Halle; Davies, Andrew; D'Souza, Deepak C; Ranganathan, Mohini

2018-07-01

Preliminary evidence suggests that cannabidiol (CBD) may be effective in the treatment of neurodegenerative disorders; however, CBD has never been evaluated for the treatment of cognitive impairments associated with schizophrenia (CIAS). This study compared the cognitive, symptomatic, and side effects of CBD versus placebo in a clinical trial. This study was a 6-week, randomized, placebo-controlled, parallel group, fixed-dose study of oral CBD (600 mg/day) or placebo augmentation in 36 stable antipsychotic-treated patients diagnosed with chronic schizophrenia. All subjects completed the MATRICS Consensus Cognitive Battery (MCCB) at baseline and at end of 6 weeks of treatment. Psychotic symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS) at baseline and biweekly. There was no main effect of time or drug on MCCB Composite score, but a significant drug × time effect was observed (p = 0.02). Post hoc analyses revealed that only placebo-treated subjects improved over time (p = 0.03). There was a significant decrease in PANSS Total scores over time (p < 0. 0001) but there was no significant drug × time interaction (p = 0.18). Side effects were similar between CBD and placebo, with the one exception being sedation, which was more prevalent in the CBD group. At the dose studied, CBD augmentation was not associated with an improvement in MCCB or PANSS scores in stable antipsychotic-treated outpatients with schizophrenia. Overall, CBD was well tolerated with no worsening of mood, suicidality, or movement side effects. https://clinicaltrials.gov/ct2/show/NCT00588731.

Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia: a randomized clinical trial - the SMART trial protocol

DEFF Research Database (Denmark)

Baandrup, Lone; Fagerlund, Birgitte; Jennum, Poul

2011-01-01

Treatment of schizophrenia frequently includes prolonged benzodiazepine administration despite a lack of evidence of its use. It is often difficult to discontinue benzodiazepines because of the development of dependence. We aim to assess if melatonin can facilitate the withdrawal of prolonged...

Validation of a 4-item Negative Symptom Assessment (NSA-4): a short, practical clinical tool for the assessment of negative symptoms in schizophrenia.

Science.gov (United States)

Alphs, Larry; Morlock, Robert; Coon, Cheryl; Cazorla, Pilar; Szegedi, Armin; Panagides, John

2011-06-01

The 16-item Negative Symptom Assessment (NSA-16) scale is a validated tool for evaluating negative symptoms of schizophrenia. The psychometric properties and predictive power of a four-item version (NSA-4) were compared with the NSA-16. Baseline data from 561 patients with predominant negative symptoms of schizophrenia who participated in two identically designed clinical trials were evaluated. Ordered logistic regression analysis of ratings using NSA-4 and NSA-16 were compared with ratings using several other standard tools to determine predictive validity and construct validity. Internal consistency and test--retest reliability were also analyzed. NSA-16 and NSA-4 scores were both predictive of scores on the NSA global rating (odds ratio = 0.83-0.86) and the Clinical Global Impressions--Severity scale (odds ratio = 0.91-0.93). NSA-16 and NSA-4 showed high correlation with each other (Pearson r = 0.85), similar high correlation with other measures of negative symptoms (demonstrating convergent validity), and lesser correlations with measures of other forms of psychopathology (demonstrating divergent validity). NSA-16 and NSA-4 both showed acceptable internal consistency (Cronbach α, 0.85 and 0.64, respectively) and test--retest reliability (intraclass correlation coefficient, 0.87 and 0.82). This study demonstrates that NSA-4 offers accuracy comparable to the NSA-16 in rating negative symptoms in patients with schizophrenia. Copyright © 2011 John Wiley & Sons, Ltd.

OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis.

Science.gov (United States)

Kraus, V B; Blanco, F J; Englund, M; Henrotin, Y; Lohmander, L S; Losina, E; Önnerfjord, P; Persiani, S

2015-05-01

The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute treatment at a time more amenable to disease modification. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Characterization of neurophysiologic and neurocognitive biomarkers for use in genomic and clinical outcome studies of schizophrenia.

Directory of Open Access Journals (Sweden)

Gregory A Light

Full Text Available Endophenotypes are quantitative, laboratory-based measures representing intermediate links in the pathways between genetic variation and the clinical expression of a disorder. Ideal endophenotypes exhibit deficits in patients, are stable over time and across shifts in psychopathology, and are suitable for repeat testing. Unfortunately, many leading candidate endophenotypes in schizophrenia have not been fully characterized simultaneously in large cohorts of patients and controls across these properties. The objectives of this study were to characterize the extent to which widely-used neurophysiological and neurocognitive endophenotypes are: 1 associated with schizophrenia, 2 stable over time, independent of state-related changes, and 3 free of potential practice/maturation or differential attrition effects in schizophrenia patients (SZ and nonpsychiatric comparison subjects (NCS. Stability of clinical and functional measures was also assessed.Participants (SZ n = 341; NCS n = 205 completed a battery of neurophysiological (MMN, P3a, P50 and N100 indices, PPI, startle habituation, antisaccade, neurocognitive (WRAT-3 Reading, LNS-forward, LNS-reorder, WCST-64, CVLT-II. In addition, patients were rated on clinical symptom severity as well as functional capacity and status measures (GAF, UPSA, SOF. 223 subjects (SZ n = 163; NCS n = 58 returned for retesting after 1 year.Most neurophysiological and neurocognitive measures exhibited medium-to-large deficits in schizophrenia, moderate-to-substantial stability across the retest interval, and were independent of fluctuations in clinical status. Clinical symptoms and functional measures also exhibited substantial stability. A Longitudinal Endophenotype Ranking System (LERS was created to rank neurophysiological and neurocognitive biomarkers according to their effect sizes across endophenotype criteria.The majority of neurophysiological and neurocognitive measures exhibited deficits in

Characterization of neurophysiologic and neurocognitive biomarkers for use in genomic and clinical outcome studies of schizophrenia.

Science.gov (United States)

Light, Gregory A; Swerdlow, Neal R; Rissling, Anthony J; Radant, Allen; Sugar, Catherine A; Sprock, Joyce; Pela, Marlena; Geyer, Mark A; Braff, David L

2012-01-01

Endophenotypes are quantitative, laboratory-based measures representing intermediate links in the pathways between genetic variation and the clinical expression of a disorder. Ideal endophenotypes exhibit deficits in patients, are stable over time and across shifts in psychopathology, and are suitable for repeat testing. Unfortunately, many leading candidate endophenotypes in schizophrenia have not been fully characterized simultaneously in large cohorts of patients and controls across these properties. The objectives of this study were to characterize the extent to which widely-used neurophysiological and neurocognitive endophenotypes are: 1) associated with schizophrenia, 2) stable over time, independent of state-related changes, and 3) free of potential practice/maturation or differential attrition effects in schizophrenia patients (SZ) and nonpsychiatric comparison subjects (NCS). Stability of clinical and functional measures was also assessed. Participants (SZ n = 341; NCS n = 205) completed a battery of neurophysiological (MMN, P3a, P50 and N100 indices, PPI, startle habituation, antisaccade), neurocognitive (WRAT-3 Reading, LNS-forward, LNS-reorder, WCST-64, CVLT-II). In addition, patients were rated on clinical symptom severity as well as functional capacity and status measures (GAF, UPSA, SOF). 223 subjects (SZ n = 163; NCS n = 58) returned for retesting after 1 year. Most neurophysiological and neurocognitive measures exhibited medium-to-large deficits in schizophrenia, moderate-to-substantial stability across the retest interval, and were independent of fluctuations in clinical status. Clinical symptoms and functional measures also exhibited substantial stability. A Longitudinal Endophenotype Ranking System (LERS) was created to rank neurophysiological and neurocognitive biomarkers according to their effect sizes across endophenotype criteria. The majority of neurophysiological and neurocognitive measures exhibited deficits in patients

Psychology Student Opinion of Virtual Reality as a Tool to Educate about Schizophrenia

Science.gov (United States)

Tichon, Jennifer; Loh, Jennifer; King, Robert

2004-01-01

Virtual Reality (VR) techniques are increasingly being used in e-health education, training and in trial clinical programs in the treatment of certain types of mental illness. Undergraduate psychology student opinion of the use of Virtual Reality (VR) to teach them about schizophrenia at the University of Queensland, was determined with reference…

Decreased value-sensitivity in schizophrenia.

Science.gov (United States)

Martinelli, Cristina; Rigoli, Francesco; Dolan, Ray J; Shergill, Sukhwinder S

2018-01-01

Pathophysiology in schizophrenia has been linked to aberrant incentive salience, namely the dysfunctional processing of value linked to abnormal dopaminergic activity. In line with this, recent studies showed impaired learning of value in schizophrenia. However, how value is used to guide behaviour independently from learning, as in risky choice, has rarely been examined in this disorder. We studied value-guided choice under risk in patients with schizophrenia and in controls using a task requiring a choice between a certain monetary reward, varying trial-by-trial, and a gamble offering an equal probability of getting double this certain amount or nothing. We observed that patients compared to controls exhibited reduced sensitivity to values, implying that their choices failed to flexibly adapt to the specific values on offer. Moreover, the degree of this value sensitivity inversely correlated with aberrant salience experience, suggesting that the inability to tune choice to value may be a key element of aberrant salience in the illness. Our results help clarify the cognitive mechanisms underlying improper attribution of value in schizophrenia and may thus inform cognitive interventions aimed at reinstating value sensitivity in patients. Copyright © 2017 Elsevier B.V. All rights reserved.

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

Science.gov (United States)

Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

2018-03-01

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

A multicenter, randomized controlled trial of individualized occupational therapy for patients with schizophrenia in Japan.

Science.gov (United States)

Shimada, Takeshi; Ohori, Manami; Inagaki, Yusuke; Shimooka, Yuko; Sugimura, Naoya; Ishihara, Ikuyo; Yoshida, Tomotaka; Kobayashi, Masayoshi

2018-01-01

The individualized occupational therapy (IOT) program is a psychosocial program that we developed to facilitate proactive participation in treatment and improve cognitive functioning and other outcomes for inpatients with acute schizophrenia. The program consists of motivational interviewing, self-monitoring, individualized visits, handicraft activities, individualized psychoeducation, and discharge planning. This multicenter, open-labeled, blinded-endpoint, randomized controlled trial evaluated the impact of adding IOT to a group OT (GOT) program as usual for outcomes in recently hospitalized patients with schizophrenia in Japanese psychiatric hospitals setting compared with GOT alone. Patients with schizophrenia were randomly assigned to the GOT+IOT group or the GOT alone group. Among 136 randomized patients, 129 were included in the intent-to-treat population: 66 in the GOT+IOT and 63 in the GOT alone groups. Outcomes were administered at baseline and discharge or 3 months following hospitalization including the Brief Assessment of Cognition in Schizophrenia Japanese version (BACS-J), the Schizophrenia Cognition Rating Scale Japanese version, the Social Functioning Scale Japanese version, the Global Assessment of Functioning scale, the Intrinsic Motivation Inventory Japanese version (IMI-J), the Morisky Medication Adherence Scale-8 (MMAS-8), the Positive and Negative Syndrome Scale (PANSS), and the Japanese version of Client Satisfaction Questionnaire-8 (CSQ-8J). Results of linear mixed effects models indicated that the IOT+GOT showed significant improvements in verbal memory (p <0.01), working memory (p = 0.02), verbal fluency (p < 0.01), attention (p < 0.01), and composite score (p < 0.01) on the BACS-J; interest/enjoyment (p < 0.01), value/usefulness (p < 0.01), perceived choice (p < 0.01), and IMI-J total (p < 0.01) on the IMI-J; MMAS-8 score (p < 0.01) compared with the GOT alone. Patients in the GOT+IOT demonstrated significant improvements on the CSQ-8J

Psychometric evaluation of the Work Readiness Questionnaire in schizophrenia.

Science.gov (United States)

Potkin, Steven G; Bugarski-Kirola, Dragana; Edgar, Chris J; Soliman, Sherif; Le Scouiller, Stephanie; Kunovac, Jelena; Miguel Velasco, Eugenio; Garibaldi, George M

2016-04-01

Unemployment can negatively impact quality of life among patients with schizophrenia. Employment status depends on ability, opportunity, education, and cultural influences. A clinician-rated scale of work readiness, independent of current work status, can be a valuable assessment tool. A series of studies were conducted to create and validate a Work Readiness Questionnaire (WoRQ) for clinicians to assess patient ability to engage in socially useful activity, independent of work availability. Content validity, test-retest and inter-rater reliability, and construct validity were evaluated in three separate studies. Content validity was supported. Cronbach's α was 0.91, in the excellent range. Clinicians endorsed WoRQ concepts, including treatment adherence, physical appearance, social competence, and symptom control. The final readiness decision showed good test-retest reliability and moderate inter-rater reliability. Work readiness was associated with higher function and lower levels of negative symptoms. Low positive and high negative predictive values confirmed the concept validity. The WoRQ has suitable psychometric properties for use in a clinical trial for patients with a broad range of symptom severity. The scale may be applicable to assess therapeutic interventions. It is not intended to assess eligibility for supported work interventions. The WoRQ is suitable for use in schizophrenia clinical trials to assess patient work functional potential.

Predictors of discontinuation of antipsychotic medication and subsequent outcomes in the European First Episode Schizophrenia Trial (EUFEST).

Science.gov (United States)

Landolt, Karin; Rössler, Wulf; Ajdacic-Gross, Vladeta; Derks, Eske M; Libiger, Jan; Kahn, René S; Fleischhacker, W Wolfgang

2016-04-01

This study had two aims: to describe patients suffering from first-episode schizophrenia who had stopped taking any antipsychotic medication, and to gain information on the predictors of successful discontinuation. We investigated data from the European First Episode Schizophrenia Trial (EUFEST). From the 325 patients included, 15.7% discontinued all antipsychotic medication. In a first analysis, clinical and sociodemographical predictors of discontinuing any antipsychotic medication were identified, using Cox regression. In the second analysis, logistic regression was used to determine variables associated with those patients who had stopped taking antipsychotic medication and had a favourable outcome, i.e., successful discontinuation. A good outcome was defined as a) having had no relapse within the whole observation period (80.6%), and b) having had no relapse and symptomatic remission at 12-month-follow-up (37.2%). Cox regression revealed that a higher proportion of patients from Western European countries and Israel stopped antipsychotic medication than from Central and Eastern European countries, that relapse was associated with discontinuation, and that discontinuers had lower compliance and higher quality of life. Predictors of successful discontinuation differed with the outcome definition used. Using definition b), successful discontinuers had a better baseline prognosis and better baseline social integration. Using definition a), successful discontinuers more often were from Western European countries. Region and clinical factors were associated with discontinuation. Prognosis and social integration played an important role in predicting successful discontinuation. As this study had several limitations, for example the observational design regarding discontinuation, further studies are needed to identify predictors of successful discontinuation. Copyright © 2016 Elsevier B.V. All rights reserved.

Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

Science.gov (United States)

Patrick-Lake, Bray

2018-02-01

Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

Longitudinal assessment of clinical risk factors for depression in schizophrenia spectrum disorders.

Science.gov (United States)

Onwuameze, Obiora E; Uga, Aghaegbulam; Paradiso, Sergio

2016-08-01

During initial assessment of individuals with schizophrenia and related disorders (schizophrenia spectrum disorders [SSDs]), clinicians tend to pay greater attention to psychotic symptoms than mood symptoms, including depression. Depression is reported to influence the course of SSDs, but not much is known about the risk factors for depression in SSDs. In the present study, we examined clinical predictors of depression in SSDs. The sample included 71 patients with SSDs followed in a modified Assertive Community Treatment program, the Community Support Network of Springfield, Illinois. The study design was naturalistic, prospective, and longitudinal (mean follow-up = 8.3 years; SD = 7.3). The GENMOD procedure appropriate for repeated measures analysis with dichotomous outcome variables followed longitudinally was computed. Rates of depression ranged from 18% to 41% over the differing assessment periods. Schizophrenia and schizoaffective disorder did not vary by depression rate. Depression independent of SSD diagnosis was associated with greater hospitalization rates. Clinical variables predict- ing depression were auditory hallucinations, delusions, poor insight, and poor judgment. Psychotic symptoms in the course of SSDs are risk factors for depression. As a consequence, the mental status examination of patients with SSDs with active psychosis should include assessment of mood changes. Further research is warranted to determine if treatment of depression among patients with SSDs may reduce their rates of hospitalization.

Transparency and public accessibility of clinical trial information in Croatia: how it affects patient participation in clinical trials.

Science.gov (United States)

Šolić, Ivana; Stipčić, Ana; Pavličević, Ivančica; Marušić, Ana

2017-06-15

Despite increased visibility of clinical trials through international trial registries, patients often remain uninformed of their existence, especially if they do not have access to adequate information about clinical research, including the language of the information. The aim of this study was to describe the context for transparency of clinical trials in Croatia in relation to countries in Central and Eastern Europe, and to assess how informed Croatian patients are about clinical trials and their accessibility. We assessed the transparency of clinical trials from the data available in the public domain. We also conducted an anonymous survey on a convenience sample of 257 patients visiting two family medicine offices or an oncology department in south Croatia, and members of national patients' associations. Despite legal provisions for transparency of clinical trials in Croatia, they are still not sufficiently visible in the public domain. Among countries from Central and Eastern Europe, Croatia has the fewest number of registered trials in the EU Clinical Trials Registry. 66% of the patients in the survey were aware of the existence of clinical trials but only 15% were informed about possibilities of participating in a trial. Although 58% of the respondents were willing to try new treatments, only 6% actually participated in a clinical trial. Only 2% of the respondents were aware of publicly available trial registries. Our study demonstrates that there is low transparency of clinical trials in Croatia, and that Croatian patients are not fully aware of clinical trials and the possibilities of participating in them, despite reported availability of Internet resources and good communication with their physicians. There is a need for active policy measures to increase the awareness of and access to clinical trials to patients in Croatia, particularly in their own language.

Clinical Global Impression of Improvement (CGI-I) as a valid proxy measure for remission in schizophrenia: analyses of ziprasidone clinical study data.

Science.gov (United States)

Masand, Prakash; O'Gorman, Cedric; Mandel, Francine S

2011-03-01

To determine the degree to which a proxy measure of remission in schizophrenia correlates with the criteria identified by the Remission in Schizophrenia Working Group, and how well early treatment response to ziprasidone predicts remission. Data from 10 ziprasidone studies were analyzed to determine rates of remission achieved with ziprasidone using a remission definition of Clinical Global Impression of Improvement (CGI-I) of 1, and compared with rates of remission achieved using the remission working group criteria. Positive and Negative Syndrome Scale (PANSS) and Brief Psychiatric Rating Scale (BPRS) scores were then investigated as predictors of remission. A CGI-I score of 1 correlated with the remission criteria developed by the remission working group. In the combined ziprasidone arms, BPRS scores at Weeks 1, 3, and 4 successfully predicted PANSS remission (pproxy measure for the assessment of remission should be easy to apply in a clinical setting and facilitates the prediction of remission in schizophrenia. Copyright © 2010 Elsevier B.V. All rights reserved.

Clinical Trials

Medline Plus

Full Text Available ... Wide Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

Non-adherence to antipsychotic medication, relapse and rehospitalisation in recent-onset schizophrenia

Directory of Open Access Journals (Sweden)

Widen Jan H

2008-04-01

Full Text Available Abstract Background The aims of this study were to describe outcome with respect to persistent psychotic symptoms, relapse of positive symptoms, hospital admissions, and application of treatment by coercion among patients with recent onset schizophrenia being adherent and non-adherent to anti-psychotic medication. Materials and methods The study included 50 patients with recent onset schizophrenia, schizoaffective or schizophreniform disorders. The patients were clinically stable at study entry and had less than 2 years duration of psychotic symptoms. Good adherence to antipsychotic medication was defined as less than one month without medication. Outcomes for poor and good adherence were compared over a 24-month follow-up period. Results The Odds Ratio (OR of having a psychotic relapse was 10.27 and the OR of being admitted to hospital was 4.00 among non-adherent patients. Use of depot-antipsychotics were associated with relapses (OR = 6.44. Conclusion Non-adherence was associated with relapse, hospital admission and having persistent psychotic symptoms. Interventions to increase adherence are needed. Trial registration Current Controlled Trials NCT00184509. Key words: Adherence, schizophrenia, antipsychotic medication, admittances, relapse.

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.

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Kloppenburg, M; Maheu, E; Kraus, V B; Cicuttini, F; Doherty, M; Dreiser, R-L; Henrotin, Y; Jiang, G-L; Mandl, L; Martel-Pelletier, J; Nelson, A E; Neogi, T; Pelletier, J-P; Punzi, L; Ramonda, R; Simon, L S; Wang, S

2015-05-01

Hand osteoarthritis (OA) is a very frequent disease, but yet understudied. However, a lot of works have been published in the past 10 years, and much has been done to better understand its clinical course and structural progression. Despite this new knowledge, few therapeutic trials have been conducted in hand OA. The last OARSI recommendations for the conduct of clinical trials in hand OA dates back to 2006. The present recommendations aimed at updating previous recommendations, by incorporating new data. The purpose of this expert opinion, consensus driven exercise is to provide evidence-based guidance on the design, execution and analysis of clinical trials in hand OA, where published evidence is available, supplemented by expert opinion, where evidence is lacking, to perform clinical trials in hand OA, both for symptom and for structure-modification. They indicate core outcome measurement sets for studies in hand OA, and list the methods and instruments that should be used to measure symptoms or structure. For both symptom- and structure-modification, at least pain, physical function, patient global assessment, HR-QoL, joint activity and hand strength should be assessed. In addition, for structure-modification trials, structural progression should be measured by radiographic changes. We also provide a research agenda listing many unsolved issues that seem to most urgently need to be addressed from the perspective of performing "good" clinical trials in hand OA. These updated OARSI recommendations should allow for better standardizing the conduct of clinical trials in hand OA in the next future. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Electroconvulsive therapy for schizophrenia.

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Tharyan, P; Adams, C E

2005-04-18

Electroconvulsive therapy (ECT) involves the induction of a seizure for therapeutic purposes by the administration of a variable frequency electrical stimulus shock via electrodes applied to the scalp. The effects of its use in people with schizophrenia are unclear. To determine whether electroconvulsive therapy (ECT) results in clinically meaningful benefit with regard to global improvement, hospitalisation, changes in mental state, behaviour and functioning for people with schizophrenia, and to determine whether variations in the practical administration of ECT influences outcome. We undertook electronic searches of Biological Abstracts (1982-1996), EMBASE (1980-1996), MEDLINE (1966-2004), PsycLIT (1974-1996),SCISEARCH (1996) and the Cochrane Schizophrenia Group's Register (July 2004). We also inspected the references of all identified studies and contacted relevant authors. We included all randomised controlled clinical trials that compared ECT with placebo, 'sham ECT', non-pharmacological interventions and antipsychotics and different schedules and methods of administration of ECT for people with schizophrenia, schizoaffective disorder or chronic mental disorder. Working independently, we selected and critically appraised studies, extracted data and analysed on an intention-to-treat basis. Where possible and appropriate we calculated risk ratios (RR) and their 95% confidence intervals (CI) with the number needed to treat (NNT). For continuous data Weighted Mean Differences (WMD) were calculated. We presented scale data for only those tools that had attained pre-specified levels of quality. We also undertook tests for heterogeneity and publication bias. This review includes 26 trials with 50 reports. When ECT is compared with placebo or sham ECT, more people improved in the real ECT group (n=392, 10 RCTs, RR 0.76 random CI 0.59 to 0.98, NNT 6 CI 4 to 12) and though data were heterogeneous (chi-square 17.49 df=9 P=0.04), its impact on variability of data was not

Quetiapine versus other atypical antipsychotics for schizophrenia

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

2014-01-01

Background In many countries of the industrialised world second generation (’atypical’) antipsychotic drugs have become the first line drug treatment for people with schizophrenia. It is not clear how the effects of the various second generation antipsychotic drugs differ. Objectives To evaluate the effects of quetiapine compared with other second generation antipsychotic drugs for people with schizophrenia and schizophrenia-like psychosis. Search methods We searched the Cochrane Schizophrenia Group Trials Register (April 2007), inspected references of all identified studies, and contacted relevant pharmaceutical companies, drug approval agencies and authors of trials for additional information. Selection criteria We included all randomised control trials comparing oral quetiapine with oral forms of amisulpride, aripiprazole, clozapine, olanzapine, risperidone, 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 relative risks (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 weighted mean differences (WMD) again based on a random-effects model. Main results The review currently includes 21 randomised control trials (RCTs) with 4101 participants. These trials provided data on four comparisons - quetiapine versus clozapine, olanzapine, risperidone or ziprasidone. A major limitation to all findings is the high number of participants leaving studies prematurely (57.6%) and the substantial risk of biases in studies. Efficacy data favoured olanzapine and risperidone compared with quetiapine (PANSS total score versus olanzapine:10 RCTs, n=1449, WMD 3.66 CI 1.93 to 5.39; versus risperidone: 9 RCTs, n=1953, WMD 3.09 CI 1.01 to 5.16), but clinical meaning is unclear

Second-generation antipsychotic use in schizophrenia and associated weight gain: a critical review and meta-analysis of behavioral and pharmacologic treatments.

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Das, Chandan; Mendez, Guillermo; Jagasia, Sonal; Labbate, Lawrence A

2012-08-01

Weight gain in schizophrenia, particularly secondary to second-generation antipsychotic (SGA) use, is a common adverse effect and often is associated with significant physical and psychological morbidity. We performed a critical literature review of all controlled clinical trials for pharmacologic and/or behavioral management of SGA-induced weight gain in schizophrenia patients by searching PubMed and Google Scholar. A meta-analysis was performed to estimate and compare weight changes for various medications and behavioral interventions. Sample sizes generally were small. Clinical trials were 6 weeks to 1 year, and weight loss was modest with any treatment. Although several adjunctive pharmacologic treatments showed no weight loss, sibutramine, metformin, and topiramate showed some benefit. Amantadine and orlistat were somewhat less effective and had lower rates of tolerability. Among the behavioral therapies, nutritional counseling combined with exercise showed the most benefit. Behavioral therapies, although modest, showed the most consistent benefits compared with controls. Scheduled pharmacologic treatment to prevent weight gain or promote weight loss in schizophrenia patients on SGA therapy is limited based on current studies. Switching antipsychotic agents has not been established as a long-term solution. Additional long-term studies are required to influence clinical practice.

Concerns about Genetic Testing for Schizophrenia among Young Adults at Clinical High Risk for Psychosis.

Science.gov (United States)

Lawrence, Ryan E; Friesen, Phoebe; Brucato, Gary; Girgis, Ragy R; Dixon, Lisa

Genetic tests for schizophrenia may introduce risks and benefits. Among young adults at clinical high-risk for psychosis, little is known about their concerns and how they assess potential risks. We conducted semi-structured interviews with 15 young adults at clinical high-risk for psychosis to ask about their concerns. Participants expressed concerns about test reliability, data interpretation, stigma, psychological harm, family planning, and privacy. Participants' responses showed some departure from the ethics literature insofar as participants were primarily interested in reporting their results to people to whom they felt emotionally close, and expressed little consideration of biological closeness. Additionally, if tests showed an increased genetic risk for schizophrenia, four clinical high-risk persons felt obligated to tell an employer and another three would "maybe" tell an employer, even in the absence of clinical symptoms. These findings suggest opportunities for clinicians and genetic counselors to intervene with education and support.

Resveratrol Supplementation Did Not Improve Cognition in Patients with Schizophrenia: Results from a Randomized Clinical Trial.

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Zortea, Karine; Franco, Viviane C; Guimarães, Paula; Belmonte-de-Abreu, Paulo S

2016-01-01

Schizophrenia (SZ) is associated with psychotic experiences and cognitive deficits. Therefore, cognitive function is one of the most critical determinants of quality of life in this pathology. Resveratrol has been related to neuroprotective action, but there are no studies evaluating resveratrol in SZ. The objective of this study was to determine the efficacy of resveratrol supplementation on cognition in individuals with SZ. This is a 1-month randomized, double-blind, and controlled trial (NCT 02062190), in which 19 men with diagnosis of SZ, aged 18-65 years, were assigned to a resveratrol supplementation group (200 mg) or placebo group (200 mg), with a 1-month follow-up. Applying a series of cognitive tests assessed neuropsychology performance (Hopkins Verbal Learning Test, Stroop Color and Word Test, and Weschler Adult Intelligence Scale) and Brief Psychiatric Rating Scale assessed psychopathology severity. There were no significant improvement in neuropsychology performance (episodic memory, working memory, attention and concentration capacity, inhibitory control, interference measures, selective attention, and mental flexibility) and psychopathology severity after 1 month of resveratrol supplementation ( P  > 0.05). In conclusion, we have shown that 1 month of a resveratrol supplementation (200 mg/day) did not improve episodic memory, working memory, attention and concentration capacity, inhibitory control, interference measures, selective attention, and mental flexibility as compared with placebo in patients with SZ.

Variants of cognitive deficiency depending on the clinical characteristics of the disease in patients with paranoid schizophrenia

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G. G. Lebedeva

2015-01-01

Full Text Available Pecific aspects of cognitive impairments in patients with paranoid schizophrenia depending on the clinical characteristics of the disease have been studied. One hundred and thirty patients were examined. A clinico-psychological, experimental psychological and statistical methods were used. Three main types of cognitive deficiency with paranoid schizophrenia, associated with the onset, disease duration, and severity of psychiatric symptomology : 1 long-term course of the disease accompanied by the average level of clinical symptomology associated with abnormal attention and visuospatial functions; 2 late onset of the disease and unexpressed clinical symptomology combined with memory impairments; 3 acute onset and early age combined with the absence of cognitive impairments.

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.

Types of Cancer Clinical Trials

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Information about the several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials. Each type of trial is designed to answer different research questions.

Polygenic signal for symptom dimensions and cognitive performance in patients with chronic schizophrenia.

Science.gov (United States)

Xavier, Rose Mary; Dungan, Jennifer R; Keefe, Richard S E; Vorderstrasse, Allison

2018-06-01

Genetic etiology of psychopathology symptoms and cognitive performance in schizophrenia is supported by candidate gene and polygenic risk score (PRS) association studies. Such associations are reported to be dependent on several factors - sample characteristics, illness phase, illness severity etc. We aimed to examine if schizophrenia PRS predicted psychopathology symptoms and cognitive performance in patients with chronic schizophrenia. We also examined if schizophrenia associated autosomal loci were associated with specific symptoms or cognitive domains. Case-only analysis using data from the Clinical Antipsychotics Trials of Intervention Effectiveness-Schizophrenia trials ( n  = 730). PRS was constructed using Psychiatric Genomics Consortium (PGC) leave one out genome wide association analysis as the discovery data set. For candidate region analysis, we selected 105-schizophrenia associated autosomal loci from the PGC study. We found a significant effect of PRS on positive symptoms at p -threshold ( P T ) of 0.5 ( R 2  = 0.007, p  = 0.029, empirical p  = 0.029) and negative symptoms at P T of 1e-07 ( R 2  = 0.005, p  = 0.047, empirical p  = 0.048). For models that additionally controlled for neurocognition, best fit PRS predicted positive ( p- threshold 0.01, R 2   =  0.007, p =  0.013, empirical p  = 0.167) and negative symptoms ( p- threshold 0.1, R 2   =  0.012, p =  0.004, empirical p  = 0.329). No associations were seen for overall neurocognitive and social cognitive performance tests. Post-hoc analyses revealed that PRS predicted working memory and vigilance performance but did not survive correction. No candidate regions that survived multiple testing corrections were associated with either symptoms or cognitive performance. Our findings point to potentially distinct pathogenic mechanisms for schizophrenia symptoms.

Resilience research in schizophrenia: a review of recent developments.

Science.gov (United States)

Mizuno, Yuya; Wartelsteiner, Fabienne; Frajo-Apor, Beatrice

2016-05-01

The concept of resilience is expected to be relevant in understanding the heterogeneous outcomes associated with schizophrenia. We reviewed recent developments in clinical studies focusing on the biological and psychological aspects of resilience in this population. We aimed to clarify current concepts of resilience in the field, elucidate gaps in the literature, and provide recommendations for future research. A total of 20 articles published between 2014 and 2015 were included. Six studies were neuroimaging studies, while the remaining studies used various psychological assessments. Most studies were cross-sectional except for three studies with naturalistic follow-up, one single-blind randomized controlled trial, and two published protocols of prospective studies. The following patterns of research were evident among the highly heterogeneous literature: studies focusing on protective factors and others emphasizing dynamic processes, studies investigating 'at-risk but resilient' groups (e.g. nonpsychotic siblings of patients with schizophrenia), and studies using psychological scales to measure resilience. The heterogeneity in how reports conceptualize, assess, and interpret resilience likely reflects the multidimensional nature of the concept itself and the lack of a 'gold standard' in assessing resilience in schizophrenia. Further research is needed to make recommendations on how to facilitate resilience in clinical care.

Women and schizophrenia

OpenAIRE

Thara, R.; Kamath, Shantha

2015-01-01

Women's mental health is closely linked to their status in society. This paper outlines the clinical features of women with schizophrenia and highlights the interpersonal and social ramifications on their lives. There is no significant gender difference in the incidence and prevalence of schizophrenia. There is no clear trend in mortality, although suicides seem to be more in women with schizophrenia. In India, women face a lot of problems, especially in relation to marriage, pregnancy, child...

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

Science.gov (United States)

Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

2016-03-22

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

Quality Assurance for Clinical Trials

Science.gov (United States)

Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

2013-01-01

Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

Clinical trials. A pending subject.

Science.gov (United States)

Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

2018-04-01

Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

Cross-Over Clinical Trials?

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Latif Gachkar

2017-01-01

Full Text Available Abstract Cross-Over Clinical Trials in comparison with Parallel groups clinical trials have some advantages such as control of confounding variables, small sample size, and short time to implement the research project. But this type of research has few essential limitations that discusses in this monogram.

Downregulated kynurenine 3-monooxygenase gene expression and enzyme activity in schizophrenia and genetic association with schizophrenia endophenotypes.

Science.gov (United States)

Wonodi, Ikwunga; Stine, O Colin; Sathyasaikumar, Korrapati V; Roberts, Rosalinda C; Mitchell, Braxton D; Hong, L Elliot; Kajii, Yasushi; Thaker, Gunvant K; Schwarcz, Robert

2011-07-01

Kynurenic acid, a metabolite of the kynurenine pathway of tryptophan degradation, is an antagonist at N-methyl-d-aspartate and α7 nicotinic acetylcholine receptors and modulates glutamate, dopamine, and acetylcholine signaling. Cortical kynurenic acid concentrations are elevated in the brain and cerebrospinal fluid of schizophrenia patients. The proximal cause may be an impairment of kynurenine 3-monooxygenase (KMO), a rate-limiting enzyme at the branching point of the kynurenine pathway. To examine KMO messenger RNA expression and KMO enzyme activity in postmortem tissue from the frontal eye field (FEF; Brodmann area 6) obtained from schizophrenia individuals compared with healthy control individuals and to explore the relationship between KMO single-nucleotide polymorphisms and schizophrenia oculomotor endophenotypes. Case-control postmortem and clinical study. Maryland Brain Collection, outpatient clinics. Postmortem specimens from schizophrenia patients (n = 32) and control donors (n = 32) and a clinical sample of schizophrenia patients (n = 248) and healthy controls (n = 228). Comparison of quantitative KMO messenger RNA expression and KMO enzyme activity in postmortem FEF tissue between schizophrenia patients and controls and association of KMO single-nucleotide polymorphisms with messenger RNA expression in postmortem FEF and schizophrenia and oculomotor endophenotypes (ie, smooth pursuit eye movements and oculomotor delayed response). In postmortem tissue, we found a significant and correlated reduction in KMO gene expression and KMO enzyme activity in the FEF in schizophrenia patients. In the clinical sample, KMO rs2275163 was not associated with a diagnosis of schizophrenia but showed modest effects on predictive pursuit and visuospatial working memory endophenotypes. Our results provide converging lines of evidence implicating reduced KMO activity in the etiopathophysiology of schizophrenia and related neurocognitive deficits.

Treatment patterns and clinical characteristics prior to initiating depot typical antipsychotics for nonadherent schizophrenia patients

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Montgomery William

2009-07-01

Full Text Available Abstract Background Nonadherence with antipsychotic medication is an important clinical and economic problem in the treatment of schizophrenia. This study identified treatment patterns and clinical characteristics that immediately precede the initiation of depot typical antipsychotics in the usual treatment of schizophrenia patients with a recent history of nonadherence with oral antipsychotic regimens. Methods Data were drawn from a large, multisite, 3-year prospective noninterventional observational study of persons treated for schizophrenia in the United States, which was conducted between 7/1997 and 9/2003. The analytical sample included patients who, in the 6 months prior to enrollment, were considered nonadherent with oral antipsychotics and were not treated with depot antipsychotics (N = 314. Patients who were subsequently initiated on typical depots during the 3-year follow-up were compared with patients who continued therapy with only oral antipsychotic agents. Group comparisons were made on patient baseline characteristics and precedent variables that were assessed 1 to 6 months prior to depot initiation. Patient assessments were made at predetermined intervals throughout the 3-year study using standard psychiatric measures, a patient-reported questionnaire, and medical record information. Results A small proportion of patients (12.4% who were recently nonadherent with oral antipsychotics were subsequently initiated on depot therapy during the 3-year study. Compared to patients treated with only oral antipsychotics, those subsequently initiated on a depot were significantly more likely to be hospitalized at depot initiation or the previous 30 days, to have recent involvement with the criminal justice system (arrests, recent illicit drug use, recent switching or augmentation of oral antipsychotics, and recent treatment with oral typical antipsychotics. Conclusion Despite prior nonadherence with oral antipsychotic medication, only a

Lessons learned in the conduct of a global, large simple trial of treatments indicated for schizophrenia.

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Kolitsopoulos, Francesca M; Strom, Brian L; Faich, Gerald; Eng, Sybil M; Kane, John M; Reynolds, Robert F

2013-03-01

Large, "practical" or streamlined trials (LSTs) are used to study the effectiveness and/or safety of medicines in real world settings with minimal study imposed interventions. While LSTs have benefits over traditional randomized clinical trials and observational studies, there are inherent challenges to their conduct. Enrollment and follow-up of a large study sample of patients with mental illness pose a particular difficulty. To assist in overcoming operational barriers in future LSTs in psychiatry, this paper describes the recruitment and observational follow-up strategies used for the ZODIAC study, an international, open-label LST, which followed 18,239 persons randomly assigned to one of two treatments indicated for schizophrenia for 1 year. ZODIAC enrolled patients in 18 countries in North America, South America, Europe, and Asia using broad study entry criteria and required minimal clinical care intervention. Recruitment of adequate numbers and continued engagement of both study centers and subjects were significant challenges. Strategies implemented to mitigate these in ZODIAC include global study expansion, study branding, field coordinator and site relations programs, monthly site newsletters, collection of alternate contact information, conduct of national death index (NDI) searches, and frequent sponsor, contract research organization (CRO) and site interaction to share best practices and address recruitment challenges quickly. We conclude that conduct of large LSTs in psychiatric patient populations is feasible, but importantly, realistic site recruitment goals and maintaining site engagement are key factors that need to be considered in early study planning and conduct. Copyright © 2012 Elsevier Inc. All rights reserved.

Unipolar Depression in Paroxysmal Schizophrenia

Directory of Open Access Journals (Sweden)

Alexander S. Bobrov

2013-12-01

Full Text Available Based on the current study, the clinical characteristics of unipolar depression in the clinical picture of schizophrenia with the paroxysmal type of disease course are presented. Given the concomitant depression with phobic symptoms, the following clinical variants are marked: depression with generalized social phobia and/or anthropophobia and depression with generalized pathological body sensations and hypochondriacal phobias. In other words, we are talking about a necessity to allocate a special type of schizophrenia with affective structure episodes and comorbid neurosis-like symptoms. Information on the basic treatment strategy of schizophrenia with depressive structure episodes and comorbid neurosis-like symptoms in everyday psychiatric practice is also provided.

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

International Nuclear Information System (INIS)

Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina

2016-01-01

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

Neurocognition in Early-Onset Schizophrenia and Schizoaffective Disorders

Science.gov (United States)

Hooper, Stephen R.; Giuliano, Anthony J.; Youngstrom, Eric A.; Breiger, David; Sikich, Linmarie; Frazier, Jean A.; Findling, Robert L.; McClellan, Jon; Hamer, Robert M.; Vitiello, Benedetto; Lieberman, Jeffrey A.

2010-01-01

Objective: We examined the neuropsychological functioning of youth enrolled in the NIMH funded trial, Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS). We compared the baseline neuropsychological functioning of youth with schizophrenia (SZ, n = 79) to those with schizoaffective disorder (SA, n = 40), and examined the relationship…

Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial

DEFF Research Database (Denmark)

Pagsberg, Anne Katrine; Jeppesen, Pia; Klauber, Dea Gowers

2014-01-01

BACKGROUND: The evidence for choices between antipsychotics for children and adolescents with schizophrenia and other psychotic disorders is limited. The main objective of the Tolerability and Efficacy of Antipsychotics (TEA) trial is to compare the benefits and harms of quetiapine versus...... aripiprazole in children and adolescents with psychosis in order to inform rational, effective and safe treatment selections. METHODS/DESIGN: The TEA trial is a Danish investigator-initiated, independently funded, multi-centre, randomised, blinded clinical trial. Based on sample size estimation, 112 patients...... about head-to-head differences in efficacy and tolerability of antipsychotics are scarce in children and adolescents. The TEA trial aims at expanding the evidence base for the use of antipsychotics in early onset psychosis in order to inform more rational treatment decisions in this vulnerable...

Polygenic dissection of diagnosis and clinical dimensions of bipolar disorder and schizophrenia

DEFF Research Database (Denmark)

Ruderfer, D M; Fanous, A H; Ripke, S

2014-01-01

(GWAS) of 19 779 bipolar disorder (BP) and schizophrenia (SCZ) cases versus 19 423 controls, in addition to a direct comparison GWAS of 7129 SCZ cases versus 9252 BP cases. In our case-control analysis, we identify five previously identified regions reaching genome-wide significance (CACNA1C, IFI44L...... differ biologically. These findings also indicate that combining clinical symptom dimensions and polygenic signatures could provide additional information that may someday be used clinically....

Medications Used for Cognitive Enhancement in Patients With Schizophrenia, Bipolar Disorder, Alzheimer's Disease, and Parkinson's Disease.

Science.gov (United States)

Hsu, Wen-Yu; Lane, Hsien-Yuan; Lin, Chieh-Hsin

2018-01-01

Cognitive impairment, which frequently occurs in patients with schizophrenia, bipolar disorder, Alzheimer's disease, and Parkinson's disease, has a significant impact on the daily lives of both patients and their family. Furthermore, since the medications used for cognitive enhancement have limited efficacy, the issue of cognitive enhancement still remains a clinically unsolved challenge. We reviewed the clinical studies (published between 2007 and 2017) that focused on the efficacy of medications used for enhancing cognition in patients with schizophrenia, bipolar disorder, Alzheimer's disease, and Parkinson's disease. Acetylcholinesterase inhibitors and memantine are the standard treatments for Alzheimer's disease and Parkinson's disease. Some studies have reported selective cognitive improvement in patients with schizophrenia following galantamine treatment. Newer antipsychotics, including paliperidone, lurasidone, aripiprazole, ziprasidone, and BL-1020, have also been reported to exert cognitive benefits in patients with schizophrenia. Dopaminergic medications were found to improve language function in patients with Parkinson's disease. However, no beneficial effects on cognitive function were observed with dopamine agonists in patients with schizophrenia. The efficacies of nicotine and its receptor modulators in cognitive improvement remain controversial, with the majority of studies showing that varenicline significantly improved the cognitive function in schizophrenic patients. Several studies have reported that N -methyl-d-aspartate glutamate receptor (NMDAR) enhancers improved the cognitive function in patients with chronic schizophrenia. NMDAR enhancers might also have cognitive benefits in patients with Alzheimer's disease or Parkinson's disease. Raloxifene, a selective estrogen receptor modulator, has also been demonstrated to have beneficial effects on attention, processing speed, and memory in female patients with schizophrenia. Clinical trials with

Effects of sertindole on cognition in clozapine-treated schizophrenia patients - a double-blinded, randomized, placebo-controlled trial

DEFF Research Database (Denmark)

Nielsen, R E; Levander, S; Nielsen, Jimmi

Nielsen RE, Levander S, Thode D, Nielsen J. Effects of sertindole on cognition in clozapine-treated schizophrenia patients. Objective:  To assess the cognitive effects of sertindole augmentation in clozapine-treated patients diagnosed with schizophrenia. Cognition is secondary outcome of the trial....... Method:  A 12-week, double-blinded, randomized, placebo-controlled, augmentation study of patients treated with clozapine. Participants were randomized 1:1 to receive 16 mg of sertindole or placebo as adjunctive treatment to clozapine. Results:  Participants displayed substantial cognitive deficits......, ranging from 1.6 standard deviation below norms at baseline to more than three standard deviations on tests of response readiness and focused attention. There were no significant differences between sertindole augmentation and placebo groups at study end. Correlation analysis of Positive and Negative...

Clinical Trials

Medline Plus

Full Text Available ... part. Randomization Most clinical trials that have comparison groups use randomization. This involves assigning patients to different comparison groups by chance, rather than choice. This ...

Motivation deficits and use of alcohol and illicit drugs among individuals with schizophrenia.

Science.gov (United States)

Bahorik, Amber L; Greeno, Catherine G; Cochran, Gerald; Cornelius, Jack R; Eack, Shaun M

2017-07-01

This study examined the impact of substance use on intrinsic motivation and evaluated the association between intrinsic motivation and substance use recovery among individuals with schizophrenia. Alcohol and illicit drug use and intrinsic motivation were evaluated at baseline and 6-months for 1434 individuals with schizophrenia from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) using self-rated substance use assessments and a derived motivation measure from the Heinrichs-Carpenter Quality of Life Scale. Results revealed patients had moderate motivation deficits overall and a considerable number were using alcohol or illicit drugs at baseline (n=576; 40.2%). Regression models at baseline showed patients with low levels of motivation had higher odds of substance use and those who were using substances had greater motivation deficits. At 6-months, substance using patients continued to demonstrate greater motivation deficits; however, those with high levels of motivation exhibited a greater reduction in their use of substances. Findings remained significant after adjusting for clinical confounds and were consistent across any substance, alcohol, and cannabis use. Our results emphasize concerns about substance use compounding motivation deficits in schizophrenia, and suggest that disentangling the motivation-substance use relationship in schizophrenia may facilitate efforts aimed at ameliorating these challenges and improving outcomes. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Esquizofrenia refratária Refractory schizophrenia

Directory of Open Access Journals (Sweden)

Helio Elkis

2007-10-01

Full Text Available OBJETIVO: O propósito deste artigo é o de revisar vários aspectos da esquizofrenia refratária levando em conta questões relacionadas à definição, aspectos clínicos, correlatos psicobiológicos, tratamentos farmacológicos e não farmacológicos, assim como preditores de resposta terapêutica. MÉTODO: Pesquisa no Medline, assim como artigos dos autores. RESULTADOS E CONCLUSÕES: Pelo menos um terço dos pacientes com esquizofrenia são refratários a tratamento com antipsicóticos e as evidências apontam a clozapina em monoterapia como a principal opção nesses casos. A politerapia com antipsicóticos não tem apoio em evidências. Ensaios clínicos recentes mostraram que a potencialização da clozapina com outros antipsicóticos não é superior ao placebo.OBJECTIVE: The aim of the present paper is to review the various aspects of refractory schizophrenia regarding issues such as definitions, clinical aspects, psychobiological correlates, pharmacological and non-pharmacological treatment options and predictors of treatment response. METHOD: Medline search as well as articles of the authors. RESULTS AND CONCLUSIONS: Refractory schizophrenia affects at least one third of patients with schizophrenia and the best evidence shows that is monotherapy with clozapine remains the mainstay for the treatment of such condition. Antipsychotic polipharmacy is not supported by current evidence and recent clinical trials have shown that clozapine augmentation with antipsychotics has no benefit over placebo.

Clinical Trials

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Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that ...

Clinical Trials

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Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are ...

Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

Directory of Open Access Journals (Sweden)

Joseph S Ross

2009-09-01

Full Text Available ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006.Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data

Concomitant NSAID use during antipsychotic treatment and risk of 2-year relapse - a population-based study of 16,253 incident patients with schizophrenia

DEFF Research Database (Denmark)

Köhler, Karl Ole; Petersen, Liselotte; Benros, Michael Eriksen

2016-01-01

OBJECTIVE: Clinical trials have indicated antipsychotic effects of non-steroidal anti-inflammatory drugs (NSAIDs) among incident patients with schizophrenia. We aimed to study, in a population-based setting, whether concomitant use of NSAIDs or paracetamol, changed 2-year relapse risk...... for schizophrenia. METHODS: We identified all incident patients with schizophrenia in Denmark diagnosed 1996-2012 initiating antipsychotic treatment within the year after diagnosis. We calculated concomitant treatment intervals for antipsychotic and NSAID or paracetamol use. Hazard rate ratios (HRR) were estimated...... using Cox regression adjusted for important covariates. MAIN OUTCOME MEASURES: 2-year relapse, i.e. (re)-hospitalizations with schizophrenia. RESULTS: Among 16,235 incident patients with schizophrenia using antipsychotics, 1480 (9.1%) used NSAIDs and 767 (4.7%) paracetamol. Concomitant use of NSAIDs...

Occipital bending in schizophrenia.

Science.gov (United States)

Maller, Jerome J; Anderson, Rodney J; Thomson, Richard H; Daskalakis, Zafiris J; Rosenfeld, Jeffrey V; Fitzgerald, Paul B

2017-01-01

To investigate the prevalence of occipital bending (an occipital lobe crossing or twisting across the midline) in subjects with schizophrenia and matched healthy controls. Occipital bending prevalence was investigated in 37 patients with schizophrenia and 44 healthy controls. Ratings showed that prevalence was nearly three times higher among schizophrenia patients (13/37 [35.1%]) than in control subjects (6/44 [13.6%]). Furthermore, those with schizophrenia had greater normalized gray matter volume but less white matter volume and had larger brain-to-cranial ratio. The results suggest that occipital bending is more prevalent among schizophrenia patients than healthy subjects and that schizophrenia patients have different gray matter-white matter proportions. Although the cause and clinical ramifications of occipital bending are unclear, the results infer that occipital bending may be a marker of psychiatric illness.

Clinical Trials

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Full Text Available ... and compare new treatments with other available treatments. Steps To Avoid Bias The researchers doing clinical trials take steps to avoid bias. "Bias" means that human choices ...

Clinical Trials

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Full Text Available ... and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, ...

Opioid detoxification : from controlled clinical trial to clinical practice

NARCIS (Netherlands)

Dijkstra, Boukje A G; De Jong, Cor A J; Wensing, Michel; Krabbe, Paul F M; van der Staak, Cees P F

2010-01-01

Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

Change in level of productivity in the treatment of schizophrenia with olanzapine or other antipsychotics

Directory of Open Access Journals (Sweden)

Osuntokun Olawale

2011-05-01

Full Text Available Abstract Background When treating schizophrenia, improving patients' productivity level is a major goal considering schizophrenia is a leading cause of functional disability. Productivity level has been identified as the most preferred treatment outcome by patients with schizophrenia. However, little has been done to systematically investigate productivity levels in schizophrenia. We set out to better understand the change in productivity level among chronically ill patients with schizophrenia treated with olanzapine compared with other antipsychotic medications. We also assessed the links between productivity level and other clinical outcomes. Methods This post hoc analysis used data from 6 randomized, double-blind clinical trials of patients with schizophrenia or schizoaffective disorder, with each trial being of approximately 6 months duration. Change in productivity level was compared between olanzapine-treated patients (HGBG, n = 172; HGHJ, n = 277; HGJB, n = 171; HGLB, n = 281; HGGN, n = 159; HGDH, n = 131 and patients treated with other antipsychotic medications (separately vs. haloperidol [HGGN, n = 97; HGDH, n = 132], risperidone [HGBG, n = 167; HGGN, n = 158], quetiapine [HGJB, n = 175], ziprasidone [HGHJ, n = 271] and aripiprazole [HGLB, n = 285]. Productivity was defined as functional activities/work including working for pay, studying, housekeeping and volunteer work. Productivity level in the prior 3 months was assessed on a 5-point scale ranging from no useful functioning to functional activity/work 75% to 100% of the time. Results Chronically ill patients treated with olanzapine (OLZ experienced significantly greater improvement in productivity when compared to patients treated with risperidone (RISP (OLZ = 0.22 ± 1.19, RISP = -0.03 ± 1.17, p = 0.033 or ziprasidone (ZIP (OLZ = 0.50 ± 1.38, ZIP = 0.25 ± 1.27, p = 0.026, but did not significantly differ from the quetiapine, aripiprazole or haloperidol treatment groups. Among

Different communication strategies for disclosing a diagnosis of schizophrenia and related disorders.

Science.gov (United States)

Farooq, Saeed; Johal, Rupinder K; Ziff, Charlotte; Naeem, Farooq

2017-10-24

Delivering the diagnosis of a serious illness is an important skill in most fields of medicine, including mental health. Research has found that communication skills can impact on a person's recall and understanding of the diagnosis, treatment options and prognosis. People may feel confused and perplexed when information about their illness is not communicated properly. Sharing information about diagnosis of a serious mental illness is particularly challenging. The nature of mental illness is often difficult to explain since there may be no clear aetiology, and the treatment options and prognosis may vary enormously. In addition, newly diagnosed psychiatric patients, who are actively ill, often may not accept their diagnosis due to lack of insight or stigma attached to the condition. There are several interventions that aim to help clinicians to communicate life changing medical diagnoses to people; however, little is known specifically for delivering a diagnosis of schizophrenia. To evaluate evidence from randomised controlled trials (RCTs) for the efficacy of different communication strategies used by clinicians to inform people about the diagnosis and outcome of schizophrenia compared with treatment as usual and to compare efficacy between different communication strategies. On 22 June 2015 and 29 June 2016, we searched the Cochrane Schizophrenia Group's Study-Based Register of Trials. We also searched sources of grey literature (e.g., dissertations, theses, clinical reports, evaluations published on websites, clinical guidelines and reports from regulatory agencies). We planned to include all relevant RCTs that included adults with schizophrenia or related disorders, including schizophreniform disorder, schizoaffective disorder and delusional disorder. The trials would have investigated the effects of communication strategy or strategies that helped clinicians deliver information specifically about a diagnosis of schizophrenia (which can also include

Schizophrenia and Suicide

Directory of Open Access Journals (Sweden)

Ozlem Cetin

2011-12-01

Full Text Available Suicide is one of the major causes of premature death among patients with schizophrenia. Follow-up studies have estimated that 4-5% of these patients die by suicide. Reducing the high rates of suicide in schizophrenia is possible with understanding of predictive risk factors. Various studies have identified risk factors for suicide in schizophrenia patients. Clinical risk factors include previous suicide attempts, comorbid depression, feelings of hopelessness, concept of insight and substance abuse. Biopsychosocial factors, such as a high intelligence quotient and high level of premorbid functioning, have also been associated with an increased risk of suicide in patients with schizophrenia. The risk of suicide is considered to be highest in the early course of illness. Antipsychotic drugs, in particular clozapine and antidepressants may be helpful in reducing the risk of suicide in schizophrenia.

The relative contributions of social cognition and self-reflectiveness to clinical insight in enduring schizophrenia.

Science.gov (United States)

Béland, Sophie; Lepage, Martin

2017-12-01

Poor clinical insight represents a major barrier to recovery in schizophrenia. Research suggests that higher-order social cognitive abilities such as theory of mind (TOM) and metacognition contribute to levels of clinical insight. However, few studies have examined whether social cognitive abilities other than TOM are related to clinical insight. Moreover, to date, no investigation has attempted to determine whether the contribution of metacognitive ability to clinical insight can be differentiated from the contribution of higher-order social cognition, despite their conceptual similarity. Therefore, the purpose of this study was to examine the relative contribution of different social cognitive abilities, as well as metacognition, to clinical insight in a large sample of 139 enduring schizophrenia patients, and controlling for established predictors of clinical insight. Hierarchical regression analyses were used to evaluate the portion of variance explained by 3 social cognitive abilities: emotion recognition, TOM, and affective empathy, and the metacognitive ability of self-reflectiveness. Clinical insight levels were assessed using the Schedule for the Assessment of Insight-Expanded version. Results indicated that affective empathy and self-reflectiveness are the strongest predictors of clinical insight. These results provide insights on the development of targeted interventions for improving clinical insight in this population. Copyright © 2017 Elsevier B.V. All rights reserved.

Residual Negative Symptoms Differentiate Cognitive Performance in Clinically Stable Patients with Schizophrenia and Bipolar Disorder

Directory of Open Access Journals (Sweden)

Rajeev Krishnadas

2014-01-01

Full Text Available Cognitive deficits in various domains have been shown in patients with bipolar disorder and schizophrenia. The purpose of the present study was to examine if residual psychopathology explained the difference in cognitive function between clinically stable patients with schizophrenia and bipolar disorder. We compared the performance on tests of attention, visual and verbal memory, and executive function of 25 patients with schizophrenia in remission and 25 euthymic bipolar disorder patients with that of 25 healthy controls. Mediation analysis was used to see if residual psychopathology could explain the difference in cognitive function between the patient groups. Both patient groups performed significantly worse than healthy controls on most cognitive tests. Patients with bipolar disorder displayed cognitive deficits that were milder but qualitatively similar to those of patients with schizophrenia. Residual negative symptoms mediated the difference in performance on cognitive tests between the two groups. Neither residual general psychotic symptoms nor greater antipsychotic doses explained this relationship. The shared variance explained by the residual negative and cognitive deficits that the difference between patient groups may be explained by greater frontal cortical neurophysiological deficits in patients with schizophrenia, compared to bipolar disorder. Further longitudinal work may provide insight into pathophysiological mechanisms that underlie these deficits.

Cigarette smoking and schizophrenia: a specific clinical and therapeutic profile? Results from the FACE-Schizophrenia cohort.

Science.gov (United States)

Mallet, J; Le Strat, Y; Schürhoff, F; Mazer, N; Portalier, C; Andrianarisoa, M; Aouizerate, B; Berna, F; Brunel, L; Capdevielle, D; Chereau, I; D'Amato, T; Denizot, H; Dubreucq, J; Faget, C; Gabayet, F; Lançon, C; Llorca, P M; Misdrahi, D; Rey, R; Roux, P; Schandrin, A; Urbach, M; Vidailhet, P; Fond, G; Dubertret, C

2017-10-03

Tobacco use is common in patients with schizophrenia (SZ) but little is known on the role of tobacco in the physiopathology or on the course of the disease. Only few studies embrace an extensive examination of clinical and therapeutic characteristics in stabilized patients. The objective of the present study was to determine the prevalence of tobacco smoking in stabilized SZ outpatients and the clinical and treatment characteristics associated with daily tobacco use in a large community-dwelling sample of patients. Three-hundred-and-sixty-one patients were included in the network of the FondaMental Expert Centers for Schizophrenia. Current tobacco status was self-declared. 53.7% were smokers. Mean age at tobacco onset was 17.2years old. In multivariate analyses, after adjustment for confounding factors, positive symptoms and mean daily antipsychotic dose were associated with a higher frequency of tobacco use (OR=1.06 95%IC[1.02-1.12], for positive symptoms, OR=1.1, 95%IC[1.02-1.18] for daily antipsychotic dose). Education level, negative symptoms, anticholinergic agents, clozapine or aripiprazole administration were independently associated with a lower frequency of tobacco use (respectively OR=0.87, 95%IC [0.79, 0.95], OR=0.95, 95%IC[0.91-0.98], OR=0.41, 95%IC[0.22-0.76], OR=0.56, 95%IC=[0.32, 0.99] and OR=0.49, 95%IC [0.26-0.91]). The prevalence of current tobacco smoking in a French community-dwelling SZ patients is higher that observed in the general population. Patients with tobacco use present clinical and therapeutic specificities that may involve interaction between cholinergic-nicotinic and dopaminergic systems. The present study suggests that some therapeutics may improve daily smoking behavior in smokers. These results should be confirmed in longitudinal studies. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative.

Science.gov (United States)

Huang, Grant D; Bull, Jonca; Johnston McKee, Kelly; Mahon, Elizabeth; Harper, Beth; Roberts, Jamie N

2018-03-01

Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Clinical characteristics and premorbid variables in childhood-onset schizophrenia: a descriptive study of twelve cases from a schizophrenia founder population.

Science.gov (United States)

Maydell, R J; van der Walt, C; Roos, J L; Scribante, L; Ladikos, A

2009-05-01

To analyze clinical and demographic data of childhood-onset (12 years and younger) schizophrenia patients collected for a genetic study in schizophrenia, undertaken nationally in South Africa, using multiple parameters. Patients with an onset of schizophrenia at 12 years or younger, were included. From the Diagnostic Interview for Genetic Studies (DIGS), patients' information and summary report data was tabulated and analyzed. Specific subgroups were further compared. This sub-population of 12 subjects was further compared with a group of the adult sample. Of the 12 patients recruited, prominent results were: male to female ratio of 1:1; all had insidious onset of psychosis; a third had all 3 multidimensional impairment (MDI) symptoms; all patients that received ADHD treatment had ADHD treatment failure; two thirds had milestone delay; 58% had birth complications; a third were predominantly bottle fed; 42% had family history of schizophrenia; a third had family history of other major psychiatric conditions; all patients had at least one non-psychotic deviant behaviour (NPDB); no patient used cannabis; all delusions were paranoid; 92% had school achievement difficulty and a third had treatment resistance. Gender comparison included: earlier onset of psychosis in females; all females had aggression versus a third of males; more females had school achievement difficulty than males; males had more treatment resistance. Patients with MDI, compared to the sample average had: earlier onset of non-psychotic deviant behaviour; lower school drop-out rate; less social difficulty and no treatment resistance. The results compare well to previous research on this topic. The new concepts introduced by the present study require further investigation.

[Clinical features of suicide occurring in schizophrenia (I). Risk-factors identification].

Science.gov (United States)

Besnier, N; Gavaudan, G; Navez, A; Adida, M; Jollant, F; Courtet, P; Lançon, C

2009-04-01

Suicide is the leading cause of premature death in schizophrenia. Approximately 10 to 13% of deaths in schizophrenia are explained by suicide, despite widespread availability of generally effective antipsychotic treatments and suicide attempts have been reported among 20 to 50% of patients. This relatively low ratio of attempts/suicide is consistent with greater lethality of means - more violent - and intents - less ambivalence - in this population. Many studies have focused on risk factors and clinical characteristics for completed and/or attempted suicide. Commonly, sociodemographic risk factors for suicide are male sex, younger age and, among women, being unmarried, divorced or widowed. Previous suicidal behaviour is a strong risk factor for suicide and contrary to the common view, schizophrenic patients often communicate their suicidal intents shortly before death. Moreover, family history of suicide is associated with a heightened risk of suicide and is independent of the diagnosis, according to the growing literature that shows that vulnerability to suicidal behaviour is independent of psychiatric diagnosis. Suicide can occur throughout the entire course of schizophrenia. This is particularly true in those high-risk periods: early phase of the disease, active illness phase, period of relapse or during a depressive episode. The role of insight and positive symptoms remains unclear and probably needs further studies. Although not specifically for people with schizophrenia, hopelessness is a major risk factor and tragic loss is often presented as a trigger for suicide. It has been suggested that treatment side-effects, such as akathisia are associated with suicidal behaviour. A better knowledge of risk and protective factors is necessary to prevent suicide and suicidality.

[The clinic of apathy in schizophrenia: a critical review of the issue].

Science.gov (United States)

Yazbek, H; Raffard, S; Del-Monte, J; Pupier, F; Larue, A; Boulenger, J-P; Gély-Nargeot, M-C; Capdevielle, D

2014-06-01

Today the concept of apathy is subject to many questions. This psychological state is present and predominant in different disorders such as neurodegenerative and psychiatric diseases or neurological acquired disorders. Apathy is a part of the clinical vocabulary, however, we can note that in the literature there remains confusion in its definition, and we can find an amalgam with other clinical symptoms. The aim of this review is to provide a clarification of the concept of apathy in clinical practice in schizophrenia as well as to highlight the gaps that exist. Apathy belongs to the negative symptoms of schizophrenia. For its understanding, it is necessary to define apathy as a multidimensional syndrome (cognitive, emotional, and behavioral) manifesting as a quantitative reduction of voluntary behaviors directed toward one or several goals. However, at present, we are witnessing a reductionist and simplistic conception of the syndrome of apathy and this especially in the Anglo-Saxon literature. Several authors reduce apathy to its behavioral component, so in other words, to avolition/amotivation. Avolition refers to a loss of self-initiated and spontaneous behaviors. In this definition only observable behavior is taken into account and not the underlying mechanisms (cognitive and emotional). In order to understand the syndrome of apathy, it is necessary to have a holistic and multidimensional outlook. Some authors have proposed diagnostic criteria for apathy by taking into account the different dimensions of apathy. Moreover not only is apathy confused with avolition, but it is also still difficult to distinguish it from depression. Apathy and depression share common clinical signs (i.e. loss of interest), but they also have distinct clinical signs (lack of motivation for apathy, and suicidal ideation for depression). Authors have shown that the presence of one symptom (apathy or depression) does not predict the presence of the other. An apathetic patient does

Clinical Trials

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Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and ...

Clinical Trials

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Full Text Available ... new treatments in small groups of people for safety and side effects. Phase II clinical trials look at how well treatments work and further review these treatments for safety. Phase ...

[Cognition, schizophrenia and the effect of antipsychotics].

Science.gov (United States)

Stip, E

2006-01-01

In this review, we conclude that cognitive impairments are as important as positive and negative symptoms in the clinical assessment and management of patients with schizophrenia. This is not a comprehensive review, considering that the new Measurement And Treatment Research to Improve Cognition in Schizophrenia (MATRICS) model will soon provide valuable data. It is however a product of the collective efforts of a French Canadian clinical research team that proposes a synthesis of data of pragmatic interest to clinicians. Medication with improved safety and cognition profile, gene-rally lead to better outcomes by facilitating compliance with drug regimens and rehabilitation programs. In addition, measures of attention and executive function (EF) appear to improve with novel antipsychotics when compared to traditional neuroleptics. Nevertheless, evaluating cognitive performance is not a routine procedure outside the domain of research. For example, procedural learning (PL) -- an important measure of cognitive function -- refers to cognitive and motor learning processes in which execution strategies cannot be explicitly described (ie learning by doing). These actions or procedures are then progressively learned through trial and error until automation of optimal performance is established. Procedural learning is rarely assessed in clinical practice. Inconsistent findings regarding the effects of neuroleptic drugs on PL have been reported. Trials using acute administration of chlorpromazine in normal subjects induced PL deficits, suggesting the direct effect of neuroleptics, presumably via a D(2) dopamine blockade in the striatum. In a recent study by our group, schizophrenia patients, divided into three groups according to their pharmacological treatment (haloperidol, clozapine and risperidone) were compared to normal controls on two PL tasks; a visuomotor learning task (mirror drawing) and a problem solving learning task (Tower of Toronto). No deficits were detected

Cortisol in schizophrenia: No association with tobacco smoking, clinical symptoms or antipsychotic medication.

Science.gov (United States)

Nedic Erjavec, Gordana; Uzun, Suzana; Nikolac Perkovic, Matea; Kozumplik, Oliver; Svob Strac, Dubravka; Mimica, Ninoslav; Hirasawa-Fujita, Mika; Domino, Edward F; Pivac, Nela

2017-07-03

Cigarette smoking is associated with higher cortisol levels in healthy subjects. In schizophrenia this relationship is not clear. There are divergent results on the association between cortisol with smoking, clinical symptoms and medication in schizophrenia. This study evaluated this association in 196 Caucasian inpatients with schizophrenia (51.30±26.68years old), subdivided into 123 smokers and 73 non-smokers. Basal salivary cortisol levels were measured twice, at 08.00 and 09.00AM, 90-120min after awakening. The effect of smoking on cortisol was evaluated according to current smoking status, the number of cigarettes/day and the nicotine addiction intensity. The influence of clinical symptoms and/or antipsychotic medication on cortisol was determined using the Positive and Negative Syndrome Scale (PANSS), and chlorpromazine equivalent doses. Non-smokers were older, received lower doses of antipsychotics, had higher PANSS scores, and had longer duration of illness than smokers. Salivary cortisol was similar in schizophrenic patients subdivided according to the smoking status, the number of cigarettes/day and nicotine addiction intensity. No significant correlation was found between salivary cortisol and PANSS scores, chlorpromazine equivalent doses, age of onset or the duration of illness. The findings revealed no association between salivary cortisol and smoking, nicotine addiction intensity, or clinical symptoms. Our preliminary data showed no correlation between salivary cortisol and chlorpromazine equivalent doses and/or antipsychotic medication. Our findings suggest that smoking does not affect the cortisol response in schizophrenic patients as it has been shown in healthy individuals. Future studies should investigate a possible desensitization of the stress system to smoking. Copyright © 2017. Published by Elsevier Inc.

Amotivation in Schizophrenia: Integrated Assessment With Behavioral, Clinical, and Imaging Measures

OpenAIRE

Wolf, Daniel H.; Satterthwaite, Theodore D.; Kantrowitz, Jacob J.; Katchmar, Natalie; Vandekar, Lillie; Elliott, Mark A.; Ruparel, Kosha

2014-01-01

Motivational deficits play a central role in disability caused by schizophrenia and constitute a major unmet therapeutic need. Negative symptoms have previously been linked to hypofunction in ventral striatum (VS), a core component of brain motivation circuitry. However, it remains unclear to what extent this relationship holds for specific negative symptoms such as amotivation, and this question has not been addressed with integrated behavioral, clinical, and imaging measures. Here, 41 indiv...

Clinical Trials

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... of Personal Stories Peers Celebrating Art Peers Celebrating Music Be Vocal Support Locator DBSA In-Person Support ... by participating in a clinical trial is to science first and to the patient second. More About ...

Clinical Trials

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Full Text Available ... study explored whether the benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials that test principles or strategies include studies that explore whether ...

Clinical Trials

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Full Text Available ... medical centers and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain access to new ...

Ethics of clinical trials in Nigeria.

Science.gov (United States)

Okonta, Patrick I

2014-05-01

The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

Neurocognitive effects of an omega-3 fatty acid and vitamins E+C in schizophrenia: A randomised controlled trial.

Science.gov (United States)

Bentsen, H; Landrø, N I

2017-10-16

There is need for more efficient treatment of neurocognitive deficits in schizophrenia. In this 16 weeks randomised, placebo-controlled trial, we examined neurocognitive effects of adding ethyl-eicosapentaenoate 2g/day and/or vitamins E 364mg/day + C 1000mg/day to antipsychotics in 53 patients aged 18-39 years with acute schizophrenia. For the sake of validating neurocognitive tests, healthy subjects, not taking trial drugs, were also included in the study. Ethyl-EPA given alone to patients with low baseline RBC polyunsaturated fatty acids (PUFA), and Vitamins E+C given alone to high PUFA patients, impaired sustained attention (Continuous Performance Test, CPT-IP d prime score), standardised effect sizes d = 0.78 and d = 0.69, respectively. These adverse effects were paralleled by excessive increases in long-chain PUFA and serum alpha-tocopherol, respectively. They were counteracted by combining ethyl-EPA and vitamins, d = 0.80 and d = 0.74 in low and high PUFA patients, respectively. No other neurocognitive tests yielded significant results. Plausible mechanisms of harmful effects are oxidative stress and lipid raft disruption. Copyright © 2017. Published by Elsevier Ltd.

Falsificationism and clinical trials.

Science.gov (United States)

Senn, S J

1991-11-01

The relevance of the philosophy of Sir Karl Popper to the planning, conduct and analysis of clinical trials is examined. It is shown that blinding and randomization can only be regarded as valuable for the purpose of refuting universal hypotheses. The purpose of inclusion criteria is also examined. It is concluded that a misplaced belief in induction is responsible for many false notions regarding clinical trials.

Smoking cessation and reduction in schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial.

Science.gov (United States)

Caponnetto, Pasquale; Polosa, Riccardo; Auditore, Roberta; Minutolo, Giuseppe; Signorelli, Maria; Maglia, Marilena; Alamo, Angela; Palermo, Filippo; Aguglia, Eugenio

2014-03-22

, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks).The goal is to propose an effective intervention to reduce the risk of tobacco smoking, as a complementary tool to treat tobacco addiction in schizophrenia. ClinicalTrials.gov, NCT01979796.

Topiramate for prevention of olanzapine associated weight gain and metabolic dysfunction in schizophrenia: a double-blind, placebo-controlled trial.

Science.gov (United States)

Narula, Preeta Kaur; Rehan, H S; Unni, K E S; Gupta, Neeraj

2010-05-01

Olanzapine associated weight gain (WG) is a major concern in patients with schizophrenia. The purpose of this study was to assess the efficacy of topiramate to prevent olanzapine induced WG in these cases. We also studied various metabolic parameters. In this 12-week, double-blind, parallel group study, seventy-two drug-naïve, first-episode schizophrenia patients were randomized to receive olanzapine+placebo (olanzapine group) or olanzapine+topiramate (100mg/day) (topiramate group). Weight, body mass index, fasting glucose, insulin, insulin resistance (IR), leptin, lipids and blood pressure were assessed at baseline and at 12 weeks. The patients were clinically evaluated using Positive and Negative Syndrome Scale (PANSS) and were monitored for adverse effects. Topiramate resulted in a weight loss of 1.27+/-2.28 kg (pweight gain and adverse metabolic effects. It also results in a greater clinical improvement when used with olanzapine in schizophrenia. Copyright (c) 2010 Elsevier B.V. All rights reserved.

Tourette syndrome and comorbid early-onset schizophrenia.

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Kerbeshian, Jacob; Peng, Chun-Zi; Burd, Larry

2009-12-01

A study of the shared phenomenology between Tourette syndrome (TS) and schizophrenia. An illustrative case report is presented. We used a chart review of 399 clinically ascertained patients with TS to identify 10 cases meeting criteria for schizophrenia. From our 10 patients, salient clinical characteristics were then tabulated. We then extracted similar clinical characteristics from a previously published series of patients with comorbid TS and schizophrenia in order to combine cases and allow for a comparison between childhood-onset schizophrenia (COS), adolescent-onset schizophrenia (AdolOS), and adult-onset schizophrenia (AduOS) cases in these groups. We found 10 cases of schizophrenia (all were males) in the 399 TS patients for a prevalence rate of 2.5% (95% CI 0.96-4.04). Mean age of tic onset for TS diagnostic criteria ranged from 2-14 years with a mean of 8.2 years. The mean age of diagnosis for schizophrenia was 14.2 (range 9-23 years). We found six cases of schizophrenia with onset of positive psychotic symptoms by 13 years of age, two cases with onset after 13 years of age and before 18 years of age, and two cases with onset after 18 years of age. Attention deficit hyperactivity disorder was present at a higher rate (70%) than one would expect in a clinically ascertained group of patients with TS. Comparison between COS, AdolOS and AduOS in our pooled cases noted a sex bias skewed toward males. Catatonic symptoms may be more likely in child or adolescent onset cases and negative symptoms more likely in AduOS cases. The 2.5% prevalence of schizophrenia in our TS sample exceeds the 1% expected rate of schizophrenia in the general population (chi-square=9.14; P=.0025). The six cases of COS (before 13 years of age) exceeds the expected rate of 1-2 per 100,000 (chi-square=4499; P=.0001). The 752-fold increase in observed rates of comorbid TS and COS over expected rates suggests a role for unknown common underlying etiologic factors. Based on clinical features

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Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...

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Full Text Available ... clinical trials are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees all research ...

Transparency in ovarian cancer clinical trial results: ClinicalTrials.gov versus PubMed, Embase and Google scholar.

Science.gov (United States)

Roberto, Anna; Radrezza, Silvia; Mosconi, Paola

2018-04-10

In recent years the question of the lack of transparency in clinical research has been debated by clinicians, researchers, citizens and their representatives, authors and publishers. This is particularly important for infrequent cancers such as ovarian cancer, where treatment still gives disappointing results in the majority of cases. Our aim was to assess the availability to the public of results in ClinicalTrials.gov, and the frequency of non-publication of results in ClinicalTrials.gov and in PubMed, Embase and Google Scholar. We collected all trials on ovarian cancer identified as "completed status" in the ClinicalTrials.gov registry on 17 January 2017. We checked the availability of the results in ClinicalTrials.gov and systematically identified published manuscripts on results. Out of 2725 trials on ovarian cancer identified, 752 were classified as "completed status". In those closed between 2008 and 2015, excluding phase I, the frequency of results in ClinicalTrials.gov was 35%. Of the 752 completed studies the frequency of published results in PubMed, Embase or Google Scholar ranged from 57.9% to 69.7% in the last years. These findings show a lack of transparency and credibility of research. Citizens or patients' representatives, with the medical community, should continuously support initiatives to improve the publication and dissemination of clinical study results.

Assessing Cognitive Function in Bipolar Disorder: Challenges and Recommendations for Clinical Trial Design

Science.gov (United States)

Burdick, Katherine E.; Ketter, Terence A.; Goldberg, Joseph F.; Calabrese, Joseph R.

2015-01-01

OBJECTIVE Neurocognitive impairment in schizophrenia has been recognized for more than a century. In contrast, only recently have significant neurocognitive deficits been recognized in bipolar disorder. Converging data suggest the importance of cognitive problems in relation to quality of life in bipolar disorder, highlighting the need for treatment and prevention efforts targeting cognition in bipolar patients. Future treatment trials targeting cognitive deficits will be met with methodological challenges due to the inherent complexity and heterogeneity of the disorder, including significant diagnostic comorbidities, the episodic nature of the illness, frequent use of polypharmacy, cognitive heterogeneity, and a lack of consensus regarding measurement of cognition and outcome in bipolar patients. Guidelines for use in designing future trials are needed. PARTICIPANTS The members of the consensus panel (each of the bylined authors) were selected based upon their expertise in bipolar disorder. Dr. Burdick is a neuropsychologist who has studied cognition in this illness for 15 years; Drs. Ketter, Calabrese, and Goldberg each bring considerable expertise in the treatment of bipolar disorder both within and outside of controlled clinical trials. This consensus statement was derived from work together at scientific meetings (e.g. symposium presention at the 2014 Annual meeting of the American Society of Clinical Psychopharmacology, among others) and ongoing discussions by conference call. With the exception of the public presentations on this topic, these meetings were closed to outside participants. EVIDENCE A literature review was undertaken by the authors to identify illness-specific challenges relevant to the design and conduct of treatment trials targeting neurocognition in bipolar disorder. Expert opinion from each of the authors guided the consensus recommendations. CONSENSUS PROCESS Consensus recommendations, reached by unanimous opinion of the authors, are

Canadian Practice Guidelines for Comprehensive Community Treatment for Schizophrenia and Schizophrenia Spectrum Disorders.

Science.gov (United States)

Addington, Donald; Anderson, Elizabeth; Kelly, Martina; Lesage, Alain; Summerville, Chris

2017-09-01

The objective of this review is to identify the features and components of a comprehensive system of services for people living with schizophrenia. A comprehensive system was conceived as one that served the full range of people with schizophrenia and was designed with consideration of the incidence and prevalence of schizophrenia. The system should provide access to the full range of evidence-based services, should be recovery oriented, and should provide patient-centred care. A systematic search was conducted for published guidelines for schizophrenia and schizophrenia spectrum disorders. The guidelines were rated by at least 2 raters, and recommendations adopted were primarily drawn from the National Institute for Clinical Excellence (2014) Guideline on Psychosis and Schizophrenia in adults and the Scottish Intercollegiate Guidelines Network guidelines on management of schizophrenia. The recommendations adapted for Canada cover the range of services required to provide comprehensive services. Comprehensive services for people with schizophrenia can be organized and delivered to improve the quality of life of people with schizophrenia and their carers. The services need to be organized in a system that provides access to those who need them.

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Childhood Onset Schizophrenia: Clinical Features, Course and Outcome

Science.gov (United States)

Sood, Mamta; Kattimani, Shivanand

2008-01-01

Schizophrenia in children is diagnosed by using adult criteria. Based on the age of onset, patients with childhood onset schizophrenia (COS) are subdivided into those with very early onset (before age 12-14 years) and those with early onset (between 14-17 years). The prevalence of COS is reported to be 1 in 10,000 before the age of 12 years;…

Postmortem evidence of cerebral inflammation in schizophrenia: a systematic review.

Science.gov (United States)

Trépanier, M O; Hopperton, K E; Mizrahi, R; Mechawar, N; Bazinet, R P

2016-08-01

Schizophrenia is a psychiatric disorder which has a lifetime prevalence of ~1%. Multiple candidate mechanisms have been proposed in the pathogenesis of schizophrenia. One such mechanism is the involvement of neuroinflammation. Clinical studies, including neuroimaging, peripheral biomarkers and randomized control trials, have suggested the presence of neuroinflammation in schizophrenia. Many studies have also measured markers of neuroinflammation in postmortem brain samples from schizophrenia patients. The objective of this study was to conduct a systematic search of the literature on neuroinflammation in postmortem brains of schizophrenia patients indexed in MEDLINE, Embase and PsycINFO. Databases were searched up until 20th March 2016 for articles published on postmortem brains in schizophrenia evaluating microglia, astrocytes, glia, cytokines, the arachidonic cascade, substance P and other markers of neuroinflammation. Two independent reviewers extracted the data. Out of 5385 articles yielded by the search, 119 articles were identified that measured neuroinflammatory markers in schizophrenic postmortem brains. Glial fibrillary acidic protein expression was elevated, lower or unchanged in 6, 6 and 21 studies, respectively, and similar results were obtained for glial cell densities. On the other hand, microglial markers were increased, lower or unchanged in schizophrenia in 11, 3 and 8 studies, respectively. Results were variable across all other markers, but SERPINA3 and IFITM were consistently increased in 4 and 5 studies, respectively. Despite the variability, some studies evaluating neuroinflammation in postmortem brains in schizophrenia suggest an increase in microglial activity and other markers such as SERPINA3 and IFITM. Variability across studies is partially explained by multiple factors including brain region evaluated, source of the brain, diagnosis, age at time of death, age of onset and the presence of suicide victims in the cohort.

Clinical outcomes in clinical trials of anti-HIV treatment

DEFF Research Database (Denmark)

Reekie, J; Mocroft, A; J, Neaton

2007-01-01

Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

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Full Text Available ... issues arise. Participation and Eligibility Each clinical trial defines who is eligible to take part in the ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the ...

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Full Text Available ... Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling the clinical trial participants which treatment they're getting. Masking, or "blinding," helps avoid bias. For this reason, ...

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Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... explore whether surgery or other medical treatments produce better results for certain illnesses or groups of people; ...

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Medications Used for Cognitive Enhancement in Patients With Schizophrenia, Bipolar Disorder, Alzheimer’s Disease, and Parkinson’s Disease

Directory of Open Access Journals (Sweden)

Wen-Yu Hsu

2018-04-01

speed, and memory in female patients with schizophrenia.ConclusionClinical trials with larger sample sizes evaluating comprehensive cognitive domains are warranted to examine the efficacy of medications in cognitive enhancement in patients with schizophrenia, bipolar disorder, Alzheimer’s disease, and Parkinson’s disease.

Inflammation and the Two-Hit Hypothesis of Schizophrenia

Science.gov (United States)

Feigenson, Keith A.; Kusnecov, Alex W.; Silverstein, Steven M.

2014-01-01

The high societal and individual cost of schizophrenia necessitates finding better, more effective treatment, diagnosis, and prevention strategies. One of the obstacles in this endeavor is the diverse set of etiologies that comprises schizophrenia. A substantial body of evidence has grown over the last few decades to suggest that schizophrenia is a heterogeneous syndrome with overlapping symptoms and etiologies. At the same time, an increasing number of clinical, epidemiological, and experimental studies have shown links between schizophrenia and inflammatory conditions. In this review, we analyze the literature on inflammation and schizophrenia, with a particular focus on comorbidity, biomarkers, and environmental insults. We then identify several mechanisms by which inflammation could influence the development of schizophrenia via the two-hit hypothesis. Lastly, we note the relevance of these findings to clinical applications in the diagnosis, prevention, and treatment of schizophrenia. PMID:24247023

Biological study in schizophrenia

International Nuclear Information System (INIS)

Kasai, Kiyoto; Yoshikawa, Akane; Natsubori, Takanobu; Koike, Shinsuke; Nagai, Tatsuya; Araki, Tsuyoshi; Nishimura, Yukika; Iwamoto, Kazuya

2012-01-01

Schizophrenia is associated with enormous morbidity, mortality, personal disability, and social cost. Although considerable research on schizophrenia has been performed, the etiology of this disease has not been fully elucidated. In recent years, imaging and genetic technologies have been developed dramatically. Disturbances in glutamate and gamma-aminobutyric acid (GABA)ergic neurotransmission may underlie the pathophysiology of schizophrenia. We attempted an integrative review, of studies pertaining to recent advances of schizophrenia research with a focus on neuroimaging and genetic studies. Additionally, we present the preliminary findings of the clinical research in our outpatient unit, specialized for early intervention, at the University of Tokyo Hospital. (author)

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Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... how you feel. Some people will need to travel or stay in hospitals to take part in ...

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