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placebo Response in Antipsychotic Clinical Trials A Meta-analysis

Alexander McGirr, Paul A Vöhringer, S Nassir Ghaemi, Raymond W Lam, Lakshmi N Yatham
BACKGROUND: Although mania and hypomania define bipolar disorder, depressive episodes are more common and impairing, with few proven treatments. Adjunctive therapy with second-generation antidepressants is widely used to treat acute bipolar depression, but their efficacy and safety remain controversial. METHODS: In this systematic review and meta-analysis, we searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and from inception to Jan 31, 2016, for randomised, double-blind, placebo-controlled trials of second-generation antidepressants adjunctive to a mood stabiliser or an antipsychotic in patients with acute bipolar depression...
December 2016: Lancet Psychiatry
S Grover, S Sarkar
Ethnic and regional variations have been found in the pharmacological treatment response. Though many efficacy studies have been conducted in India for antipsychotic treatment modalities of schizophrenia, there is a lack meta-analytic data of the existing literature from India. This study aimed to conduct a systematic review and meta-analysis of the antipsychotic treatment trials of schizophrenia in the Indian context. All controlled trials from India evaluating the clinical efficacy of antipsychotics in patients with schizophrenia were evaluated and 28 trials were included in the metanalysis...
November 2015: Indian Journal of Pharmaceutical Sciences
Myrto T Samara, Markus Dold, Myrsini Gianatsi, Adriani Nikolakopoulou, Bartosz Helfer, Georgia Salanti, Stefan Leucht
IMPORTANCE: In treatment-resistant schizophrenia, clozapine is considered the standard treatment. However, clozapine use has restrictions owing to its many adverse effects. Moreover, an increasing number of randomized clinical trials (RCTs) of other antipsychotics have been published. OBJECTIVE: To integrate all the randomized evidence from the available antipsychotics used for treatment-resistant schizophrenia by performing a network meta-analysis. DATA SOURCES: MEDLINE, EMBASE, Biosis, PsycINFO, PubMed, Cochrane Central Register of Controlled Trials, World Health Organization International Trial Registry, and clinicaltrials...
March 2016: JAMA Psychiatry
Samir Kumar Praharaj, Sreejayan Kongasseri, Rishikesh V Behere, Podila Satya Venkata Narasimha Sharma
OBJECTIVE: To conduct a systematic review and meta-analysis of randomized placebo-controlled trials of mirtazapine for the treatment of antipsychotic-induced acute akathisia (AIAA). METHODS: Studies were identified using online searches of PUBMED/MEDLINE and Cochrane database (CENTRAL), along with websites recording trial information such as,, and The study eligibility criteria were randomized, double-blind clinical trials comparing mirtazapine with placebo for AIAA with standardized rating for akathisia as outcome measure...
October 2015: Therapeutic Advances in Psychopharmacology
Alexander T Chen, John T Chibnall, Henry A Nasrallah
BACKGROUND: Omega-3 fatty acids have shown promise as an adjunctive treatment for schizophrenia. However, efficacy across studies has been inconsistent. We conducted a meta-analysis of published controlled studies with the goal of detecting different efficacy profiles at various stages of schizophrenia. METHODS: An online search was conducted for randomized, double-blind, placebo-controlled clinical trials, and a meta-analysis was conducted. RESULTS: Ten studies met the criteria for inclusion...
November 2015: Annals of Clinical Psychiatry: Official Journal of the American Academy of Clinical Psychiatrists
Taro Kishi, Tomoya Hirota, Shinji Matsunaga, Nakao Iwata
OBJECTIVES: We performed an updated meta-analysis of antipsychotic treatment in patients with delirium, based on a previous meta-analysis published in 2007. METHODS: Included in this study were randomised, placebo-controlled or usual care (UC) controlled trials of antipsychotics in adult patients with delirium. Our primary outcome measure was response rate at the study end point. The secondary outcome measures included improvement of severity of delirium, Clinical Global Impression-Severity Scale (CGI-S), time to response (TTR), discontinuation rate and individual adverse effects...
July 2016: Journal of Neurology, Neurosurgery, and Psychiatry
Bret R Rutherford, Emily Pott, Jane M Tandler, Melanie M Wall, Steven P Roose, Jeffrey A Lieberman
IMPORTANCE: Because increasing placebo response rates decrease drug-placebo differences and increase the number of failed trials, it is imperative to determine what is causing this trend. OBJECTIVES: To investigate the relationship between antipsychotic medication and placebo response by publication year, and to identify associated study design and implementation variables. DATA SOURCES: MEDLINE, PsycINFO, and PubMed were searched to identify randomized clinical trials of antipsychotic medications published from 1960 to July 2013...
December 1, 2014: JAMA Psychiatry
Changsu Han, Chi-Un Pae, Sheng-Min Wang, Soo-Jung Lee, Ashwin A Patkar, Praksh S Masand, Alssandro Serretti
Despite the fact that the majority of currently available treatment guidelines propose antidepressants as the first-line pharmacological therapy for posttraumatic stress disorder (PTSD), a substantial portion of patients fail to show an adequate response following this type of treatment. In this context, a number of small, open-label studies and randomized controlled clinical trials (RCTs) have found atypical antipsychotics (AAs) to be a beneficial treatment for patients with PTSD. Thus, the present meta-analysis was conducted to enhance the sample size power and further the current understanding of the role of AAs for the treatment of PTSD...
September 2014: Journal of Psychiatric Research
Jijun Wang, Stephanie Sampson
BACKGROUND: Sulpiride is a relatively old antipsychotic drug reputed to have a low incidence of adverse effects and an effect on the negative symptoms of schizophrenia. This relatively inexpensive antipsychotic drug has a similar neuropharmacological profile to several novel atypical drugs. OBJECTIVES: To evaluate the effects of sulpiride for schizophrenia and other similar serious mental illnesses in comparison with placebo. SEARCH METHODS: We searched the Cochrane Schizophrenia Group Trials Register (September 2008) and references of all identified studies for further trial citations...
2014: Cochrane Database of Systematic Reviews
S J Edwards, V Hamilton, L Nherera, N Trevor
BACKGROUND: Patients with treatment-resistant depression (TRD) are those with major depressive disorder that has not responded adequately to treatment. The causes of depression are not fully understood, although there is evidence to suggest that depression is a complex interaction among biological, genetic, psychosocial and environmental factors. Strategies available for the treatment of patients with TRD include pharmacological, non-pharmacological, and psychological and psychosocial interventions...
November 2013: Health Technology Assessment: HTA
Ofer Agid, Cynthia O Siu, Steven G Potkin, Shitij Kapur, Eric Watsky, Douglas Vanderburg, Robert B Zipursky, Gary Remington
OBJECTIVE: Large placebo response presents a major challenge for psychopharmacologic drug development and contributes to the increasing failure of psychiatric trials. The objective of this meta-regression analysis was to identify potential contributors to placebo response in randomized controlled trials of antipsychotic treatment in schizophrenia. METHOD: The authors extracted trial design and clinical variables from eligible randomized controlled trials (N=50) identified through searches of MEDLINE (1960-2010) and other sources...
November 2013: American Journal of Psychiatry
Glen I Spielmans, Margit I Berman, Eftihia Linardatos, Nicholas Z Rosenlicht, Angela Perry, Alexander C Tsai
BACKGROUND: Atypical antipsychotic medications are widely prescribed for the adjunctive treatment of depression, yet their total risk-benefit profile is not well understood. We thus conducted a systematic review of the efficacy and safety profiles of atypical antipsychotic medications used for the adjunctive treatment of depression. METHODS AND FINDINGS: We included randomized trials comparing adjunctive antipsychotic medication to placebo for treatment-resistant depression in adults...
2013: PLoS Medicine
Armin Szegedi, Pierre Verweij, Wilbert van Duijnhoven, Mary Mackle, Pilar Cazorla, Hein Fennema
CONTEXT: Asenapine is an approved treatment for schizophrenia in the United States. OBJECTIVE: Meta-analyses were conducted to evaluate the efficacy of asenapine in acute schizophrenia compared with placebo and other antipsychotics. DATA SOURCES: Four asenapine trials from the asenapine development program were pooled for the meta-analysis. To compare asenapine versus placebo treatment effect with other antipsychotics, we added integrated asenapine data to a previously published meta-analysis...
December 2012: Journal of Clinical Psychiatry
Marianne Klemp, Ingunn Fride Tvete, Tor Skomedal, Jørund Gaasemyr, Bent Natvig, Ivar Aursnes
AIMS: The objective of the study was to examine the efficacy and the degree of adverse effects connected with atypical neuroleptic drugs and haloperidol by using a previously described Bayesian statistical method that includes both direct and indirect comparisons simultaneously. METHODS: The authors used the results of 30 double-blind, randomized studies including comparisons of 4 atypical neuroleptics and haloperidol, head-to-head or against placebo. We calculated the response ratios for drugs against placebo and thereafter the relative response ratios for one drug against another...
December 2011: Journal of Clinical Psychopharmacology
Catherine A Harrington, Clayton English
STUDY OBJECTIVE: To assess the drug-related risk of adverse events associated with ziprasidone. DESIGN: Meta-analysis of 19 randomized, placebo-controlled trials. PATIENTS: A total of 4132 adults taking oral ziprasidone who had adverse-event data reported in the studies identified. MEASUREMENTS AND MAIN RESULTS: A systematic review (January 1996-October 2010) was conducted by using the EMBASE and MEDLINE databases to identify Cochrane reviews, controlled clinical trials, meta-analyses, randomized controlled trials, and systematic reviews; studies were limited to those published in English and those conducted in humans...
September 2011: Pharmacotherapy
M Dold, M Aigner, R Lanzenberger, S Kasper
Only 40 - 60 % of all patients with obsessive-compulsive disorder (OCD) respond to serotonin reuptake inhibitors (SRIs). Therefore, the evaluation of additive treatment in the presence of treatment resistance has high clinical relevance. All double-blind, randomised, placebo-controlled trials that evaluated the efficacy of a combination therapy of SRIs and antipsychotics in treatment-resistant OCD were identified by systematic literature searches and combined in a meta-analysis. 11 studies with a total of 356 treatment-resistant patients were included...
August 2011: Fortschritte der Neurologie-Psychiatrie
Carlos D LaLonde, Ryan J Van Lieshout
Most individuals with generalized anxiety disorder (GAD) fail to achieve remission despite standard treatments. As a result, we examined the efficacy and tolerability of second-generation antipsychotics (SGAs) as (a) augmentation or (b) monotherapy for GAD. We searched MEDLINE, EMBASE, PsycINFO, the Cochrane Library, controlled trials databases, and the abstracts of scientific meetings for all trials of GAD treatment with SGAs in adults. Randomized, double-blind, parallel-group trials examining SGA augmentation and monotherapy were meta-analyzed...
June 2011: Journal of Clinical Psychopharmacology
Konstantinos N Fountoulakis, Eduard Vieta, Frank Schmidt
INTRODUCTION: Aripiprazole is approved for the acute and maintenance treatment of manic and mixed episodes associated with bipolar I disorder. The aim of the present work was to review and meta-analyze the findings of all the available randomized double-blind controlled trials (RCTs) on the efficacy of aripiprazole in the treatment of bipolar disorder. MATERIAL AND METHODS: Aripiprazole RCTs were identified with a systematic search of MEDLINE and repositories. Standard meta-analytic techniques were applied...
October 2011: Journal of Affective Disorders
Yeh-Fong Chen, Sue-Jane Wang, Ni A Khin, H M James Hung, Thomas P Laughren
In recent years, we have seen an increasing trend of foreign data as part of clinical trial data submitted in new drug applications (NDA) to US Food and Drug Administration (FDA). To understand the design and analysis characteristics, we studied schizophrenia multi-regional clinical trials (MRCTs). The schizophrenia data set consisted of a total of 12,585 patients collected from 33 clinical trials with 63.8% patients from North America, the largest region. The data set constituted 10 schizophrenia drug programs in support of NDAs submitted to FDA from December 1993 to December 2005...
July 2010: Pharmaceutical Statistics
Surendra P Singh, Vidhi Singh, Nilamadhab Kar, Kelvin Chan
BACKGROUND: Treatment of negative symptoms in chronic schizophrenia continues to be a major clinical issue. AIMS: To analyse the efficacy of add-on antidepressants for the treatment of negative symptoms of chronic schizophrenia. METHOD: Systematic review and meta-analysis of randomised controlled trials comparing the effect of antidepressants and placebo on the negative symptoms of chronic schizophrenia, measured through standardised rating scales...
September 2010: British Journal of Psychiatry: the Journal of Mental Science
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