Lead Investigator: Stefan Leucht, Technical University of Munich
Title of Proposal Research: Antipsychotic drugs versus placebo in the treatment of antipsychotic naïve and/or first episode children or adolescents with psychosis: A systematic review and meta-analysis of double-blind randomized controlled
Vivli Data Request: 7776
Funding Source: None
Potential Conflicts of Interest: In the past 3 years, Stefan Leucht has received honoraria as a consultant and/or advisor and/or for lectures from Alkermes, Angelini, Eisai, Gedeon Richter, Janssen, Lundbeck, Lundbeck Institute, Merck Sharpp and Dome, Otsuka, Recordati, Rovi, Sanofi Aventis, TEVA, Medichem, Mitshubishi. These potential conflicts will be disclosed in all papers resulting from this project.
Summary of the Proposed Research:
The efficacy of antipsychotics is doubted by critiques, because the effect sizes in the randomised trials conducted in usually chronic patients are relatively small. We are therefore planning a pairwise meta-analysis of antipsychotic drugs versus placebo in antipsychotic naïve children or adolescents to summarize all the available evidence of double-blind randomized controlled trials. There is currently not a single study comparing antipsychotic drugs versus placebo in antipsychotic naïve children or adolescents. However, studies in children and adolescents should include a number of antipsychotic naïve or first episode patients. We expect the observed effect sizes of efficacy to be higher in this population. The results have the potential to inform drug choice made by individuals with psychosis.
Requested Studies:
Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia
Data Contributor: Lilly
Study ID: NCT00051298
Sponsor ID: 4066
Aripiprazole in Adolescents With Schizophrenia
Data Contributor: Otsuka Pharmaceuticals
Study ID: NCT00102063
Sponsor ID: 31-03-239