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A Meta-analysis of Tardive Dyskinesia Rates in Studies Comparing Second Generation Antipsychotics (SGAs) with each other or to First-Generation Antipsychotics (FGAs).
Proposal
1624
Title of Proposed Research
A Meta-analysis of Tardive Dyskinesia Rates in Studies Comparing Second Generation Antipsychotics (SGAs) with each other or to First-Generation Antipsychotics (FGAs).
Lead Researcher
Christoph U Correll
Affiliation
The Zucker Hillside Hospital
Funding Source
None
Potential Conflicts of Interest
Dr. Correll has been a consultant and/or advisor to or has received honoraria from: AbbVie, Acadia, Actavis, Actelion, Alexza; Alkermes, Bristol-Myers Squibb, Cephalon, Eli Lilly, Genentech, Gerson Lehrman Group, IntraCellular Therapies, Janssen/J&J, Lundbeck, Medavante, Medscape, Merck, Otsuka, Pfizer, ProPhase, Reviva, Roche, Sunovion, Supernus, Takeda, Teva, and Vanda. He has received grant support from the American Academy of Child and Adolescent Psychiatry, the Bendheim Foundation, Bristol-Myers Squibb, the National Institute of Mental Health, Novo Nordisk A/S, Otsuka, Takeda and the Thrasher Foundation.
Data Sharing Agreement Date
Lay Summary
Tardive dyskinesia is a rare side effect of antipsychotics. This disorder is characterized by involuntary movements typically of the facial region, but also other body parts. These movements begin only after a longer exposure to antipsychotics, and are thus not necessarily seen in the clinical registration trials. However, in long-term trials, such as phase 3 or 4 trials, subjects are more likely to be identified. While old antipsychotics caused this side effect in up to one fifth of long-term treated subjects, newer antipsychotics show much lower rates. However, the exact frequency of these rare cases for each specific second generation antipsychotic is not known. In our study, we aim to summarize and meta-analyze the frequencies and severities of tardive dyskinesia during clinical trials with second generation antipsychotics.
Study Data Provided
[{ "PostingID": 1961, "Title": "LILLY-F1D-VI-HGCH", "Description": "Efficacy and Safety of Olanzapine Versus Fluphenazine" },{ "PostingID": 4003, "Title": "LILLY-F1D-MC-HGGN", "Description": "The Comparative Efficacy of Olanzapine, Risperidone, and Haloperidol for Cognition in Schizophrenia" },{ "PostingID": 4004, "Title": "LILLY-F1D-MC-HGDH", "Description": "The Acute and Long-Term Efficacy of Olanzapine in First-Episode Psychotic Disorders: A Randomized Double-Blind Comparison with Haloperidol" },{ "PostingID": 4256, "Title": "LILLY-FID-US-HGJB", "Description": "A Controlled Trial of Olanzapine Versus Quetiapine in the Treatment of Schizophrenic and Schizoaffective Subjects with Prominent Negative Symptoms" },{ "PostingID": 4257, "Title": "LILLY-F1D-US-HGJU", "Description": "A Controlled Trial of Olanzapine Versus Ziprasidone in the Treatment of Schizophrenic and Schizoaffective Subjects with Comorbid Depression" },{ "PostingID": 4258, "Title": "LILLY-F1D-MC-HGHJ", "Description": "Olanzapine Versus Ziprasidone in the Treatment of Schizophrenia" },{ "PostingID": 4259, "Title": "LILLY-F1D-SN-S010", "Description": "Quality of Life in Asian Patients with Schizophrenia: Comparing Olanzapine with Haloperidol" },{ "PostingID": 4260, "Title": "LILLY-F1D-CA-P022", "Description": "Olanzapine versus Haloperidol and Risperidone in the Treatment of Schizophrenia
Medicine: Olanzapine, Condition: Schizophrenia, Phase: 4, Clinical Study ID: F1D-CA-P022, Sponsor: Lilly" }]
Statistical Analysis Plan
Standard statistical techniques for meta-analysis using Comprehensive Meta-analysis will be used. For the dichotomous outcome, pooled estimates of relative risks will be calculated with 95% confidence intervals, using random-effects models. Study heterogeneity will be measured using the I2 statistics, with I2=50% indicating significant heterogeneity. Begg's funnel plot and Egger's test will be used to explore the possibility of publication bias.Professor Correll is an established expert in the conduct of meta-analysis.
Publication Citation
Carbon M, Kane JM, Leucht S, Correll CU. Tardive dyskinesia risk with first-and second-generation antipsychotics in comparative randomized controlled trials:
a meta-analysis. World Psychiatry. 2018 Oct;17(3):330-340. doi:
10.1002/wps.20579. PubMed PMID: 30192088; PubMed Central PMCID: PMC6127753.
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