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Proposal 1624

Title of the 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

28 October 2016

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

LILLY-F1D-VI-HGCH: Efficacy and Safety of Olanzapine Versus Fluphenazine
LILLY-F1D-MC-HGGN: The Comparative Efficacy of Olanzapine, Risperidone, and Haloperidol for Cognition in Schizophrenia
LILLY-F1D-MC-HGDH: The Acute and Long-Term Efficacy of Olanzapine in First-Episode Psychotic Disorders: A Randomized Double-Blind Comparison with Haloperidol
LILLY-FID-US-HGJB: A Controlled Trial of Olanzapine Versus Quetiapine in the Treatment of Schizophrenic and Schizoaffective Subjects with Prominent Negative Symptoms
LILLY-F1D-US-HGJU: A Controlled Trial of Olanzapine Versus Ziprasidone in the Treatment of Schizophrenic and Schizoaffective Subjects with Comorbid Depression
LILLY-F1D-MC-HGHJ: Olanzapine Versus Ziprasidone in the Treatment of Schizophrenia
LILLY-F1D-SN-S010: Quality of Life in Asian Patients with Schizophrenia: Comparing Olanzapine with Haloperidol
LILLY-F1D-CA-P022: Olanzapine versus Haloperidol and Risperidone in the Treatment of Schizophrenia

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.