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Trial Information
Generic NameTopiramateProduct NameTOPAMAX®Therapeutic AreaBehaviors and Mental DisordersEnrollment434% Female53%% White93%
Product ClassAnticonvulsantsSponsor Protocol NumberTOPMAT-PDMD-004Data PartnerJohnson & JohnsonCondition StudiedBipolar DisorderMean/Median Age (Years)43
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2023-5534 : Quality tolerance limit and duplicated patient investigation in clinical trials
- 2022-5090 : Consistency checks to improve measurement with the Young Mania Rating Scale (YMRS)
- 2022-5062 : Heterogeneous treatment effects estimation with multi-source data: evidence from bipolar disorder and schizophrenia trials
- 2020-4521 : Causally interpretable meta-analysis with missing data: Generalizing evidence from bipolar disorder and schizophrenia trials to a target population
- 2020-4276 : Psychiatric Symptoms as Adverse Events of Topiramate Therapy: Systematic Review and Meta-Analysis
- 2019-3958 : Machine Learning for predicting treatment efficacy and clinical categorizations across mental health disorders.
- 2015-0649 : Population Representativeness of Clinical Trial Study Samples
- 2015-0644 : Generalizing treatment effects for bipolar disorder and schizophrenia to the US population: Generalizability of network meta-analysis
- 2014-0364 : Initial severity and efficacy of antipsychotics for schizophrenia and bipolar mania: Individual patient level analyses of placebo-controlled trials