Study Phase 3

A Randomized, Double-Blind, Multicenter, Placebo-Controlled 12-Week Study of the Safety and Efficacy of Topiramate in Patients With Acute Manic or Mixed Episodes of Bipolar I Disorder With an Optional Open-Label Extension

Trial Information

Generic NameTopiramateProduct NameTOPAMAX®Therapeutic AreaBehaviors and Mental DisordersEnrollment338% Female53%% White93%
Product ClassAnticonvulsantsSponsor Protocol NumberTOPMAT-PDMD-008Data 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


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