Study Phase 3

A Randomized, Double-Blind, Multicenter, Placebo-Controlled 4-Week Study of the Safety and Efficacy of Topiramate in Adolescents With Acute Manic or Mixed Episodes of Bipolar I Disorder, With an Optional 6-Month Open-Label Extension

  • 1 CSR Summary Not Available
  • 1 NCT00035802
  • 1 Primary Citation Trial has yet to be published
  • Data Specification Not Available

Trial Information

Generic NameTopiramateProduct NameTOPAMAX®Therapeutic AreaBehaviors and Mental DisordersEnrollment13% FemaleN/A% WhiteN/A
Product ClassAnticonvulsantsSponsor Protocol NumberTOPMAT-PDMD-009Data PartnerJohnson & JohnsonCondition StudiedBipolar DisorderMean/Median Age (Years)N/A

Supporting Documentation

  • Clinical Study Report Available
Additional Information

Please note: individual participant-level data are not available for this trial. Only the protocol with amendments and clinical study report are available.

Approved Data Requests Associated with this Trial

Disclaimer

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