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

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT00035802
  • Notebook for Primary Citation Primary Citation Trial has yet to be published
  • Spreadsheet for Data Specification Data Specification Not Available

Trial Information

Generic NameTopiramateProduct NameTOPAMAX®Therapeutic AreaNervous SystemProduct ClassAntiepilepticsPharmacological SubgroupAntiepilepticsChemical SubgroupOther AntiepilepticsCondition StudiedBipolar Disorder
Sponsor Protocol NumberTOPMAT-PDMD-009Enrollment13Data PartnerJohnson & Johnson% FemaleN/AMean/Median Age (Years)N/A% WhiteN/A

Supporting Documentation

  • Protocol with Amendments Available
  • 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

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.