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NCT00035802 - 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

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


CSR Summary

Not Available


Primary Citation

Trial has yet to be published


Data Specification

Not Available


Annotated CRF

Not Available

Product Info

Generic Name
Topiramate
Product Name
TOPAMAX®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
13
% Female
N/A
% White
N/A
Product Class
Anticonvulsants
Sponsor Protocol Number
TOPMAT-PDMD-009
Data Partner
Johnson & Johnson
Condition Studied
Bipolar Disorder
Mean/Median Age (Years)
N/A

Supporting Documentation

Clinical Study Report
Study Phase 
3
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.

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.