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A Randomized, Double-Blind, Multicenter, Placebo-Controlled, 21-Day Study of the Safety and Efficacy of Topiramate for the Treatment of Acute Manic or Mixed Episodes in Subjects With Bipolar I Disorder With an Optional Open-Label Extension

A Randomized, Double-Blind, Multicenter, Placebo-Controlled, 21-Day Study of the Safety and Efficacy of Topiramate for the Treatment of Acute Manic or Mixed Episodes in Subjects With Bipolar I Disorder With an Optional Open-Label Extension

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NCT Number

Not Available


Data Specification

Not Available


Annotated CRF

Not Available

Product Info

Generic Name
Topiramate
Product Name
TOPAMAX®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
215
% Female
53.0%
% White
93.0%
Product Class
Anticonvulsants
Sponsor Protocol Number
TOPMAT-PDMD-006
Data Holder
Johnson & Johnson
Condition Studied
Bipolar Disorder
Mean/Median Age (Years)
43.0

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

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.