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NCT00035230 - 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

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

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Data Specification

Not Available


Annotated CRF

Not Available

Product Info

Generic Name
Topiramate
Product Name
TOPAMAX®
Therapeutic Area
Behaviors and Mental Disorders
Enrollment
338
% Female
53.0%
% White
93.0%
Product Class
Anticonvulsants
Sponsor Protocol Number
TOPMAT-PDMD-008
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.