A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder
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|ClinicalTrials.gov Identifier: NCT00035230|
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Topiramate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||338 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||July 2001|
|Actual Study Completion Date :||November 2002|
- Change from baseline to Day 21 in the total Young Mania Rating Scale (YMRS) score.
- Changes from baseline to Day 21 and Week 12 in the scores of CGI, MADRS, BPRS, and GAS. Response to treatment, indicated by no longer meeting DSM-IV criteria for manic/mixed episode. Incidence of adverse events monitored throughout the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035230
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|