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: NCT00037674|
Recruitment Status : Completed
First Posted : May 21, 2002
Last Update Posted : May 18, 2011
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Topiramate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||434 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind, Multicenter, Placebo-Controlled 12-Week Study of the Safety and Efficacy of Two Doses of Topiramate for the Treatment of Acute Manic or Mixed Episodes in Patients With Bipolar I Disorder With an Optional Open-Label Extension|
|Study Start Date :||January 2001|
|Actual Study Completion Date :||May 2003|
- Change from baseline to Day 21 in the total Young Mania Rating Scale (YMRS) score.
- Change from baseline to Day 21 and Week 12 in scores of MADRS, BPRS, CGI, 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): NCT00037674
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|