A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with lithium or placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Diagnosis of Bipolar I Disorder by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I

• )

• At least one previous manic or mixed episode

• Meeting minimum severity criteria (a Young Mania Rating Scale [YMRS] score of >=20 at screening and baseline visits) for the current acute manic or mixed episode

• Females must be postmenopausal, surgically sterile, or using adequate contraceptive measures, and have a negative pregnancy test

Exclusion Criteria:

• DSM-IV diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence)

• DSM-IV Axis I diagnosis of schizoaffective disorder or impulse control disorder

• Experienced a manic episode while taking an antidepressant or psychostimulant drug

• Known hypersensitivity to topiramate or previously participated in a topiramate study