A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with 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), and currently experiencing a manic or mixed episode by DSM-IV and Structured Clinical Interview criteria

• experienced at least one previous manic or mixed episode

• Young Mania Rating Scale (YMSR) score >=20

• physically healthy

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

Exclusion Criteria:

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

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

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

• no significant and untreated or unstable medical illness of the liver, kidney, heart, lungs, or endocrine system

• no hypersensitivity to topiramate or have previously participated in a topiramate study.