Status:
COMPLETED
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Bipolar Disorders
Mood Disorders
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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.
Detailed Description
This is a randomized, double-blind, placebo-controlled study to evaluate the effectiveness of two dose levels of topiramate (400 and 600 milligrams/day) compared with placebo in the treatment of acute...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2002
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT00240721
Start Date
October 1 2000
End Date
September 1 2002
Last Update
June 8 2011
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