NCT00035802View on ClinicalTrials.gov

A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

January 31, 2002

Study Completion Date

April 30, 2002

Conditions
Bipolar DisorderAffective Disorders, PsychoticMood DisordersMental Disorders
Interventions
DRUG

Topiramate

"Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days.~OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months."

DRUG

Placebo

Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.

All Listed Sponsors
lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

NCT00035802 - A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder | Biotech Hunter | Biotech Hunter