NCT00035802

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

A Randomized, Double-Blind, Multicenter, Placebo-Controlled 4-Week Study of the Safety and Efficacy of Topiramate in Adolescents With Acute Manic or Mixed Episodes of Bipolar I Disorder, With an Optional 6-Month Open-Label Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder.

Detailed description

This is a 4-week study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder with an optional 6-month open-label (OL) extension for qualified patients following completion of the study. On Days 1-28 patients will receive placebo or topiramate 2x/day by mouth except for the 1st and last doses which will be a single evening dose and a single morning dose, respectively. Study drug will be titrated in 100-mg increments to 400 mg/day and patients maintained on a stable dose through Day 28. During the OL extension phase, topiramate will be titrated over 5 days to 200 mg/day. After Day 7, topiramate may be tapered down to 100 mg/day or up to 600 mg/day, as clinically indicated.

Conditions

• Bipolar Disorder
• Affective Disorders, Psychotic
• Mood Disorders
• Mental Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2002-01-01
• Completion: 2002-04-01
• First posted: 2002-05-07
• Last updated: 2011-06-27