NCT00394095

Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine

A Double-Blind, Randomized, Placebo-Controlled, Pilot Study of Topiramate vs. Placebo in Combination With Olanzapine for the Prevention of Weight Gain in Manic or Mixed Youth With Bipolar Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder. The secondary objective is to examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.

Detailed description

After consent and screening, patients will be initiated on 5mg or 10mg per day of olanzapine. Olanzapine doses will be titrated to 10-20 mg of olanzapine over one week, to a maximum of 20mg by day 21. Patients will also receive either topiramate (25mg bid titrated over 18 days to 150 mg bid. with flexibility to titrate to 200mg bid) or matched placebo. Topiramate will be initiated at a dose of 25 mg bid and will be increased by 25 mg bid every three days as tolerated. Patients will be evaluated by a blinded (to treatment status and adverse events) rater.

Conditions

• Bipolar Disorder
• Weight Gain

Interventions

Type	Name	Description
DRUG	Topiramate	Oral topiramate 300-400mg/day for 12 weeks
DRUG	Placebo	Matched placebo to Experimental arm

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-08-01
• Completion: 2009-09-01
• First posted: 2006-10-31
• Last updated: 2025-04-09
• Results posted: 2013-04-04

Locations

1 site across 1 country: United States