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

NCT00394095 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-04-09

Study results available
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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.

Conditions

Interventions

DRUG

Topiramate

Oral topiramate 300-400mg/day for 12 weeks

DRUG

Placebo

Matched placebo to Experimental arm

Sponsors & Collaborators

Principal Investigators

  • Melissa P DelBello, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-08-31
Completion
2009-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00394095 on ClinicalTrials.gov