At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 31 enrolled
Drug / intervention
Topiramate +1 moredrug
Likely dose
Topiramate 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Topiramate and Placebo for Bipolar Disorder and Weight Gain. Completed, enrolled 31 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Weight Gain
CountriesUnited States
CollaboratorsEli Lilly and Company
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2006
Enrollment StartDec 2006
Primary CompletionAug 2009
Study CompletionSep 2009
TodayJul 2026
First PostedOct 31, 2006
Enrollment StartDec 1, 2006
Primary CompletionAug 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 19.7 years ago
Interventions
Topiramatedrug
Oral topiramate 300-400mg/day for 12 weeks
Placebodrug
Matched placebo to Experimental arm