At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 12 enrolled
Drug / intervention
Topiramatedrug
Likely dose
Topiramate 25 mgfrom 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.
Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder
In Brief
A Phase 4 clinical trial evaluating Topiramate for Bipolar Disorder and 2 related conditions. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study is determine whether the use of topiramate is effective in the treatment of alcohol dependence (i.e. decreases drinking) in patients with bipolar disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Alcoholism, Alcohol Dependence
CountriesUnited States
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedDec 2007
Primary CompletionJul 2014
TodayJul 2026
First PostedDec 12, 2007
Enrollment StartAug 1, 2007
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 18.6 years ago
Interventions
Topiramatedrug
Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.