Clinical trial NCT00572117
Conditions: Bipolar Disorder Alcoholism Alcohol Dependence
Keywords: Bipolar Disorder Manic Disorder Alcoholism Alcohol Abuse Alcohol Dependence Clinical Trial Evaluation Trial Intervention Trial Validation Studies
Sponsor: Stanford University
Start date: 2007-08-01; Completion date: 2014-07-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
Alcohol and substance use disorders are more common in bipolar disorder bipolar disorder than in any other DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) Axis I disorder, estimated to occur in up to 60% of patients with bipolar disorder. Alcohol use is associated with poor outcome in bipolar disorder, and yet these co-occurring conditions are understudied. To date, there is only one published placebo-controlled trial of an agent for the treatment of alcohol dependence alcohol dependence in bipolar disorder. The purpose of the proposed study is to evaluate the efficacy of a topiramate as a treatment for alcohol dependence in patients with bipolar disorder. This is a 12-week, randomized, placebo-controlled study of the efficacy of topiramate adjunctive to standard treatment for bipolar disorder in patients with alcohol dependence and bipolar disorder. Additional aims of the study are to document the safety and tolerability of topiramate in this population, and to evaluate to effect of decreased drinking on mood symptoms. The study involves the enrollment of a total of 80 patients with co-occurring alcohol dependence and bipolar disorder over the course of 40 months at the Massachusetts General Hospital (MGH) Bipolar Clinic and Research Program (BCRP) (www.manicdepressive.org). With a conservative estimate of a 30% dropout rate, approximately 56 of the 80 patients with these two comorbid conditions will complete 12 weeks treatment with either topiramate or placebo.

Arms: arm 1: Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks. arm 2: Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills 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.
Interventions: intervention 1: Topiramate
Intervention descriptions: intervention 1: 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.

Protocol documents: