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Sponsors and Collaborators: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00572117 |
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.
Condition | Intervention | Phase |
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Bipolar Disorder Manic Disorder Manic-Depressive Alcoholism Alcohol Abuse |
Drug: Topiramate Other: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder |
Estimated Enrollment: | 80 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | July 2013 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Topiramate -- Subjects will continue Weeks 5-12 of the study.
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Drug: Topiramate
Medication will be titrated slowly over 5 weeks from 25 mg qD to 150 mg BID in an effort to minimize side effects and the possible unblinding of participants and raters to treatment. Subjects will continue on 150 mg BID for Weeks 5-12 of the study.
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2: Placebo Comparator
placebo
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Other: Placebo
placebo
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael J. Ostacher, MD, MPH | 617-726-5258 | mostacher@partners.org |
Contact: Jonathan Stange | 617-726-0997 | jstange@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital Bipolar Clinic and Research Program | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Dr. Michael J. Ostacher, MD, MPH | |
Principal Investigator: Michael J. Ostacher, MD, MPH |
Principal Investigator: | Michael J. Ostacher, MD, MPH | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital Bipolar Clinic and Research Program ( Michael J. Ostacher, MD, MPH, Principal Investigator ) |
Study ID Numbers: | TIL-NIAAA-016340-01, NIH grant K23 A016340-01 |
Study First Received: | December 10, 2007 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00572117 |
Health Authority: | United States: Federal Government |
Bipolar Disorder Manic Disorder Manic-Depressive Alcoholism Alcohol Abuse |
Alcohol Dependence Clinical Trial Evaluation Trial Intervention Trial Validation Studies |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Alcoholism Mood Disorders Substance-Related Disorders |
Topiramate Disorders of Environmental Origin Psychotic Disorders Alcohol-Related Disorders Ethanol |
Anti-Obesity Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |