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| Sponsor: | University of Texas Southwestern Medical Center |
|---|---|
| Information provided by: | University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00457197 |
Purpose
The purpose of this study is to find out whether an investigational drug called quetiapine can treat bipolar disorder, improve mood and reduce alcohol use and craving.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Alcohol Dependence |
Drug: Quetiapine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Quetiapine for Bipolar Disorder and Alcohol Dependence |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2007 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: Quetiapine
Quetiapine
|
|
Active Comparator: 2
Quetiapine
|
Drug: Quetiapine
Quetiapine
|
The primary aim in the study is to determine if quetiapine treatment is associated with greater reduction in alcohol use than placebo in outpatients with bipolar disorder and alcohol dependence. We will also examine if quetiapine treatment is associated with greater reduction in alcohol craving than placebo in outpatients with bipolar disorder and alcohol dependence and if quetiapine treatment is associated with greater improvement in depressive symptoms than placebo in outpatients with bipolar disorder and alcohol dependence.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Psychoneuroendocrine Research Program | |
| Dallas, Texas, United States, 75235 | |
| Principal Investigator: | E. Sherwood Brown, MD PhD | UT Southwestern Medical Center |
More Information
| Responsible Party: | E.S. Brown M.D., Ph.D., UT southwestern Medical Center at Dallas |
| ClinicalTrials.gov Identifier: | NCT00457197 History of Changes |
| Other Study ID Numbers: | 112006-046 |
| Study First Received: | April 4, 2007 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
bipolar disorder alcohol dependence mania manic disorder depression |
|
Alcoholism Bipolar Disorder Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Affective Disorders, Psychotic Mood Disorders Quetiapine |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |