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Sponsored by: |
University of Texas Southwestern Medical Center |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00457197 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Quetiapine for Bipolar Disorder and Alcohol Dependence |
Estimated Enrollment: | 120 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: Quetiapine
Quetiapine
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2: Active Comparator
Quetiapine
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Drug: Quetiapine
Quetiapine
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amber Marchand, B.S., M.S. | 214-645-6957 | Amber.Marchand@utsouthwestern.edu |
Contact: Jackie Todd, B.A. | 214-645-6960 | Jackie.Peterson@utsouthwestern.edu |
United States, Texas | |
Psychoneuroendocrine Research Program | Recruiting |
Dallas, Texas, United States, 75235 |
Principal Investigator: | E. Sherwood Brown, MD PhD | UT Southwestern Medical Center |
Responsible Party: | UT southwestern Medical Center at Dallas ( E.S. Brown M.D., Ph.D. ) |
Study ID Numbers: | 112006-046 |
Study First Received: | April 4, 2007 |
Last Updated: | August 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00457197 History of Changes |
Health Authority: | United States: Food and Drug Administration |
bipolar disorder alcohol dependence mania |
manic disorder mania depression |
Tranquilizing Agents Depression Bipolar Disorder Psychotropic Drugs Central Nervous System Depressants Disorders of Environmental Origin Antipsychotic Agents Depressive Disorder Affective Disorders, Psychotic |
Quetiapine Mental Disorders Alcoholism Substance-Related Disorders Mood Disorders Alcohol-Related Disorders Psychotic Disorders Ethanol |
Disease Tranquilizing Agents Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Disorders of Environmental Origin Antipsychotic Agents Pharmacologic Actions Affective Disorders, Psychotic |
Quetiapine Pathologic Processes Mental Disorders Therapeutic Uses Alcoholism Substance-Related Disorders Mood Disorders Alcohol-Related Disorders Central Nervous System Agents |