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| Sponsored by: |
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 |
| MedlinePlus related topics: | Alcoholism Bipolar Disorder |
| ChemIDplus related topics: | Quetiapine Quetiapine fumarate Ethanol |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Quetiapine for Bipolar Disorder and Alcohol Dependence |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2007 |
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| Contact: Jeremy Thurmon, BS | 214-645-6963 | jeremy.thurmon@utsouthwestern.edu |
| Contact: Barry Gabrielson, BS | 214-645-6967 | barry.gabrielson@utsouthwestern.edu |
| United States, Texas | |||||
| Psychoneuroendocrine Research Program | Recruiting | ||||
| Dallas, Texas, United States, 75235 | |||||
| University of Texas Southwestern Medical Center |
| Principal Investigator: | E. Sherwood Brown, MD PhD | UT Southwestern Medical Center |
More Information
| Study ID Numbers: | 112006-046 |
| First Received: | April 4, 2007 |
| Last Updated: | April 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00457197 |
| Health Authority: | United States: Food and Drug Administration |
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