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| Sponsor: | University of Pennsylvania |
|---|---|
| Information provided by: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00124059 |
Purpose
The purpose of this study is to determine whether seroquel is effective in the treatment of type A and type B alcohol dependence.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcoholism |
Drug: Seroquel Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind Study of Quetiapine Fumarate (Seroquel) for the Treatment of Type A vs.Type B Alcoholics. |
| Enrollment: | 61 |
| Study Start Date: | March 2003 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Type A SERO |
Drug: Seroquel
400mg/day quetiapine
|
| Experimental: Type B SERO |
Drug: Seroquel
400mg/day quetiapine
|
| Placebo Comparator: Type A PLA |
Drug: Placebo
400mg/day placebo
|
| Placebo Comparator: Type B PLA |
Drug: Placebo
400mg/day placebo
|
The purpose of this study is to obtain preliminary data regarding the safety, efficacy and tolerability of quetiapine [Seroquel (SQL)] in treating Type A vs B alcohol dependent outpatients seeking treatment.
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, Pennsylvania | |
| University of Pennsylvania Treatment Research Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Helen M Pettinati, PhD | University of Pennsylvania Treatment Research Center |
More Information
| Responsible Party: | Helen Pettinati Ph.D., University of Pennsylvania Treatment Research Center |
| ClinicalTrials.gov Identifier: | NCT00124059 History of Changes |
| Other Study ID Numbers: | 706689 |
| Study First Received: | July 22, 2005 |
| Last Updated: | April 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
alcohol dependence |
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Quetiapine Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |