Overview

Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence

Status:
Completed
Trial end date:
2004-08-01
Target enrollment:
0
Participant gender:
All
Summary
The abuse of alcohol is especially common in people with bipolar disorder. However, very little is known about the pharmacotherapy of people with both bipolar disorder and alcohol abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine add-on therapy is associated with greater improvement in mood, impulsivity, functioning and decreased alcohol use than placebo.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Treatments:
Quetiapine Fumarate
Criteria
Inclusion Criteria:

- Bipolar I or II

- Ages 18-70

Exclusion Criteria:

- Life threatening medical condition causing participation in the study hazardous

- Alcohol abuse within the past 2 weeks

- History of cataracts or likely cataracts on baseline eye exam

- History of hepatic cirrhosis or AST or ALT more than three times normal limit

- Current active suicidal or homicidal ideation

- History of allergic reaction, poor response or intolerable side effects to quetiapine

- Antipsychotic use within 7 days of beginning quetiapine therapy

- Mental retardation, dementia or other severe cognitive impairment