Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Bipolar I Disorder; Alcohol Dependence

Treatments: Drug: Quetiapine fumarate; Drug: lithium; Drug: divalproex

Study type: Interventional

Funder types: Industry

Identifiers

NCT00114686

D144AL00002

Details and patient eligibility

About

The purpose of this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol Dependence

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets criteria for Bipolar I Disorder with Alcohol dependence
• Outpatient Status
• Recent history of heavy drinking

Exclusion criteria

• Unstable medical illness
• Recent antipsychotic use
• Poorly controlled Diabetes Mellitus or Diabetes related illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind