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

Condition(s) targeted: Bipolar I Disorder; Alcohol Dependence

Intervention: Quetiapine fumarate (Drug); lithium (Drug); divalproex (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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

Official title: A Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Versus Placebo as Adjunct Therapy With Mood Stabilizers (Lithium or Divalproex) for the Treatment of Alcohol Dependence in Patients With Bipolar I Disorder

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale

Secondary outcome:

Change in the mean number of standardized drinks per day from Baseline to Week 12 & to monthly intervals, as derived from the TLFB scale

Change in manic symptoms as assessed by the change from Baseline to each visit in the Young Mania Rating Scale (YMRS) total score

Minimum age: 21 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Research Site, Cerritos, California, United States

Research Site, San Diego, California, United States

Research Site, New Haven, Connecticut, United States

Research Site, Maitland, Florida, United States

Research Site, Orlando, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Eagle, Idaho, United States

Research Site, Shreveport, Louisiana, United States

Research Site, Glen Burnie, Maryland, United States

Research Site, Boston, Massachusetts, United States

Research Site, St. Louis, Missouri, United States

Research Site, Moorestown, New Jersey, United States

Research Site, Albuquerque, New Mexico, United States

Research Site, Bronx, New York, United States

Research Site, New York, New York, United States

Research Site, Staten Island, New York, United States

Research Site, Chapel Hill, North Carolina, United States

Research Site, Research Triangle Park, North Carolina, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Cleveland, Ohio, United States

Research Site, Dayton, Ohio, United States

Research Site, Portland, Oregon, United States

Research Site, Media, Pennsylvania, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, Columbia, South Carolina, United States

Research Site, Memphis, Tennessee, United States

Research Site, Nashville, Tennessee, United States

Research Site, Wichita Falls, Texas, United States

Research Site, Austin, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Richmond, Virginia, United States

Research Site, Kirkland, Washington, United States

Research Site, Seattle, Washington, United States

Research Site, Bellevue, Washington, United States

Research Site, Milwaukee, Wisconsin, United States

Starting date: January 2006
Ending date: December 2006
Last updated: December 14, 2007