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

Alcohol Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114686
• Other study ID #: D144AL00002
• Status: Completed
• Phase: Phase 3
• First received: June 16, 2005
• Last updated: January 3, 2013
• Start date: January 2006
• Est. completion date: April 2007

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Bipolar I Disorder

Intervention

Drug:
• Quetiapine fumarate

• lithium

• divalproex

Locations

Country	Name	City	State
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Austin	Texas
United States	Research Site	Bellevue	Washington
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bronx	New York
United States	Research Site	Cerritos	California
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Columbia	South Carolina
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Eagle	Idaho
United States	Research Site	Glen Burnie	Maryland
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kirkland	Washington
United States	Research Site	Maitland	Florida
United States	Research Site	Media	Pennsylvania
United States	Research Site	Memphis	Tennessee
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Moorestown	New Jersey
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Haven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Research Triangle Park	North Carolina
United States	Research Site	Richmond	Virginia
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Seattle	Washington
United States	Research Site	Shreveport	Louisiana
United States	Research Site	St. Louis	Missouri
United States	Research Site	Staten Island	New York
United States	Research Site	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale
Secondary	Change in the mean number of standardized drinks per day from Baseline to Week 12 & to monthly intervals, as derived from the TLFB scale
Secondary	Change in manic symptoms as assessed by the change from Baseline to each visit in the Young Mania Rating Scale (YMRS) total score