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

AstraZeneca350 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

350

Conditions

Bipolar I Disorder Alcohol Dependence

Interventions

Quetiapine fumarateDRUG

lithiumDRUG

divalproexDRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (38)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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Research Site

Cerritos, California, United States

Research Site

San Diego, California, United States

Research Site

New Haven, Connecticut, United States

Research Site

Jacksonville, Florida, United States

Research Site

Maitland, Florida, United States

Research Site

Orlando, 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

...and 28 more locations