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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00114686
First received: June 16, 2005
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Bipolar I Disorder
Alcohol Dependence
 Drug: Quetiapine fumarate
Drug: lithium
Drug: divalproex
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 350
Study Start Date: January 2006
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114686

  Show 38 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00114686     History of Changes
Other Study ID Numbers: D144AL00002
Study First Received: June 16, 2005
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Bipolar I Disorder
Alcohol Dependency

Additional relevant MeSH terms:
Alcoholism
Bipolar Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Affective Disorders, Psychotic
Mood Disorders
Valproic Acid
Lithium
Quetiapine
Anticonvulsants
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipsychotic Agents

ClinicalTrials.gov processed this record on May 21, 2013