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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00114686

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Alcoholism Bipolar Disorder

Drug Information available for: Ethanol Quetiapine Quetiapine fumarate Lithium carbonate Lithium citrate

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

Study ID Numbers:	D144AL00002
Study First Received:	June 16, 2005
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00114686 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Bipolar I Disorder
Alcohol Dependency

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Central Nervous System Depressants
Enzyme Inhibitors
Antipsychotic Agents
Antimanic Agents
Valproic Acid

Pharmacologic Actions
Quetiapine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
GABA Agents
Alcohol-Related Disorders
Central Nervous System Agents
Anticonvulsants
Lithium

ClinicalTrials.gov processed this record on February 08, 2010