A Randomized, Double-Blind, Placebo-Controlled Add-On Trial Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence - Full Text View

A Randomized, Double-Blind, Placebo-Controlled Add-On Trial Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence

This study is ongoing, but not recruiting participants.

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00223249

Purpose

The abuse of alcohol is especially common in people with bipolar disorder. However, very little is known about the pharmacotherapy of people with both bipolar disorder and alcohol abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine add-on therapy is associated with greater improvement in mood, impulsivity, functioning and decreased alcohol use than placebo.

Condition	Intervention	Phase
Bipolar Disorder Alcohol Abuse/Dependence	Drug: Quetiapine	Phase IV

MedlinePlus related topics:

Bipolar Disorder

ChemIDplus related topics:

Quetiapine Quetiapine fumarate Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Bipolar I or II
Ages 18-70

Exclusion Criteria:

Life threatening medical condition causing participation in the study hazardous
Alcohol abuse within the past 2 weeks
History of cataracts or likely cataracts on baseline eye exam
History of hepatic cirrhosis or AST or ALT more than three times normal limit
Current active suicidal or homicidal ideation
History of allergic reaction, poor response or intolerable side effects to quetiapine
Antipsychotic use within 7 days of beginning quetiapine therapy
Mental retardation, dementia or other severe cognitive impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223249

Locations


United States, Texas
	The UT Southwestern Medical Center at Dallas
	Dallas, Texas, United States, 75390-8843

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators


Principal Investigator:	E. Sherwood Brown, Ph.D., M.D.	The UT Southwestern Medical Center at Dallas

More Information

Publications indexed to this study:

Brown ES, Garza M, Carmody TJ. A randomized, double-blind, placebo-controlled add-on trial of quetiapine in outpatients with bipolar disorder and alcohol use disorders. J Clin Psychiatry. 2008 May;69(5):701-5.

Study ID Numbers:	IRUSQUET0233
First Received:	September 15, 2005
Last Updated:	January 27, 2008
ClinicalTrials.gov Identifier:	NCT00223249
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Quetiapine

Affective Disorders, Psychotic

Mental Disorders

Bipolar Disorder

Alcoholism

Substance-Related Disorders

Mood Disorders

Disorders of Environmental Origin

Alcohol-Related Disorders

Psychotic Disorders

Ethanol

Additional relevant MeSH terms:

Tranquilizing Agents

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Antipsychotic Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008