Acamprosate vs. Placebo in Bipolar Alcoholics - Full Text View

Purpose

To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. The study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use and mood symptoms relative to placebo.

The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with acamprosate will have greater mood stability as compared to those treated with mood stabilizers alone.

Condition	Intervention	Phase
Alcohol Dependence Bipolar Disorder	Drug: Acamprosate	Phase IV

MedlinePlus related topics:

Alcoholism Bipolar Disorder Depression

ChemIDplus related topics:

Acamprosate Acamprosate calcium Ethanol Glutamic acid

U.S. FDA Resources

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

Official Title:	A Double-Blind, Randomized, Placebo-Controlled Trial of Acamprosate in Alcohol-Dependent Individuals With Comorbid Bipolar Disorder

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Percent of days abstinent
Days until relapse
Drinks per drinking day
Percent of heavy drinking days
Carbohydrate-deficient transferrin
Gamma-glutamyltransferase
Total alcohol consumption

Secondary Outcome Measures:

Montgomery Asberg Depression Rating Scale score
Young Mania Rating Scale score
Obsessive Compulsive Drinking Scale score
Clinical Global Impression scale score

Estimated Enrollment:	40
Study Start Date:	April 2007
Estimated Study Completion Date:	March 2009

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults ages 18-65
Meet DSM-IV criteria for current (past 90 days) alcohol dependence
Meet DSM-IV criteria for bipolar I or bipolar II disorder
Currently on a mood stabilizing medication regimen, including the use of lithium, valproic acid, lamotrigine, carbamazepine, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past 30 days
Must be able to remain free from alcohol for at least 3 days prior to medication initiation
Subjects must be able to adequately provide informed consent and function at an intellectual level sufficient to allow the accurate completion of all assessment instruments
Subjects must consent to random assignment and be willing to commit to medication treatment and follow-up assessments

Exclusion Criteria:

Individuals with a primary psychiatric disorder other than bipolar disorder
Individuals with an uncontrolled neurologic condition that could confound the results of the study
Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject’s safety
Participants with creatinine clearance less than or equal to half of normal value as indicated by chem. 7 results conducted at screening visit.
Concomitant use of other psychotropic medications not allowed per the protocol
Women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control
Current suicidal or homicidal risk
Baseline scores of > 35 on the Montgomery Asberg Depression Rating Scale and/or > 25 on the Young Mania Rating Scale

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466661

Contacts


Contact: Bryan K Tolliver, M.D., Ph.D	(843) 792-5205	tollive@musc.edu

Contact: Delisa G Brown, BA	(843) 792-0572

Locations


United States, South Carolina
	Institute of Psychiatry, Medical University of South Carolina	Recruiting
	Charleston, South Carolina, United States, 29425
	Contact: Bryan K Tolliver, M.D., Ph.D. 843-792-5205 tollive@musc.edu

Sponsors and Collaborators

Medical University of South Carolina

Forest Laboratories

Investigators


Principal Investigator:	Bryan K Tolliver, M.D., Ph.D.	Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina

Study Director:	Kathleen T Brady, M.D., Ph.D.	Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina

More Information

Study ID Numbers:	HR#16928
First Received:	April 25, 2007
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00466661
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:

Acamprosate

Alcoholism

Bipolar disorder

Comorbidity

Craving

Depression

GABA

Glutamate

Mania

Pharmacotherapy

Withdrawal

Study placed in the following topic categories:

Depression

Bipolar Disorder

Disorders of Environmental Origin

Depressive Disorder

Acamprosate

Affective Disorders, Psychotic

Mental Disorders

Alcoholism

Substance-Related Disorders

Mood Disorders

Alcohol-Related Disorders

Psychotic Disorders

Ethanol

Additional relevant MeSH terms:

Pathologic Processes

Disease

Therapeutic Uses

Central Nervous System Agents

Pharmacologic Actions

Alcohol Deterrents

ClinicalTrials.gov processed this record on August 29, 2008

Sponsors and Collaborators:	Medical University of South Carolina Forest Laboratories
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00466661