ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Acamprosate vs. Placebo in Bipolar Alcoholics

This study is currently recruiting participants.
Verified by Medical University of South Carolina, April 2007

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

  1. Adults ages 18-65
  2. Meet DSM-IV criteria for current (past 90 days) alcohol dependence
  3. Meet DSM-IV criteria for bipolar I or bipolar II disorder
  4. 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
  5. Must be able to remain free from alcohol for at least 3 days prior to medication initiation
  6. 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
  7. Subjects must consent to random assignment and be willing to commit to medication treatment and follow-up assessments

Exclusion Criteria:

  1. Individuals with a primary psychiatric disorder other than bipolar disorder
  2. Individuals with an uncontrolled neurologic condition that could confound the results of the study
  3. Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject’s safety
  4. Participants with creatinine clearance less than or equal to half of normal value as indicated by chem. 7 results conducted at screening visit.
  5. Concomitant use of other psychotropic medications not allowed per the protocol
  6. Women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control
  7. Current suicidal or homicidal risk
  8. 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




Links to all studies - primarily for crawlers