Status:
COMPLETED
Acamprosate vs. Placebo in Bipolar Alcoholics
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Forest Laboratories
Conditions:
Alcohol Dependence
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00466661
Start Date
April 1 2007
End Date
February 1 2010
Last Update
December 14 2018
Active Locations (1)
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1
Institute of Psychiatry, Medical University of South Carolina
Charleston, South Carolina, United States, 29425