Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
33 participants
INTERVENTIONAL
2007-04-30
2010-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Acamprosate
666 mg p.o. TID
Acamprosate
666 mg po TID
Placebo
Matching placebo
Placebo
2 tabs po TID
Interventions
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Acamprosate
666 mg po TID
Placebo
2 tabs po TID
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Medical University of South Carolina
OTHER
Responsible Party
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Principal Investigators
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Bryan K Tolliver, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
Kathleen T Brady, M.D., Ph.D.
Role: STUDY_DIRECTOR
Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina
Locations
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Institute of Psychiatry, Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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HR#16928
Identifier Type: -
Identifier Source: org_study_id