Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
9 participants
INTERVENTIONAL
2006-04-30
2007-06-30
Brief Summary
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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
NONE
Interventions
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Acamprosate
Eligibility Criteria
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Inclusion Criteria
* 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, and/or antipsychotic agent FDA approved to treat bipolar disorder without any dosage adjustments in the past month
* 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 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 creatine 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
18 Years
65 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
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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HR15882
Identifier Type: -
Identifier Source: org_study_id