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NCT00466661 · ClinicalTrials.gov registry record · Phase 4
Acamprosate vs. Placebo in Bipolar Alcoholics
A Phase 4 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
NCT00466661 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 33 participants.
The verdict
NCT00466661, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
Study 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 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.
Interventions
- DRUG Placebo
- DRUG Acamprosate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2007-04 |
| Est. Completion | 2010-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00466661
The ClinicalTrials.gov registry entry for NCT00466661 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00466661 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00466661 about?
NCT00466661 is a clinical study titled "Acamprosate vs. Placebo in Bipolar Alcoholics". 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...
What is the current status of trial NCT00466661?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2007-04. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00466661?
The interventions under investigation include: Placebo (DRUG), Acamprosate (DRUG).
Who is sponsoring clinical trial NCT00466661?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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