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NCT01015586 · ClinicalTrials.gov registry record · Phase 4
Treatment of Alcohol Dependence and Comorbid Bipolar Disorder
A Phase 4 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 4
- Development phase
- 43
- Enrollment target
NCT01015586: Completed Phase 4 study, sponsored by Medical University of South Carolina.
NCT01015586 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 43 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01015586, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 43 participants
- Enrollment target
Study Summary
The study will determine if individuals with co-occurring bipolar disorder and alcohol dependence report reduced alcohol consumption, improvement in mood symptoms, and cognitive performance if treated with lamotrigine plus their usual mood stabilizing medications relative to subjects treated with placebo plus usual mood stabilizing medications over a 16 week period.
Primary Outcome
Percentage of days in trial without consumption of alcoholic beverages per participant self-report; minimum = 0, maximum = 100; higher numbers indicate better outcome. Percent days abstinent was calculated as: (number of days abstinent per self-report / total number of days in trial)\*100.
Interventions
- DRUG Placebo
- DRUG Lamotrigine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2010-02 |
| Est. Completion | 2014-09 |
| Phase | Phase 4 |
What the finished NCT01015586 record still lists
NCT01015586 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01015586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01015586 about?
NCT01015586 is a clinical study titled "Treatment of Alcohol Dependence and Comorbid Bipolar Disorder". The study will determine if individuals with co-occurring bipolar disorder and alcohol dependence report reduced alcohol consumption, improvement in mood symptoms, and cognitive performance if treated with lamotrigine plus their usual mood stabilizing medications relative to subjects treated with pl...
What is the current status of trial NCT01015586?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2010-02. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01015586?
The interventions under investigation include: Placebo (DRUG), Lamotrigine (DRUG).
Who is sponsoring clinical trial NCT01015586?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01015586's enrollment target sits among peer trials
43 1371st of 2000 higher than 621 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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