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NCT00004554 · ClinicalTrials.gov registry record · Phase 4
Sertraline for Alcohol Dependence and Depression
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 171
- Enrollment target
NCT00004554: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT00004554 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 171 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004554, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 171 participants
- Enrollment target
Study Summary
This study will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depression over either medication alone or placebo. A secondary aim is to determine whether certain patient features will predict response to sertraline, naltrexone or the combination of the two drugs. Subjects will be randomized into treatment groups for 14 weeks. The followup phase includes two visits at 6 and 9 months after treatment.
Interventions
- DRUG Placebo
- DRUG naltrexone (Revia)
- DRUG sertraline (Zoloft)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2000-01 |
| Est. Completion | 2006-02 |
| Phase | Phase 4 |
What the finished NCT00004554 record still lists
NCT00004554 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00004554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004554 about?
NCT00004554 is a clinical study titled "Sertraline for Alcohol Dependence and Depression". This study will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depression over either medication alone or placebo. A secondary aim is to determine whether certain patient features w...
What is the current status of trial NCT00004554?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 171 participants. The study started on 2000-01. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00004554?
The interventions under investigation include: Placebo (DRUG), naltrexone (Revia) (DRUG), sertraline (Zoloft) (DRUG).
Who is sponsoring clinical trial NCT00004554?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004554's enrollment target sits among peer trials
171 484th of 2000 higher than 1,517 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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