Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00452543 · ClinicalTrials.gov registry record · Phase 4
Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT00452543: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00452543 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00452543, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is a study about treatment for people who suffer from both major depression and alcohol abuse or dependence. The study will examine whether the addition of acamprosate to escitalopram and behavioral interventions will improve outcomes for this population.
Primary Outcome
Scores on the HAM-D-17 typically fall into the following ranges: a) Not depressed: 0-7; b) Mildly depressed: 7-15; c) Moderately depressed: 15-25; d) Severely depressed: over 25. A decrease of 50% or more in the Hamilton-D score is considered to be a positive response to treatment, while a score of 7 or less is considered typical of remission. We measure the change in total score from Baseline to Week 12 or week of early termination visit.
Interventions
- DRUG Placebo
- BEHAVIORAL Medical management
- DRUG escitalopram
- DRUG acamprosate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2007-03 |
| Est. Completion | 2010-05 |
| Phase | Phase 4 |
What the finished NCT00452543 record still lists
NCT00452543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00452543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00452543 about?
NCT00452543 is a clinical study titled "Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism". This is a study about treatment for people who suffer from both major depression and alcohol abuse or dependence. The study will examine whether the addition of acamprosate to escitalopram and behavioral interventions will improve outcomes for this population.
What is the current status of trial NCT00452543?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2007-03. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00452543?
The interventions under investigation include: Placebo (DRUG), Medical management (BEHAVIORAL), escitalopram (DRUG), acamprosate (DRUG).
Who is sponsoring clinical trial NCT00452543?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00452543's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03616041 · 23 participants
Capsule Endoscopy for Severe Hematochezia
- NCT04348747 · 23 participants · Phase 2
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
- NCT04587687 · 23 participants · Phase 2
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
- NCT04715022 · 23 participants · Phase 1
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia