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NCT00449007 · ClinicalTrials.gov registry record · Phase 4
Fluoxetine and Bupropion to Treat Patients With Depression and Alcoholism
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT00449007: Clinical Trial Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT00449007 is a Phase 4 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00449007, a Phase 4 study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
We will study patients with a current major depressive episode, comorbid alcoholism and a history of a past suicide attempt. All subjects with alcohol dependence will be evaluated for risk of alcohol withdrawal prior to randomization. The study will provide six months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention. Patients will also be encouraged to attend daily Alcoholics Anonymous meetings. The outcome measures will be: 1) occurrence of suicide events; 2) reduction of suicidal ideation; 3) reduction in neuropsychological measures of impulsivity.
Primary Outcome
patients have either a suicide death, a suicide attempt, or suicidal ideation severe enough to warrant a medical intervention. this is assessed using the Columbia Suicide History Form and a consensus conference rules on whether the event meets criteria or not. Medical interventions can include hospitalization, a change in medication (adding adjunctive meds) or an increase in frequency of visits or other methods to monitor the patient. The range is 0 and up and denotes the number of suicide even
Interventions
- DRUG bupropion
- DRUG fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2006-02 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
Why NCT00449007 stopped before completion
NCT00449007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which bupropion is the first listed.
NCT00449007 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00449007 about?
NCT00449007 is a clinical study titled "Fluoxetine and Bupropion to Treat Patients With Depression and Alcoholism". We will study patients with a current major depressive episode, comorbid alcoholism and a history of a past suicide attempt. All subjects with alcohol dependence will be evaluated for risk of alcohol withdrawal prior to randomization. The study will provide six months of antidepressant pharmacothera...
What is the current status of trial NCT00449007?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2006-02. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00449007?
The interventions under investigation include: bupropion (DRUG), fluoxetine (DRUG).
Who is sponsoring clinical trial NCT00449007?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00449007's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 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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