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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 is a Phase 4 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 5 participants.
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.
Interventions
- DRUG bupropion
- DRUG fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2006-02 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00449007
The ClinicalTrials.gov registry entry for NCT00449007 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which bupropion is the first listed.
NCT00449007 reports 0 study locations.
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.
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