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NCT00578669 · ClinicalTrials.gov registry record · Phase 3
Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
A Phase 3 study, sponsored by Butler Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 206
- Enrollment target
NCT00578669 is a Phase 3 study that has completed, run by Butler Hospital. The registered enrollment target is 206 participants.
The verdict
NCT00578669, a Phase 3 study, has completed, sponsored by Butler Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 206 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine whether, among smokers with elevated depressive symptoms, sequential antidepressant pharmacotherapy with fluoxetine (20 mg) begun 8 weeks prior to and extended throughout standard smoking cessation treatment with transdermal nicotine patch (ST-TNP) will result in superior short-and long-term smoking cessation outcomes compared to sequential pharmacotherapy with placebo medication combined with ST-TNP. The secondary aim of the study is to test the hypothesis that, among smokers with elevated depressive symptoms, sequential treatment with fluoxetine will result in lower levels of depressive symptoms and negative mood and higher levels of positive mood immediately prior to and throughout the course of smoking cessation treatment relative to the placebo condition.
Interventions
- DRUG Fluoxetine
- DRUG Dextrose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2008-04 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00578669
The ClinicalTrials.gov registry entry for NCT00578669 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Butler Hospital, which has 103 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fluoxetine is the first listed.
NCT00578669 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00578669 about?
NCT00578669 is a clinical study titled "Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms". The primary purpose of this study is to determine whether, among smokers with elevated depressive symptoms, sequential antidepressant pharmacotherapy with fluoxetine (20 mg) begun 8 weeks prior to and extended throughout standard smoking cessation treatment with transdermal nicotine patch (ST-TNP) w...
What is the current status of trial NCT00578669?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2008-04. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00578669?
The interventions under investigation include: Fluoxetine (DRUG), Dextrose (DRUG).
Who is sponsoring clinical trial NCT00578669?
This trial is sponsored by Butler Hospital, which has 103 total clinical trials registered on ClinicalTrials.gov.
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