Phase 3
Completed N=206
Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
Major Depressive Disorder · Nicotine Dependence · Depression
Source: ClinicalTrials.gov NCT00578669 ↗
Enrolled (actual)
206
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Number of Participants Achieving Smoking Abstinence — 24; 18 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Smoking Abstinence |
24; 18 | — |
| SECONDARY Self-reported Depressive Symptoms |
9.9; 9.64 | — |
Eligibility Criteria
Inclusion Criteria
- Regular smoker for at least one year
- Currently smokes at least 10 cigarettes per day
- Elevated depressive symptoms
- Uses no other tobacco products
Exclusion Criteria
- Current Axis I disorder, including Major Depressive Disorder
- Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
- Current use of psychotropic medication
- Use of antidepressant medication within past 6 months
- Current suicidal risk
- History of significant medical illness, such as cardiovascular disease, neurological, gastrointestinal, or other systemic illness
- Pregnancy or breast feeding
- Use of nicotine replacement therapy or of any medication for smoking cessation not provided by the researchers during the quit attempt
Data sourced from ClinicalTrials.gov (NCT00578669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.