CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 206 enrolled
Drug / intervention
Fluoxetine +1 moredrug
Likely dose
Fluoxetine 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00578669
NCT00578669Phase 3Completed

Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms

Butler Hospital·interventional·Posted Dec 21, 2007·Updated Oct 16, 2018

In Brief

A Phase 3 clinical trial evaluating Fluoxetine and Dextrose for Major Depressive Disorder and 2 related conditions. Completed, enrolled 206 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 21, 2007
Enrollment StartApr 1, 2008
Primary CompletionJul 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 18.5 years ago

Interventions

Fluoxetinedrug

20mg once daily for 16 weeks

Dextrosedrug

Once daily for 16 weeks