Trial · NCT00578669
Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
NCT00578669, Phase 3, Completed, Butler Hospital; results first posted 2018-10-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms. Trials, record NCT00578669. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00578669
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
- NCT number
- NCT00578669
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 206 participants, actual
- Lead sponsor
- Butler Hospital
- Conditions
- Major Depressive Disorder, Nicotine Dependence, Depression
- Interventions
- Fluoxetine, Dextrose
- First posted
- 2007-12-21
- Last updated
- 2018-10-16
- Results first posted
- 2018-10-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Smoking Abstinence | One year | 7-day point prevalence abstinence |
| Secondary | Self-reported Depressive Symptoms | One year | Self-reported depressive symptoms based on the Center for Epidemiologic Studies-Depression (CES-D) scale. CES-D consists of 20 items, with total scores on the scale ranging from 0 - 60. Higher scores are indicative of greater levels of depressive symptoms. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving Smoking Abstinence | One year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Self-reported Depressive Symptoms | One year | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving Smoking Abstinence | Sequential Fluoxetine | 24 | Participants | ||
| Number of Participants Achieving Smoking Abstinence | Sequential Placebo | 18 | Participants | ||
| Self-reported Depressive Symptoms | Sequential Fluoxetine | 9.9 | Standard Deviation 8.14 | score on a scale | |
| Self-reported Depressive Symptoms | Sequential Placebo | 9.64 | Standard Deviation 8.53 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequential Fluoxetine | 107 | |
| Overall Study | STARTED | Sequential Placebo | 99 | |
| Overall Study | COMPLETED | Sequential Fluoxetine | 107 | |
| Overall Study | COMPLETED | Sequential Placebo | 99 | |
| Overall Study | NOT COMPLETED | Sequential Fluoxetine | 0 | |
| Overall Study | NOT COMPLETED | Sequential Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Frequent bowel movements | Gastrointestinal disorders | Sequential Fluoxetine | 1 | 107 | 1 |
| other | Frequent bowel movements | Gastrointestinal disorders | Sequential Placebo | 0 | 99 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sequential Fluoxetine | 0 | 107 |
| Total, all-cause mortality | Sequential Placebo | 0 | 99 |
| Total, other adverse events | Sequential Fluoxetine | 1 | 107 |
| Total, other adverse events | Sequential Placebo | 0 | 99 |
| Total, serious adverse events | Sequential Fluoxetine | 0 | 107 |
| Total, serious adverse events | Sequential Placebo | 0 | 99 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA023190 | Sequential Use of Fluoxetine for Smokers with Elevated Depressive Symptoms | BROWN, RICHARD A | BUTLER HOSPITAL (PROVIDENCE, RI) | NATIONAL INSTITUTE ON DRUG ABUSE | 2007 to 2011 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sequential Fluoxetine vs Sequential Placebo: Number of Participants Achieving Smoking Abstinence | Trial comparisons |
| Sequential Fluoxetine vs Sequential Placebo: deaths from any cause | Trial comparisons |
| Sequential Fluoxetine vs Sequential Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00578669
GET https://conductscience.org/api/trials/v1/NCT00578669/registered