Trial · NCT01808612
A Study of Fluoxetine in Major Depressive Disorder (MDD) Short-Term Dosing
NCT01808612, Phase 3, Completed, Eli Lilly and Company; results first posted 2015-05-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Fluoxetine in Major Depressive Disorder (MDD) Short-Term Dosing. Trials, record NCT01808612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01808612
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Fluoxetine in Major Depressive Disorder (MDD) Short-Term Dosing
- NCT number
- NCT01808612
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 513 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Major Depressive Disorder
- Interventions
- Fluoxetine, Placebo
- First posted
- 2013-03-11
- Last updated
- 2015-05-12
- Results first posted
- 2015-05-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score | Baseline, 6 weeks | HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score. |
| Secondary | Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores | Baseline, 6 weeks | HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score. |
| Secondary | Percentage of Participants Achieving a Response at 6-Week Endpoint | up to 6 weeks | The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100. |
| Secondary | Percentage of Participants Achieving a Remission at 6-Week Endpoint | up to 6 weeks | The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100. |
| Secondary | Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale | Baseline, 6 weeks | CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score. |
| Secondary | Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores | Baseline, up to 6 weeks | SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score. |
| Secondary | Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) | Baseline through 6 weeks | C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score | Baseline, 6 weeks | Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores | Baseline, 6 weeks | Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score during the Treatment Period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving a Response at 6-Week Endpoint | up to 6 weeks | Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Remission at 6-Week Endpoint | up to 6 weeks | Randomized participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale | Baseline, 6 weeks | Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores | Baseline, up to 6 weeks | Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only postbaseline data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) | Baseline through 6 weeks | Randomized participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during the Treatment Period. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score | 20 mg Fluoxetine | -6.18 | Standard Error 0.57 | units on a scale | |
| Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score | 40 mg Fluoxetine | -6.25 | Standard Error 0.77 | units on a scale | |
| Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score | Placebo | -6.91 | Standard Error 0.49 | units on a scale | |
| Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores | 20 mg Fluoxetine | HAMD17 total score | -5.59 | Standard Error 0.53 | units on a scale |
| Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores | 40 mg Fluoxetine | HAMD17 total score | -5.61 | Standard Error 0.71 | units on a scale |
| Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores | Placebo | HAMD17 total score | -6.27 | Standard Error 0.45 | units on a scale |
| Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores | 20 mg Fluoxetine | Maier subscale score | -3.35 | Standard Error 0.30 | units on a scale |
| Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores | 40 mg Fluoxetine | Maier subscale score | -3.39 | Standard Error 0.40 | units on a scale |
| Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores | Placebo | Maier subscale score | -3.30 | Standard Error 0.26 | units on a scale |
| Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores | 20 mg Fluoxetine | Anxiety/Somatization subscale score | -2.04 | Standard Error 0.21 | units on a scale |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | 20 mg Fluoxetine | 169 | |
| Treatment Period | STARTED | 40 mg Fluoxetine | 84 | |
| Treatment Period | STARTED | Placebo | 260 | |
| Treatment Period | Received at Least 1 Dose of Study Drug | 20 mg Fluoxetine | 168 | |
| Treatment Period | Received at Least 1 Dose of Study Drug | 40 mg Fluoxetine | 83 | |
| Treatment Period | Received at Least 1 Dose of Study Drug | Placebo | 259 | |
| Treatment Period | COMPLETED | 20 mg Fluoxetine | 154 | |
| Treatment Period | COMPLETED | 40 mg Fluoxetine | 77 | |
| Treatment Period | COMPLETED | Placebo | 246 | |
| Treatment Period | NOT COMPLETED | 20 mg Fluoxetine | 15 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events648
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 | Anaemia | Blood and lymphatic system disorders | Placebo (Treatment Period) | 1 | 259 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | 20 mg Fluoxetine (Treatment Period) | 0 | 168 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 40 mg Fluoxetine (Treatment Period) | 0 | 83 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Discontinuation From Placebo) | 0 | 145 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Discontinuation From 20 mg Fluoxetine) | 0 | 87 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Discontinuation From 40 mg Fluoxetine) | 0 | 38 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Placebo (Treatment Period) | 1 | 259 | 1 |
| other | Atrioventricular block first degree | Cardiac disorders | 20 mg Fluoxetine (Treatment Period) | 0 | 168 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | 40 mg Fluoxetine (Treatment Period) | 0 | 83 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Placebo (Discontinuation From Placebo) | 0 | 145 | 0 |
1 to 10 of 648Source ClinicalTrials.gov
See all 648 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Treatment Period) | ||
| Total, all-cause mortality | 20 mg Fluoxetine (Treatment Period) | ||
| Total, all-cause mortality | 40 mg Fluoxetine (Treatment Period) | ||
| Total, all-cause mortality | Placebo (Discontinuation From Placebo) | ||
| Total, all-cause mortality | Placebo (Discontinuation From 20 mg Fluoxetine) | ||
| Total, all-cause mortality | Placebo (Discontinuation From 40 mg Fluoxetine) | ||
| Total, other adverse events | Placebo (Treatment Period) | 75 | 259 |
| Total, other adverse events | 20 mg Fluoxetine (Treatment Period) | 49 | 168 |
| Total, other adverse events | 40 mg Fluoxetine (Treatment Period) | 30 | 83 |
| Total, other adverse events | Placebo (Discontinuation From Placebo) | 5 | 145 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01808612
GET https://conductscience.org/api/trials/v1/NCT01808612/results?page=2