Trial · NCT00666757
A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression
NCT00666757, Phase 4, Completed, Eli Lilly and Company; results first posted 2010-06-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression. Trials, record NCT00666757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00666757
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression
- NCT number
- NCT00666757
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 750 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Depression
- Interventions
- duloxetine, fluoxetine, citalopram, paroxetine, sertraline
- First posted
- 2008-04-25
- Last updated
- 2010-06-15
- Results first posted
- 2010-06-15
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] | 12 weeks | Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score \[TS\]\</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit \& continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups. |
| Secondary | Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 weeks | The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression. |
| Secondary | Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint] | 12 weeks | Visitwise percentages of participants meeting remission criteria HAMD-17 total score \[TS\] \</=7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, \& included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, \& continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, \& represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy. |
| Secondary | Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | Baseline, 12-Weeks | Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, \& included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, \& continuous, fixed covariate of baseline QIDS-SR. The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy. |
| Secondary | Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | Baseline, 12-Weeks | Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, \& included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, \& continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, \& represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy. |
| Secondary | Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). |
| Secondary | Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe). Mean change from baseline to endpoint. |
| Secondary | Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 weeks | HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). |
| Secondary | Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe). |
| Secondary | Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] | 12 weeks | Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284 | Probability of remission | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 weeks | Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284 | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint] | 12 weeks | Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371 and Week 12: Duloxetine N=272, SSRI N=283 | Probability of remission | LEAST_SQUARES_MEAN |
| SECONDARY | Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | Baseline, 12-Weeks | Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284 | Probability of response | LEAST_SQUARES_MEAN |
| SECONDARY | Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | Baseline, 12-Weeks | Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and Week 12: Duloxetine N=272, SSRI N=283 | Probability of response | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and; and Week 12: Duloxetine N=272, SSRI N=283 | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284 | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 weeks | Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284 | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274; SSRI N=284 | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure) | Baseline, 12 Weeks | Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284 | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] | Duloxetine | 0.36 | Standard Error 0.03 | Probability of remission | |
| Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint] | Selective Serotonin Reuptake Inhibitor (SSRI) | 0.32 | Standard Error 0.03 | Probability of remission | |
| Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure) | Duloxetine | -13.4 | Standard Error 0.36 | units on a scale | |
| Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure) | Selective Serotonin Reuptake Inhibitor (SSRI) | -12.6 | Standard Error 0.35 | units on a scale | |
| Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint] | Duloxetine | 0.53 | Standard Error 0.03 | Probability of remission | |
| Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint] | Selective Serotonin Reuptake Inhibitor (SSRI) | 0.44 | Standard Error 0.03 | Probability of remission | |
| Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | Duloxetine | 0.71 | Standard Error 0.03 | Probability of response | |
| Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | Selective Serotonin Reuptake Inhibitor (SSRI) | 0.64 | Standard Error 0.03 | Probability of response | |
| Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | Duloxetine | 0.73 | Standard Error 0.03 | Probability of response | |
| Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint] | Selective Serotonin Reuptake Inhibitor (SSRI) | 0.61 | Standard Error 0.03 | Probability of response |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Duloxetine | 372 | |
| Overall Study | STARTED | Selective Serotonin Reuptake Inhibitor (SSRI) | 378 | |
| Overall Study | COMPLETED | Duloxetine | 272 | |
| Overall Study | COMPLETED | Selective Serotonin Reuptake Inhibitor (SSRI) | 281 | |
| Overall Study | NOT COMPLETED | Duloxetine | 100 | |
| Overall Study | NOT COMPLETED | Selective Serotonin Reuptake Inhibitor (SSRI) | 97 |
Source ClinicalTrials.gov
Adverse events130
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 | Constipation | Gastrointestinal disorders | Duloxetine | 33 | 372 | 35 |
| other | Constipation | Gastrointestinal disorders | Citalopram | 8 | 157 | 8 |
| other | Constipation | Gastrointestinal disorders | Fluoxetine | 1 | 57 | 2 |
| other | Constipation | Gastrointestinal disorders | Paroxetine | 2 | 45 | 2 |
| other | Constipation | Gastrointestinal disorders | Sertraline | 3 | 119 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Duloxetine | 36 | 372 | 41 |
| other | Diarrhoea | Gastrointestinal disorders | Citalopram | 17 | 157 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | Fluoxetine | 10 | 57 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | Paroxetine | 3 | 45 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Sertraline | 18 | 119 | 20 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Duloxetine | ||
| Total, all-cause mortality | Citalopram | ||
| Total, all-cause mortality | Fluoxetine | ||
| Total, all-cause mortality | Paroxetine | ||
| Total, all-cause mortality | Sertraline | ||
| Total, other adverse events | Duloxetine | 277 | 372 |
| Total, other adverse events | Citalopram | 112 | 157 |
| Total, other adverse events | Fluoxetine | 47 | 57 |
| Total, other adverse events | Paroxetine | 36 | 45 |
| Total, other adverse events | Sertraline | 86 | 119 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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
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/NCT00666757
GET https://conductscience.org/api/trials/v1/NCT00666757/registered?page=2