Trial · NCT02229825
Study to Assess Clinical Response of Duloxetine in Patients Hospitalized for Severe Depression
NCT02229825, Phase 4, Completed, Boehringer Ingelheim; results first posted 2023-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess Clinical Response of Duloxetine in Patients Hospitalized for Severe Depression. Trials, record NCT02229825. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02229825
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess Clinical Response of Duloxetine in Patients Hospitalized for Severe Depression
- NCT number
- NCT02229825
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 339 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Depressive Disorder, Major
- Interventions
- Duloxetine, Placebo
- First posted
- 2014-09-01
- Last updated
- 2023-10-23
- Results first posted
- 2023-10-23
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4 | At baseline and at Week 4. | The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) scored from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Secondary | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | At baseline and at Week 1, 2, 3 and Week 4. | HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Secondary | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | At baseline and at Week 6 and Week 8. | HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Secondary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3 | At baseline and at Week 1, 2 and Week 3. | The MADRS total score is used to measure the severity of depression. It is based total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Secondary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | At baseline and at Week 6 and Week 8. | The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Secondary | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | At week 1, 2, 3 and week 4. | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline. The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Secondary | Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | At week 6 and week 8. | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline. The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Secondary | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | At week 1, 2, 3 and week 4. | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline. HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine). |
| Secondary | Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | At week 6 and week 8. | Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline. HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
| Secondary | Percentage of Patients Reaching Remission at Week 8 | At week 8. | Remission is defined as a total Montgomery-Asberg Depression Rating Scale (MADRS) score of ≤ 12 at week 8. The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each and a total MADRS score ranging from 0 to 60. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4 | At baseline and at Week 4. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen. | Units on a scale | MEAN |
| SECONDARY | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | At baseline and at Week 1, 2, 3 and Week 4. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen. | Units on a scale | MEAN |
| SECONDARY | Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | At baseline and at Week 6 and Week 8. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Only participants with non-missing values are reported. Post-week 4 treatment groups. | Units on a scale | MEAN |
| SECONDARY | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3 | At baseline and at Week 1, 2 and Week 3. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen. | Units on a scale | MEAN |
| SECONDARY | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups | At baseline and at Week 6 and Week 8. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Only participants with non-missing values are reported. Post-week 4 treatment groups. | Units on a scale | MEAN |
| SECONDARY | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale | At week 1, 2, 3 and week 4. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment-regimen. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups | At week 6 and week 8. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6) | At week 1, 2, 3 and week 4. | Full Analysis Set (FAS): All participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Treatment regimen. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group | At week 6 and week 8. | Full-Analysis Set (FAS): This included all participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Reaching Remission at Week 8 | At week 8. | Full-Analysis Set (FAS): This included all participants who received at least one dose of duloxetine and who had at least one baseline value and one post-baseline value available for efficacy evaluation. Post-week 4 treatment groups. | Percentage of participants | NUMBER |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group574
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4 | 60 mg Duloxetine | -20.1 | Standard Deviation 10.6 | Units on a scale | |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4 | 120 mg Duloxetine | -19.9 | Standard Deviation 10.0 | Units on a scale | |
| Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | 60 mg Duloxetine | Change from baseline to week 1 | -3.1 | Standard Deviation 3.6 | Units on a scale |
| Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | 120 mg Duloxetine | Change from baseline to week 1 | -2.7 | Standard Deviation 3.3 | Units on a scale |
| Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | 60 mg Duloxetine | Change from baseline to week 2 | -5.8 | Standard Deviation 4.6 | Units on a scale |
| Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | 120 mg Duloxetine | Change from baseline to week 2 | -5.2 | Standard Deviation 4.2 | Units on a scale |
| Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | 60 mg Duloxetine | Change from baseline to week 3 | -7.2 | Standard Deviation 4.4 | Units on a scale |
| Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | 120 mg Duloxetine | Change from baseline to week 3 | -6.8 | Standard Deviation 4.4 | Units on a scale |
| Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | 60 mg Duloxetine | Change from baseline to week 4 | -8.0 | Standard Deviation 4.8 | Units on a scale |
| Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4 | 120 mg Duloxetine | Change from baseline to week 4 | -8.1 | Standard Deviation 4.7 | Units on a scale |
1 to 10 of 574Source ClinicalTrials.gov
See all 574 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 60 mg Duloxetine | 167 | |
| Overall Study | STARTED | 120 mg Duloxetine | 172 | |
| Overall Study | Treated | 60 mg Duloxetine | 167 | |
| Overall Study | Treated | 120 mg Duloxetine | 171 | |
| Overall Study | COMPLETED | 60 mg Duloxetine | 143 | |
| Overall Study | COMPLETED | 120 mg Duloxetine | 142 | |
| Overall Study | NOT COMPLETED | 60 mg Duloxetine | 24 | |
| Overall Study | NOT COMPLETED | 120 mg Duloxetine | 30 |
Source ClinicalTrials.gov
Adverse events28
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 | Nasopharyngitis | Infections and infestations | 60 mg Duloxetine | 4 | 167 | |
| other | Nasopharyngitis | Infections and infestations | 120 mg Duloxetine | 9 | 171 | |
| other | Nausea | Gastrointestinal disorders | 60 mg Duloxetine | 37 | 167 | |
| other | Nausea | Gastrointestinal disorders | 120 mg Duloxetine | 21 | 171 | |
| other | Constipation | Gastrointestinal disorders | 60 mg Duloxetine | 8 | 167 | |
| other | Constipation | Gastrointestinal disorders | 120 mg Duloxetine | 16 | 171 | |
| other | Headache | Nervous system disorders | 60 mg Duloxetine | 26 | 167 | |
| other | Headache | Nervous system disorders | 120 mg Duloxetine | 19 | 171 | |
| other | Dry mouth | Gastrointestinal disorders | 60 mg Duloxetine | 9 | 167 | |
| other | Dry mouth | Gastrointestinal disorders | 120 mg Duloxetine | 12 | 171 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 60 mg Duloxetine | 0 | 167 |
| Total, all-cause mortality | 120 mg Duloxetine | 0 | 171 |
| Total, other adverse events | 60 mg Duloxetine | 67 | 167 |
| Total, other adverse events | 120 mg Duloxetine | 54 | 171 |
| Total, serious adverse events | 60 mg Duloxetine | 6 | 167 |
| Total, serious adverse events | 120 mg Duloxetine | 6 | 171 |
Source ClinicalTrials.gov
Papers0
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 60 mg Duloxetine vs 120 mg Duloxetine: Number of Patients With Treatment Emergent Adverse Event | Trial comparisons |
| 60 mg Duloxetine vs 120 mg Duloxetine: Number of Patients Withdrawn Due to Adverse Events | Trial comparisons |
| 60 mg Duloxetine vs 120 mg Duloxetine: deaths from any cause | Trial comparisons |
| 60 mg Duloxetine vs 120 mg Duloxetine: 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.
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