Trial · NCT00406848
A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients
NCT00406848, Phase 4, Completed, Eli Lilly and Company; results first posted 2010-09-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients. Trials, record NCT00406848. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00406848
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients
- NCT number
- NCT00406848
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 370 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Major Depressive Disorder
- Interventions
- duloxetine hydrochloride, placebo
- First posted
- 2006-12-04
- Last updated
- 2010-09-29
- Results first posted
- 2010-09-29
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale | baseline (Week 1), Week 13 | The Maier subscale (Items 1,2,7,8,9,10) represents symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). |
| Secondary | Change From Baseline on the 30-item Geriatric Depression Scale (GDS) | baseline (Week 1), Week 13, Week 25 | The 30-item Geriatric Depression Scale (GDS) is a self-administered test of 30 questions to measure the severity of depression. The yes/no questions result in a range of scores from 0 (normal) to 30 (severe depression). |
| Secondary | Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items | baseline (Week 1), Week 13, Week 25 | Total Score assess depression severity (scores 0-52). Core, Maier and Bech subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier; 0-22=Bech). Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher numbers indicate more severe symptoms. |
| Secondary | Change From Baseline in the Brief Pain Inventory (BPI) Severity and Interference Scores | baseline (Week 1), Week 13, Week 25 | The Brief Pain Inventory (severity and interference scales) (BPI) is a self-reported scale that measures the severity of pain and the interference of pain on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. |
| Secondary | Change From Baseline in the Numeric Rating Scales (NRS) for Pain Item Scores | baseline (Week 1), Week 13, Week 25 | Numeric Rating Scales (Semantic Differential Scales) for Pain are 6 self-administered scales that assesses experience of overall pain, back pain, headache, shoulder pain, time in pain while awake, and pain interference with daily activities, during the past week. Each item is scored on a numeric 11-point semantic differential scale (0-10) from 0 = no pain to 10 = pain as severe as you can imagine; or 0 = none of the time to 10 = all of the time; or 0 = no interference to 10 = unable to do any activities at all. |
| Secondary | Patient's Global Impression of Improvement (PGI-I) at 13 Weeks and 25 Weeks | Week 13, Week 25 | The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse." |
| Secondary | Change From Baseline in the Clinical Global Impression-Severity (CGI-S) | baseline (Week 1), Week 13, Week 25 | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
| Secondary | Change From Baseline in the Mini-Mental State Exam (MMSE) | baseline (Week 1), Week 9, Week 25 | Mini-Mental State Examination (MMSE)is a widely used rating measure of cognitive ability. Scores range from 0 to 30. The MMSE will be used to categorize patients as with or without dementia. Higher number indicates better cognitive ability. Patients with a MMSE score of 20 to 23 will be categorized as having mild dementia, while those with a score of ≥ 24 will be categorized as having no dementia. |
| Secondary | Change From Baseline in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q-SF) | baseline (Week 1), Week 13, Week 25 | The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) measures the degree of enjoyment and satisfaction experienced in various areas of daily life. The short version is a self-administered 16 item scale evaluating satisfaction of general activities on a 5-point Likert scale that indicates the degree of enjoyment or satisfaction achieved during the past week (1 = very poor and 5 = very good). |
| Secondary | Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10 | Week 13, Week 25 | Remission (visitwise binary outcome, yes/no) is defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for remission (either Total Score ≤7 or ≤10) was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale | baseline (Week 1), Week 13 | All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline on the 30-item Geriatric Depression Scale (GDS) | baseline (Week 1), Week 13, Week 25 | All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items | baseline (Week 1), Week 13, Week 25 | Randomized patients with non-missing data at baseline and post-baseline visit. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Brief Pain Inventory (BPI) Severity and Interference Scores | baseline (Week 1), Week 13, Week 25 | All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Numeric Rating Scales (NRS) for Pain Item Scores | baseline (Week 1), Week 13, Week 25 | All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient's Global Impression of Improvement (PGI-I) at 13 Weeks and 25 Weeks | Week 13, Week 25 | All participants randomized under protocol amendment c,d,e, and have at least one post-randomization observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Clinical Global Impression-Severity (CGI-S) | baseline (Week 1), Week 13, Week 25 | All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Mini-Mental State Exam (MMSE) | baseline (Week 1), Week 9, Week 25 | All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q-SF) | baseline (Week 1), Week 13, Week 25 | All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10 | Week 13, Week 25 | All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation. | probability of remission | LEAST_SQUARES_MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group402
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale | Duloxetine | -4.34 | Standard Error 0.29 | units on a scale | |
| Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale | Placebo | -3.90 | Standard Error 0.44 | units on a scale | |
| Change From Baseline on the 30-item Geriatric Depression Scale (GDS) | Duloxetine | Week 13 change | -6.01 | Standard Error 0.53 | units on a scale |
| Change From Baseline on the 30-item Geriatric Depression Scale (GDS) | Placebo | Week 13 change | -4.53 | Standard Error 0.79 | units on a scale |
| Change From Baseline on the 30-item Geriatric Depression Scale (GDS) | Duloxetine | Week 25 change | -7.02 | Standard Error 0.58 | units on a scale |
| Change From Baseline on the 30-item Geriatric Depression Scale (GDS) | Placebo | Week 25 change | -3.66 | Standard Error 1.00 | units on a scale |
| Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items | Duloxetine | Total - Week 13 Change | -7.42 | Standard Error 0.52 | units on a scale |
| Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items | Placebo | Total - Week 13 Change | -7.15 | Standard Error 0.77 | units on a scale |
| Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items | Duloxetine | Total - Week 25 Change | -8.98 | Standard Error 0.57 | units on a scale |
| Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items | Placebo | Total - Week 25 Change | -7.00 | Standard Error 1.01 | units on a scale |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 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 | 249 | |
| Overall Study | STARTED | Placebo | 121 | |
| Overall Study | COMPLETED | Duloxetine | 156 | |
| Overall Study | COMPLETED | Placebo | 67 | |
| Overall Study | NOT COMPLETED | Duloxetine | 93 | |
| Overall Study | NOT COMPLETED | Placebo | 54 |
Source ClinicalTrials.gov
Adverse events111
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 | 37 | 249 | 37 |
| other | Constipation | Gastrointestinal disorders | Placebo | 5 | 121 | 6 |
| other | Constipation | Gastrointestinal disorders | Rescued Placebo | 3 | 35 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Duloxetine | 31 | 249 | 33 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 121 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Rescued Placebo | 0 | 35 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Duloxetine | 34 | 249 | 35 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 7 | 121 | 7 |
| other | Dry mouth | Gastrointestinal disorders | Rescued Placebo | 1 | 35 | 1 |
| other | Nausea | Gastrointestinal disorders | Duloxetine | 28 | 249 | 29 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Duloxetine | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Rescued Placebo | ||
| Total, other adverse events | Duloxetine | 199 | 249 |
| Total, other adverse events | Placebo | 77 | 121 |
| Total, other adverse events | Rescued Placebo | 17 | 35 |
| Total, serious adverse events | Duloxetine | 13 | 249 |
| Total, serious adverse events | Placebo | 4 | 121 |
| Total, serious adverse events | Rescued Placebo | 1 | 35 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Duloxetine vs Placebo: Number of Participants With Abnormal Laboratory Values - Low Leukocyte Count |
Source Trial comparisons
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Cancellation Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
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/NCT00406848
GET https://conductscience.org/api/trials/v1/NCT00406848/registered?page=2