Trial · NCT01155661
A Safety Study in Participants With Major Depressive Disorder
NCT01155661, Phase 3, Completed, Eli Lilly and Company; results first posted 2018-04-17
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ConductScience Library. A Safety Study in Participants With Major Depressive Disorder. Trials, record NCT01155661. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01155661
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety Study in Participants With Major Depressive Disorder
- NCT number
- NCT01155661
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 608 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Depressive Disorder, Major
- Interventions
- LY2216684 (edivoxetine), SSRI
- First posted
- 2010-07-02
- Last updated
- 2018-04-17
- Results first posted
- 2018-04-17
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants Experiencing Clinically Significant Effects | Baseline through 54 weeks | A clinically significant effect was defined as a serious adverse event, regardless of causality. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Event module. |
| Secondary | Percent of Participants With Suicidal Ideation and Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline through Week 54 | The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was 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. |
| Secondary | Change From Baseline to 54 Week Endpoint in the Arizona Sexual Experiences (ASEX) Scale | Baseline, Week 54 | The ASEX scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 \[extremely\] to 6 \[no/never\]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30 with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit. |
| Secondary | Change From Baseline to 54 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) | Baseline, Week 54 | The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit. |
| Secondary | Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items | Baseline, Week 54 | The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit. |
| Secondary | Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score | Baseline, Week 54 | The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscales. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit. |
| Secondary | Change From Baseline to 54 Week Endpoint in Clinical Global Impression - Severity (CGI-S) | Baseline, Week 54 | Clinical Global Impression - Severity (CGI-S) measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit. |
| Secondary | Change From Baseline to 54 Week Endpoint in Fatigue Associated With Depression (FAsD) Average Score and Subscale Scores | Baseline, Week 54 | The Fatigue Associated with Depression (FAsD) is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The "Experience Score" was derived by taking the mean of Items 1 through 6, the "Impact Score" was derived by taking the mean of Items 7 through 13 (applicable items only), and the "Average Score" was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit. |
| Secondary | Probability of Meeting the Response Criteria for Depressive Symptoms at Week 54 Endpoint | Baseline, Week 54 | Response criteria was defined as at least a 50% decrease from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). This analysis models the probability of response at each visit, and the estimated probabilities were adjusted for visit and the baseline MADRS total score. |
| Secondary | Probability of Meeting the Remission Criteria for Depressive Symptoms at Week 54 Endpoint | Baseline, Week 54 | Remission criteria was defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of \<= 10. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). This analysis models the probability of remission at each visit, and the estimated probabilities were adjusted for visit and the baseline MADRS total score. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants Experiencing Clinically Significant Effects | Baseline through 54 weeks | All enrolled participants who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit. | participants | NUMBER |
| SECONDARY | Percent of Participants With Suicidal Ideation and Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline through Week 54 | All enrolled participants with a baseline and at least one post-baseline C-SSRS value. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to 54 Week Endpoint in the Arizona Sexual Experiences (ASEX) Scale | Baseline, Week 54 | All enrolled participants with a baseline and at least one post-baseline ASEX total score value. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 54 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) | Baseline, Week 54 | All enrolled participants with a baseline and at least one post-baseline CPFQ total score value. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items | Baseline, Week 54 | All enrolled participants with a baseline and at least one post-baseline MADRS individual item and total score value. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score | Baseline, Week 54 | All enrolled participants with a baseline and at least one post-baseline Hospital Anxiety and Depression Scale (HADS) depression subscale value. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 54 Week Endpoint in Clinical Global Impression - Severity (CGI-S) | Baseline, Week 54 | All enrolled participants with a baseline and at least one post-baseline Clinical Global Impression - Severity (CGI-S) value. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 54 Week Endpoint in Fatigue Associated With Depression (FAsD) Average Score and Subscale Scores | Baseline, Week 54 | All enrolled participants with a baseline and at least one post-baseline Fatigue Associated with Depression (FAsD) average score and subscale score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Probability of Meeting the Response Criteria for Depressive Symptoms at Week 54 Endpoint | Baseline, Week 54 | All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value. | Probability of response | NUMBER |
| SECONDARY | Probability of Meeting the Remission Criteria for Depressive Symptoms at Week 54 Endpoint | Baseline, Week 54 | All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value. | Probability of remission | NUMBER |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants Experiencing Clinically Significant Effects | LY2216684 + SSRI | 13 | participants | ||
| Percent of Participants With Suicidal Ideation and Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | LY2216684 + SSRI | Suicidal Ideation | 11.71 | percentage of participants | |
| Percent of Participants With Suicidal Ideation and Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | LY2216684 + SSRI | Suicidal Behavior | 0.17 | percentage of participants | |
| Change From Baseline to 54 Week Endpoint in the Arizona Sexual Experiences (ASEX) Scale | LY2216684 + SSRI | -2.28 | Standard Error 0.25 | units on a scale | |
| Change From Baseline to 54 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) | LY2216684 + SSRI | -8.64 | Standard Error 0.30 | units on a scale | |
| Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items | LY2216684 + SSRI | MADRS Item 1: Apparent Sadness | -2.17 | Standard Error 0.05 | units on a scale |
| Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items | LY2216684 + SSRI | MADRS Item 2: Reported Sadness | -2.38 | Standard Error 0.06 | units on a scale |
| Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items | LY2216684 + SSRI | MADRS Item 3: Inner Tension | -1.56 | Standard Error 0.06 | units on a scale |
| Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items | LY2216684 + SSRI | MADRS Item 4: Reduced Sleep | -1.97 | Standard Error 0.07 | units on a scale |
| Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items | LY2216684 + SSRI | MADRS Item 5: Reduced Appetite | -1.08 | Standard Error 0.04 | units on a scale |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LY2216684 + SSRI | 608 | |
| Overall Study | COMPLETED | LY2216684 + SSRI | 328 | |
| Overall Study | NOT COMPLETED | LY2216684 + SSRI | 280 |
Source ClinicalTrials.gov
Adverse events62
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 | Palpitations | Cardiac disorders | LY2216684 + SSRI Open-Label Phase | 25 | 600 | 26 |
| other | Palpitations | Cardiac disorders | Discontinuation Phase | 4 | 472 | 4 |
| other | Constipation | Gastrointestinal disorders | LY2216684 + SSRI Open-Label Phase | 72 | 600 | 77 |
| other | Constipation | Gastrointestinal disorders | Discontinuation Phase | 0 | 472 | 0 |
| other | Dry mouth | Gastrointestinal disorders | LY2216684 + SSRI Open-Label Phase | 56 | 600 | 58 |
| other | Dry mouth | Gastrointestinal disorders | Discontinuation Phase | 2 | 472 | 2 |
| other | Nausea | Gastrointestinal disorders | LY2216684 + SSRI Open-Label Phase | 88 | 600 | 99 |
| other | Nausea | Gastrointestinal disorders | Discontinuation Phase | 12 | 472 | 12 |
| other | Vomiting | Gastrointestinal disorders | LY2216684 + SSRI Open-Label Phase | 40 | 600 | 46 |
| other | Vomiting | Gastrointestinal disorders | Discontinuation Phase | 1 | 472 | 1 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY2216684 + SSRI Open-Label Phase | ||
| Total, all-cause mortality | Discontinuation Phase | ||
| Total, other adverse events | LY2216684 + SSRI Open-Label Phase | 448 | 600 |
| Total, other adverse events | Discontinuation Phase | 99 | 472 |
| Total, serious adverse events | LY2216684 + SSRI Open-Label Phase | 13 | 600 |
| Total, serious adverse events | Discontinuation Phase | 0 | 472 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| LY2216684 + SSRI Open-Label Phase vs Discontinuation Phase: serious adverse events |
Source 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/NCT01155661
GET https://conductscience.org/api/trials/v1/NCT01155661/registered?page=2