A Phase 2 interventional study of LY2216684 and Placebo in Depressive Disorder, Major, sponsored by Eli Lilly and Company. Completed at 24 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-24.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
The primary purpose is to study the efficacy, safety, and tolerability of LY2216684 as an adjunctive treatment for participants with major depressive disorder (MDD), who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI) (as defined by history).
This is a 12 week multi-center, double-blind, placebo-controlled study on the efficacy of LY2216684 augmentation of selective serotonin reuptake inhibitors (SSRIs) in participants with MDD who have a partial response to treatment with an SSRI. While remaining on a steady dose of their SSRI treatment at entry into the study, participants will be randomly assigned to adjunctive treatment with LY2216684 or placebo in a 1:1 ratio for 10 weeks of acute treatment.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 227 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: LY2216684
Drug: Placebo
Starting dose is 6 milligrams (mg), then titrate up to 9 mg, 12 mg, or 18 mg (3 tablets) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2 week taper.
3 tablets PO QD for up to 12 weeks
Change From Baseline to 8 Weeks in Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS is a 10-item checklist with items rated on a scale of 0-6, for a total scores range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for investigator, treatment-by-visit, baseline score, and baseline-by-visit.
Time frame: Baseline, 8 weeks
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Total Score
QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). The total score ranges from 0 to 27 with higher scores indicating greater severity of depression. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Time frame: Baseline, 8 weeks
Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items
QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). Least Squares (LS) means are calculated using mixed model repeated measure (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Time frame: Baseline, 8 weeks
Change From Baseline to 8 Weeks in Hospital Anxiety and Depression Scale (HADS)
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 each subscale. 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 is 'normal.' Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, visit, treatment-by-visit, investigator, and baseline score.
Time frame: Baseline, up to 8 weeks
Change From Baseline to 8 Weeks in Clinical Global Impression of Severity (CGI-S)
CGI-S 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 participants). Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by visit, baseline score, and baseline-by-visit.
Time frame: Baseline, 8 weeks
Change From Baseline to 8 Weeks in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
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 is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42. Higher scores indicate greater disease severity. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Time frame: Baseline, 8 weeks
Change From Baseline to 8 Weeks in Fatigue Associated With Depression Participant-Reported Outcome (FAsD PRO)
The FAsD PRO is a 16-item participant-rated scale. Seven items ask how often the participants experience different aspects of fatigue with each item rated on a 5-point scale: 1 (Never) to 5 (Always). Nine items ask how often fatigue impacts various aspects of the participants lives with each item rated on a 5-point scale: 1 (Not at all) to 5 (Very much). The Fatigue Experience Score is the mean of Items 1-5, and 7, the Fatigue Impact Score is the mean of Items 8-12, 14, and 16, and the Overall Average Score is the mean of Items 1-5, 7-12, 14 and 16. The Experience, Impact and Overall Mean Scores range from 1 to 5, lower scores indicate less experience/impact. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
Time frame: Baseline, up to 8 weeks
Change From Baseline to 8 Weeks in Visual Analog Scale for Fatigue (VAS-F)
VAS-F is a self-rated assessment on 2 items: the overall severity of fatigue and the interferences with daily activities due to fatigue. For the overall severity of fatigue the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to fatigue, the participant is asked to place a vertical mark on a 100 mm line between 2 anchors: 0 (not at all) and 100 \[complete disability (unable to do any activities)\]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
Time frame: Baseline, up to 8 weeks
Change From Baseline to 8 Weeks in Visual Analog Scale for Pain (VAS-P)
VAS-P is a self-rated assessment for 2 items: the overall severity of pain and the interferences with daily activities due to pain. For the overall severity of pain the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to pain, the participant is asked to place a vertical mark on a 100-mm line between 2 anchors: 0 (not at all) and 100 \[complete disability (unable to do any activities)\]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
Time frame: Baseline, up to 8 weeks
Change From Baseline to 8 Weeks in Sheehan Disability Scale (SDS)
The SDS is a 3-item, participant completed assessment and is used to assess the effect of the participant's symptoms on their work/social/family life. The Global Functional Impairment Total Score is a total of the 3 individual item scores, each with a scores range from 0 (not at all) to 10 (extremely). The Global Functional Impairment Total Scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
Time frame: Baseline, up to 8 weeks
Change From Baseline to 8 Weeks in Quality of Life Enjoyment and Satisfaction Survey-Short Form (Q-LES-Q-SF)
The Q-LES-Q-SF is a self-administered 16-item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week, and is rated on a 5-point Likert scale: 1 (very poor) to 5 (very good). The Q-LES-Q-SF Total Raw Score is the sum of Items 1 to 14 and ranges from 14 to 70. The Q-LES-Q-SF Raw Scores are converted to, and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
Time frame: Baseline, up to 8 weeks
Change From Baseline to 8 Weeks Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ)
The MGH-SFQ is a 6-item participant-rated scale quantifying sexual interest, arousal (subjective excitement), ability to reach orgasm, erectile function (for males), and overall satisfaction and are scored on a 6-point scale: 1 (greater than normal) to 6 (totally absent); and overall improvement since last medication change is scored on a 6-point scale: 1 (very much improved) to 6 (much worse). Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
Time frame: Baseline, up to 8 weeks
Colombia-Suicide Severity Rating Scale (C-SSRS)
Percent of participants with suicidal ideation, behavior and acts based on C-SSRS. The C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any 1 of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide). Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions (wish to be dead, and 4 different categories of active suicidal ideation). Suicidal act: a "yes" answer to actual attempt or completed suicide.
Time frame: Baseline, 8 weeks
Change From Baseline to 8 Weeks in Supine Systolic and Diastolic Blood Pressure
Blood pressure is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Time frame: Baseline, 8 weeks
Change From Baseline to 8 Weeks in Supine Pulse
Pulse is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
Time frame: Baseline, 8 weeks
| Milestone | LY2216684 | Placebo |
|---|---|---|
| Started | 111 | 116 |
| Completed | 90 | 80 |
| Not completed | 21 | 36 |
| Withdrew: Adverse event | 6 | 8 |
| Withdrew: Lack of efficacy | 2 | 0 |
| Withdrew: Lost to follow-up | 5 | 12 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Protocol violation | 2 | 4 |
| Withdrew: Withdrawal by subject | 6 | 11 |
| Milestone | LY2216684 | Placebo |
|---|---|---|
| Started | 90 | 82 |
| Completed | 87 | 80 |
| Not completed | 3 | 2 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). The total score ranges from 0 to 27 with higher scores indicating greater severity of depression. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
| units on a scale | LY2216684 | Placebo |
|---|---|---|
| Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Total Score | -4.71 ± 0.625 | -2.97 ± 0.628 |
QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). Least Squares (LS) means are calculated using mixed model repeated measure (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
| units on a scale | LY2216684 | Placebo |
|---|---|---|
| Highest Score from Items 1-4 | -0.49 ± 0.113 | -0.26 ± 0.115 |
| Item 5 | -0.88 ± 0.124 | -0.45 ± 0.126 |
| Highest Score from Items 6-9 | -0.32 ± 0.131 | -0.29 ± 0.133 |
| Item 10 | -0.61 ± 0.094 | -0.33 ± 0.095 |
| Item 11 | -0.77 ± 0.127 | -0.39 ± 0.129 |
| Item 12 | -0.21 ± 0.048 | -0.19 ± 0.049 |
| Item 13 | -0.55 ± 0.139 | -0.48 ± 0.140 |
| Item 14 | -0.65 ± 0.109 | -0.28 ± 0.110 |
| Highest Score from Items 15-16 | -0.53 ± 0.129 | -0.14 ± 0.130 |
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS is a 10-item checklist with items rated on a scale of 0-6, for a total scores range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for investigator, treatment-by-visit, baseline score, and baseline-by-visit.
| units on a scale | LY2216684 | Placebo |
|---|---|---|
| Change From Baseline to 8 Weeks in Montgomery-Asberg Depression Rating Scale (MADRS) | -8.13 ± 1.251 | -5.76 ± 1.249 |
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 each subscale. 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 is 'normal.' Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, visit, treatment-by-visit, investigator, and baseline score.
| units on a scale | LY2216684 | Placebo |
|---|---|---|
| Anxiety Subscale Score | -2.19 ± 0.484 | -1.42 ± 0.483 |
| Depression Subscale Score | -3.28 ± 0.549 | -1.93 ± 0.551 |
CGI-S 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 participants). Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by visit, baseline score, and baseline-by-visit.
| units on a scale | LY2216684 | Placebo |
|---|---|---|
| Change From Baseline to 8 Weeks in Clinical Global Impression of Severity (CGI-S) | -0.74 ± 0.135 | -0.71 ± 0.135 |
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 is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42. Higher scores indicate greater disease severity. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
| units on a scale | LY2216684 | Placebo |
|---|---|---|
| Change From Baseline to 8 Weeks in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) | -5.69 ± 0.831 | -2.62 ± 0.833 |
The FAsD PRO is a 16-item participant-rated scale. Seven items ask how often the participants experience different aspects of fatigue with each item rated on a 5-point scale: 1 (Never) to 5 (Always). Nine items ask how often fatigue impacts various aspects of the participants lives with each item rated on a 5-point scale: 1 (Not at all) to 5 (Very much). The Fatigue Experience Score is the mean of Items 1-5, and 7, the Fatigue Impact Score is the mean of Items 8-12, 14, and 16, and the Overall Average Score is the mean of Items 1-5, 7-12, 14 and 16. The Experience, Impact and Overall Mean Scores range from 1 to 5, lower scores indicate less experience/impact. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
| units on a scale | LY2216684 | Placebo |
|---|---|---|
| Overall Average Score | -0.75 ± 0.124 | -0.41 ± 0.127 |
| Fatigue Experience Score | -0.60 ± 0.126 | -0.42 ± 0.129 |
| Fatigue Impact Score | -0.92 ± 0.140 | -0.41 ± 0.140 |
VAS-F is a self-rated assessment on 2 items: the overall severity of fatigue and the interferences with daily activities due to fatigue. For the overall severity of fatigue the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to fatigue, the participant is asked to place a vertical mark on a 100 mm line between 2 anchors: 0 (not at all) and 100 \[complete disability (unable to do any activities)\]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
| units on a scale | LY2216684 | Placebo |
|---|---|---|
| Severity | -16.42 ± 3.407 | -13.81 ± 3.412 |
| Interference | -18.91 ± 3.698 | -10.33 ± 3.701 |
VAS-P is a self-rated assessment for 2 items: the overall severity of pain and the interferences with daily activities due to pain. For the overall severity of pain the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to pain, the participant is asked to place a vertical mark on a 100-mm line between 2 anchors: 0 (not at all) and 100 \[complete disability (unable to do any activities)\]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
| units on a scale | LY2216684 | Placebo |
|---|---|---|
| Severity | -4.17 ± 3.450 | -0.91 ± 3.448 |
| Interference | -9.56 ± 3.611 | -0.13 ± 3.613 |
The SDS is a 3-item, participant completed assessment and is used to assess the effect of the participant's symptoms on their work/social/family life. The Global Functional Impairment Total Score is a total of the 3 individual item scores, each with a scores range from 0 (not at all) to 10 (extremely). The Global Functional Impairment Total Scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
| units on a scale | LY2216684 | Placebo |
|---|---|---|
| Change From Baseline to 8 Weeks in Sheehan Disability Scale (SDS) | -5.95 ± 1.116 | -2.63 ± 1.123 |
The Q-LES-Q-SF is a self-administered 16-item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week, and is rated on a 5-point Likert scale: 1 (very poor) to 5 (very good). The Q-LES-Q-SF Total Raw Score is the sum of Items 1 to 14 and ranges from 14 to 70. The Q-LES-Q-SF Raw Scores are converted to, and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
| percentage of the maximum possible score | LY2216684 | Placebo |
|---|---|---|
| Change From Baseline to 8 Weeks in Quality of Life Enjoyment and Satisfaction Survey-Short Form (Q-LES-Q-SF) | 12.94 ± 2.073 | 5.44 ± 2.078 |
The MGH-SFQ is a 6-item participant-rated scale quantifying sexual interest, arousal (subjective excitement), ability to reach orgasm, erectile function (for males), and overall satisfaction and are scored on a 6-point scale: 1 (greater than normal) to 6 (totally absent); and overall improvement since last medication change is scored on a 6-point scale: 1 (very much improved) to 6 (much worse). Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.
| units on a scale | LY2216684 | Placebo |
|---|---|---|
| Interest | -0.70 ± 0.133 | -0.25 ± 0.136 |
| Arousal | -0.74 ± 0.130 | -0.27 ± 0.132 |
| Ability to Reach Orgasm | -0.81 ± 0.142 | -0.36 ± 0.144 |
| Erectile Function - Males Only | -0.30 ± 0.237 | -0.48 ± 0.233 |
| Overall Satisfaction | -0.63 ± 0.141 | -0.48 ± 0.144 |
| Overall Improvement | 3.45 ± 0.119 | 3.62 ± 0.121 |
Percent of participants with suicidal ideation, behavior and acts based on C-SSRS. The C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a "yes" answer to any 1 of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide). Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions (wish to be dead, and 4 different categories of active suicidal ideation). Suicidal act: a "yes" answer to actual attempt or completed suicide.
| percentage of participants | LY2216684 | Placebo |
|---|---|---|
| Suicidal Ideation | 11.2 | 7.3 |
| Suicidal Behavior | 0.9 | 0.0 |
| Suicidal Acts | 0.0 | 0.0 |
Blood pressure is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
| millimeters of mercury (mm Hg) | LY2216684 | Placebo |
|---|---|---|
| Systolic Blood Pressure | 3.61 ± 1.131 | 1.31 ± 1.195 |
| Diastolic Blood Pressure | 2.67 ± 0.730 | 0.77 ± 0.772 |
Pulse is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.
| beats per minute (bpm) | LY2216684 | Placebo |
|---|---|---|
| Change From Baseline to 8 Weeks in Supine Pulse | 6.74 ± 0.986 | 0.65 ± 1.038 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY2216684 | — | 3/111 (2.7%) | 65/111 (58.6%) |
| Placebo | — | 2/116 (1.7%) | 48/116 (41.4%) |
| LY2216684-Taper Phase | — | 1/90 (1.1%) | 8/90 (8.9%) |
| Placebo-Taper Phase | — | 0/82 (0%) | 8/82 (9.8%) |
| Event | LY2216684 | Placebo | LY2216684-Taper Phase | Placebo-Taper Phase |
|---|---|---|---|---|
| Haemoglobin decreasedInvestigations | 1/111 | 0/116 | 1/90 | 0/82 |
| Angina pectorisCardiac disorders | 1/111 | 0/116 | 0/90 | 0/82 |
| ParaesthesiaNervous system disorders | 1/111 | 0/116 | 0/90 | 0/82 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/111 | 1/116 | 0/90 | 0/82 |
| Suicidal ideationPsychiatric disorders | 0/111 | 1/116 | 0/90 | 0/82 |
| Event | LY2216684 | Placebo | LY2216684-Taper Phase | Placebo-Taper Phase |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 8/111 | 3/116 | 1/90 | 0/82 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 8/111 | 1/116 | 0/90 | 0/82 |
| Erectile dysfunctionReproductive system and breast disorders | 2/32 | 0/37 | 0/27 | 0/23 |
| Testicular painReproductive system and breast disorders | 2/32 | 0/37 | 0/27 | 0/23 |
| DizzinessNervous system disorders | 5/111 | 1/116 | 0/90 | 0/82 |
| Upper respiratory tract infectionInfections and infestations | 3/111 | 1/116 | 0/90 | 3/82 |
| InfluenzaInfections and infestations | 4/111 | 1/116 | 0/90 | 0/82 |
| Urinary hesitationRenal and urinary disorders | 4/111 | 0/116 | 0/90 | 0/82 |
| HeadacheNervous system disorders | 1/111 | 4/116 | 0/90 | 1/82 |
| InsomniaPsychiatric disorders | 0/111 | 4/116 | 0/90 | 0/82 |
All randomized participants.
| Age, Continuous(years) | LY2216684 | Placebo | Total |
|---|---|---|---|
| Mean | 46.1 ± 10.71 | 44.1 ± 10.90 | 45.0 ± 10.83 |
| Sex: Female, Male(Participants) | LY2216684 | Placebo | Total |
|---|---|---|---|
| Female | 79 | 79 | 158 |
| Male | 32 | 37 | 69 |
| Ethnicity (NIH/OMB)(Participants) | LY2216684 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 20 | 22 | 42 |
| Not Hispanic or Latino | 91 | 94 | 185 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | LY2216684 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 31 | 30 | 61 |
| White | 67 | 71 | 138 |
| More than one race | 7 | 7 | 14 |
| Unknown or Not Reported | 2 | 4 | 6 |
| Region of Enrollment(Participants) | LY2216684 | Placebo | Total |
|---|---|---|---|
| United States | 111 | 116 | 227 |
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