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A Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00840034
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Interventions Drug: LY2216684
Drug: Placebo
Enrollment 227
Recruitment Details  
Pre-assignment Details In the Acute Treatment Phase participants are randomized to either LY2216684 or placebo treatment groups. Participants who complete the Acute Treatment Phase or discontinue early after 4 or more weeks in the Acute Treatment phase are eligible to participate in the 2 week Taper Phase, but not all elected to participate.
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets varying in strength) administered orally, once daily for up to 10 weeks, followed by a 2-week Taper Phase. Placebo: 3 tablets PO QD for up to 12 weeks.
Period Title: Acute Treatment Phase
Started 111 116
Completed 90 80
Not Completed 21 36
Reason Not Completed
Adverse Event             6             8
Lack of Efficacy             2             0
Lost to Follow-up             5             12
Physician Decision             0             1
Protocol Violation             2             4
Withdrawal by Subject             6             11
Period Title: Taper Phase
Started 90 [1] 82 [1]
Completed 87 80
Not Completed 3 2
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             1             1
Withdrawal by Subject             1             1
[1]
Completed Acute Treatment (AT) or discontinued ≥4 weeks of AT and chose to participate in Taper.
Arm/Group Title LY2216684 Placebo Total
Hide Arm/Group Description LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase. Placebo: 3 tablets PO QD for up to 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 111 116 227
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 116 participants 227 participants
46.1  (10.71) 44.1  (10.90) 45.0  (10.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 116 participants 227 participants
Female
79
  71.2%
79
  68.1%
158
  69.6%
Male
32
  28.8%
37
  31.9%
69
  30.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 116 participants 227 participants
Hispanic or Latino
20
  18.0%
22
  19.0%
42
  18.5%
Not Hispanic or Latino
91
  82.0%
94
  81.0%
185
  81.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 116 participants 227 participants
American Indian or Alaska Native
1
   0.9%
2
   1.7%
3
   1.3%
Asian
3
   2.7%
2
   1.7%
5
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
31
  27.9%
30
  25.9%
61
  26.9%
White
67
  60.4%
71
  61.2%
138
  60.8%
More than one race
7
   6.3%
7
   6.0%
14
   6.2%
Unknown or Not Reported
2
   1.8%
4
   3.4%
6
   2.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 111 participants 116 participants 227 participants
111
 100.0%
116
 100.0%
227
 100.0%
1.Primary Outcome
Title Change From Baseline to 8 Weeks in Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline MADRS Total Score.
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 62 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.13  (1.251) -5.76  (1.249)
2.Secondary Outcome
Title Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline QIDS-SR16 Total Score.
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 63 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.71  (0.625) -2.97  (0.628)
3.Secondary Outcome
Title Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline QIDS-SR16 Individual Score.
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 63 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
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)
4.Secondary Outcome
Title Change From Baseline to 8 Weeks in Hospital Anxiety and Depression Scale (HADS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline HADS Score; last observation carried forward (LOCF).
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 61 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Anxiety Subscale Score Number Analyzed 61 participants 63 participants
-2.19  (0.484) -1.42  (0.483)
Depression Subscale Score Number Analyzed 61 participants 62 participants
-3.28  (0.549) -1.93  (0.551)
5.Secondary Outcome
Title Change From Baseline to 8 Weeks in Clinical Global Impression of Severity (CGI-S)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline CGI-Severity Score.
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 63 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.74  (0.135) -0.71  (0.135)
6.Secondary Outcome
Title Change From Baseline to 8 Weeks in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline CPFQ Total Score.
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 63 68
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.69  (0.831) -2.62  (0.833)
7.Secondary Outcome
Title Change From Baseline to 8 Weeks in Fatigue Associated With Depression Participant-Reported Outcome (FAsD PRO)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline FAsD-PRO Score; last observation carried forward (LOCF).
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 58 59
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Overall Average Score Number Analyzed 57 participants 59 participants
-0.75  (0.124) -0.41  (0.127)
Fatigue Experience Score Number Analyzed 57 participants 59 participants
-0.60  (0.126) -0.42  (0.129)
Fatigue Impact Score Number Analyzed 58 participants 59 participants
-0.92  (0.140) -0.41  (0.140)
8.Secondary Outcome
Title Change From Baseline to 8 Weeks in Visual Analog Scale for Fatigue (VAS-F)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline VAS-F Score; last observation carried forward (LOCF).
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 59 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Severity -16.42  (3.407) -13.81  (3.412)
Interference -18.91  (3.698) -10.33  (3.701)
9.Secondary Outcome
Title Change From Baseline to 8 Weeks in Visual Analog Scale for Pain (VAS-P)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline VAS-P Score; last observation carried forward (LOCF).
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 59 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Severity -4.17  (3.450) -0.91  (3.448)
Interference -9.56  (3.611) -0.13  (3.613)
10.Secondary Outcome
Title Change From Baseline to 8 Weeks in Sheehan Disability Scale (SDS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis is determined by treatment group participants are randomly assigned regardless of treatment received, includes all participants who do not respond in Weeks 1-2, have baseline and at least 1 post-baseline SDS Total Score; last observation carried forward. Missing work score imputed with average of other 2-item scores.
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 58 56
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.95  (1.116) -2.63  (1.123)
11.Secondary Outcome
Title Change From Baseline to 8 Weeks in Quality of Life Enjoyment and Satisfaction Survey-Short Form (Q-LES-Q-SF)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis is determined by treatment group participants are randomly assigned regardless of treatment received, includes all participants who do not respond in Weeks 1-2, have baseline and at least 1 post-baseline Q-LES-Q-SF Total Score; last observation carried forward. If ≤2 items are missing mean of all other items are imputed.
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 59 58
Least Squares Mean (Standard Error)
Unit of Measure: percentage of the maximum possible score
12.94  (2.073) 5.44  (2.078)
12.Secondary Outcome
Title Change From Baseline to 8 Weeks Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline MGH-SFQ Score.
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 103 104
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Interest Number Analyzed 103 participants 104 participants
-0.70  (0.133) -0.25  (0.136)
Arousal Number Analyzed 103 participants 104 participants
-0.74  (0.130) -0.27  (0.132)
Ability to Reach Orgasm Number Analyzed 103 participants 104 participants
-0.81  (0.142) -0.36  (0.144)
Erectile Function - Males Only Number Analyzed 31 participants 31 participants
-0.30  (0.237) -0.48  (0.233)
Overall Satisfaction Number Analyzed 103 participants 104 participants
-0.63  (0.141) -0.48  (0.144)
Overall Improvement Number Analyzed 102 participants 104 participants
3.45  (0.119) 3.62  (0.121)
13.Secondary Outcome
Title Colombia-Suicide Severity Rating Scale (C-SSRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline C-SSRS Score.
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 107 109
Measure Type: Number
Unit of Measure: percentage of participants
Suicidal Ideation 11.2 7.3
Suicidal Behavior 0.9 0.0
Suicidal Acts 0.0 0.0
14.Other Pre-specified Outcome
Title Change From Baseline to 8 Weeks in Supine Systolic and Diastolic Blood Pressure
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who have baseline and at least 1 post-baseline supine systolic and diastolic blood pressure measure.
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 107 109
Least Squares Mean (Standard Error)
Unit of Measure: millimeters of mercury (mm Hg)
Systolic Blood Pressure 3.61  (1.131) 1.31  (1.195)
Diastolic Blood Pressure 2.67  (0.730) 0.77  (0.772)
15.Other Pre-specified Outcome
Title Change From Baseline to 8 Weeks in Supine Pulse
Hide Description 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
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Hide Analysis Population Description
Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and included all participants who have baseline and at least 1 post-baseline supine pulse rate measure.
Arm/Group Title LY2216684 Placebo
Hide Arm/Group Description:
LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2-week Taper Phase.
Placebo: 3 tablets PO QD for up to 12 weeks.
Overall Number of Participants Analyzed 107 109
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute (bpm)
6.74  (0.986) 0.65  (1.038)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2216684 Placebo LY2216684-Taper Phase Placebo-Taper Phase
Hide Arm/Group Description LY2216684: Starting dose is 6 milligrams (mg), then titrated up to 9 mg, 12 mg, or 18 mg (3 tablets, varying in strength) administered orally, once daily for up to 10 weeks followed by a 2-week Taper Phase. Placebo: 3 tablets orally, once daily for up to 12 weeks. LY2216684: Participants who completed or discontinued Acute Treatment Phase at or after 4 weeks were administered 12 mg orally, once daily for 1 week followed by 6 mg once daily for 1 week or 6 mg orally, once daily for 2 weeks. Placebo: Participants who completed or discontinued Acute Treatment Phase at or after 4 weeks continued on placebo 3 tablets orally, once daily for 2 weeks.
All-Cause Mortality
LY2216684 Placebo LY2216684-Taper Phase Placebo-Taper Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2216684 Placebo LY2216684-Taper Phase Placebo-Taper Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/111 (2.70%)      2/116 (1.72%)      1/90 (1.11%)      0/82 (0.00%)    
Cardiac disorders         
Angina pectoris  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Investigations         
Haemoglobin decreased  1  1/111 (0.90%)  1 0/116 (0.00%)  0 1/90 (1.11%)  1 0/82 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Colon cancer  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Nervous system disorders         
Paraesthesia  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Psychiatric disorders         
Suicidal ideation  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LY2216684 Placebo LY2216684-Taper Phase Placebo-Taper Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   65/111 (58.56%)      48/116 (41.38%)      8/90 (8.89%)      8/82 (9.76%)    
Blood and lymphatic system disorders         
Lymphadenopathy  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Cardiac disorders         
Myocardial ischaemia  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Palpitations  1  2/111 (1.80%)  2 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Sinus bradycardia  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Tachycardia  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Congenital, familial and genetic disorders         
Uterine hypoplasia  1  0/79 (0.00%)  0 1/79 (1.27%)  1 0/63 (0.00%)  0 0/59 (0.00%)  0
Ear and labyrinth disorders         
Deafness unilateral  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Ear pain  1  0/111 (0.00%)  0 0/116 (0.00%)  0 1/90 (1.11%)  1 0/82 (0.00%)  0
Tinnitus  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Vertigo  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Eye disorders         
Blepharospasm  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Conjunctivitis  1  0/111 (0.00%)  0 0/116 (0.00%)  0 1/90 (1.11%)  1 0/82 (0.00%)  0
Vision blurred  1  2/111 (1.80%)  2 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Gastrointestinal disorders         
Abdominal discomfort  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Abdominal pain upper  1  1/111 (0.90%)  1 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Constipation  1  1/111 (0.90%)  1 2/116 (1.72%)  2 0/90 (0.00%)  0 0/82 (0.00%)  0
Diarrhoea  1  1/111 (0.90%)  1 2/116 (1.72%)  3 0/90 (0.00%)  0 0/82 (0.00%)  0
Dry mouth  1  1/111 (0.90%)  1 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Dyspepsia  1  2/111 (1.80%)  2 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Gastrooesophageal reflux disease  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Haemorrhoids  1  0/111 (0.00%)  0 0/116 (0.00%)  0 0/90 (0.00%)  0 1/82 (1.22%)  1
Lip swelling  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Nausea  1  8/111 (7.21%)  8 3/116 (2.59%)  3 1/90 (1.11%)  1 0/82 (0.00%)  0
Vomiting  1  3/111 (2.70%)  3 0/116 (0.00%)  0 1/90 (1.11%)  1 0/82 (0.00%)  0
General disorders         
Chills  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Fatigue  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Feeling cold  1  2/111 (1.80%)  2 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Feeling jittery  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Influenza like illness  1  0/111 (0.00%)  0 0/116 (0.00%)  0 1/90 (1.11%)  1 0/82 (0.00%)  0
Irritability  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Pain  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Pyrexia  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Sluggishness  1  0/111 (0.00%)  0 1/116 (0.86%)  2 0/90 (0.00%)  0 0/82 (0.00%)  0
Thirst  1  1/111 (0.90%)  1 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Immune system disorders         
Seasonal allergy  1  0/111 (0.00%)  0 1/116 (0.86%)  1 1/90 (1.11%)  1 0/82 (0.00%)  0
Infections and infestations         
Bronchitis  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 1/82 (1.22%)  1
Ear infection  1  1/111 (0.90%)  1 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Fungal skin infection  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Gastroenteritis  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Gastroenteritis viral  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 1/82 (1.22%)  1
Herpes zoster  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Influenza  1  4/111 (3.60%)  5 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Lower respiratory tract infection  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Nasopharyngitis  1  2/111 (1.80%)  2 3/116 (2.59%)  3 0/90 (0.00%)  0 1/82 (1.22%)  1
Oral herpes  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Parotitis  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Sinusitis  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Tooth abscess  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Upper respiratory tract infection  1  3/111 (2.70%)  3 1/116 (0.86%)  1 0/90 (0.00%)  0 3/82 (3.66%)  3
Urinary tract infection  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Injury, poisoning and procedural complications         
Animal scratch  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Arthropod bite  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Contusion  1  0/111 (0.00%)  0 1/116 (0.86%)  3 0/90 (0.00%)  0 0/82 (0.00%)  0
Drug exposure during pregnancy  1  0/79 (0.00%)  0 1/79 (1.27%)  1 0/63 (0.00%)  0 0/59 (0.00%)  0
Eye burns  1  0/111 (0.00%)  0 0/116 (0.00%)  0 1/90 (1.11%)  1 0/82 (0.00%)  0
Muscle strain  1  1/111 (0.90%)  1 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Road traffic accident  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Skeletal injury  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Investigations         
Blood cholesterol increased  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Blood creatine phosphokinase increased  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Blood potassium decreased  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Blood pressure increased  1  2/111 (1.80%)  2 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Electrocardiogram qt prolonged  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Heart rate increased  1  2/111 (1.80%)  2 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Neutrophil count increased  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Urine output decreased  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Weight decreased  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
White blood cell count increased  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Metabolism and nutrition disorders         
Anorexia  1  2/111 (1.80%)  2 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Decreased appetite  1  3/111 (2.70%)  3 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Dehydration  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Hyperglycaemia  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Back pain  1  2/111 (1.80%)  2 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Muscle spasms  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Muscle twitching  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Musculoskeletal chest pain  1  1/111 (0.90%)  2 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Musculoskeletal stiffness  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Myalgia  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Neck mass  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Neck pain  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Pain in extremity  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Torticollis  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Nervous system disorders         
Convulsion  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Disturbance in attention  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Dizziness  1  5/111 (4.50%)  6 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Dysgeusia  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Headache  1  1/111 (0.90%)  1 4/116 (3.45%)  6 0/90 (0.00%)  0 1/82 (1.22%)  1
Hypoaesthesia  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Lethargy  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Memory impairment  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Migraine  1  2/111 (1.80%)  2 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Nerve compression  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Poor quality sleep  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Sinus headache  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Somnolence  1  2/111 (1.80%)  2 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Syncope  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Tension headache  1  0/111 (0.00%)  0 2/116 (1.72%)  2 0/90 (0.00%)  0 0/82 (0.00%)  0
Tremor  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Psychiatric disorders         
Abnormal dreams  1  1/111 (0.90%)  1 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Agitation  1  1/111 (0.90%)  1 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Anxiety  1  3/111 (2.70%)  3 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Blunted affect  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Dermatillomania  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Initial insomnia  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Insomnia  1  0/111 (0.00%)  0 4/116 (3.45%)  4 0/90 (0.00%)  0 0/82 (0.00%)  0
Libido decreased  1  0/111 (0.00%)  0 1/116 (0.86%)  1 1/90 (1.11%)  1 0/82 (0.00%)  0
Loss of libido  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Middle insomnia  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Nightmare  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Panic attack  1  0/111 (0.00%)  0 0/116 (0.00%)  0 1/90 (1.11%)  1 0/82 (0.00%)  0
Restlessness  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Sleep attacks  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Renal and urinary disorders         
Nephrolithiasis  1  1/111 (0.90%)  1 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Pollakiuria  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Residual urine  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Urinary hesitation  1  4/111 (3.60%)  4 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Urinary retention  1  1/111 (0.90%)  2 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Reproductive system and breast disorders         
Ejaculation disorder  1  1/32 (3.13%)  1 0/37 (0.00%)  0 0/27 (0.00%)  0 0/23 (0.00%)  0
Erectile dysfunction  1  2/32 (6.25%)  2 0/37 (0.00%)  0 0/27 (0.00%)  0 0/23 (0.00%)  0
Ovarian cyst  1  0/79 (0.00%)  0 1/79 (1.27%)  1 0/63 (0.00%)  0 0/59 (0.00%)  0
Sexual dysfunction  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Testicular pain  1  2/32 (6.25%)  2 0/37 (0.00%)  0 0/27 (0.00%)  0 0/23 (0.00%)  0
Testicular swelling  1  1/32 (3.13%)  1 0/37 (0.00%)  0 0/27 (0.00%)  0 0/23 (0.00%)  0
Vulvovaginal discomfort  1  0/79 (0.00%)  0 1/79 (1.27%)  1 0/63 (0.00%)  0 0/59 (0.00%)  0
Vulvovaginal pruritus  1  0/79 (0.00%)  0 1/79 (1.27%)  1 0/63 (0.00%)  0 0/59 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Nasal congestion  1  0/111 (0.00%)  0 0/116 (0.00%)  0 1/90 (1.11%)  1 0/82 (0.00%)  0
Oropharyngeal pain  1  0/111 (0.00%)  0 2/116 (1.72%)  2 0/90 (0.00%)  0 0/82 (0.00%)  0
Skin and subcutaneous tissue disorders         
Cold sweat  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Decubitus ulcer  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Hyperhidrosis  1  8/111 (7.21%)  8 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Onychoclasis  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Pruritus  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Pruritus generalised  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Rash  1  1/111 (0.90%)  1 2/116 (1.72%)  2 0/90 (0.00%)  0 0/82 (0.00%)  0
Rash generalised  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Rash maculo-papular  1  0/111 (0.00%)  0 1/116 (0.86%)  1 0/90 (0.00%)  0 0/82 (0.00%)  0
Vascular disorders         
Haematoma  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Hot flush  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Peripheral coldness  1  1/111 (0.90%)  1 0/116 (0.00%)  0 0/90 (0.00%)  0 0/82 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00840034     History of Changes
Other Study ID Numbers: 12850
H9P-MC-LNDK ( Other Identifier: Eli Lilly and Company )
First Submitted: February 9, 2009
First Posted: February 10, 2009
Results First Submitted: February 17, 2018
Results First Posted: April 24, 2018
Last Update Posted: April 24, 2018