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A Study in Participants With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor

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ClinicalTrials.gov Identifier: NCT01185340
Recruitment Status : Completed
First Posted : August 19, 2010
Results First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: LY2216684
Drug: Placebo
Drug: SSRI
Enrollment 1056
Recruitment Details  
Pre-assignment Details The first 3 weeks of the study was a double-blind Confirmation Phase during which participants continued to receive their SSRI with adjunctive placebo. If randomization criteria were met, participants were randomized to adjunctive LY2216684 or adjunctive placebo. If criteria were not met, participants continued on placebo to maintain the blind.
Arm/Group Title Placebo + SSRI (Pre-randomized Participants) LY2216684 + SSRI (Randomized Participants) Placebo + SSRI (Randomized Participants) Placebo + SSRI (Non-randomized Participants)
Hide Arm/Group Description Placebo: Administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Period Title: Confirmation (CF) Phase, 3 Weeks
Started 1056 0 0 0
Entered Discontinuation (DC) Phase 18 [1] 0 0 0
Completed 968 [2] 0 0 0
Not Completed 88 0 0 0
Reason Not Completed
Adverse Event             24             0             0             0
Lack of Efficacy             6             0             0             0
Lost to Follow-up             5             0             0             0
Physician Decision             2             0             0             0
Protocol Violation             16             0             0             0
Withdrawal by Subject             32             0             0             0
Sponsor Decision             3             0             0             0
[1]
Participants who discontinued the CF Phase early had the option to enter the DC Phase.
[2]
Participants who completed the CF Phase entered the Adjunctive Treatment (AT) Phase.
Period Title: Adjunctive Treatment (AT) Phase, 8 Weeks
Started 0 230 219 519
Entered Discontinuation (DC) Phase 0 206 [1] 204 [1] 483 [1]
Completed 0 195 186 458
Not Completed 0 35 33 61
Reason Not Completed
Adverse Event             0             13             8             13
Lack of Efficacy             0             4             7             4
Lost to Follow-up             0             4             5             7
Physician Decision             0             1             0             1
Protocol Violation             0             5             2             5
Withdrawal by Subject             0             8             8             24
Sponsor Decision             0             0             3             7
[1]
Participants who completed the AT Phase or discontinued early had the option to enter the DC Phase.
Arm/Group Title LY2216684 + SSRI (Randomized Participants) Placebo + SSRI (Randomized Participants) Placebo + SSRI (Non-randomized Participants) Total
Hide Arm/Group Description LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) Total of all reporting groups
Overall Number of Baseline Participants 230 219 519 968
Hide Baseline Analysis Population Description
Participants who completed the Confirmation (CF) Phase and were randomized to adjunctive LY2216684 or adjunctive placebo or who did not met randomization criteria and continued on placebo to maintain the blind.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 230 participants 219 participants 519 participants 968 participants
48.29  (11.90) 48.44  (11.39) 47.39  (12.68) 47.84  (12.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 219 participants 519 participants 968 participants
Female
155
  67.4%
145
  66.2%
354
  68.2%
654
  67.6%
Male
75
  32.6%
74
  33.8%
165
  31.8%
314
  32.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 219 participants 519 participants 968 participants
Hispanic or Latino
19
   8.3%
12
   5.5%
31
   6.0%
62
   6.4%
Not Hispanic or Latino
164
  71.3%
158
  72.1%
370
  71.3%
692
  71.5%
Unknown or Not Reported
47
  20.4%
49
  22.4%
118
  22.7%
214
  22.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 219 participants 519 participants 968 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
3
   0.6%
3
   0.3%
Asian
2
   0.9%
1
   0.5%
3
   0.6%
6
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
17
   7.4%
31
  14.2%
53
  10.2%
101
  10.4%
White
207
  90.0%
185
  84.5%
457
  88.1%
849
  87.7%
More than one race
4
   1.7%
2
   0.9%
2
   0.4%
8
   0.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   0.2%
1
   0.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 219 participants 519 participants 968 participants
United States
93
  40.4%
89
  40.6%
195
  37.6%
377
  38.9%
Belgium
7
   3.0%
4
   1.8%
13
   2.5%
24
   2.5%
Austria
10
   4.3%
10
   4.6%
25
   4.8%
45
   4.6%
Australia
22
   9.6%
20
   9.1%
84
  16.2%
126
  13.0%
Germany
58
  25.2%
63
  28.8%
95
  18.3%
216
  22.3%
United Kingdom
19
   8.3%
15
   6.8%
30
   5.8%
64
   6.6%
Sweden
21
   9.1%
18
   8.2%
77
  14.8%
116
  12.0%
1.Primary Outcome
Title Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The Montgomery-Asberg Depression Rating Scale (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 treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 225 217
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.73  (0.55) -8.49  (0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 + SSRI, Placebo + SSRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.751
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Hide Description The Sheehan Disability Scale (SDS) was completed by the participant and used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work life (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 218 208
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.50  (0.47) -4.38  (0.48)
3.Secondary Outcome
Title Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Impact Subscale Score
Hide Description 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 impact subscale score was derived by taking the mean of Items 7 through 13 (applicable items only). 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. The FAsD impact subscale score ranges from 1 to 5. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 218 209
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.69  (0.06) -0.59  (0.07)
4.Secondary Outcome
Title Probability of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 at Week 8
Hide Description A Montgomery-Asberg Depression Rating Scale (MADRS) total score of less than or equal to 10 was defined as remission criteria. 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). A categorical repeated measures analysis modeled the probability of remission at each visit, and the estimated probabilities were adjusted for treatment, visit, baseline MADRS total score, and treatment-by-visit.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 225 217
Least Squares Mean (Standard Error)
Unit of Measure: probability
0.313  (0.034) 0.251  (0.032)
5.Secondary Outcome
Title Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement
Hide Description A Montgomery-Asberg Depression Rating Scale (MADRS) total score of less than or equal to 10 for at least 2 consecutive measurements, including the participant's last measurement was defined as remission criteria at last 2 consecutive visits. 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). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission at last 2 consecutive visits by the total number of participants analyzed, multiplied by 100%.
Time Frame Randomization up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 225 218
Measure Type: Number
Unit of Measure: percentage of participants
20.89 17.89
6.Secondary Outcome
Title Change From Randomization to Week 8 in Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score
Hide Description The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 224 217
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.20  (0.22) -1.78  (0.23)
7.Secondary Outcome
Title Probability of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8
Hide Description A greater than or equal to 50 percent improvement (that is, a decrease from baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score was defined as response criteria. 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). A categorical repeated measures analysis modeled the probability of response at each visit, and the estimated probabilities were adjusted for treatment, visit, baseline MADRS total score, and treatment-by-visit.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 225 217
Least Squares Mean (Standard Error)
Unit of Measure: probability
0.357  (0.034) 0.352  (0.034)
8.Secondary Outcome
Title Change From Randomization to Week 8 in The Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
Hide Description The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 224 217
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.82  (0.27) -2.64  (0.27)
9.Secondary Outcome
Title Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Hide Description The Montgomery-Asberg Depression Rating Scale (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 treatment, investigator, visit, baseline item score, treatment-by-visit and baseline item score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 225 217
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Apparent Sadness -1.10  (0.09) -1.26  (0.09)
Reported Sadness -1.17  (0.09) -1.19  (0.09)
Inner Tension -0.72  (0.08) -0.71  (0.09)
Reduced Sleep -0.83  (0.09) -0.76  (0.10)
Reduced Appetite -0.54  (0.08) -0.72  (0.08)
Concentration Difficulties -1.07  (0.09) -0.82  (0.09)
Lassitude -1.11  (0.09) -0.98  (0.09)
Inability to Feel -1.17  (0.09) -1.08  (0.09)
Pessimistic Thoughts -0.88  (0.08) -0.77  (0.08)
Suicidal Thoughts -0.23  (0.05) -0.24  (0.05)
10.Secondary Outcome
Title Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)
Hide Description 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 treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 224 217
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.08  (0.08) -1.02  (0.08)
11.Secondary Outcome
Title Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score
Hide Description 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 subscale score was derived by taking the mean of Items 1 through 6, 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 treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 217 210
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
FAsD average score Number Analyzed 217 participants 209 participants
-0.62  (0.06) -0.55  (0.06)
FAsD experience subscale score Number Analyzed 217 participants 210 participants
-0.57  (0.06) -0.50  (0.06)
12.Secondary Outcome
Title Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items
Hide Description The Sheehan Disability Scale (SDS) was completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit, and baseline item score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 218 209
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Work impairment score Number Analyzed 138 participants 135 participants
-1.41  (0.22) -1.20  (0.22)
Social life impairment score Number Analyzed 218 participants 209 participants
-1.64  (0.17) -1.53  (0.17)
Family life impairment score Number Analyzed 218 participants 208 participants
-1.56  (0.17) -1.53  (0.17)
13.Secondary Outcome
Title Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Hide Description The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (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 on a 5-point Likert scale (1=very poor and 5=very good). The total raw score is the sum of Items 1 to 14 and ranges from 14 to 70. The 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 were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 218 208
Least Squares Mean (Standard Error)
Unit of Measure: percentage of the maximum possible score
10.37  (1.09) 9.30  (1.12)
14.Secondary Outcome
Title Change From Randomization to Week 8 in the EuroQol Questionnaire-5 Dimension (EQ-5D)
Hide Description The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 216 209
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
10.367  (1.218) 9.644  (1.252)
15.Secondary Outcome
Title Percentage of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description The Columbia-Suicide Severity Rating Scale (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. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present at baseline. Percentage of participants was calculated by dividing the number of participants with suicide-related TE events by the total number of participants at risk, multiplied by 100%. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
Time Frame Randomization up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 224 218
Measure Type: Number
Unit of Measure: percentage of participants
TE suicidal ideation Number Analyzed 224 participants 218 participants
4.46 5.96
TE suicidal behavior Number Analyzed 206 participants 193 participants
0.00 0.52
16.Secondary Outcome
Title Change From Randomization to Week 8 in Arizona Sexual Experiences (ASEX) Scale
Hide Description The Arizona Sexual Experiences (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]) of 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 treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 214 204
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.92  (0.25) -0.68  (0.26)
17.Secondary Outcome
Title Change From Randomization to Week 8 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
Hide Description The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (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. Higher scores indicate greater disease severity. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 218 210
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.12  (0.39) -3.68  (0.40)
18.Secondary Outcome
Title Change From Randomization to Week 8 in Blood Pressure
Hide Description Blood pressure measurements were collected when the participant was in a sitting position. Three measurements of sitting blood pressure collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit, and baseline value-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 225 217
Least Squares Mean (Standard Error)
Unit of Measure: millimeters of mercury (mmHg)
Systolic blood pressure 3.09  (0.67) 0.27  (0.69)
Diastolic blood pressure 4.54  (0.53) 0.53  (0.54)
19.Secondary Outcome
Title Change From Randomization to Week 8 in Pulse Rate
Hide Description Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit, and baseline value-by-visit.
Time Frame Randomization, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.
Arm/Group Title LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Overall Number of Participants Analyzed 225 216
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute (bpm)
9.64  (0.67) -1.49  (0.69)
Time Frame Confirmation (CF) Phase: Week 0 through Week 3 Adjunctive Treatment (AT) Phase: Week 4 through Week 11 Discontinuation (DC) Phase: The week following completion of the AT Phase (Week 12) or early discontinuation of the CF Phase or AT Phase
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo + SSRI (Pre-randomized) - CF Phase LY2216684 + SSRI (Randomized) - AT Phase Placebo + SSRI (Randomized) - AT Phase Placebo + SSRI (Non-randomized) - AT Phase Placebo + SSRI (Pre-randomized) - DC Phase LY2216684 + SSRI (Randomized) - DC Phase Placebo + SSRI (Randomized) - DC Phase Placebo + SSRI (Non-randomized) - DC Phase
Hide Arm/Group Description

Placebo: Administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)

Includes all enrolled participants who did not discontinue for the reason ‘Lost to Follow-up’ at the first post-baseline visit during the Confirmation (CF) Phase.

LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)

Includes randomized participants who did not discontinue for the reason ‘Lost to Follow-up’ at the first post-randomization visit during the Adjunctive Treatment (AT) Phase.

Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)

Includes randomized participants who did not discontinue for the reason ‘Lost to Follow-up’ at the first post-randomization visit during the Adjunctive Treatment (AT) Phase.

Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)

Includes all non-randomized participants who did not discontinue for the reason ‘Lost to Follow-up’ at the first post-randomization visit during the Adjunctive Treatment (AT) Phase.

No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.

Includes all enrolled participants who abruptly discontinued placebo after early withdrawal during the Confirmation (CF) Phase and who did not discontinue for the reason ‘Lost to Follow-up’ at the Discontinuation (DC) Phase visit.

No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.

Includes all randomized participants who abruptly discontinued LY2216684 either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason ‘Lost to Follow-up’ at the Discontinuation (DC) Phase visit.

No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.

Includes all randomized participants who abruptly discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason ‘Lost to Follow-up’ at the Discontinuation (DC) Phase visit.

No study drug was administered. Participants were to maintain their selective serotonin reuptake inhibitor (SSRI) treatment at a stable dose for 1 week.

Includes all non-randomized participants who abruptly discontinued placebo either at the end of the study or after early withdrawal from the study and who did not discontinue for the reason ‘Lost to Follow-up’ at the Discontinuation (DC) Phase visit.

All-Cause Mortality
Placebo + SSRI (Pre-randomized) - CF Phase LY2216684 + SSRI (Randomized) - AT Phase Placebo + SSRI (Randomized) - AT Phase Placebo + SSRI (Non-randomized) - AT Phase Placebo + SSRI (Pre-randomized) - DC Phase LY2216684 + SSRI (Randomized) - DC Phase Placebo + SSRI (Randomized) - DC Phase Placebo + SSRI (Non-randomized) - DC Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo + SSRI (Pre-randomized) - CF Phase LY2216684 + SSRI (Randomized) - AT Phase Placebo + SSRI (Randomized) - AT Phase Placebo + SSRI (Non-randomized) - AT Phase Placebo + SSRI (Pre-randomized) - DC Phase LY2216684 + SSRI (Randomized) - DC Phase Placebo + SSRI (Randomized) - DC Phase Placebo + SSRI (Non-randomized) - DC Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/1052 (0.86%)      7/228 (3.07%)      7/218 (3.21%)      12/519 (2.31%)      1/18 (5.56%)      2/206 (0.97%)      4/202 (1.98%)      4/482 (0.83%)    
Cardiac disorders                 
Atrial fibrillation  1  0/1052 (0.00%)  0 0/228 (0.00%)  0 2/218 (0.92%)  2 0/519 (0.00%)  0 0/18 (0.00%)  0 0/206 (0.00%)  0 1/202 (0.50%)  1 0/482 (0.00%)  0
Myocardial infarction  1  0/1052 (0.00%)  0 1/228 (0.44%)  1 0/218 (0.00%)  0 0/519 (0.00%)  0 0/18 (0.00%)  0 1/206 (0.49%)  1 0/202 (0.00%)  0 0/482 (0.00%)  0
Gastrointestinal disorders                 
Faecaloma  1  0/1052 (0.00%)  0 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Food poisoning  1  0/1052 (0.00%)  0 1/228 (0.44%)  1 0/218 (0.00%)  0 0/519 (0.00%)  0 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Gastritis  1  0/1052 (0.00%)  0 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 1/482 (0.21%)  1
General disorders                 
Non-cardiac chest pain  1  0/1052 (0.00%)  0 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Infections and infestations                 
Pneumonia  1  0/1052 (0.00%)  0 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 1/482 (0.21%)  1
Postoperative wound infection  1  1/1052 (0.10%)  1 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Injury, poisoning and procedural complications                 
Facial bones fracture  1  1/1052 (0.10%)  1 0/228 (0.00%)  0 0/218 (0.00%)  0 0/519 (0.00%)  0 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Multiple injuries  1  0/1052 (0.00%)  0 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Road traffic accident  1  0/1052 (0.00%)  0 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Tibia fracture  1  1/1052 (0.10%)  1 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Investigations                 
Blood creatinine increased  1  0/1052 (0.00%)  0 1/228 (0.44%)  1 1/218 (0.46%)  1 0/519 (0.00%)  0 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Blood urea increased  1  0/1052 (0.00%)  0 1/228 (0.44%)  1 0/218 (0.00%)  0 0/519 (0.00%)  0 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Metabolism and nutrition disorders                 
Diabetes mellitus  1  1/1052 (0.10%)  1 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Rotator cuff syndrome  1  1/1052 (0.10%)  1 0/228 (0.00%)  0 1/218 (0.46%)  1 0/519 (0.00%)  0 0/18 (0.00%)  0 0/206 (0.00%)  0 1/202 (0.50%)  1 0/482 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Breast cancer  1  0/1052 (0.00%)  0 1/228 (0.44%)  1 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Nervous system disorders                 
Cerebral infarction  1  0/1052 (0.00%)  0 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Sciatica  1  1/1052 (0.10%)  1 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 1/482 (0.21%)  1
Psychiatric disorders                 
Anxiety  1  1/1052 (0.10%)  1 0/228 (0.00%)  0 0/218 (0.00%)  0 0/519 (0.00%)  0 1/18 (5.56%)  1 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Depression  1  1/1052 (0.10%)  1 2/228 (0.88%)  2 0/218 (0.00%)  0 0/519 (0.00%)  0 0/18 (0.00%)  0 1/206 (0.49%)  1 0/202 (0.00%)  0 0/482 (0.00%)  0
Major depression  1  0/1052 (0.00%)  0 1/228 (0.44%)  1 0/218 (0.00%)  0 0/519 (0.00%)  0 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Suicidal ideation  1  0/1052 (0.00%)  0 0/228 (0.00%)  0 2/218 (0.92%)  2 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 2/202 (0.99%)  2 0/482 (0.00%)  0
Suicide attempt  1  1/1052 (0.10%)  1 0/228 (0.00%)  0 2/218 (0.92%)  2 0/519 (0.00%)  0 0/18 (0.00%)  0 0/206 (0.00%)  0 1/202 (0.50%)  1 0/482 (0.00%)  0
Renal and urinary disorders                 
Nephrolithiasis  1  0/1052 (0.00%)  0 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 1/482 (0.21%)  1
Respiratory, thoracic and mediastinal disorders                 
Pulmonary embolism  1  0/1052 (0.00%)  0 0/228 (0.00%)  0 0/218 (0.00%)  0 1/519 (0.19%)  1 0/18 (0.00%)  0 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + SSRI (Pre-randomized) - CF Phase LY2216684 + SSRI (Randomized) - AT Phase Placebo + SSRI (Randomized) - AT Phase Placebo + SSRI (Non-randomized) - AT Phase Placebo + SSRI (Pre-randomized) - DC Phase LY2216684 + SSRI (Randomized) - DC Phase Placebo + SSRI (Randomized) - DC Phase Placebo + SSRI (Non-randomized) - DC Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   270/1052 (25.67%)      87/228 (38.16%)      44/218 (20.18%)      128/519 (24.66%)      5/18 (27.78%)      39/206 (18.93%)      22/202 (10.89%)      70/482 (14.52%)    
Gastrointestinal disorders                 
Abdominal discomfort  1  6/1052 (0.57%)  7 2/228 (0.88%)  2 0/218 (0.00%)  0 2/519 (0.39%)  2 1/18 (5.56%)  1 1/206 (0.49%)  1 0/202 (0.00%)  0 2/482 (0.41%)  2
Dry mouth  1  33/1052 (3.14%)  35 9/228 (3.95%)  9 4/218 (1.83%)  4 7/519 (1.35%)  7 1/18 (5.56%)  1 2/206 (0.97%)  2 0/202 (0.00%)  0 1/482 (0.21%)  1
Nausea  1  54/1052 (5.13%)  56 19/228 (8.33%)  24 7/218 (3.21%)  9 16/519 (3.08%)  17 2/18 (11.11%)  2 4/206 (1.94%)  4 5/202 (2.48%)  5 10/482 (2.07%)  10
Vomiting  1  7/1052 (0.67%)  7 14/228 (6.14%)  16 4/218 (1.83%)  5 7/519 (1.35%)  7 1/18 (5.56%)  1 2/206 (0.97%)  2 1/202 (0.50%)  1 1/482 (0.21%)  1
Infections and infestations                 
Nasopharyngitis  1  36/1052 (3.42%)  37 12/228 (5.26%)  13 11/218 (5.05%)  12 31/519 (5.97%)  31 1/18 (5.56%)  1 2/206 (0.97%)  2 0/202 (0.00%)  0 6/482 (1.24%)  6
Nervous system disorders                 
Dizziness  1  28/1052 (2.66%)  30 14/228 (6.14%)  14 6/218 (2.75%)  6 7/519 (1.35%)  7 1/18 (5.56%)  1 3/206 (1.46%)  3 4/202 (1.98%)  4 9/482 (1.87%)  9
Headache  1  117/1052 (11.12%)  137 26/228 (11.40%)  35 14/218 (6.42%)  17 53/519 (10.21%)  64 3/18 (16.67%)  3 27/206 (13.11%)  30 14/202 (6.93%)  14 47/482 (9.75%)  53
Somnolence  1  11/1052 (1.05%)  12 0/228 (0.00%)  0 1/218 (0.46%)  1 3/519 (0.58%)  3 1/18 (5.56%)  1 0/206 (0.00%)  0 0/202 (0.00%)  0 2/482 (0.41%)  2
Tension headache  1  2/1052 (0.19%)  2 1/228 (0.44%)  1 1/218 (0.46%)  1 3/519 (0.58%)  3 1/18 (5.56%)  1 0/206 (0.00%)  0 0/202 (0.00%)  0 0/482 (0.00%)  0
Tremor  1  4/1052 (0.38%)  4 4/228 (1.75%)  5 0/218 (0.00%)  0 4/519 (0.77%)  4 1/18 (5.56%)  1 2/206 (0.97%)  2 1/202 (0.50%)  1 4/482 (0.83%)  4
Psychiatric disorders                 
Disorientation  1  0/1052 (0.00%)  0 1/228 (0.44%)  1 0/218 (0.00%)  0 0/519 (0.00%)  0 1/18 (5.56%)  1 0/206 (0.00%)  0 0/202 (0.00%)  0 1/482 (0.21%)  1
Skin and subcutaneous tissue disorders                 
Hyperhidrosis  1  29/1052 (2.76%)  29 27/228 (11.84%)  27 2/218 (0.92%)  2 14/519 (2.70%)  14 0/18 (0.00%)  0 4/206 (1.94%)  4 1/202 (0.50%)  1 1/482 (0.21%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01185340     History of Changes
Other Study ID Numbers: 12183
H9P-MC-LNBR ( Other Identifier: Eli Lilly and Company )
First Submitted: August 18, 2010
First Posted: August 19, 2010
Results First Submitted: February 17, 2018
Results First Posted: April 27, 2018
Last Update Posted: April 27, 2018