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A Study of Flexible or Fixed Dose LY2216684 as Adjunctive Treatment for Participants With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment

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ClinicalTrials.gov Identifier: NCT01187407
Recruitment Status : Completed
First Posted : August 24, 2010
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 Major Depressive Disorder (MDD)
Interventions Drug: LY2216684
Drug: Placebo
Drug: SSRI
Enrollment 1480
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) 12 or 18 mg LY2216684 + SSRI (Randomized Participants) 6 mg LY2216684 + SSRI (Randomized Participants) Placebo + SSRI (Randomized Participants) Placebo + SSRI (Non-randomized Participants)
Hide Arm/Group Description Placebo: administered orally, once daily (QD) for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, QD for 8 weeks, adjunctive to an SSRI LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Period Title: Confirmation (CF) Phase, 3 Weeks
Started 1480 0 0 0 0
Entered Discontinuation (DC) Phase 25 [1] 0 0 0 0
Completed 1390 [2] 0 0 0 0
Not Completed 90 0 0 0 0
Reason Not Completed
Adverse Event             29             0             0             0             0
Lack of Efficacy             4             0             0             0             0
Lost to Follow-up             9             0             0             0             0
Physician Decision             2             0             0             0             0
Protocol Violation             13             0             0             0             0
Withdrawal by Subject             29             0             0             0             0
Sponsor Decision             4             0             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 0 232 226 231 701
Entered Discontinuation (DC) Phase 0 212 [1] 215 [1] 220 [1] 660 [1]
Completed 0 196 191 202 626
Not Completed 0 36 35 29 75
Reason Not Completed
Adverse Event             0             13             6             5             12
Lack of Efficacy             0             3             8             5             13
Lost to Follow-up             0             3             5             2             9
Physician Decision             0             0             0             1             2
Protocol Violation             0             6             5             3             10
Withdrawal by Subject             0             9             9             11             22
Sponsor Decision             0             2             2             2             7
[1]
Participants who completed the AT Phase or discontinued early had the option to enter the DC Phase.
Arm/Group Title 12 or 18 mg LY2216684 + SSRI (Randomized Participants) 6 mg LY2216684 + SSRI (Randomized Participants) Placebo + SSRI (Randomized Participants) Placebo + SSRI (Non-randomized Participants) Total
Hide Arm/Group Description LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI Total of all reporting groups
Overall Number of Baseline Participants 232 226 231 701 1390
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 meet randomization criteria and continued on placebo to maintain the blind.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 232 participants 226 participants 231 participants 701 participants 1390 participants
46.63  (12.00) 47.06  (12.76) 47.30  (12.10) 46.35  (12.42) 46.67  (12.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants 226 participants 231 participants 701 participants 1390 participants
Female
149
  64.2%
153
  67.7%
156
  67.5%
465
  66.3%
923
  66.4%
Male
83
  35.8%
73
  32.3%
75
  32.5%
236
  33.7%
467
  33.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants 226 participants 231 participants 701 participants 1390 participants
Hispanic or Latino
11
   4.7%
9
   4.0%
14
   6.1%
49
   7.0%
83
   6.0%
Not Hispanic or Latino
183
  78.9%
181
  80.1%
178
  77.1%
562
  80.2%
1104
  79.4%
Unknown or Not Reported
38
  16.4%
36
  15.9%
39
  16.9%
90
  12.8%
203
  14.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants 226 participants 231 participants 701 participants 1390 participants
American Indian or Alaska Native
1
   0.4%
0
   0.0%
3
   1.3%
4
   0.6%
8
   0.6%
Asian
21
   9.1%
26
  11.5%
20
   8.7%
54
   7.7%
121
   8.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
16
   6.9%
25
  11.1%
18
   7.8%
63
   9.0%
122
   8.8%
White
192
  82.8%
173
  76.5%
186
  80.5%
572
  81.6%
1123
  80.8%
More than one race
2
   0.9%
2
   0.9%
3
   1.3%
8
   1.1%
15
   1.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   0.4%
0
   0.0%
1
   0.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants 226 participants 231 participants 701 participants 1390 participants
United States
103
  44.4%
98
  43.4%
104
  45.0%
377
  53.8%
682
  49.1%
Czechia
44
  19.0%
44
  19.5%
46
  19.9%
119
  17.0%
253
  18.2%
Slovakia
33
  14.2%
35
  15.5%
34
  14.7%
39
   5.6%
141
  10.1%
Finland
18
   7.8%
12
   5.3%
17
   7.4%
61
   8.7%
108
   7.8%
Croatia
9
   3.9%
10
   4.4%
7
   3.0%
26
   3.7%
52
   3.7%
Japan
20
   8.6%
23
  10.2%
19
   8.2%
53
   7.6%
115
   8.3%
Hungary
2
   0.9%
2
   0.9%
1
   0.4%
3
   0.4%
8
   0.6%
Romania
3
   1.3%
2
   0.9%
3
   1.3%
23
   3.3%
31
   2.2%
1.Primary Outcome
Title Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 231 220 228
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.36  (0.55) -9.59  (0.55) -9.36  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 12 or 18 mg Flexible Dose LY2216684 + SSRI, Placebo + SSRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.997
Comments Primary comparison.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 6 mg Fixed Dose LY2216684 + SSRI, Placebo + SSRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.769
Comments Secondary comparison.
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change From Randomization to Week 8 in the Sheehan Disability Scale (SDS) Global Functional Impairment Score
Hide Description The 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 225 210 221
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.30  (0.43) -6.29  (0.44) -4.30  (0.43)
3.Secondary Outcome
Title Change From Randomization to Week 8 in the Fatigue Associated With Depression (FAsD) Impact Subscale Score
Hide Description The 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 225 210 221
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.71  (0.06) -0.67  (0.06) -0.56  (0.06)
4.Secondary Outcome
Title Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 up to Week 8
Hide Description A 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 (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). 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 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. Last observation carried forward (LOCF) methodology was used.
Arm/Group Title 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 231 221 228
Measure Type: Number
Unit of Measure: percentage of participants
26.84 29.41 26.32
5.Secondary Outcome
Title Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement
Hide Description A 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 (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 231 221 228
Measure Type: Number
Unit of Measure: percentage of participants
17.75 19.00 14.47
6.Secondary Outcome
Title Change From Randomization to Week 8 in the Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score
Hide Description The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0 to 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 to 10 represent 'borderline' and scores of 0 to 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 231 220 228
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.24  (0.24) -2.64  (0.24) -2.05  (0.24)
7.Secondary Outcome
Title Percentage of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization up to Week 8
Hide Description A greater than or equal to 50 percent improvement (that is, a decrease from baseline) in the 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 (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). 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 meeting response criteria at last visit 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. Last observation carried forward (LOCF) methodology was used.
Arm/Group Title 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 231 221 228
Measure Type: Number
Unit of Measure: percentage of participants
30.74 34.84 32.46
8.Secondary Outcome
Title Change From Randomization to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
Hide Description The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0 to 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 to 10 represent 'borderline' and scores of 0 to 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 231 220 228
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.40  (0.26) -3.62  (0.27) -2.55  (0.26)
9.Secondary Outcome
Title Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items
Hide Description The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 231 220 228
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Apparent sadness Number Analyzed 231 participants 220 participants 228 participants
-1.34  (0.08) -1.25  (0.08) -1.26  (0.08)
Reported sadness Number Analyzed 231 participants 219 participants 228 participants
-1.41  (0.09) -1.31  (0.09) -1.26  (0.09)
Inner tension Number Analyzed 231 participants 220 participants 228 participants
-0.96  (0.08) -0.91  (0.08) -0.87  (0.08)
Reduced sleep Number Analyzed 231 participants 220 participants 228 participants
-0.82  (0.09) -0.96  (0.09) -0.92  (0.09)
Reduced appetite Number Analyzed 231 participants 220 participants 228 participants
-0.57  (0.08) -0.67  (0.08) -0.71  (0.08)
Concentration difficulties Number Analyzed 231 participants 220 participants 228 participants
-1.13  (0.08) -1.14  (0.08) -0.98  (0.08)
Lassitude Number Analyzed 231 participants 220 participants 228 participants
-1.15  (0.09) -1.07  (0.09) -1.16  (0.09)
Inability to feel Number Analyzed 231 participants 220 participants 228 participants
-1.11  (0.09) -1.30  (0.09) -1.14  (0.09)
Pessimistic thoughts Number Analyzed 231 participants 220 participants 228 participants
-0.84  (0.07) -0.82  (0.07) -0.91  (0.07)
Suicidal thoughts Number Analyzed 231 participants 220 participants 228 participants
-0.17  (0.03) -0.19  (0.03) -0.17  (0.03)
10.Secondary Outcome
Title Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)
Hide Description 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 231 220 228
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.20  (0.08) -1.21  (0.08) -1.14  (0.07)
11.Secondary Outcome
Title Change From Randomization to Week 8 in The Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score
Hide Description The 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 225 210 221
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
FAsD average score -0.67  (0.05) -0.68  (0.06) -0.53  (0.05)
FAsD experience score -0.63  (0.06) -0.67  (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 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 225 210 221
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Work impairment score Number Analyzed 151 participants 138 participants 145 participants
-1.81  (0.19) -1.93  (0.20) -1.32  (0.19)
Social life impairment score Number Analyzed 225 participants 210 participants 221 participants
-1.79  (0.16) -2.11  (0.16) -1.52  (0.16)
Family life impairment score Number Analyzed 225 participants 210 participants 221 participants
-1.75  (0.15) -2.16  (0.15) -1.47  (0.15)
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 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 224 210 221
Least Squares Mean (Standard Error)
Unit of Measure: percentage of maximum possible score
10.54  (1.00) 10.05  (1.02) 8.74  (0.99)
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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 225 210 221
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
11.457  (1.218) 11.895  (1.239) 9.530  (1.207)
15.Secondary Outcome
Title Percentage of Participants With Treatment-emergent (TE) Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a "yes" answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. 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 analyzed, 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 through 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI)
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 232 221 228
Measure Type: Number
Unit of Measure: percentage of participants
TE suicidal ideation Number Analyzed 232 participants 221 participants 228 participants
5.17 3.62 4.39
TE suicidal behavior Number Analyzed 203 participants 198 participants 202 participants
0.00 0.00 0.00
16.Secondary Outcome
Title Change From Randomization to Week 8 in the Arizona Sexual Experiences (ASEX) Scale
Hide Description The ASEX scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 224 209 220
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.62  (0.29) -1.29  (0.29) -0.97  (0.29)
17.Secondary Outcome
Title Change From Randomization to Week 8 in the 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 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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 225 210 221
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.74  (0.38) -4.67  (0.39) -3.64  (0.38)
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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 232 220 228
Least Squares Mean (Standard Error)
Unit of Measure: millimeters of mercury (mmHg)
Systolic blood pressure 1.64  (0.62) 2.93  (0.63) 0.78  (0.62)
Diastolic blood pressure 3.46  (0.49) 4.47  (0.50) 1.01  (0.49)
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 12 or 18 mg Flexible Dose LY2216684 + SSRI 6 mg Fixed Dose LY2216684 + SSRI Placebo + SSRI
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 232 220 228
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute (bpm)
9.26  (0.65) 7.32  (0.66) -1.03  (0.65)
20.Secondary Outcome
Title Pharmacokinetics: Plasma Concentrations of LY2216684
Hide Description A validated bioanalytical assay was used to determine plasma LY2216684 concentrations.
Time Frame Pre-randomization, 1 week, 4 weeks, and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants exposed to LY2216684 with evaluable plasma concentration values. Samples with concentrations below the lower quantification limit (BQL) of the assay were treated as missing values for the analysis and samples with incomplete dosing information were not included in the pharmacokinetic assessment.
Arm/Group Title LY2216684
Hide Arm/Group Description:
LY2216684: flexible dose of 12 or 18 milligrams (mg) or fixed dose of 6 mg, administered orally, once daily (QD)
Overall Number of Participants Analyzed 400
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
6-mg dose Number Analyzed 197 participants
17.0  (10.2)
12-mg dose Number Analyzed 197 participants
32.2  (21.1)
18-mg dose Number Analyzed 136 participants
52.4  (34.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo + SSRI (Pre-randomized) - CF Phase 12 or 18 mg LY2216684 + SSRI (Randomized) - AT Phase 6 mg LY2216684 + SSRI (Randomized) - AT Phase Placebo + SSRI (Randomized) - AT Phase Placebo + SSRI (Non-randomized) - AT Phase Placebo + SSRI (Pre-randomized) - DC Phase 12 or 18 mg LY2216684 + SSRI (Randomized) - DC Phase 6 mg 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 who did not discontinue for the reason 'Lost to Follow-up' at the first post-baseline visit during the Confirmation (CF) Phase.

LY2216684: flexible dose of 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.

LY2216684: fixed dose of 6 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 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 12 or 18 mg LY2216684 + SSRI (Randomized) - AT Phase 6 mg LY2216684 + SSRI (Randomized) - AT Phase Placebo + SSRI (Randomized) - AT Phase Placebo + SSRI (Non-randomized) - AT Phase Placebo + SSRI (Pre-randomized) - DC Phase 12 or 18 mg LY2216684 + SSRI (Randomized) - DC Phase 6 mg 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo + SSRI (Pre-randomized) - CF Phase 12 or 18 mg LY2216684 + SSRI (Randomized) - AT Phase 6 mg LY2216684 + SSRI (Randomized) - AT Phase Placebo + SSRI (Randomized) - AT Phase Placebo + SSRI (Non-randomized) - AT Phase Placebo + SSRI (Pre-randomized) - DC Phase 12 or 18 mg LY2216684 + SSRI (Randomized) - DC Phase 6 mg 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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/1476 (0.47%)      2/232 (0.86%)      1/223 (0.45%)      2/231 (0.87%)      5/699 (0.72%)      3/25 (12.00%)      0/212 (0.00%)      2/213 (0.94%)      1/220 (0.45%)      2/659 (0.30%)    
Cardiac disorders                     
Atrial fibrillation  1  2/1476 (0.14%)  2 0/232 (0.00%)  0 0/223 (0.00%)  0 0/231 (0.00%)  0 0/699 (0.00%)  0 1/25 (4.00%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 0/659 (0.00%)  0
General disorders                     
Inflammation  1  0/1476 (0.00%)  0 1/232 (0.43%)  1 0/223 (0.00%)  0 0/231 (0.00%)  0 0/699 (0.00%)  0 0/25 (0.00%)  0 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 0/659 (0.00%)  0
Infections and infestations                     
Appendicitis  1  0/1476 (0.00%)  0 1/232 (0.43%)  1 0/223 (0.00%)  0 0/231 (0.00%)  0 0/699 (0.00%)  0 0/25 (0.00%)  0 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 0/659 (0.00%)  0
Diverticulitis  1  0/1476 (0.00%)  0 0/232 (0.00%)  0 0/223 (0.00%)  0 0/231 (0.00%)  0 1/699 (0.14%)  1 0/25 (0.00%)  0 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 0/659 (0.00%)  0
Mastitis  1  0/1476 (0.00%)  0 0/232 (0.00%)  0 0/223 (0.00%)  0 0/231 (0.00%)  0 1/699 (0.14%)  1 0/25 (0.00%)  0 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 1/659 (0.15%)  1
Pneumonia  1  0/1476 (0.00%)  0 0/232 (0.00%)  0 0/223 (0.00%)  0 0/231 (0.00%)  0 1/699 (0.14%)  1 0/25 (0.00%)  0 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 1/659 (0.15%)  1
Injury, poisoning and procedural complications                     
Accidental overdose  1  0/1476 (0.00%)  0 0/232 (0.00%)  0 0/223 (0.00%)  0 0/231 (0.00%)  0 1/699 (0.14%)  1 0/25 (0.00%)  0 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 0/659 (0.00%)  0
Musculoskeletal and connective tissue disorders                     
Osteoarthritis  1  1/1476 (0.07%)  1 0/232 (0.00%)  0 0/223 (0.00%)  0 1/231 (0.43%)  1 0/699 (0.00%)  0 0/25 (0.00%)  0 0/212 (0.00%)  0 0/213 (0.00%)  0 1/220 (0.45%)  1 0/659 (0.00%)  0
Nervous system disorders                     
Syncope  1  0/1476 (0.00%)  0 0/232 (0.00%)  0 0/223 (0.00%)  0 0/231 (0.00%)  0 0/699 (0.00%)  0 0/25 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1 0/220 (0.00%)  0 0/659 (0.00%)  0
Psychiatric disorders                     
Mania  1  1/1476 (0.07%)  1 0/232 (0.00%)  0 0/223 (0.00%)  0 0/231 (0.00%)  0 0/699 (0.00%)  0 1/25 (4.00%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 0/659 (0.00%)  0
Suicidal ideation  1  2/1476 (0.14%)  2 0/232 (0.00%)  0 0/223 (0.00%)  0 0/231 (0.00%)  0 0/699 (0.00%)  0 1/25 (4.00%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 0/659 (0.00%)  0
Suicide attempt  1  0/1476 (0.00%)  0 0/232 (0.00%)  0 0/223 (0.00%)  0 0/231 (0.00%)  0 1/699 (0.14%)  1 0/25 (0.00%)  0 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 0/659 (0.00%)  0
Reproductive system and breast disorders                     
Cervical dysplasia  1  1/979 (0.10%)  1 0/149 (0.00%)  0 1/152 (0.66%)  1 0/156 (0.00%)  0 0/464 (0.00%)  0 0/16 (0.00%)  0 0/133 (0.00%)  0 1/148 (0.68%)  1 0/145 (0.00%)  0 0/441 (0.00%)  0
Fibrocystic breast disease  1  0/1476 (0.00%)  0 0/232 (0.00%)  0 0/223 (0.00%)  0 0/231 (0.00%)  0 1/699 (0.14%)  1 0/25 (0.00%)  0 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 1/659 (0.15%)  1
Metrorrhagia  1  0/979 (0.00%)  0 0/149 (0.00%)  0 0/152 (0.00%)  0 1/156 (0.64%)  1 0/464 (0.00%)  0 0/16 (0.00%)  0 0/133 (0.00%)  0 0/148 (0.00%)  0 0/145 (0.00%)  0 0/441 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Acute respiratory failure  1  0/1476 (0.00%)  0 0/232 (0.00%)  0 0/223 (0.00%)  0 0/231 (0.00%)  0 1/699 (0.14%)  1 0/25 (0.00%)  0 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 0/659 (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 12 or 18 mg LY2216684 + SSRI (Randomized) - AT Phase 6 mg LY2216684 + SSRI (Randomized) - AT Phase Placebo + SSRI (Randomized) - AT Phase Placebo + SSRI (Non-randomized) - AT Phase Placebo + SSRI (Pre-randomized) - DC Phase 12 or 18 mg LY2216684 + SSRI (Randomized) - DC Phase 6 mg 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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   231/1476 (15.65%)      57/232 (24.57%)      39/223 (17.49%)      38/231 (16.45%)      115/699 (16.45%)      0/25 (0.00%)      18/212 (8.49%)      22/213 (10.33%)      17/220 (7.73%)      64/659 (9.71%)    
Cardiac disorders                     
Tachycardia  1  6/1476 (0.41%)  6 12/232 (5.17%)  12 5/223 (2.24%)  5 0/231 (0.00%)  0 2/699 (0.29%)  2 0/25 (0.00%)  0 0/212 (0.00%)  0 0/213 (0.00%)  0 0/220 (0.00%)  0 0/659 (0.00%)  0
Gastrointestinal disorders                     
Nausea  1  77/1476 (5.22%)  80 12/232 (5.17%)  17 12/223 (5.38%)  13 9/231 (3.90%)  10 25/699 (3.58%)  41 0/25 (0.00%)  0 2/212 (0.94%)  2 4/213 (1.88%)  4 2/220 (0.91%)  2 13/659 (1.97%)  13
Infections and infestations                     
Nasopharyngitis  1  35/1476 (2.37%)  35 12/232 (5.17%)  12 7/223 (3.14%)  7 7/231 (3.03%)  7 27/699 (3.86%)  27 0/25 (0.00%)  0 1/212 (0.47%)  1 1/213 (0.47%)  1 2/220 (0.91%)  2 5/659 (0.76%)  5
Nervous system disorders                     
Headache  1  112/1476 (7.59%)  127 14/232 (6.03%)  15 15/223 (6.73%)  18 22/231 (9.52%)  33 61/699 (8.73%)  81 0/25 (0.00%)  0 13/212 (6.13%)  14 19/213 (8.92%)  19 14/220 (6.36%)  14 47/659 (7.13%)  54
Skin and subcutaneous tissue disorders                     
Hyperhidrosis  1  34/1476 (2.30%)  35 18/232 (7.76%)  19 7/223 (3.14%)  8 4/231 (1.73%)  4 11/699 (1.57%)  11 0/25 (0.00%)  0 4/212 (1.89%)  4 0/213 (0.00%)  0 0/220 (0.00%)  0 7/659 (1.06%)  7
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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-597
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01187407     History of Changes
Other Study ID Numbers: 12182
H9P-MC-LNBQ ( Other Identifier: Eli Lilly and Company )
First Submitted: August 20, 2010
First Posted: August 24, 2010
Results First Submitted: February 17, 2018
Results First Posted: April 24, 2018
Last Update Posted: April 24, 2018