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A Study of LY2216684 in Participants With Major Depression Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01370499
Recruitment Status : Completed
First Posted : June 10, 2011
Results First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: LY2216684
Drug: SSRI
Enrollment 288
Recruitment Details  
Pre-assignment Details This is an open-label study with 1 treatment (12 or 18 milligrams [mg] LY2216684 + SSRI). However, the data were analyzed by the participants' treatment group from 2 parent studies (Study LNBM: NCT01173601 or Study LNBQ: NCT01187407). In these prior, parent studies, participants were randomized to receive Placebo + SSRI or LY2216684 + SSRI.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI) LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Period Title: Overall Study
Started 195 93
Entered Abrupt Discontinuation Phase 188 85 [1]
Received at Least 1 Dose of Study Drug 195 92
Completed 84 49
Not Completed 111 44
Reason Not Completed
Adverse Event             38             12
Lack of Efficacy             4             2
Lost to Follow-up             2             1
Physician Decision             3             3
Protocol Violation             5             4
Withdrawal by Subject             18             7
Sponsor Decision             41             15
[1]
One participant who entered the abrupt discontinuation phase did not receive study drug.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study) Total
Hide Arm/Group Description LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI Total of all reporting groups
Overall Number of Baseline Participants 195 93 288
Hide Baseline Analysis Population Description
All enrolled participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 195 participants 93 participants 288 participants
39.28  (9.41) 37.40  (9.18) 38.68  (9.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 93 participants 288 participants
Female 88 45 133
Male 107 48 155
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 195 participants 93 participants 288 participants
195 93 288
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Japan Number Analyzed 195 participants 93 participants 288 participants
195 93 288
1.Primary Outcome
Title Number of Participants With Clinically Significant Events
Hide Description Clinically significant events were defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
Time Frame Baseline through 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who took at least one dose of study medication and did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 195 92
Measure Type: Count of Participants
Unit of Measure: Participants
Contusion 0 1
Hyperglycaemia 0 1
Subdural hygroma 1 0
2.Secondary Outcome
Title Percentage of Participants With Suicidal Behaviors and Ideations Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description The C-SSRS captures 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 was defined as treatment-emergent (TE) if not present at baseline. Percentage of participants was calculated by dividing the number of participants with suicide-related 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 Baseline through 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who took at least one dose of study medication and had a baseline and at least one post-baseline value.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 195 92
Measure Type: Number
Unit of Measure: percentage of participants
TE of suicidal ideation 8.72 8.70
Suicidal behavior 0.51 0.00
3.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items
Hide Description The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has 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 are 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 pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with a baseline and at least one post-baseline value.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 195 93
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
MADRS total score -4.33  (0.69) -6.63  (1.00)
Apparent sadness -0.36  (0.10) -1.01  (0.16)
Reported sadness -0.51  (0.12) -0.92  (0.20)
Inner tension -0.53  (0.10) -0.85  (0.18)
Reduced sleep -0.49  (0.12) -0.33  (0.19)
Reduced appetite -0.24  (0.08) -0.25  (0.16)
Concentration difficulties -0.72  (0.11) -1.12  (0.17)
Lassitude -0.71  (0.09) -0.78  (0.16)
Inability to feel -0.41  (0.11) -0.77  (0.14)
Pessimistic thoughts -0.31  (0.09) -0.63  (0.14)
Suicidal thoughts -0.19  (0.06) -0.25  (0.07)
4.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in Clinical Global Impression - 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 pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with a baseline and at least one post-baseline value.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 195 93
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.80  (0.10) -0.78  (0.13)
5.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in Fatigue Associated With Depression (FAsD) Average Score and Subscale Scores
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 Score" was derived by taking the mean of Items 1 through 6, the "Impact Score" was derived by taking the mean of Items 7 through 13 (applicable items only), and the "Average Score" was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with a baseline and at least one post-baseline value.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 183 86
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Average score -0.32  (0.07) -0.18  (0.08)
Experience score -0.28  (0.08) -0.15  (0.09)
Impact score -0.34  (0.07) -0.19  (0.08)
6.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores
Hide Description The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. The anxiety subscale score is the sum of the 7 odd-numbered items and depression subscale score is the sum of the 7 even-numbered items, giving maximum scores of 21 for each 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, 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with a baseline and at least one post-baseline value.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 189 87
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Anxiety -1.46  (0.28) -0.55  (0.38)
Depression -1.95  (0.34) -1.24  (0.44)
7.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores
Hide Description The SDS Global Functional Impairment Score (total score) and subscores were completed by the participant and were used to assess the effect of the participant's symptoms on his or her 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 high 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 pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with a baseline and at least one post-baseline value.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 177 81
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Global functional impairment score Number Analyzed 117 participants 81 participants
-3.11  (0.63) -2.37  (0.70)
Work impairment score Number Analyzed 131 participants 58 participants
-0.98  (0.29) -1.42  (0.42)
Social life impairment score Number Analyzed 177 participants 81 participants
-1.01  (0.21) -0.66  (0.25)
Family life impairment score Number Analyzed 177 participants 81 participants
-1.10  (0.20) -0.55  (0.24)
8.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in EuroQol Questionnaire - 5 Dimension (EQ-5D)
Hide Description The 5Q-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 pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with a baseline and at least one post-baseline value.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 177 81
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
9.445  (1.846) 9.989  (2.288)
9.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in 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 possible scores range from 16 to 80. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with a baseline and at least one post-baseline value.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 177 81
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
6.28  (1.30) 5.19  (1.58)
10.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)
Hide Description The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who took at least one dose of study medication and had a baseline and at least one post-baseline value.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 183 86
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.02  (0.54) -2.53  (0.75)
11.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint in Arizona Sexual Experiences (ASEX) Scale
Hide Description The Arizona Sexual Experiences (ASEX) scale is used to assess sexual functioning in both males and females. The ASEX total score for the male and female version is calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30, with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who took at least one dose of study medication and had a baseline and at least one post-baseline value.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 183 85
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.65  (0.39) -0.40  (0.55)
12.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint 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 pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who took at least one dose of study medication and had a baseline and at least one post-baseline value.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 195 92
Least Squares Mean (Standard Error)
Unit of Measure: millimeters of mercury (mmHg)
Sitting systolic blood pressure 6.66  (0.93) 3.68  (1.28)
Sitting diastolic blood pressure 7.55  (0.83) 6.34  (1.03)
13.Secondary Outcome
Title Change From Baseline to 52 Week Endpoint 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 pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who took at least one dose of study medication and had a baseline and at least one post-baseline value.
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study)
Hide Arm/Group Description:
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to an SSRI
Overall Number of Participants Analyzed 195 92
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute (bpm)
17.00  (1.24) 10.98  (1.49)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study) LY2216684 + SSRI (Placebo Prior Study) DC Phase LY2216684 + SSRI (LY2216684 Prior Study) DC Phase
Hide Arm/Group Description

LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)

Includes all randomized participants who received at least 1 dose of study drug.

LY2216684: 12 mg or 18 mg, administered orally, once daily for 52 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)

Includes all randomized participants who received at least 1 dose of study drug.

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 received at least 1 dose of study drug and 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 SSRI treatment at a stable dose for 1 week.

Includes all participants who received at least 1 dose of study drug and 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.

All-Cause Mortality
LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study) LY2216684 + SSRI (Placebo Prior Study) DC Phase LY2216684 + SSRI (LY2216684 Prior Study) DC Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study) LY2216684 + SSRI (Placebo Prior Study) DC Phase LY2216684 + SSRI (LY2216684 Prior Study) DC Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/195 (0.51%)      2/92 (2.17%)      0/188 (0.00%)      0/84 (0.00%)    
Injury, poisoning and procedural complications         
Contusion  1  0/195 (0.00%)  0 1/92 (1.09%)  1 0/188 (0.00%)  0 0/84 (0.00%)  0
Metabolism and nutrition disorders         
Hyperglycaemia  1  0/195 (0.00%)  0 1/92 (1.09%)  1 0/188 (0.00%)  0 0/84 (0.00%)  0
Nervous system disorders         
Subdural hygroma  1  1/195 (0.51%)  1 0/92 (0.00%)  0 0/188 (0.00%)  0 0/84 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY2216684 + SSRI (Placebo Prior Study) LY2216684 + SSRI (LY2216684 Prior Study) LY2216684 + SSRI (Placebo Prior Study) DC Phase LY2216684 + SSRI (LY2216684 Prior Study) DC Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   158/195 (81.03%)      67/92 (72.83%)      9/188 (4.79%)      3/84 (3.57%)    
Cardiac disorders         
Palpitations  1  36/195 (18.46%)  38 12/92 (13.04%)  12 2/188 (1.06%)  2 1/84 (1.19%)  1
Tachycardia  1  62/195 (31.79%)  77 17/92 (18.48%)  20 0/188 (0.00%)  0 0/84 (0.00%)  0
Gastrointestinal disorders         
Constipation  1  19/195 (9.74%)  20 7/92 (7.61%)  7 0/188 (0.00%)  0 0/84 (0.00%)  0
Nausea  1  26/195 (13.33%)  29 8/92 (8.70%)  10 0/188 (0.00%)  0 1/84 (1.19%)  1
Vomiting  1  14/195 (7.18%)  14 3/92 (3.26%)  4 0/188 (0.00%)  0 0/84 (0.00%)  0
Infections and infestations         
Nasopharyngitis  1  56/195 (28.72%)  94 29/92 (31.52%)  39 3/188 (1.60%)  3 0/84 (0.00%)  0
Investigations         
Blood pressure increased  1  11/195 (5.64%)  11 0/92 (0.00%)  0 1/188 (0.53%)  1 1/84 (1.19%)  1
Heart rate increased  1  25/195 (12.82%)  31 7/92 (7.61%)  11 0/188 (0.00%)  0 0/84 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  4/195 (2.05%)  4 6/92 (6.52%)  7 0/188 (0.00%)  0 0/84 (0.00%)  0
Nervous system disorders         
Dizziness  1  21/195 (10.77%)  28 4/92 (4.35%)  4 1/188 (0.53%)  1 0/84 (0.00%)  0
Headache  1  17/195 (8.72%)  45 7/92 (7.61%)  8 2/188 (1.06%)  2 1/84 (1.19%)  1
Renal and urinary disorders         
Urinary hesitation  1  14/195 (7.18%)  14 0/92 (0.00%)  0 0/188 (0.00%)  0 0/84 (0.00%)  0
Urinary retention  1  10/195 (5.13%)  10 4/92 (4.35%)  4 0/188 (0.00%)  0 0/84 (0.00%)  0
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  33/195 (16.92%)  33 16/92 (17.39%)  16 0/188 (0.00%)  0 0/84 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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: NCT01370499     History of Changes
Other Study ID Numbers: 12849
H9P-JE-LNDJ ( Other Identifier: Eli Lilly and Company )
First Submitted: June 8, 2011
First Posted: June 10, 2011
Results First Submitted: February 19, 2018
Results First Posted: October 25, 2018
Last Update Posted: October 25, 2018