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Trial record 47 of 1896 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder

Safety and Efficacy of MK-6096 as Adjunctive Therapy in Participants With Major Depressive Disorder And Partial Response to Antidepressant Monotherapy (MK-6096-022)

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ClinicalTrials.gov Identifier: NCT01554176
Recruitment Status : Terminated (Low Enrollment)
First Posted : March 14, 2012
Results First Posted : November 7, 2016
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder, Recurrent
Interventions Drug: Filorexant
Drug: Placebo
Enrollment 129
Recruitment Details One participant in the Filorexant 10 mg (Treatment Phase) arm did not receive study drug and was discontinued from the study; the reason given for discontinuation is given as "non-compliance with study drug".
Pre-assignment Details During the 1-2 week screening period participants will be evaluated to determine if they meet study entry criteria. The screening period will serve as a wash-out period for participants taking prohibited medications.
Arm/Group Title Filorexant 10 mg (Treatment Phase) Placebo (Treatment Phase) Filorexant 10 mg/Filorexant 10 mg (Run-out Phase) Filorexant 10 mg/Placebo (Run-out Phase) Placebo/Placebo (Run-out Phase)
Hide Arm/Group Description Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks. Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks. Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase. Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase. Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Period Title: Treatment Phase
Started 65 64 0 0 0
Treated 64 64 0 0 0
Completed 57 59 0 0 0
Not Completed 8 5 0 0 0
Reason Not Completed
Protocol Violation             1             2             0             0             0
Physician Decision             1             1             0             0             0
Lack of Efficacy             0             1             0             0             0
Adverse event, non-fatal             1             1             0             0             0
Non-compliance with study drug             1             0             0             0             0
Withdrawal by Subject             1             0             0             0             0
Lost to Follow-up             3             0             0             0             0
Period Title: Run-out Phase
Started 0 0 29 28 59
Treated 0 0 29 28 59
Completed 0 0 29 27 59
Not Completed 0 0 0 1 0
Reason Not Completed
Protocol Violation             0             0             0             1             0
Arm/Group Title Filorexant 10 mg (Treatment Phase) Placebo (Treatment Phase) Total
Hide Arm/Group Description Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks. Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 65 64 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 64 participants 129 participants
47.8  (12.4) 50.0  (10.3) 48.9  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 129 participants
Female
40
  61.5%
42
  65.6%
82
  63.6%
Male
25
  38.5%
22
  34.4%
47
  36.4%
1.Primary Outcome
Title Change From Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with total scores ranging from 0 to 60; higher scores correspond to greater symptom severity. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 value.
Arm/Group Title Filorexant 10 mg (Treatment Phase) Placebo (Treatment Phase)
Hide Arm/Group Description:
Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
Overall Number of Participants Analyzed 58 61
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 30.3  (4.6) 31  (4.3)
Change at Week 6 -11  (9.5) -10.3  (8.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filorexant 10 mg (Treatment Phase), Placebo (Treatment Phase)
Comments Number of participants included for calculation of mean ± SD baseline and mean ± SD change from baseline MADRS Total Score is 119. Constrained longitudinal data analysis (cLDA) model uses efficacy Full Analysis Set (FAS) population (number of participants: filorexant 10 mg - 64, placebo - 64; total number of participants in cLDA analysis - 128).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.679
Comments cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items [HAM-D17] ≤20, >20) and insomnia severity index (ISI ≤14, >14).
Method cLDA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-3.8 to 2.5
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With an Adverse Event (AE) During Treatment Phase
Hide Description An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the treatment phase (up to study Week 6) are counted once in this summary.
Time Frame Up to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.
Arm/Group Title Filorexant 10 mg (Treatment Phase) Placebo (Treatment Phase)
Hide Arm/Group Description:
Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
Overall Number of Participants Analyzed 64 64
Measure Type: Number
Unit of Measure: Participants
27 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filorexant 10 mg (Treatment Phase), Placebo (Treatment Phase)
Comments Estimated parameter is between-group difference in percentage of participants with an AE = percentage (filorexant 10 mg) - percentage (placebo) for participants with one or more AE.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage incidence
Estimated Value 15.6
Confidence Interval (2-Sided) 95%
-0.9 to 31.4
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Phase
Hide Description An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the treatment phase (up to study Week 6) are counted once in this summary.
Time Frame Up to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.
Arm/Group Title Filorexant 10 mg (Treatment Phase) Placebo (Treatment Phase)
Hide Arm/Group Description:
Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
Overall Number of Participants Analyzed 64 64
Measure Type: Number
Unit of Measure: Participants
1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filorexant 10 mg (Treatment Phase), Placebo (Treatment Phase)
Comments Estimated parameter is between-group difference in percentage of participants discontinued from study drug due to an AE = percentage (filorexant 10 mg) - percentage (placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage incidence
Estimated Value 0
Confidence Interval (2-Sided) 95%
-7 to 7
Estimation Comments [Not Specified]
4.Primary Outcome
Title Number of Participants With an AE During Run-out Phase
Hide Description An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the 2-week run-out phase and/or during the 2-week follow up after the last dose of study drug, are counted once in this summary.
Time Frame From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.
Arm/Group Title Filorexant 10 mg/Filorexant 10 mg (Run-out Phase) Filorexant 10 mg/Placebo (Run-out Phase) Placebo/Placebo (Run-out Phase)
Hide Arm/Group Description:
Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Overall Number of Participants Analyzed 29 28 59
Measure Type: Number
Unit of Measure: Participants
6 3 9
5.Primary Outcome
Title Number of Participants Who Discontinued Study Drug Due to an AE During Run-out Phase
Hide Description An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) or a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the 2-week run-out phase are counted once in this summary.
Time Frame From first run-out dose (following Week 6 visit) up to Week 8 (2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.
Arm/Group Title Filorexant 10 mg/Filorexant 10 mg (Run-out Phase) Filorexant 10 mg/Placebo (Run-out Phase) Placebo/Placebo (Run-out Phase)
Hide Arm/Group Description:
Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
Overall Number of Participants Analyzed 29 28 59
Measure Type: Number
Unit of Measure: Participants
0 0 0
6.Secondary Outcome
Title Change From Baseline to Week 6 in MADRS Total Score Excluding the Sleep Item
Hide Description The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with higher scores indicating greater symptom severity. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity. This measure considered 9 of the 10 MADRS items: apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. It excluded "reduced sleep." The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 MADRS score.
Arm/Group Title Filorexant 10 mg (Treatment Phase) Placebo (Treatment Phase)
Hide Arm/Group Description:
Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
Overall Number of Participants Analyzed 58 61
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 26.5  (4.1) 27.2  (4.1)
Change at Week 6 -9.5  (8.5) -9.1  (7.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filorexant 10 mg (Treatment Phase), Placebo (Treatment Phase)
Comments Pairwise Comparison: Filorexant 10 mg vs. Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.820
Comments cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items [HAM-D17] ≤20, >20) and insomnia severity index (ISI ≤14, >14).
Method cLDA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-3.2 to 2.5
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Week 6 in the Hamilton Depression Rating Scale, 17-item Version (HAM-D17) Bech Subscale Score
Hide Description The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). The Bech subscale of the HAM-D17 is composed of 6 identified items out of the 17 items rated. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). Total score ranged from 0 to 22, with a higher score indicating greater symptom severity. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). The reported measure is the change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 HAM-D17 Beck Subscale score.
Arm/Group Title Filorexant 10 mg (Treatment Phase) Placebo (Treatment Phase)
Hide Arm/Group Description:
Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
Overall Number of Participants Analyzed 56 61
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 13.1  (2.4) 13.0  (2.1)
Change at Week 6 -4.7  (4.8) -4.2  (4.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filorexant 10 mg (Treatment Phase), Placebo (Treatment Phase)
Comments Pairwise Comparison: Filorexant 10 mg vs. Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.701
Comments cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items [HAM-D17] ≤20, >20) and insomnia severity index (ISI ≤14, >14).
Method cLDA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.9 to 1.3
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With HAM-D17 Remission (HAM-D17 Total Score ≤7) at Week 6
Hide Description The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4), with higher scores indicating greater symptom severity. Total score ranged from 0 to 54. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization). The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss. A participant with HAM-D17 total score ≤7 at Week 6 of the Treatment Phase was defined to have achieved HAM-D17 remission.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 HAM-D17 score.
Arm/Group Title Filorexant 10 mg (Treatment Phase) Placebo (Treatment Phase)
Hide Arm/Group Description:
Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
Overall Number of Participants Analyzed 56 61
Measure Type: Number
Unit of Measure: percentage of participants
21.4 9.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filorexant 10 mg (Treatment Phase), Placebo (Treatment Phase)
Comments Pairwise Comparison: Filorexant 10 mg vs. Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0965
Comments Generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction.
Method Generalized Linear Mixed Effects Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Odds Ratio
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
0.8 to 7.3
Estimation Comments [Not Specified]
Time Frame Treatment Phase: Up to Week 6 Run-out Phase: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks)
Adverse Event Reporting Description All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.
 
Arm/Group Title Filorexant 10 mg (Treatment Phase) Placebo (Treatment Phase) Filorexant 10 mg/Filorexant 10 mg (Run-out Phase) Filorexant 10 mg/Placebo (Run-out Phase) Placebo/Placebo (Run-out Phase)
Hide Arm/Group Description Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks. Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks. Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase. Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase. Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the treatment phase.
All-Cause Mortality
Filorexant 10 mg (Treatment Phase) Placebo (Treatment Phase) Filorexant 10 mg/Filorexant 10 mg (Run-out Phase) Filorexant 10 mg/Placebo (Run-out Phase) Placebo/Placebo (Run-out Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Filorexant 10 mg (Treatment Phase) Placebo (Treatment Phase) Filorexant 10 mg/Filorexant 10 mg (Run-out Phase) Filorexant 10 mg/Placebo (Run-out Phase) Placebo/Placebo (Run-out Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/64 (1.56%)      0/64 (0.00%)      0/29 (0.00%)      0/28 (0.00%)      1/59 (1.69%)    
Infections and infestations           
Diverticulitis  1  1/64 (1.56%)  1 0/64 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/59 (0.00%)  0
Nervous system disorders           
Presyncope  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 1/59 (1.69%)  1
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%
Filorexant 10 mg (Treatment Phase) Placebo (Treatment Phase) Filorexant 10 mg/Filorexant 10 mg (Run-out Phase) Filorexant 10 mg/Placebo (Run-out Phase) Placebo/Placebo (Run-out Phase)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/64 (20.31%)      7/64 (10.94%)      3/29 (10.34%)      1/28 (3.57%)      1/59 (1.69%)    
Nervous system disorders           
Dizziness  1  0/64 (0.00%)  0 4/64 (6.25%)  4 0/29 (0.00%)  0 0/28 (0.00%)  0 0/59 (0.00%)  0
Headache  1  4/64 (6.25%)  5 5/64 (7.81%)  6 0/29 (0.00%)  0 0/28 (0.00%)  0 0/59 (0.00%)  0
Somnolence  1  5/64 (7.81%)  5 0/64 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/59 (0.00%)  0
Psychiatric disorders           
Suicidal ideation  1  5/64 (7.81%)  5 1/64 (1.56%)  1 3/29 (10.34%)  3 1/28 (3.57%)  1 1/59 (1.69%)  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.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01554176     History of Changes
Other Study ID Numbers: 6096-022
2011-005200-15 ( EudraCT Number )
First Submitted: March 12, 2012
First Posted: March 14, 2012
Results First Submitted: September 15, 2016
Results First Posted: November 7, 2016
Last Update Posted: November 7, 2018