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A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed Dose Study Evaluating the Efficacy and Safety of Orvepitant in Subjects With Major Depressive Disorder (orvepitant MDD)

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ClinicalTrials.gov Identifier: NCT00880399
Recruitment Status : Terminated (To allow assessment of isolated events of seizure during program)
First Posted : April 13, 2009
Results First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Interventions Drug: orvepitant
Other: placebo
Enrollment 328
Recruitment Details This study was conducted at 20 centers across the United States of America (USA) (17 centers) and Canada (3 centers) from 04 March 2009 to 16 June 2010.
Pre-assignment Details A total of 787 participants were screened for study eligibility, of which 331 participants were randomized. Out of 331 participants, 3 did not receive the study medication. All subjects population included all participants who had received at least one dose of the study medication and comprised of 328 participants.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks. Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Period Title: Overall Study
Started 108 113 107
Completed 77 84 81
Not Completed 31 29 26
Reason Not Completed
Adverse Event             4             6             5
Lack of Efficacy             1             4             2
Protocol Violation             4             4             6
Study closed/terminated             3             7             4
Lost to Follow-up             8             5             3
Physician Decision             5             0             3
Withdrawal by Subject             6             3             3
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg Total
Hide Arm/Group Description Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks. Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 108 113 107 328
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 113 participants 107 participants 328 participants
39.7  (11.67) 41.0  (11.45) 38.2  (11.15) 39.7  (11.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 113 participants 107 participants 328 participants
Female
76
  70.4%
68
  60.2%
70
  65.4%
214
  65.2%
Male
32
  29.6%
45
  39.8%
37
  34.6%
114
  34.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 113 participants 107 participants 328 participants
American Indian or Alaska Native
1
   0.9%
1
   0.9%
2
   1.9%
4
   1.2%
Asian
4
   3.7%
2
   1.8%
3
   2.8%
9
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
16
  14.8%
17
  15.0%
21
  19.6%
54
  16.5%
White
86
  79.6%
92
  81.4%
79
  73.8%
257
  78.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.9%
1
   0.9%
2
   1.9%
4
   1.2%
1.Primary Outcome
Title Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score
Hide Description The HAM-D is designed to measure severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items (1: depressed mood, 2: feelings of guilt, 3: suicide, insomnia early, 4: insomnia early, 5: insomnia middle, 6: insomnia late, 7: work and activities, 8: retardation, 9: agitation, 10: anxiety psychic item 10: anxiety psychic, item 11: anxiety somatic, item 12: somatic symptoms gastrointestinal, 13: somatic symptoms general, 14: genital symptoms, 15: hypochondriasis, 16: loss of weight and 17: insight) that are ranked on a scale of 0 to 4 or 0 to 2 (4 and 2: highly severe and 0: not present). The HAM-D total score is calculated by summing individual response scores on the HAM-D questionnaire. The highest possible score is 52, representing most severe measure of depression; lowest possible score is 0, representing no depression. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time Frame Baseline (Day 1) to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population comprised of all participants who were randomized and received at least one dose of double blind medication and for whom at least one post-randomization assessment was available. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
Week 1 Number Analyzed 102 participants 110 participants 103 participants
-3.72  (0.438) -4.19  (0.417) -4.87  (0.433)
Week 2 Number Analyzed 94 participants 102 participants 100 participants
-5.32  (0.540) -7.21  (0.515) -7.16  (0.525)
Week 4 Number Analyzed 85 participants 97 participants 93 participants
-7.40  (0.665) -9.61  (0.627) -10.45  (0.641)
Week 6 Number Analyzed 78 participants 86 participants 84 participants
-9.08  (0.777) -11.49  (0.735) -11.93  (0.749)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitatnt 30 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4295
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-1.65 to 0.70
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitatnt 60 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0586
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-2.34 to 0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitatnt 30 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0111
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.89
Confidence Interval (2-Sided) 95%
-3.34 to -0.43
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitatnt 60 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0141
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.84
Confidence Interval (2-Sided) 95%
-3.30 to -0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitatnt 30 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0152
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.22
Confidence Interval (2-Sided) 95%
-4.00 to -0.43
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitatnt 60 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.06
Confidence Interval (2-Sided) 95%
-4.86 to -1.25
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitatnt 30 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0245
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.41
Confidence Interval (2-Sided) 95%
-4.50 to -0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitatnt 60 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0082
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.86
Confidence Interval (2-Sided) 95%
-4.97 to -0.75
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With a >= 50 Percent (%) Reduction From Baseline in HAM-D Total Score
Hide Description Participants who had 50% or greater reduction from Baseline in their total HAMD score were termed as responders. The HAM-D was designed to measure the severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items that are ranked on a scale of 0 to 4 or 0 to 2. Items with quantifiable severity are scored 0 to 4 (4 indicating the greatest severity) or 0 to 2 (2 indicating the greatest severity) with 0 indicating not present. The HAM-D Total Score is calculated by summing the individual response scores on the HAM-D questionnaire. The highest possible score is 52, which represents the most severe measure of depression; the lowest possible score is 0, which represents an absence of depression. The HAM-D is also useful for monitoring changes in depressive symptoms with treatment and in comparing the efficacy of various interventions if the participant requires more than one type of treatment. Baseline was Day 1.
Time Frame Baseline (Day 1) to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 102 participants 110 participants 103 participants
5 5 4
Week 2 Number Analyzed 94 participants 102 participants 100 participants
10 15 12
Week 4 Number Analyzed 85 participants 97 participants 93 participants
19 27 33
Week 6 Number Analyzed 78 participants 86 participants 84 participants
29 42 39
3.Secondary Outcome
Title Number of Participants With (Maintained) Clinical Response
Hide Description Clinical response or antidepressant response was defined as >= 50% reduction from randomization in their HAMD total score, where this response was maintained until the end of the Treatment Phase (Week 6). Participants who met the >= 50% reduction at Week 6 without also having met it at Week 4 were not considered to have reached a maintained response, and therefore were censored at Week 6. Number of participants with maintained clinical response are reported.
Time Frame Up to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Measure Type: Number
Unit of Measure: Participants
13 21 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
0.80 to 3.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.66
Confidence Interval (2-Sided) 95%
0.84 to 3.30
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAMD Scale)
Hide Description The Bech Melancholia is sum of scores on 6 items/questions (item 1: depressed mood, item 2: feelings of guilt, item 7: work and activities, item 8: retardation, item 10: anxiety psychic and item 13: somatic symptoms general) pertaining to melancholia within HAM-D. The items are rated on a scale of 0 to 4 (items 1, 2, 7, 8 and 10) or 0 to 2 (item 13), higher scores reflecting greater severity. The highest possible score is 24, which represents the most severe measure of melancholy; the lowest possible score is 0, which represents an absence of melancholy. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time Frame Baseline (Day 1) to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
Week 1 Number Analyzed 102 participants 110 participants 103 participants
-1.68  (0.237) -1.77  (0.225) -1.83  (0.233)
Week 2 Number Analyzed 94 participants 102 participants 100 participants
-2.35  (0.289) -3.39  (0.276) -3.26  (0.281)
Week 4 Number Analyzed 85 participants 97 participants 93 participants
-3.20  (0.366) -4.49  (0.345) -4.88  (0.352)
Week 6 Number Analyzed 78 participants 86 participants 84 participants
-4.30  (0.424) -5.53  (0.402) -5.84  (0.409)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7859
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.72 to 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6429
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.79 to 0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0092
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-1.82 to -0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0230
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-1.69 to -0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0104
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.29
Confidence Interval (2-Sided) 95%
-2.27 to -0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.68
Confidence Interval (2-Sided) 95%
-2.67 to -0.69
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0361
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.22
Confidence Interval (2-Sided) 95%
-2.37 to -0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0092
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.54
Confidence Interval 95%
-2.69 to -0.38
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score
Hide Description The QIDS-SR is a self-report rating scale that assesses symptom severity of major depressive disorders. The QIDS-SR utilized during this study contained 16 separate items which correspond to 9 symptom criterion domains: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation,(5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation. The QIDS-SR total score was calculated using the sum of the domain scores. The highest possible total QIDS-SR score is 27, which represents the most severe measure of depression. The lowest possible score is 0, which represents an absence of depression. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time Frame Baseline (Day 1) to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
Week 1 Number Analyzed 102 participants 109 participants 103 participants
-2.47  (0.381) -3.19  (0.364) -3.13  (0.375)
Week 2 Number Analyzed 94 participants 102 participants 100 participants
-3.48  (0.428) -4.50  (0.408) -4.03  (0.415)
Week 4 Number Analyzed 85 participants 95 participants 93 participants
-4.16  (0.483) -5.85  (0.457) -6.26  (0.466)
Week 6 Number Analyzed 77 participants 85 participants 83 participants
-5.05  (0.551) -6.34  (0.523) -6.73  (0.532)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1662
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-1.74 to 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2116
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-1.69 to 0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0820
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.02
Confidence Interval (2-Sided) 95%
-2.17 to 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3498
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.71 to 0.61
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0107
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.69
Confidence Interval (2-Sided) 95%
-2.99 to -0.40
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.10
Confidence Interval (2-Sided) 95%
-3.40 to -0.79
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0880
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.29
Confidence Interval (2-Sided) 95%
-2.78 to 0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0282
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.68
Confidence Interval (2-Sided) 95%
-3.17 to -0.18
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17)
Hide Description The HAMD anxiety factor score includes 6 items/questions (item 10: anxiety psychic, item 11: anxiety somatic, item 12: somatic symptoms gastrointestinal, item 13: somatic symptoms general, item 15: hypochondriasis and item 17: insight). The items are rated on a scale of 0 to 4 (items 10, 11 and 15) or 0 to 2 (items 12, 13 and 17), higher scores reflecting greater severity. The highest possible score is 18, which represents the most severe measure of anxiety; the lowest possible score is 0, which represents an absence of anxiety. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time Frame Baseline (Day 1) to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
Week 1 Number Analyzed 102 participants 110 participants 103 participants
-1.06  (0.165) -1.07  (0.157) -1.28  (0.163)
Week 2 Number Analyzed 94 participants 102 participants 100 participants
-1.47  (0.188) -1.90  (0.179) -1.91  (0.183)
Week 4 Number Analyzed 85 participants 97 participants 93 participants
-2.19  (0.226) -2.51  (0.212) -2.78  (0.218)
Week 6 Number Analyzed 78 participants 86 participants 84 participants
-2.60  (0.256) -3.06  (0.242) -3.30  (0.248)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9854
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.00
Confidence Interval (2-Sided) 95%
-0.45 to 0.44
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3476
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.66 to 0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0898
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-0.94 to 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0928
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-0.95 to 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2937
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.93 to 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0587
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-1.20 to 0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1950
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-1.14 to 0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0498
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-1.40 to -0.00
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved)
Hide Description The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. Global improvement (CGI-I) item is rated on a 1-7 scale. The CGI-I assessed scores range from 1 - very much improved to 7 - very much worse. For the CGI-I, the investigator or delegated qualified clinician indicated their assessment of the participant’s total improvement or worsening compared with the individual’s condition at the start of the study whether or not the change was judged to be due to drug treatment. A participant with a CGI-I score of 1 'very much improved' or 2 'much improved' was considered a responder. Percentage of responders are reported.
Time Frame Up to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 102 participants 110 participants 103 participants
5 10 4
Week 2 Number Analyzed 94 participants 102 participants 100 participants
10 22 16
Week 4 Number Analyzed 85 participants 97 participants 93 participants
22 35 32
Week 6 Number Analyzed 78 participants 86 participants 84 participants
31 44 40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1731
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 2.14
Confidence Interval (2-Sided) 95%
0.72 to 6.40
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7084
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.20 to 2.97
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0247
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 2.60
Confidence Interval (2-Sided) 95%
1.13 to 5.98
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1862
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.80
Confidence Interval (2-Sided) 95%
0.75 to 4.30
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0630
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.87
Confidence Interval (2-Sided) 95%
0.97 to 3.61
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1413
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.65
Confidence Interval (2-Sided) 95%
0.85 to 3.23
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0806
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.77
Confidence Interval (2-Sided) 95%
0.93 to 3.37
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2007
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
0.80 to 2.92
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score
Hide Description The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. For the CGI-S, an independent site rater assessed the participant’s severity of illness considering (1) their total clinical experience with the particular population being studied and (2) information obtained during the Baseline HAM-D interview with the participant. The severity of illness (CGI-S) item is rated on a 1 to 7 scale such that 1 (normal, not at all ill) and 7 (among the most extremely ill). Higher scores indicate worsening. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time Frame Baseline (Day 1) to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
Week 1 Number Analyzed 102 participants 110 participants 103 participants
-0.34  (0.060) -0.43  (0.057) -0.43  (0.059)
Week 2 Number Analyzed 94 participants 102 participants 100 participants
-0.51  (0.077) -0.88  (0.073) -0.73  (0.074)
Week 4 Number Analyzed 85 participants 97 participants 93 participants
-0.80  (0.104) -1.14  (0.098) -1.26  (0.100)
Week 6 Number Analyzed 78 participants 86 participants 84 participants
-1.07  (0.127) -1.52  (0.120) -1.56  (0.122)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2523
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.25 to 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2639
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.25 to 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.58 to -0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0348
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.43 to -0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0166
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.62 to -0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.75 to -0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0099
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.79 to -0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0059
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.83 to -0.14
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score
Hide Description The CPFQ is a brief self-report scale which is designed to measure cognitive and executive dysfunction in mood and anxiety disorders. The scale comprises 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question is rated on a scale of 1 to 6, (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following five areas were included: motivation/interest/enthusiasm; wakefulness/alertness; energy; focus/sustain attention; remember/recall information; find words and sharpness/mental acuity. The total score (sum of individual question scores) ranged from 7 to 42. Lower score 7 represents greater than normal functioning and higher score 42 indicate poorer functioning (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time Frame Baseline (Day 1) and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
Week 1 Number Analyzed 101 participants 109 participants 103 participants
-3.24  (0.582) -3.72  (0.553) -3.22  (0.572)
Week 2 Number Analyzed 94 participants 100 participants 100 participants
-3.80  (0.567) -5.31  (0.541) -4.37  (0.550)
Week 4 Number Analyzed 85 participants 94 participants 92 participants
-5.12  (0.659) -6.34  (0.623) -6.27  (0.637)
Week 6 Number Analyzed 78 participants 84 participants 84 participants
-5.51  (0.729) -7.67  (0.693) -7.85  (0.704)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5473
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-2.04 to 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9814
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-1.56 to 1.60
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0515
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.51
Confidence Interval (2-Sided) 95%
-3.03 to 0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4680
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-2.09 to 0.96
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1757
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.22
Confidence Interval (2-Sided) 95%
-2.98 to 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2048
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-2.93 to 0.63
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0312
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.16
Confidence Interval (2-Sided) 95%
-4.12 to -0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0202
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.34
Confidence Interval (2-Sided) 95%
-4.31 to -0.37
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Morning Sleep Questionnaire (MSQ) Values for Total Sleep Time (TST), Sleep Onset Latency (SOL) and Wake Time After Sleep Onset (WTSO)
Hide Description The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following six variables were assessed in order to determine effects on sleep: (1) total sleep time, (2) sleep onset latency, (3) number of nocturnal awakenings, (4) wake time after sleep onset, (5) sleep quality (where poor=1 and excellent= 10) and (6) the refreshing value of the sleep (where poor=1 and excellent= 10). During the conduct of the study, participants self-administered the MSQ via an Interactive Voice Response System (IVRS) from their home the morning of each clinic visit. Participants were provided paper MSQ diary cards for note taking prior to completing the IVRS call. If a participant did not remember to place the IVRS MSQ call the morning of the clinic visit from home, they were allowed to place the call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time Frame Baseline (Day 1) to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Least Squares Mean (Standard Error)
Unit of Measure: Minutes (mins)
TST; Week 1 36.09  (9.204) 40.54  (8.834) 63.46  (9.148)
TST; Week 2 34.62  (9.728) 42.74  (9.371) 48.14  (9.440)
TST; Week 4 49.57  (10.991) 32.07  (10.309) 70.68  (10.472)
TST; Week 6 39.79  (9.930) 44.26  (9.443) 51.26  (9.523)
SOL; Week 1 -7.16  (5.658) -18.68  (5.440) -31.06  (5.620)
SOL; Week 2 -14.60  (5.609) -22.27  (5.405) -39.28  (5.444)
SOL; Week 4 -21.75  (6.354) -32.46  (5.949) -37.06  (6.041)
SOL; Week 6 -34.50  (5.212) -27.66  (4.940) -37.75  (4.998)
WTSO; Week 1 -12.09  (7.248) -9.69  (6.799) -21.38  (7.252)
WTSO; Week 2 -2.12  (7.397) -17.99  (7.196) -24.38  (7.343)
WTSO; Week 4 -15.76  (11.019) -13.60  (10.306) -17.43  (10.819)
WTSO; Week 6 -16.99  (10.713) -21.08  (10.428) -14.08  (11.198)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, TST at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7246
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.45
Confidence Interval (2-Sided) 95%
-20.38 to 29.28
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, TST at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0332
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 27.36
Confidence Interval (2-Sided) 95%
2.20 to 52.52
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, TST at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5439
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8.12
Confidence Interval (2-Sided) 95%
-18.18 to 34.41
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, TST at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3127
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 13.52
Confidence Interval (2-Sided) 95%
-12.80 to 39.85
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, TST at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2419
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -17.51
Confidence Interval (2-Sided) 95%
-46.90 to 11.89
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, TST at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1606
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 21.11
Confidence Interval (2-Sided) 95%
-8.43 to 50.64
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, TST at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7412
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.48
Confidence Interval 95%
-22.21 to 31.16
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, TST at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3974
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.47
Confidence Interval (2-Sided) 95%
-15.19 to 38.14
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, SOL at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1397
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -11.52
Confidence Interval (2-Sided) 95%
-26.83 to 3.79
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, SOL at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -23.90
Confidence Interval (2-Sided) 95%
-39.40 to -8.41
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, SOL at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3206
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.67
Confidence Interval (2-Sided) 95%
-22.85 to 7.50
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, SOL at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0015
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -24.67
Confidence Interval (2-Sided) 95%
-39.86 to -9.49
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, SOL at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2157
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -10.71
Confidence Interval (2-Sided) 95%
-27.70 to 6.28
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, SOL at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0784
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -15.31
Confidence Interval (2-Sided) 95%
-32.37 to 1.75
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, SOL at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3345
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.84
Confidence Interval (2-Sided) 95%
-7.09 to 20.78
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, SOL at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6471
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.25
Confidence Interval (2-Sided) 95%
-17.19 to 10.70
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, WTSO at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8071
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.40
Confidence Interval (2-Sided) 95%
-16.95 to 21.75
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, WTSO at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3564
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9.30
Confidence Interval (2-Sided) 95%
-29.11 to 10.52
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, WTSO at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1220
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -15.86
Confidence Interval (2-Sided) 95%
-36.00 to 4.28
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, WTSO at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0313
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -22.25
Confidence Interval (2-Sided) 95%
-42.49 to -2.01
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, WTSO at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8861
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.15
Confidence Interval (2-Sided) 95%
-27.45 to 31.76
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, WTSO at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9132
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.67
Confidence Interval (2-Sided) 95%
-31.87 to 28.53
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, WTSO at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7844
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.09
Confidence Interval (2-Sided) 95%
-33.55 to 25.37
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 30 mg, WTSO at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8497
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.90
Confidence Interval (2-Sided) 95%
-27.33 to 33.14
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in MSQ Values for Number of Nocturnal Awakenings
Hide Description The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following six variables were assessed in order to determine effects on sleep: (1) total sleep time, (2) sleep onset latency, (3) number of nocturnal awakenings, (4) wake time after sleep onset, (5) sleep quality (where poor=1 and excellent= 10) and (6) the refreshing value of the sleep (where poor=1 and excellent= 10). During the conduct of the study, participants self-administered the MSQ via an Interactive Voice Response System (IVRS) from their home the morning of each clinic visit. Participants were provided paper MSQ diary cards for note taking prior to completing the IVRS call. If a participant did not remember to place the IVRS MSQ call the morning of the clinic visit from home, they were allowed to place the call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time Frame Baseline (Day 1) to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Least Squares Mean (Standard Error)
Unit of Measure: Awakenings
Week 1 Number Analyzed 73 participants 80 participants 72 participants
-0.07  (0.225) -0.29  (0.214) 0.09  (0.227)
Week 2 Number Analyzed 68 participants 69 participants 68 participants
-0.42  (0.120) -0.53  (0.116) -0.66  (0.119)
Week 4 Number Analyzed 55 participants 61 participants 58 participants
-0.42  (0.140) -0.41  (0.130) -0.71  (0.137)
Week 6 Number Analyzed 50 participants 51 participants 46 participants
-0.36  (0.152) -0.67  (0.147) -0.84  (0.157)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4814
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.83 to 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6179
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-0.47 to 0.79
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5022
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.44 to 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1389
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.57 to 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9663
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.36 to 0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1311
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.67 to 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1362
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.73 to 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0275
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-0.91 to -0.05
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in MSQ Values for Sleep Quality (SQ) and Refreshing Value of Sleep (RVS)
Hide Description The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The score relating to SQ and RVS was measured by items/questions 4 and 5 respectively of the MSQ. The following two variables SQ and RVS were assessed in order to determine effects on sleep. Participants were asked to rate their SQ and RVS on a scale of 1 to 10. This scale has no subscales. The total score for SQ and RVS, both, ranged from 1 to 10 where 1=poor and 10=excellent. Lower scores indicated poor SQ and RVS and higher scores indicated excellent SQ and excellent RVS. During the conduct of study, participants self-administered MSQ via an IVRS from their home the morning of each clinic visit. If a participant did not remember to place IVRS MSQ call the morning of the clinic visit from home, they were allowed to place call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Time Frame Baseline (Day 1) to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
SQ; Week 1 Number Analyzed 99 participants 105 participants 99 participants
0.79  (0.201) 1.30  (0.192) 1.48  (0.199)
SQ; Week 2 Number Analyzed 92 participants 97 participants 97 participants
0.81  (0.207) 1.75  (0.199) 1.65  (0.201)
SQ; Week 4 Number Analyzed 83 participants 94 participants 92 participants
1.45  (0.224) 1.58  (0.209) 2.27  (0.214)
SQ; Week 6 Number Analyzed 76 participants 83 participants 83 participants
1.53  (0.238) 2.19  (0.226) 2.30  (0.228)
RVS; Week 1 Number Analyzed 99 participants 105 participants 99 participants
0.75  (0.198) 1.14  (0.190) 1.45  (0.196)
RVS; Week 2 Number Analyzed 92 participants 97 participants 97 participants
1.10  (0.208) 1.70  (0.200) 1.69  (0.202)
RVS; Week 4 Number Analyzed 83 participants 94 participants 92 participants
1.55  (0.230) 1.52  (0.215) 2.32  (0.219)
RVS; Week 6 Number Analyzed 76 participants 83 participants 83 participants
1.67  (0.246) 2.31  (0.234) 2.41  (0.236)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, SQ at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0606
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
-0.02 to 1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, SQ at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0132
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.15 to 1.24
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, SQ at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.38 to 1.50
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, SQ at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.28 to 1.40
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, SQ at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6692
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.47 to 0.72
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, SQ at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.22 to 1.42
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, SQ at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0440
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.02 to 1.30
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, SQ at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0181
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.13 to 1.41
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, RVS at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1484
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
-0.14 to 0.92
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, RVS at Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0108
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.16 to 1.24
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, RVS at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0361
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.60
Confidence Interval 95%
0.04 to 1.16
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, RVS at Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0418
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.02 to 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, RVS at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9305
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.64 to 0.58
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 60 mg, RVS at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0141
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.16 to 1.39
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 30 mg
Comments Placebo Vs Orvepitant 30 mg, RVS at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0562
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
-0.02 to 1.31
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Orvepitant 60 mg
Comments Placebo Vs Orvepitant 30 mg, RVS at Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0296
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.07 to 1.40
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants Who Remit (Have an Endpoint HAM-D Total Score <= 7) Who Continue to Show Symptoms on the HAM-D Sleep Items
Hide Description A HAM-D remitter was defined as a participant with a HAM-D total score less than or equal to 7. The HAM-D was designed to measure the severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items that are ranked on a scale of 0 to 4 or 0 to 2. Items with quantifiable severity are scored 0 to 4 (4 indicating the greatest severity) or 0 to 2 (2 indicating the greatest severity) with 0 indicating not present. The HAM-D Total Score is calculated by summing the individual response scores on the HAM-D questionnaire. The highest possible score is 52, which represents the most severe measure of depression; the lowest possible score is 0, which represents an absence of depression. The HAM-D is also useful for monitoring changes in depressive symptoms with treatment and in comparing the efficacy of various interventions if the participant requires more than one type of treatment.
Time Frame Up to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Measure Type: Number
Unit of Measure: Participants
Week 1 Number Analyzed 102 participants 110 participants 103 participants
1 2 0
Week 2 Number Analyzed 94 participants 102 participants 100 participants
2 2 4
Week 4 Number Analyzed 85 participants 97 participants 93 participants
5 10 10
Week 6 Number Analyzed 78 participants 86 participants 84 participants
8 16 15
14.Secondary Outcome
Title Number of Participants With Suicidal Behavior, Ideation, and Most Common Ideation Using the Columbia Suicidality Severity Rating Scale (C-SSRS)
Hide Description The C-SSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both behavior and ideation. It has 3 sections, Suicidal Behavior (SB), Suicidal Ideation (SI) and Intensity of Ideation (II). For SB, participants (par) were scored non-suicidal:0, preparatory acts or behavior communicating ideation:1, aborted attempt:2, interrupted attempt:3 or actual attempt:4 (most severe). For SI, par were scored non-suicidal:0, wish to be dead:1, non-specific active suicidal thoughts:2, active suicidal ideation with associated thoughts of methods without intent:3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan:4, active suicidal ideation with plan and intent:5 (most severe). II scale made of 5 questions measuring frequency, duration, controllability, deterrent and reasons; par received a separate score on most common ideation and on most severe. Total II score is obtained by adding scores from all 5 questions.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 103 110 107
Measure Type: Number
Unit of Measure: Participants
Suicidal Ideation score 1 27 26 27
Suicidal Ideation score 2 5 7 6
Suicidal Ideation score 3 1 3 4
Suicidal Ideation score 4 0 1 0
Suicidal Ideation score 5 1 1 0
15.Secondary Outcome
Title Number of Discontinuation-emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)
Hide Description The discontinuation signs and symptoms scale consists of 43 signs and symptoms, scored as ‘new symptom’, ‘old symptom but worse’, ‘old symptom but improved’ or ‘ symptom not present/old symptom but unchanged’. A frequency table for each symptom is reported by treatment and visit. The total number of new signs and symptoms, old symptoms but worse, old symptoms but improved and the total number of new or old-but-worse signs and symptoms are calculated for treatment and visit and reported.
Time Frame Week 1 to Week 8/Follow up 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects population comprised of all participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Orvepitant 30 mg Orvepitant 60 mg
Hide Arm/Group Description:
Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Overall Number of Participants Analyzed 108 113 107
Mean (Standard Deviation)
Unit of Measure: Signs and symptoms
New symptom; Week 1 Number Analyzed 2 participants 1 participants 1 participants
1.5  (0.71) 2.0 [1]   (NA) 2.0 [1]   (NA)
Old Symptom But Improved; Week 1 Number Analyzed 1 participants 0 participants 1 participants
1.0 [2]   (NA) 3.0 [2]   (NA)
Old Symptom But Worsened; Week 1 Number Analyzed 3 participants 0 participants 3 participants