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Trial record 29 of 413 for:    depression AND Major Depression AND HAM- | "Depression"

A Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Orvepitant in Subjects With Major Depressive Disorder (Orvepitant MDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00880048
Recruitment Status : Terminated (To allow assessment of isolated events of seizure during program)
First Posted : April 13, 2009
Results First Posted : October 13, 2017
Last Update Posted : October 13, 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
Interventions Drug: orvepitant
Other: Placebo
Enrollment 343
Recruitment Details The study was conducted at 31 centers across the North America (27 centers in United States of America and 4 centers in Canada) during the period 06 April 2009 to 21 June 2010. Total of 1604 participants were screened for study eligibility, of which 343 participants were randomized into the study.
Pre-assignment Details A total of 339 participants were included in Intent-to-treat (ITT) population. ITT population comprised of all participants who gave informed consent, were randomized, received at least one dose of double blind medication and for whom at least one post-randomization assessment was available.
Arm/Group Title Placebo GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks. Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks. Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Period Title: Overall Study
Started 116 115 112
Completed 88 82 77
Not Completed 28 33 35
Reason Not Completed
Adverse Event             2             3             5
Lack of Efficacy             1             2             2
Protocol Violation             4             6             5
Lost to Follow-up             6             6             5
Physician Decision             1             1             7
Withdrawal by Subject             5             8             5
Study closed/terminated             9             7             6
Arm/Group Title Placebo GW823296 30 mg GW823296 60 mg Total
Hide Arm/Group Description Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks. Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks. Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 116 115 112 343
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 116 participants 115 participants 112 participants 343 participants
41.7  (10.61) 40.4  (11.35) 43.1  (10.66) 41.7  (10.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 115 participants 112 participants 343 participants
Female
68
  58.6%
75
  65.2%
73
  65.2%
216
  63.0%
Male
48
  41.4%
40
  34.8%
39
  34.8%
127
  37.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 115 participants 112 participants 343 participants
American Indian or Alaska Native
0
   0.0%
1
   0.9%
0
   0.0%
1
   0.3%
Asian
3
   2.6%
3
   2.6%
1
   0.9%
7
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.9%
0
   0.0%
1
   0.3%
Black or African American
32
  27.6%
24
  20.9%
33
  29.5%
89
  25.9%
White
78
  67.2%
83
  72.2%
76
  67.9%
237
  69.1%
More than one race
2
   1.7%
2
   1.7%
2
   1.8%
6
   1.7%
Unknown or Not Reported
1
   0.9%
1
   0.9%
0
   0.0%
2
   0.6%
1.Primary Outcome
Title Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score
Hide Description HAM-D was use to measure the severity of depressive symptoms in participants with primary depressive illness. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. Items with quantifiable severity were scored 0 (lowest severity) to 4 (greatest severity); The HAM-D total score was calculated by summing the individual response scores. The lowest possible score was 0 (absence of depression) and the highest possible score was 52 (most severe measure of depression). For the last observation carried forward analyses, the most recent post randomization total score (as opposed to individual responses) was "carried forward" and used in the calculation of the change from randomization (Baseline) value. If the responses to more than 1 question were missing for a participant at a particular time point, the total score was not calculated. Change from Baseline in total score was the difference between HAM-D total score at the time point being analyzed and randomization.
Time Frame Baseline and 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 GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description:
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Overall Number of Participants Analyzed 116 112 111
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1 Number Analyzed 114 participants 112 participants 107 participants
-2.85  (0.454) -4.45  (0.462) -5.11  (0.470)
Week 2 Number Analyzed 107 participants 102 participants 93 participants
-4.35  (0.531) -5.92  (0.545) -6.00  (0.565)
Week 4 Number Analyzed 97 participants 92 participants 90 participants
-6.87  (0.672) -8.68  (0.691) -8.90  (0.703)
Week 6 Number Analyzed 91 participants 83 participants 76 participants
-8.29  (0.727) -9.95  (0.754) -9.05  (0.777)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0133
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.60
Confidence Interval (2-Sided) 95%
-2.87 to -0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.26
Confidence Interval (2-Sided) 95%
-3.54 to -0.98
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0394
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.57
Confidence Interval (2-Sided) 95%
-3.06 to -0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 2
Type of Statistical Test Superiority
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 -1.65
Confidence Interval (2-Sided) 95%
-3.16 to -0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0601
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.82
Confidence Interval (2-Sided) 95%
-3.71 to 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0369
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.03
Confidence Interval (2-Sided) 95%
-3.94 to -0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1122
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%
-3.73 to 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4713
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-2.85 to 1.32
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With a >=50% Reduction From Baseline in HAM-D Total Score
Hide Description HAM-D was use to measure the severity of depressive symptoms in participants with primary depressive illness. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The HAM-D Total Score was calculated by summing the individual response scores. The lowest possible score was 0 (absence of depression) and the highest possible score was 52 (most severe measure of depression). For the last observation carried forward analyses, the most recent post randomization total score (as opposed to individual responses) was "carried forward" and used in the calculation of the change from randomization value. If the responses to more than 1 question were missing for a participant at a particular time point, the total score was not calculated. Data was presented as percent of HAM-D responders which was defined as participants who has a >=50% reduction from randomization in HAM-D total score.
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 GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description:
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Overall Number of Participants Analyzed 116 112 111
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 114 participants 112 participants 107 participants
4 7 10
Week 2 Number Analyzed 107 participants 102 participants 93 participants
9 14 13
Week 4 Number Analyzed 97 participants 92 participants 90 participants
22 27 29
Week 6 Number Analyzed 91 participants 83 participants 76 participants
27 37 30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2232
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.15
Confidence Interval (2-Sided) 95%
0.63 to 7.39
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0559
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.15
Confidence Interval (2-Sided) 95%
0.97 to 10.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3395
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
0.64 to 3.61
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4256
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
0.59 to 3.50
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3790
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
0.69 to 2.64
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2554
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
0.76 to 2.86
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1961
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
0.80 to 2.91
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6916
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.58 to 2.25
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Who Maintained Clinical Response by Week 6
Hide Description The start of the ‘maintained antidepressant response’ was the time at which a participant demonstrates a 50% reduction from randomization in their HAM-D total score and where this response was maintained until the end of the treatment phase (week 6). Participants who met the 50% reduction at week 6 without having met it at week 4 were considered to have reached a maintained response, and therefore were censored at week 6. Where a participant met the criteria for maintained antidepressant response, the “time (in days) to maintained antidepressant response” was calculated as: (Date of assessment at which the maintained response commences minus Date of randomization) plus 1. Where a participant did not met the criteria for maintained antidepressant response, their time to response was censored at the last on-treatment assessment they undertake, up to and including the week 6 assessment.
Time Frame Up to Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description:
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Overall Number of Participants Analyzed 116 112 111
Measure Type: Number
Unit of Measure: Participants
14 20 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.50 to 1.95
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.36 to 1.54
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 HAM-D Scale)
Hide Description The BECH scale was extracted from the HAMD-17 and comprised the 6 items (sum of items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D scale): Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic and Somatic Symptoms General. The BECH Total Score was calculated by summing the individual response scores. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The lowest possible score was 0 (absence of depression) and the highest possible score was 22 (most severe measure of depression). Due to the small number of items , missing data was not imputed for the BECH Total Score. If any of the 6 items above were missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in BECH Total Score was the difference between BECH Total Score at the time point being analyzed to randomization.
Time Frame Baseline and 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 GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description:
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Overall Number of Participants Analyzed 116 112 111
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1 Number Analyzed 114 participants 112 participants 107 participants
-1.24  (0.233) -1.94  (0.237) -2.05  (0.241)
Week 2 Number Analyzed 107 participants 102 participants 93 participants
-2.17  (0.287) -2.64  (0.296) -2.79  (0.307)
Week 4 Number Analyzed 97 participants 92 participants 90 participants
-3.34  (0.357) -4.01  (0.368) -4.09  (0.374)
Week 6 Number Analyzed 91 participants 83 participants 76 participants
-3.69  (0.394) -4.78  (0.409) -4.21  (0.421)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0362
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%
-1.34 to -0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0155
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.81
Confidence Interval (2-Sided) 95%
-1.46 to -0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2593
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%
-1.27 to 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1407
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-1.44 to 0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1933
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-1.67 to 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1500
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%
-1.76 to 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0550
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.09
Confidence Interval (2-Sided) 95%
-2.21 to 0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3627
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%
-1.65 to 0.61
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 QIDS-SR assessed symptoms severity of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criterion for major depressive disorder. It consisted of 16 separate items, defining 9 DSM-IV symptom criterion domains. A total score was obtained by summing scores on each domain. The lowest possible score was 0, which represented an absence of depression; the highest possible score was 27, which represented the most severe measure of depression. Due to the small number of items, missing data was not imputed for the QIDS-SR total score. If any of the 9 domains above were missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in total score was the difference between QIDS total score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Time Frame Baseline and 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 GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description:
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Overall Number of Participants Analyzed 116 112 111
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1 Number Analyzed 114 participants 108 participants 107 participants
-2.14  (0.386) -3.17  (0.395) -4.41  (0.399)
Week 2 Number Analyzed 106 participants 101 participants 92 participants
-3.64  (0.445) -5.08  (0.455) -5.48  (0.473)
Week 4 Number Analyzed 96 participants 92 participants 90 participants
-5.20  (0.498) -6.78  (0.510) -7.06  (0.523)
Week 6 Number Analyzed 92 participants 84 participants 74 participants
-6.17  (0.543) -7.70  (0.562) -7.58  (0.588)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0616
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.03
Confidence Interval (2-Sided) 95%
-2.11 to 0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.28
Confidence Interval (2-Sided) 95%
-3.36 to -1.19
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0239
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.44
Confidence Interval (2-Sided) 95%
-2.68 to -0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
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%
-3.12 to -0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0270
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.58
Confidence Interval (2-Sided) 95%
-2.97 to -0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0103
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.86
Confidence Interval (2-Sided) 95%
-3.27 to -0.44
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0497
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.53
Confidence Interval (2-Sided) 95%
-3.06 to -0.00
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0794
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.41
Confidence Interval (2-Sided) 95%
-2.98 to 0.17
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 anxiety score was extracted from the HAM-D-17 and comprises of items 10, 11, 12, 13 and 15 from the HAM-D scale. The anxiety score was calculated by summing the individual response scores to these questions. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The lowest possible score was 0 (absence of depression) and the highest possible score was 18 (most severe measure of depression). Due to the small number of items, missing data was not imputed for the anxiety score. If either of the anxiety items was missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in anxiety score was the difference between the anxiety score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Time Frame Baseline and 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 GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description:
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Overall Number of Participants Analyzed 116 112 111
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1 Number Analyzed 114 participants 112 participants 107 participants
-0.81  (0.169) -1.09  (0.172) -1.57  (0.175)
Week 2 Number Analyzed 107 participants 102 participants 93 participants
-1.40  (0.185) -1.55  (0.189) -1.73  (0.197)
Week 4 Number Analyzed 97 participants 92 participants 90 participants
-1.96  (0.233) -2.31  (0.239) -2.63  (0.243)
Week 6 Number Analyzed 91 participants 83 participants 76 participants
-2.37  (0.235) -2.70  (0.244) -2.56  (0.254)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2400
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.75 to 0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.23 to -0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5605
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.67 to 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2215
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.86 to 0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2870
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-1.01 to 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0465
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-1.33 to -0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3399
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%
-0.99 to 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5931
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.86 to 0.49
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score
Hide Description The CGI-I assessed scores range from 1 – Very much Improved to 7 – Very much worse, with 0 representing a participant that was not assessed. The assessed scores were dichotomized. Scores of 1 or 2 was in the first category, scoring 1. All other scores (except zero which was regarded as missing) was in the second category, scoring 0. The percentage of participants in the first category was calculated for each assessment.
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 GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description:
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Overall Number of Participants Analyzed 116 112 111
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 113 participants 112 participants 108 participants
4 12 9
Week 2 Number Analyzed 107 participants 101 participants 93 participants
10 25 18
Week 4 Number Analyzed 97 participants 92 participants 89 participants
33 36 39
Week 6 Number Analyzed 92 participants 84 participants 76 participants
35 44 42
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0562
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.83
Confidence Interval (2-Sided) 95%
0.97 to 8.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1596
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.22
Confidence Interval (2-Sided) 95%
0.73 to 6.73
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0067
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.91
Confidence Interval (2-Sided) 95%
1.34 to 6.30
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1154
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.93
Confidence Interval (2-Sided) 95%
0.85 to 4.36
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6895
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.62 to 2.07
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3654
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
0.72 to 2.41
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2408
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
0.78 to 2.65
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3066
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
0.74 to 2.60
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-S assessed scores range from 1 – Very much Improved to 7 – Very much worse, with 0 representing a participant that was not assessed. For the CGI-S, remote, blinded MedAvante, raters assessed the participant’s severity of illness considering their total clinical experience with the particular population being studied and information obtained during the Baseline HAMD interview with the participant. Value at randomization was the Baseline value. Change from Baseline in total score was the difference between CGI-S Score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Time Frame Baseline and 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 GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description:
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Overall Number of Participants Analyzed 116 112 111
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1 Number Analyzed 113 participants 112 participants 107 participants
-0.42  (0.075) -0.57  (0.076) -0.69  (0.077)
Week 2 Number Analyzed 107 participants 102 participants 93 participants
-0.58  (0.093) -0.83  (0.095) -0.78  (0.099)
Week 4 Number Analyzed 97 participants 92 participants 90 participants
-0.98  (0.111) -1.25  (0.114) -1.26  (0.116)
Week 6 Number Analyzed 91 participants 83 participants 76 participants
-1.07  (0.123) -1.45  (0.127) -1.27  (0.132)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1472
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.36 to 0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 1
Type of Statistical Test Superiority
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 -0.27
Confidence Interval (2-Sided) 95%
-0.48 to -0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0603
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%
-0.51 to 0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1458
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.46 to 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0941
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.58 to 0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority
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 -0.27
Confidence Interval (2-Sided) 95%
-0.59 to 0.04
Estimation Comments Placebo vs GW823296 60mg: Week 4
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30mg: Week 6
Type of Statistical Test Superiority
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 -0.38
Confidence Interval (2-Sided) 95%
-0.73 to -0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60mg: Week 6
Type of Statistical Test Superiority
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 -0.20
Confidence Interval (2-Sided) 95%
-0.55 to 0.15
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score
Hide Description CPFQ was a brief self-report scale which was designed to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ comprised of 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question was rated on a scale of 1 to 6, with 1 indicating greater than normal functioning, 2, indicating normal functioning, and with higher numbers indicating poorer functioning. Two versions of the CPFQ were utilized during the study. The Baseline CPFQ requested the participant reflect back over the past month. For the treatment period, the CPFQ requested the participant reflect back over the past week. Value at randomization was the Baseline value. Change from Baseline in Total Score was the difference between CPFQ Score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Time Frame Baseline and 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 GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description:
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Overall Number of Participants Analyzed 116 112 111
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1 Number Analyzed 114 participants 111 participants 107 participants
-2.56  (0.543) -4.13  (0.551) -3.30  (0.560)
Week 2 Number Analyzed 107 participants 100 participants 92 participants
-3.43  (0.588) -4.83  (0.605) -5.37  (0.625)
Week 4 Number Analyzed 97 participants 89 participants 86 participants
-5.91  (0.631) -6.68  (0.652) -6.64  (0.670)
Week 6 Number Analyzed 91 participants 82 participants 75 participants
-6.34  (0.688) -7.28  (0.717) -7.53  (0.746)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0421
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.57
Confidence Interval (2-Sided) 95%
-3.08 to -0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3394
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%
-2.27 to 0.78
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0963
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.40
Confidence Interval (2-Sided) 95%
-3.05 to 0.25
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0235
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.94
Confidence Interval (2-Sided) 95%
-3.62 to -0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3956
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%
-2.54 to 1.01
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4273
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.73
Confidence Interval (2-Sided) 95%
-2.53 to 1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3429
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%
-2.89 to 1.01
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2403
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.19
Confidence Interval (2-Sided) 95%
-3.18 to 0.80
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset
Hide Description The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Time Frame Baseline and 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 GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description:
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Overall Number of Participants Analyzed 116 112 111
Least Squares Mean (Standard Error)
Unit of Measure: minutes (min)
Week 1, total sleep time Number Analyzed 111 participants 109 participants 104 participants
20.79  (9.733) 43.31  (9.800) 54.00  (10.056)
Week 2, total sleep time Number Analyzed 103 participants 101 participants 94 participants
34.02  (9.635) 41.64  (9.743) 55.42  (10.128)
Week 4, total sleep time Number Analyzed 97 participants 90 participants 89 participants
33.07  (10.144) 63.94  (10.463) 69.59  (10.641)
Week 6, total sleep time Number Analyzed 90 participants 81 participants 73 participants
52.03  (9.986) 54.21  (10.394) 80.43  (10.956)
Week 1, sleep onset latency Number Analyzed 111 participants 109 participants 104 participants
-12.50  (6.310) -36.40  (6.372) -37.99  (6.547)
Week 2, sleep onset latency Number Analyzed 103 participants 101 participants 94 participants
-21.70  (7.417) -34.15  (7.508) -19.95  (7.815)
Week 4, sleep onset latency Number Analyzed 97 participants 90 participants 89 participants
-27.84  (6.940) -40.76  (7.143) -38.39  (7.290)
Week 6, sleep onset latency Number Analyzed 90 participants 81 participants 73 participants
-18.93  (8.284) -47.51  (8.684) -48.99  (9.163)
Week 1, wake time after sleep onset Number Analyzed 85 participants 81 participants 74 participants
4.61  (4.661) -12.58  (4.807) -11.54  (5.061)
Week 2, wake time after sleep onset Number Analyzed 83 participants 73 participants 68 participants
-8.10  (5.652) -6.21  (6.061) -2.83  (6.298)
Week 4, wake time after sleep onset Number Analyzed 70 participants 60 participants 57 participants
-7.36  (5.087) -9.86  (5.505) -16.80  (5.670)
Week 6, wake time after sleep onset Number Analyzed 61 participants 52 participants 46 participants
1.34  (6.926) -13.17  (7.479) -15.76  (7.932)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 1, total sleep time
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1030
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mixed effects repeated measures model
Estimated Value 22.52
Confidence Interval (2-Sided) 95%
-4.58 to 49.61
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 1, total sleep time
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0179
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 33.21
Confidence Interval (2-Sided) 95%
5.76 to 60.65
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 2, total sleep time
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5773
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.62
Confidence Interval (2-Sided) 95%
-19.25 to 34.49
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 2, total sleep time
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1250
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 21.40
Confidence Interval (2-Sided) 95%
-5.97 to 48.76
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 4, total sleep time
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0344
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 30.87
Confidence Interval (2-Sided) 95%
2.29 to 59.45
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 4, total sleep time
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0131
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 36.52
Confidence Interval (2-Sided) 95%
7.72 to 65.32
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 6, total sleep time
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8794
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.18
Confidence Interval (2-Sided) 95%
-26.10 to 30.46
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 6, total sleep time
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0556
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 28.40
Confidence Interval (2-Sided) 95%
-0.69 to 57.50
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 1, sleep onset latency
Type of Statistical Test Superiority
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 -23.90
Confidence Interval (2-Sided) 95%
-41.46 to -6.33
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 1, sleep onset latency
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -25.49
Confidence Interval (2-Sided) 95%
-43.30 to -7.68
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 2, sleep onset latency
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2373
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -12.45
Confidence Interval (2-Sided) 95%
-33.14 to 8.24
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 2, sleep onset latency
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8707
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.75
Confidence Interval (2-Sided) 95%
-19.38 to 22.87
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo va GW823296 30 mg: Week 4, sleep onset latency
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1933
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -12.92
Confidence Interval (2-Sided) 95%
-32.43 to 6.59
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 4, sleep onset latency
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2933
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -10.55
Confidence Interval (2-Sided) 95%
-30.26 to 9.17
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 6, sleep onset latency
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0177
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -28.58
Confidence Interval (2-Sided) 95%
-52.15 to -5.01
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 6, sleep onset latency
Type of Statistical Test Superiority
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 -30.07
Confidence Interval (2-Sided) 95%
-54.29 to -5.84
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 1, wake time after sleep onset
Type of Statistical Test Superiority
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 -17.19
Confidence Interval (2-Sided) 95%
-30.36 to -4.01
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 1, wake time after sleep onset
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0190
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -16.15
Confidence Interval (2-Sided) 95%
-29.61 to -2.68
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 2, wake time after sleep onset
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8195
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%
-14.43 to 18.21
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 2, wake time after sleep onset
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5327
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.27
Confidence Interval (2-Sided) 95%
-11.35 to 21.89
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 4, wake time after sleep onset
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7387
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.50
Confidence Interval (2-Sided) 95%
-17.24 to 12.25
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 4, wake time after sleep onset
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2134
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9.44
Confidence Interval (2-Sided) 95%
-24.35 to 5.48
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 6, wake time after sleep onset
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1561
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -14.51
Confidence Interval (2-Sided) 95%
-34.61 to 5.60
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 6, wake time after sleep onset
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1054
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -17.10
Confidence Interval (2-Sided) 95%
-37.84 to 3.64
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in the MSQ Number of Nocturnal Awakenings
Hide Description The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Time Frame Baseline and upto 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 GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description:
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Overall Number of Participants Analyzed 116 112 111
Least Squares Mean (Standard Error)
Unit of Measure: Number of awakenings
Week 1 Number Analyzed 85 participants 81 participants 74 participants
-0.06  (0.130) -0.63  (0.134) -0.16  (0.141)
Week 2 Number Analyzed 83 participants 73 participants 68 participants
-0.52  (0.116) -0.77  (0.124) -0.47  (0.130)
Week 4 Number Analyzed 70 participants 60 participants 57 participants
-0.38  (0.174) -0.43  (0.187) -0.78  (0.194)
Week 6 Number Analyzed 61 participants 52 participants 46 participants
-0.63  (0.152) -0.42  (0.165) -0.87  (0.175)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-0.94 to -0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6146
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.47 to 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1442
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%
-0.59 to 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8001
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.30 to 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8439
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.55 to 0.45
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1259
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.91 to 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3709
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.24 to 0.64
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo
Comments Placebo vs GW823296 60 mg: Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2993
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.70 to 0.22
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep
Hide Description The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.
Time Frame Baseline and 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 GW823296 30 mg GW823296 60 mg
Hide Arm/Group Description:
Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Overall Number of Participants Analyzed 116 112 111
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1, sleep quality Number Analyzed 111 participants 109 participants 104 participants
0.73  (0.196) 1.32  (0.198) 1.45  (0.203)
Week 2, sleep quality Number Analyzed 103 participants 101 participants 94 participants
1.03  (0.204) 1.46  (0.206) 1.54  (0.214)
Week 4, sleep quality Number Analyzed 97 participants 90 participants 89 participants
1.39  (0.212) 2.12  (0.219) 1.82  (0.222)
Week 6, sleep quality Number Analyzed 90 participants 81 participants 73 participants
1.77  (0.234) 2.34  (0.243) 2.09  (0.254)
Week 1, refreshing value of sleep Number Analyzed 111 participants 109 participants 104 participants
0.97  (0.193) 1.31  (0.195) 1.60  (0.200)
Week 2, refreshing value of sleep Number Analyzed 103 participants 101 participants 94 participants
1.15  (0.201) 1.48  (0.203) 1.80  (0.211)
Week 4, refreshing value of sleep Number Analyzed 97 participants 90 participants 89 participants
1.61  (0.216) 2.30  (0.223) 2.00  (0.227)
Week 6, refreshing value of sleep Number Analyzed 90 participants 81 participants 73 participants
1.86  (0.242) 2.23  (0.252) 2.57  (0.264)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 1, sleep quality
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0344
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%
0.04 to 1.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 1, sleep quality
Type of Statistical Test Superiority
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 0.72
Confidence Interval (2-Sided) 95%
0.17 to 1.27
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 2, sleep quality
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1443
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
-0.15 to 0.99
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 2, sleep quality
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0873
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
-0.07 to 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 4, sleep quality
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0170
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.13 to 1.33
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 4, sleep quality
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1675
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
-0.18 to 1.02
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 6, sleep quality
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0956
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%
-0.10 to 1.23
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 6, sleep quality
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3503
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%
-0.35 to 1.00
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 1, refreshing value of sleep
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2147
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%
-0.20 to 0.88
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 1, refreshing value of sleep
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0233
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
0.09 to 1.17
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 2, refreshing value of sleep
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2404
Comments [Not Specified]
Method Mixed Models Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
-0.22 to 0.89
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 60 mg
Comments Placebo vs GW823296 60 mg: Week 2, refreshing value of sleep
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0247
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%
0.08 to 1.22
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, GW823296 30 mg
Comments Placebo vs GW823296 30 mg: Week 4, refreshing value of sleep
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0271
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%
0.08 to 1.29
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14