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Trial record 53 of 1053 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)

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ClinicalTrials.gov Identifier: NCT02942004
Recruitment Status : Completed
First Posted : October 21, 2016
Results First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postpartum Depression
Interventions Drug: Placebo
Drug: SAGE-547 60 μg/kg/h
Drug: SAGE-547 90 μg/kg/h
Enrollment 138
Recruitment Details Participants took part in the study at 32 centers in United States from 01 August 2016 to 19 October 2017.
Pre-assignment Details A total of 138 participants were randomized into the study to receive either placebo or SAGE-547. Forty-three received placebo, and 79 received SAGE-547.
Arm/Group Title Placebo SAGE-547 60 μg/kg/h SAGE-547 90 μg/kg/h
Hide Arm/Group Description Participants received infusion rates equivalent to either the 60 micrograms per kilogram per hour (μg/kg/h) or 90 μg/kg/h group. Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours). Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
Period Title: Overall Study
Started 46 47 45
Participants Who Received Study Drug 43 38 41
Completed 42 35 36
Not Completed 4 12 9
Reason Not Completed
Withdrawal by Subject             0             2             3
Lost to Follow-up             1             1             2
Randomized but not dosed             3             9             4
Arm/Group Title Placebo SAGE-547 60 μg/kg/h SAGE-547 90 μg/kg/h Total
Hide Arm/Group Description Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group. Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours). Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours). Total of all reporting groups
Overall Number of Baseline Participants 43 38 41 122
Hide Baseline Analysis Population Description
All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 38 participants 41 participants 122 participants
27.2  (6.13) 27.7  (6.46) 27.5  (6.05) 27.4  (6.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 38 participants 41 participants 122 participants
Female
43
 100.0%
38
 100.0%
41
 100.0%
122
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 38 participants 41 participants 122 participants
American Indian or Alaska Native
1
   2.3%
0
   0.0%
0
   0.0%
1
   0.8%
Asian
0
   0.0%
0
   0.0%
1
   2.4%
1
   0.8%
Black or African American
15
  34.9%
12
  31.6%
8
  19.5%
35
  28.7%
Native Hawaiian & Other Pacific Islander
0
   0.0%
0
   0.0%
1
   2.4%
1
   0.8%
White
27
  62.8%
25
  65.8%
29
  70.7%
81
  66.4%
Other
0
   0.0%
1
   2.6%
2
   4.9%
3
   2.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 38 participants 41 participants 122 participants
Hispanic or Latina
7
  16.3%
3
   7.9%
7
  17.1%
17
  13.9%
Not Hispanic or Latina
36
  83.7%
35
  92.1%
34
  82.9%
105
  86.1%
Hamilton Rating Scale for Depression (HAM-D) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 43 participants 38 participants 41 participants 122 participants
28.6  (2.54) 29.0  (2.70) 28.4  (2.47) 28.7  (2.55)
[1]
Measure Description: The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression.
1.Primary Outcome
Title Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score
Hide Description The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time Frame Baseline, Hour 60
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo SAGE-547 60 μg/kg/h SAGE-547 90 μg/kg/h
Hide Arm/Group Description:
Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
Overall Number of Participants Analyzed 43 37 39
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-14.04  (1.148) -19.54  (1.231) -17.72  (1.193)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value -5.50
Confidence Interval (2-Sided) 95%
-8.80 to -2.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.664
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0252
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.68
Confidence Interval (2-Sided) 95%
-6.90 to -0.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.622
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in HAM-D Total Score at Day 30
Hide Description The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time Frame Baseline, Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo SAGE-547 60 μg/kg/h SAGE-547 90 μg/kg/h
Hide Arm/Group Description:
Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
Overall Number of Participants Analyzed 42 35 36
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-13.82  (1.324) -19.45  (1.435) -17.62  (1.400)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0044
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.63
Confidence Interval (2-Sided) 95%
-9.46 to -1.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.936
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0481
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.79
Confidence Interval (2-Sided) 95%
-7.56 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.899
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in HAM-D Total Score
Hide Description The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time Frame Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14, and 21
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
Arm/Group Title Placebo SAGE-547 60 μg/kg/h SAGE-547 90 μg/kg/h
Hide Arm/Group Description:
Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
Overall Number of Participants Analyzed 43 38 41
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-5.04  (0.669) -4.99  (0.721) -4.89  (0.707)
Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-6.88  (0.841) -8.99  (0.902) -7.18  (0.879)
Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-8.13  (0.928) -10.18  (0.994) -8.50  (0.966)
Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-9.79  (0.992) -11.04  (1.069) -9.07  (1.034)
Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-10.71  (1.121) -15.00  (1.199) -13.03  (1.157)
Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-12.58  (1.114) -17.69  (1.203) -13.93  (1.157)
Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-13.55  (1.195) -18.04  (1.282) -16.89  (1.239)
Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-14.67  (1.197) -19.69  (1.285) -17.19  (1.243)
Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-13.34  (1.268) -17.41  (1.353) -14.93  (1.315)
Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-14.64  (1.457) -17.56  (1.586) -15.64  (1.521)
Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-13.23  (1.380) -18.15  (1.529) -16.74  (1.451)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9591
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-1.83 to 1.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.951
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8677
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
-1.66 to 1.97
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.917
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0827
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.11
Confidence Interval (2-Sided) 95%
-4.51 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.208
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7968
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-2.62 to 2.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.172
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1292
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.04
Confidence Interval (2-Sided) 95%
-4.69 to 0.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.336
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7801
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-2.94 to 2.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.299
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3840
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.25
Confidence Interval (2-Sided) 95%
-4.10 to 1.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.436
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6097
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.71
Confidence Interval (2-Sided) 0.71%
-2.05 to 3.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.395
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0094
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.28
Confidence Interval (2-Sided) 95%
-7.50 to -1.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.622
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1440
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.32
Confidence Interval (2-Sided) 95%
-5.45 to 0.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.577
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.12
Confidence Interval (2-Sided) 95%
-8.33 to -1.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.620
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3906
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.36
Confidence Interval (2-Sided) 95%
-4.47 to 1.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.572
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0110
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.49
Confidence Interval (2-Sided) 95%
-7.93 to -1.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.735
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0511
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.33
Confidence Interval (2-Sided) 95%
-6.68 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.690
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0046
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.02
Confidence Interval (2-Sided) 95%
-8.47 to -1.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.738
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1389
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.53
Confidence Interval (2-Sided) 95%
-5.88 to 0.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.694
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0288
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.07
Confidence Interval (2-Sided) 95%
-7.71 to -0.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.837
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3799
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.58
Confidence Interval (2-Sided) 95%
-5.15 to 1.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.797
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1747
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.92
Confidence Interval (2-Sided) 95%
-7.16 to 1.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.139
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6310
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.00
Confidence Interval (2-Sided) 95%
-5.13 to 3.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.080
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0178
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.92
Confidence Interval (2-Sided) 95%
-8.98 to -0.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.045
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0786
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.51
Confidence Interval (2-Sided) 95%
-7.43 to 0.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.976
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With HAM-D Response
Hide Description The HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time Frame Hour 60, Days 7 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
Arm/Group Title Placebo SAGE-547 60 μg/kg/h SAGE-547 90 μg/kg/h
Hide Arm/Group Description:
Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
Overall Number of Participants Analyzed 43 38 41
Measure Type: Number
Unit of Measure: percentage of participants
Hour 60 Number Analyzed 43 participants 37 participants 39 participants
55.8 86.5 74.4
Day 7 Number Analyzed 43 participants 38 participants 40 participants
48.8 68.4 52.5
Day 30 Number Analyzed 42 participants 35 participants 36 participants
50.0 82.9 69.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
1.7 to 17.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0493
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
1.0 to 6.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0572
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
1.0 to 6.5
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6768
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.5 to 3.0
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
1.7 to 16.8
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0347
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
1.1 to 7.8
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With HAM-D Remission
Hide Description The HAM-D remission is defined as having a HAM-D total score of ≤7. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time Frame Hour 60, Days 7 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
Arm/Group Title Placebo SAGE-547 60 μg/kg/h SAGE-547 90 μg/kg/h
Hide Arm/Group Description:
Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
Overall Number of Participants Analyzed 43 38 41
Measure Type: Number
Unit of Measure: percentage of participants
Hour 60 Number Analyzed 43 participants 37 participants 39 participants
16.3 51.4 30.8
Day 7 Number Analyzed 43 participants 38 participants 40 participants
30.2 31.6 20.0
Day 30 Number Analyzed 42 participants 35 participants 36 participants
31.0 48.6 38.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.0
Confidence Interval (2-Sided) 95%
2.1 to 17.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0828
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
0.9 to 7.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7749
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.4 to 3.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3401
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.2 to 1.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1052
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
0.8 to 6.0
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3507
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
0.6 to 4.2
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in HAM-D Bech 6 Subscale
Hide Description The HAM-D Bech 6 subscale score is calculated as the sum of the following six items: Item # 1 (depressed mood), Item # 2 (feelings of guilt), Item # 7 (work and activities), Item # 8 (retardation), Item # 10 (anxiety psychic), and Item # 13 (general somatic symptoms). Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores were transformed to a 100-point scale with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time Frame Baseline, Hour 60, Days 7 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
Arm/Group Title Placebo SAGE-547 60 μg/kg/h SAGE-547 90 μg/kg/h
Hide Arm/Group Description:
Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
Overall Number of Participants Analyzed 43 38 41
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-32.60  (2.962) -44.67  (3.178) -38.49  (3.081)
Day 7 Number Analyzed 43 participants 38 participants 40 participants
-29.43  (3.116) -38.52  (3.327) -31.67  (3.236)
Day 30 Number Analyzed 42 participants 35 participants 36 participants
-30.94  (3.122) -42.62  (3.385) -39.20  (3.304)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -12.07
Confidence Interval (2-Sided) 95%
-20.58 to -3.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.294
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1622
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.89
Confidence Interval (2-Sided) 95%
-14.19 to 2.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.188
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0462
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -9.09
Confidence Interval (2-Sided) 95%
-18.02 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.510
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6124
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.24
Confidence Interval (2-Sided) 95%
-10.97 to 6.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.410
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0116
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -11.68
Confidence Interval (2-Sided) 95%
-20.71 to -2.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.556
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0667
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -8.26
Confidence Interval (2-Sided) 95%
-17.10 to 0.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.464
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in HAM-D Individual Item Scores
Hide Description The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time Frame Baseline, Hour 2, Hour 4, Hour 8, Hour 12, Hour 24, Hour 36, Hour 48, Hour 60, Hour 72 and Days 7, 14, 21 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
Arm/Group Title Placebo SAGE-547 60 μg/kg/h SAGE-547 90 μg/kg/h
Hide Arm/Group Description:
Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.
Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).
Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
Overall Number of Participants Analyzed 43 38 41
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Depressed Mood, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.54  (0.133) -0.54  (0.143) -0.45  (0.139)
Depressed Mood, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.79  (0.165) -0.97  (0.176) -0.79  (0.171)
Depressed Mood, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-1.02  (0.166) -1.23  (0.178) -0.94  (0.172)
Depressed Mood, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-1.33  (0.170) -1.50  (0.184) -1.15  (0.177)
Depressed Mood, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-1.40  (0.163) -1.40  (0.175) -1.47  (0.169)
Depressed Mood, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-1.47  (0.170) -2.03  (0.184) -1.49  (0.176)
Depressed Mood, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-1.58  (0.173) -2.07  (0.186) -1.84  (0.180)
Depressed Mood, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-1.56  (0.169) -2.27  (0.181) -1.92  (0.176)
Depressed Mood, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-1.75  (0.162) -2.32  (0.174) -1.97  (0.169)
Depressed Mood, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-1.49  (0.170) -1.94  (0.182) -1.55  (0.177)
Depressed Mood, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-1.53  (0.205) -2.06  (0.225) -1.65  (0.213)
Depressed Mood, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-1.48  (0.204) -1.79  (0.229) -1.75  (0.214)
Depressed Mood, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-1.53  (0.170) -2.19  (0.186) -1.97  (0.183)
Feelings of Guilt, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.46  (0.133) -0.54  (0.143) -0.40  (0.138)
Feelings of Guilt, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.70  (0.157) -1.12  (0.168) -0.84  (0.162)
Feelings of Guilt, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.84  (0.162) -1.25  (0.173) -0.94  (0.168)
Feelings of Guilt, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-1.04  (0.164) -1.25  (0.178) -0.76  (0.171)
Feelings of Guilt, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-1.04  (0.162) -1.50  (0.173) -1.03  (0.167)
Feelings of Guilt, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-1.23  (0.150) -1.59  (0.162) -1.26  (0.156)
Feelings of Guilt, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-1.25  (0.152) -1.64  (0.163) -1.60  (0.158)
Feelings of Guilt, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-1.23  (0.149) -1.68  (0.160) -1.63  (0.155)
Feelings of Guilt, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-1.42  (0.145) -1.69  (0.157) -1.57  (0.152)
Feelings of Guilt, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-1.18  (0.152) -1.38  (0.163) -1.36  (0.159)
Feelings of Guilt, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-1.33  (0.158) -1.49  (0.173) -1.56  (0.169)
Feelings of Guilt, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-1.10  (0.162) -1.51  (0.181) -1.51  (0.171)
Feelings of Guilt, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-1.40  (0.149) -1.61  (0.163) -1.62  (0.161)
Suicide, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.57  (0.101) -0.87  (0.107) -0.48  (0.104)
Suicide, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.64  (0.098) -0.92  (0.105) -0.61  (0.101)
Suicide, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.81  (0.088) -1.00  (0.094) -0.63  (0.091)
Suicide, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.92  (0.089) -0.89  (0.096) -0.66  (0.092)
Suicide, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-0.87  (0.086) -0.96  (0.092) -0.68  (0.088)
Suicide, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.90  (0.068) -1.00  (0.074) -0.75  (0.071)
Suicide, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.88  (0.063) -0.94  (0.069) -0.95  (0.066)
Suicide, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-0.81  (0.065) -1.03  (0.071) -0.98  (0.069)
Suicide, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-0.88  (0.068) -1.01  (0.074) -0.90  (0.071)
Suicide, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-0.71  (0.089) -0.90  (0.095) -0.77  (0.093)
Suicide, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.92  (0.084) -0.99  (0.093) -0.80  (0.090)
Suicide, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.61  (0.133) -0.80  (0.152) -0.88  (0.141)
Suicide, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-0.76  (0.080) -0.99  (0.088) -0.88  (0.086)
Insomnia - Early, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.27  (0.078) -0.04  (0.084) -0.19  (0.082)
Insomnia - Early, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.29  (0.097) -0.22  (0.104) -0.29  (0.100)
Insomnia - Early, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.29  (0.103) -0.17  (0.110) -0.36  (0.107)
Insomnia - Early, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.22  (0.092) -0.25  (0.100) -0.26  (0.097)
Insomnia - Early, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-0.47  (0.138) -1.10  (0.149) -0.87  (0.142)
Insomnia - Early, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.55  (0.142) -1.16  (0.155) -0.84  (0.147)
Insomnia - Early, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.76  (0.144) -1.07  (0.155) -1.27  (0.149)
Insomnia - Early, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-0.85  (0.140) -1.10  (0.151) -1.19  (0.146)
Insomnia - Early, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-0.57  (0.142) -0.96  (0.153) -0.91  (0.148)
Insomnia - Early, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-0.69  (0.144) -1.20  (0.154) -0.97  (0.150)
Insomnia - Early, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.97  (0.174) -1.19  (0.192) -1.06  (0.182)
Insomnia - Early, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.69  (0.154) -1.28  (0.173) -1.11  (0.160)
Insomnia - Early, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-0.67  (0.141) -1.34  (0.155) -1.09  (0.153)
Insomnia - Middle, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.13  (0.073) 0.03  (0.078) -0.17  (0.076)
Insomnia - Middle, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.16  (0.096) -0.21  (0.102) -0.24  (0.099)
Insomnia - Middle, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.20  (0.099) -0.16  (0.105) -0.32  (0.102)
Insomnia - Middle, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.16  (0.091) -0.18  (0.098) -0.22  (0.095)
Insomnia - Middle, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-0.57  (0.135) -0.98  (0.145) -0.93  (0.139)
Insomnia - Middle, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.74  (0.130) -1.03  (0.141) -1.02  (0.135)
Insomnia - Middle, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.90  (0.132) -1.17  (0.142) -1.19  (0.137)
Insomnia - Middle, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-0.83  (0.130) -1.22  (0.140) -1.23  (0.135)
Insomnia - Middle, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-0.93  (0.132) -1.22  (0.143) -1.09  (0.138)
Insomnia - Middle, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-0.95  (0.128) -1.05  (0.136) -0.87  (0.133)
Insomnia - Middle, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.72  (0.146) -1.36  (0.161) -0.98  (0.154)
Insomnia - Middle, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.77  (0.146) -1.27  (0.164) -0.90  (0.152)
Insomnia - Middle, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-0.78  (0.134) -1.21  (0.147) -0.99  (0.144)
Insomnia - Late, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.16  (0.090) 0.01  (0.096) -0.22  (0.094)
Insomnia - Late, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.16  (0.104) -0.12  (0.111) -0.34  (0.108)
Insomnia - Late, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.14  (0.103) -0.20  (0.110) -0.37  (0.106)
Insomnia - Late, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.16  (0.103) -0.01  (0.111) -0.31  (0.107)
Insomnia - Late, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-0.68  (0.123) -0.94  (0.133) -0.95  (0.127)
Insomnia - Late, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.75  (0.127) -0.91  (0.139) -0.90  (0.132)
Insomnia - Late, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.89  (0.125) -1.16  (0.135) -1.15  (0.130)
Insomnia - Late, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-0.89  (0.121) -1.16  (0.130) -1.22  (0.126)
Insomnia - Late, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-1.07  (0.121) -1.13  (0.131) -1.12  (0.126)
Insomnia - Late, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-0.89  (0.126) -0.80  (0.135) -1.04  (0.132)
Insomnia - Late, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.79  (0.155) -0.96  (0.172) -0.86  (0.164)
Insomnia - Late, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.77  (0.157) -0.89  (0.176) -0.74  (0.164)
Insomnia - Late, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-0.77  (0.130) -1.03  (0.143) -1.09  (0.140)
Work and Activities, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.30  (0.105) -0.43  (0.113) -0.25  (0.111)
Work and Activities, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.51  (0.126) -0.74  (0.135) -0.43  (0.131)
Work and Activities, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.81  (0.160) -0.95  (0.170) -0.67  (0.165)
Work and Activities, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-1.02  (0.160) -1.20  (0.173) -0.83  (0.166)
Work and Activities, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-1.07  (0.169) -1.19  (0.180) -1.04  (0.174)
Work and Activities, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-1.39  (0.162) -1.77  (0.176) -1.09  (0.168)
Work and Activities, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-1.51  (0.179) -1.80  (0.192) -1.57  (0.185)
Work and Activities, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-1.46  (0.171) -2.04  (0.184) -1.70  (0.178)
Work and Activities, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-1.67  (0.164) -2.18  (0.177) -1.67  (0.171)
Work and Activities, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-1.39  (0.176) -1.82  (0.187) -1.57  (0.182)
Work and Activities, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-1.58  (0.198) -1.57  (0.218) -1.60  (0.208)
Work and Activities, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-1.35  (0.191) -1.96  (0.214) -1.87  (0.200)
Work and Activities, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-1.55  (0.174) -2.08  (0.189) -1.93  (0.185)
Retardation, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.18  (0.084) 0.17  (0.090) -0.01  (0.087)
Retardation, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.34  (0.090) -0.02  (0.096) -0.03  (0.093)
Retardation, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.36  (0.092) -0.20  (0.098) -0.16  (0.095)
Retardation, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.57  (0.099) -0.47  (0.107) -0.42  (0.103)
Retardation, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-0.48  (0.092) -0.47  (0.099) -0.47  (0.095)
Retardation, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.71  (0.103) -0.87  (0.112) -0.65  (0.107)
Retardation, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.57  (0.098) -0.70  (0.105) -0.60  (0.101)
Retardation, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-0.76  (0.090) -0.84  (0.097) -0.74  (0.094)
Retardation, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-0.67  (0.092) -0.87  (0.099) -0.80  (0.096)
Retardation, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-0.67  (0.091) -1.02  (0.097) -0.70  (0.095)
Retardation, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.74  (0.117) -0.87  (0.128) -0.77  (0.123)
Retardation, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.72  (0.104) -1.05  (0.115) -0.81  (0.108)
Retardation, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-0.66  (0.088) -1.08  (0.096) -0.91  (0.095)
Agitation, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.46  (0.108) -0.52  (0.115) -0.45  (0.111)
Agitation, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.56  (0.103) -0.70  (0.109) -0.52  (0.106)
Agitation, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.51  (0.112) -0.68  (0.119) -0.55  (0.116)
Agitation, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.56  (0.114) -0.65  (0.123) -0.59  (0.118)
Agitation, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-0.54  (0.108) -0.86  (0.115) -0.69  (0.110)
Agitation, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.63  (0.111) -0.82  (0.121) -0.74  (0.115)
Agitation, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.74  (0.098) -0.78  (0.105) -0.78  (0.102)
Agitation, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-0.58  (0.105) -0.85  (0.113) -0.70  (0.110)
Agitation, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-0.65  (0.112) -0.85  (0.120) -0.82  (0.116)
Agitation, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-0.60  (0.098) -0.78  (0.104) -0.66  (0.102)
Agitation, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.87  (0.114) -0.75  (0.126) -0.82  (0.121)
Agitation, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.61  (0.142) -0.69  (0.161) -0.76  (0.149)
Agitation, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-0.64  (0.112) -0.80  (0.122) -0.62  (0.121)
Anxiety Psychic, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.60  (0.134) -0.70  (0.144) -0.76  (0.140)
Anxiety Psychic, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.90  (0.158) -1.26  (0.169) -1.12  (0.164)
Anxiety Psychic, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-1.25  (0.161) -1.41  (0.172) -1.22  (0.167)
Anxiety Psychic, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-1.39  (0.154) -1.52  (0.167) -1.35  (0.161)
Anxiety Psychic, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-1.16  (0.148) -1.79  (0.159) -1.59  (0.153)
Anxiety Psychic, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-1.37  (0.149) -1.99  (0.162) -1.41  (0.155)
Anxiety Psychic, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-1.41  (0.149) -1.86  (0.161) -1.71  (0.156)
Anxiety Psychic, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-1.48  (0.141) -1.97  (0.152) -1.64  (0.149)
Anxiety Psychic, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-1.55  (0.152) -1.84  (0.164) -1.61  (0.159)
Anxiety Psychic, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-1.25  (0.149) -1.44  (0.160) -1.30  (0.156)
Anxiety Psychic, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-1.42  (0.184) -1.45  (0.204) -1.17  (0.195)
Anxiety Psychic, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-1.17  (0.197) -1.26  (0.221) -1.34  (0.207)
Anxiety Psychic, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-1.15  (0.161) -1.45  (0.176) -1.43  (0.173)
Anxiety Somatic, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.56  (0.133) -0.67  (0.142) -0.75  (0.137)
Anxiety Somatic, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.86  (0.144) -1.09  (0.154) -0.88  (0.149)
Anxiety Somatic, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.79  (0.135) -1.22  (0.145) -1.05  (0.140)
Anxiety Somatic, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.86  (0.130) -1.16  (0.141) -0.91  (0.135)
Anxiety Somatic, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-0.77  (0.116) -1.24  (0.125) -1.12  (0.120)
Anxiety Somatic, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.86  (0.127) -1.34  (0.140) -1.08  (0.133)
Anxiety Somatic, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.86  (0.125) -1.42  (0.136) -1.20  (0.131)
Anxiety Somatic, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-1.00  (0.122) -1.58  (0.132) -1.31  (0.128)
Anxiety Somatic, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-0.91  (0.131) -1.58  (0.142) -1.29  (0.137)
Anxiety Somatic, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-0.91  (0.134) -1.28  (0.143) -0.98  (0.140)
Anxiety Somatic, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.70  (0.153) -1.08  (0.169) -0.88  (0.162)
Anxiety Somatic, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.94  (0.155) -1.40  (0.175) -1.05  (0.163)
Anxiety Somatic, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-0.80  (0.151) -1.40  (0.166) -0.99  (0.163)
Somatic Symptoms GI, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.28  (0.110) -0.29  (0.118) -0.30  (0.114)
Somatic Symptoms GI, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.28  (0.103) -0.55  (0.111) -0.44  (0.107)
Somatic Symptoms GI, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.42  (0.109) -0.60  (0.117) -0.57  (0.113)
Somatic Symptoms GI, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.51  (0.111) -0.79  (0.121) -0.56  (0.116)
Somatic Symptoms GI, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-0.47  (0.115) -0.88  (0.123) -0.79  (0.118)
Somatic Symptoms GI, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.54  (0.111) -1.14  (0.122) -0.78  (0.116)
Somatic Symptoms GI, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.61  (0.110) -1.16  (0.119) -0.84  (0.115)
Somatic Symptoms GI, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-0.82  (0.100) -1.24  (0.109) -0.96  (0.106)
Somatic Symptoms GI, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-0.68  (0.102) -1.23  (0.111) -1.01  (0.107)
Somatic Symptoms GI, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-0.63  (0.114) -1.00  (0.123) -0.66  (0.119)
Somatic Symptoms GI, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.77  (0.126) -1.03  (0.139) -0.89  (0.134)
Somatic Symptoms GI, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.70  (0.132) -1.17  (0.149) -0.91  (0.139)
Somatic Symptoms GI, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-0.82  (0.112) -1.14  (0.123) -0.91  (0.121)
Somatic Symptoms General, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.23  (0.086) -0.28  (0.092) -0.14  (0.089)
Somatic Symptoms General, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.27  (0.093) -0.44  (0.099) -0.33  (0.096)
Somatic Symptoms General, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.27  (0.093) -0.33  (0.099) -0.28  (0.096)
Somatic Symptoms General, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.51  (0.108) -0.50  (0.117) -0.49  (0.113)
Somatic Symptoms General, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-0.60  (0.119) -0.67  (0.127) -0.55  (0.122)
Somatic Symptoms General, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.64  (0.111) -0.70  (0.122) -0.79  (0.116)
Somatic Symptoms General, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.67  (0.113) -1.05  (0.122) -0.90  (0.117)
Somatic Symptoms General, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-0.78  (0.111) -1.06  (0.120) -0.95  (0.117)
Somatic Symptoms General, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-0.81  (0.113) -1.26  (0.121) -1.00  (0.117)
Somatic Symptoms General, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-0.62  (0.121) -0.91  (0.129) -0.61  (0.125)
Somatic Symptoms General, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.64  (0.138) -0.92  (0.152) -0.59  (0.144)
Somatic Symptoms General, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.55  (0.138) -1.04  (0.154) -0.72  (0.144)
Somatic Symptoms General, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-0.66  (0.129) -1.00  (0.140) -0.95  (0.137)
Genital Symptoms, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
0.00  (0.055) 0.00  (0.059) -0.16  (0.057)
Genital Symptoms, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
0.00  (0.067) -0.11  (0.072) -0.13  (0.069)
Genital Symptoms, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.07  (0.087) -0.16  (0.093) -0.16  (0.090)
Genital Symptoms, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.07  (0.075) -0.08  (0.082) -0.24  (0.079)
Genital Symptoms, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-0.16  (0.100) -0.28  (0.106) -0.28  (0.102)
Genital Symptoms, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.23  (0.102) -0.46  (0.111) -0.51  (0.106)
Genital Symptoms, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.35  (0.107) -0.46  (0.115) -0.63  (0.110)
Genital Symptoms, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-0.35  (0.108) -0.48  (0.116) -0.67  (0.112)
Genital Symptoms, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-0.32  (0.107) -0.57  (0.115) -0.72  (0.110)
Genital Symptoms, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-0.51  (0.113) -0.71  (0.120) -0.79  (0.117)
Genital Symptoms, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.49  (0.131) -0.70  (0.144) -0.83  (0.138)
Genital Symptoms, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.68  (0.141) -0.90  (0.159) -0.87  (0.147)
Genital Symptoms, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-0.82  (0.131) -0.97  (0.143) -0.95  (0.140)
Hypochondriasis, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.23  (0.105) -0.29  (0.113) -0.34  (0.109)
Hypochondriasis, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.32  (0.111) -0.39  (0.119) -0.34  (0.116)
Hypochondriasis, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.23  (0.114) -0.47  (0.122) -0.41  (0.118)
Hypochondriasis, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.32  (0.109) -0.41  (0.118) -0.44  (0.114)
Hypochondriasis, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-0.39  (0.105) -0.55  (0.112) -0.48  (0.109)
Hypochondriasis, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.39  (0.104) -0.61  (0.113) -0.49  (0.109)
Hypochondriasis, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.49  (0.105) -0.63  (0.113) -0.58  (0.109)
Hypochondriasis, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-0.49  (0.100) -0.60  (0.108) -0.59  (0.105)
Hypochondriasis, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-0.60  (0.098) -0.66  (0.106) -0.55  (0.103)
Hypochondriasis, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-0.49  (0.095) -0.68  (0.102) -0.58  (0.100)
Hypochondriasis, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.54  (0.120) -0.59  (0.132) -0.51  (0.127)
Hypochondriasis, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.84  (0.107) -0.80  (0.119) -0.57  (0.114)
Hypochondriasis, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-0.60  (0.099) -0.66  (0.109) -0.60  (0.108)
Loss of Weight, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.05  (0.057) 0.03  (0.061) 0.06  (0.059)
Loss of Weight, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.07  (0.052) -0.04  (0.055) 0.01  (0.054)
Loss of Weight, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.07  (0.060) -0.02  (0.064) -0.04  (0.062)
Loss of Weight, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.09  (0.068) 0.03  (0.074) -0.09  (0.071)
Loss of Weight, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
-0.07  (0.084) -0.12  (0.090) -0.24  (0.086)
Loss of Weight, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.14  (0.076) -0.10  (0.082) -0.19  (0.079)
Loss of Weight, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.05  (0.083) -0.12  (0.089) -0.26  (0.086)
Loss of Weight, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-0.09  (0.095) -0.26  (0.102) -0.35  (0.098)
Loss of Weight, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-0.14  (0.090) -0.20  (0.097) -0.26  (0.094)
Loss of Weight, Change at Day 7 Number Analyzed 43 participants 38 participants 39 participants
-0.30  (0.129) -0.36  (0.137) -0.60  (0.135)
Loss of Weight, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.43  (0.150) -0.42  (0.164) -0.64  (0.158)
Loss of Weight, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.49  (0.160) -0.59  (0.177) -0.61  (0.169)
Loss of Weight, Change at Day 30 Number Analyzed 42 participants 35 participants 35 participants
-0.24  (0.133) -0.55  (0.144) -0.48  (0.143)
Insight, Change at Hour 2 Number Analyzed 43 participants 38 participants 41 participants
-0.01  (0.037) 0.02  (0.040) 0.02  (0.039)
Insight, Change at Hour 4 Number Analyzed 43 participants 38 participants 41 participants
-0.01  (0.037) -0.01  (0.040) 0.04  (0.039)
Insight, Change at Hour 8 Number Analyzed 43 participants 38 participants 41 participants
-0.03  (0.037) -0.04  (0.040) 0.04  (0.039)
Insight, Change at Hour 12 Number Analyzed 43 participants 36 participants 40 participants
-0.03  (0.037) -0.06  (0.041) 0.07  (0.039)
Insight, Change at Hour 24 Number Analyzed 42 participants 37 participants 41 participants
0.04  (0.038) -0.01  (0.040) 0.04  (0.039)
Insight, Change at Hour 36 Number Analyzed 43 participants 35 participants 40 participants
-0.03  (0.037) -0.04  (0.041) -0.01  (0.039)
Insight, Change at Hour 48 Number Analyzed 43 participants 37 participants 40 participants
-0.03  (0.037) 0.02  (0.040) 0.02  (0.039)
Insight, Change at Hour 60 Number Analyzed 43 participants 37 participants 39 participants
-0.06  (0.037) -0.06  (0.040) -0.09  (0.039)
Insight, Change at Hour 72 Number Analyzed 43 participants 37 participants 40 participants
-0.06  (0.037) -0.01  (0.040) -0.06  (0.039)
Insight, Change at Day 7 Number Analyzed 43 participants 38 participants 40 participants
-0.06  (0.037) -0.06  (0.040) -0.03  (0.039)
Insight, Change at Day 14 Number Analyzed 29 participants 23 participants 26 participants
-0.03  (0.041) -0.07  (0.045) -0.09  (0.044)
Insight, Change at Day 21 Number Analyzed 29 participants 22 participants 27 participants
-0.10  (0.042) -0.08  (0.047) -0.09  (0.044)
Insight, Change at Day 30 Number Analyzed 42 participants 35 participants 36 participants
-0.01  (0.038) -0.06  (0.041) -0.08  (0.041)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9681
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.39 to 0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.191
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6337
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.28 to 0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.185
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4690
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.64 to 0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.238
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9905
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.46 to 0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.232
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3984
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.68 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.240
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7042
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.37 to 0.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.234
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4941
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.66 to 0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.247
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4572
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.30 to 0.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.240
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9866
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.47 to 0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.236
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7490
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.53 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.229
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0235
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-1.06 to -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.247
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9286
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.50 to 0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.239
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0544
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.99 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.251
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2903
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-0.74 to 0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.244
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0044
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-1.19 to -0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.244
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1339
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.83 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.238
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0149
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-1.04 to -0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.234
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3213
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.68 to 0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.228
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0703
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.94 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.246
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8152
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.53 to 0.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.240
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0805
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-1.13 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.301
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6964
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.69 to 0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.291
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2998
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.92 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.304
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3448
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.85 to 0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.291
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0089
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-1.15 to -0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.248
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0772
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-0.92 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.244
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6809
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.46 to 0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.191
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7297
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.30 to 0.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.185
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0626
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-0.87 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.226
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5196
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.58 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.220
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 60 μg/kg/h
Comments Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0772
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.88 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.234
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6610
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.55 to 0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.228
Estimation Comments [Not Specified]