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Trial record 48 of 1067 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02942017
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 90 μg/kg/h
Enrollment 108
Recruitment Details Participants took part in the study at 32 centers in United States from 25 July 2016 to 11 October 2017.
Pre-assignment Details A total of 108 participants were randomized into the study to receive either placebo or SAGE-547, 104 of whom received the study drug.
Arm/Group Title Placebo SAGE-547 90 μg/kg/h
Hide Arm/Group Description Participants received an infusion rate equivalent to the 90 micrograms per kilogram per hour (μg/kg/h) group. 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 54 54
Treated 53 51
Completed 52 48
Not Completed 2 6
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             0             1
Lost to Follow-up             1             1
Randomized but not dosed             1             3
Arm/Group Title Placebo SAGE-547 90 μg/kg/h Total
Hide Arm/Group Description Participants received an infusion rate equivalent to the 90 μg/kg/h group. 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 53 51 104
Hide Baseline Analysis Population Description
Participants who received the study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 51 participants 104 participants
27.3  (5.90) 28.2  (6.09) 27.8  (5.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 51 participants 104 participants
Female
53
 100.0%
51
 100.0%
104
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 51 participants 104 participants
Black or African American
19
  35.8%
22
  43.1%
41
  39.4%
White
33
  62.3%
29
  56.9%
62
  59.6%
Other
1
   1.9%
0
   0.0%
1
   1.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 51 participants 104 participants
Hispanic or Latina
14
  26.4%
10
  19.6%
24
  23.1%
Not Hispanic or Latina
39
  73.6%
41
  80.4%
80
  76.9%
Hamilton Rating Scale for Depression (HAMD) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 53 participants 51 participants 104 participants
22.7  (1.59) 22.6  (1.56) 22.7  (1.57)
[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 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 90 μg/kg/h
Hide Arm/Group Description:
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
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 52 49
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-12.12  (0.773) -14.62  (0.782)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 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 0.0160
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value -2.50
Confidence Interval (2-Sided) 95%
-4.52 to -0.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.019
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 90 μg/kg/h
Hide Arm/Group Description:
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
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 52 48
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-15.23  (0.934) -14.69  (0.955)
Show Statistical Analysis 1 Hide Statistical Analysis 1
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 0.6710
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
-1.98 to 3.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.271
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 90 μg/kg/h
Hide Arm/Group Description:
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
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 53 51
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Change at Hour 2 Number Analyzed 53 participants 51 participants
-4.00  (0.598) -4.60  (0.595)
Change at Hour 4 Number Analyzed 53 participants 51 participants
-6.55  (0.701) -7.32  (0.702)
Change at Hour 8 Number Analyzed 53 participants 51 participants
-7.44  (0.738) -8.38  (0.740)
Change at Hour 12 Number Analyzed 52 participants 50 participants
-7.96  (0.758) -9.10  (0.762)
Change at Hour 24 Number Analyzed 53 participants 50 participants
-9.81  (0.820) -11.42  (0.827)
Change at Hour 36 Number Analyzed 53 participants 49 participants
-10.45  (0.833) -12.31  (0.843)
Change at Hour 48 Number Analyzed 53 participants 49 participants
-10.59  (0.860) -13.00  (0.873)
Change at Hour 72 Number Analyzed 53 participants 49 participants
-11.83  (0.829) -15.31  (0.841)
Change at Day 7 Number Analyzed 53 participants 50 participants
-10.74  (1.042) -13.98  (1.061)
Change at Day 14 Number Analyzed 33 participants 31 participants
-11.40  (0.989) -13.43  (1.013)
Change at Day 21 Number Analyzed 33 participants 32 participants
-13.26  (1.022) -13.59  (1.041)
Show Statistical Analysis 1 Hide Statistical Analysis 1
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 as explanatory variables were 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 0.4216
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-2.06 to 0.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.738
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 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 as explanatory variables were 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 0.3947
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.77
Confidence Interval (2-Sided) 95%
-2.57 to 1.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.905
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 as explanatory variables were 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 0.3280
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-2.86 to 0.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.962
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 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 0.2522
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.14
Confidence Interval (2-Sided) 95%
-3.12 to 0.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.994
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
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 0.1431
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.61
Confidence Interval (2-Sided) 95%
-3.78 to 0.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.091
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 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 0.0991
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.85
Confidence Interval (2-Sided) 95%
-4.06 to 0.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.113
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
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 0.0389
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.42
Confidence Interval (2-Sided) 95%
-4.71 to -0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.155
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 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 0.0022
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.48
Confidence Interval (2-Sided) 95%
-5.67 to -1.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.108
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
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 0.0255
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.24
Confidence Interval (2-Sided) 95%
-6.08 to -0.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.429
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 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 0.1375
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.03
Confidence Interval (2-Sided) 95%
-4.73 to 0.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.356
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
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 0.8170
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-3.11 to 2.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.400
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 90 μg/kg/h
Hide Arm/Group Description:
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
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 53 51
Measure Type: Number
Unit of Measure: percentage of participants
Hour 60 Number Analyzed 52 participants 49 participants
59.6 75.5
Day 7 Number Analyzed 53 participants 50 participants
50.9 66.0
Day 30 Number Analyzed 52 participants 48 participants
78.8 70.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0168
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%
1.2 to 6.7
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 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0482
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 6.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 0.5857
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.3 to 2.0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With HAM-D Remission
Hide Description 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 90 μg/kg/h
Hide Arm/Group Description:
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
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 53 51
Measure Type: Number
Unit of Measure: percentage of participants
Hour 60 Number Analyzed 52 participants 49 participants
38.5 61.2
Day 7 Number Analyzed 53 participants 50 participants
32.1 56.0
Day 30 Number Analyzed 52 participants 48 participants
61.5 47.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
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 remission 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 as explanatory variables were included in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments Hour 60:
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
1.5 to 7.9
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 Day 7: GEE method was used for analysis. The HAM-D remission 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 as explanatory variables were included in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0046
Comments [Not Specified]
Method GEE method
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.7
Confidence Interval (2-Sided) 95%
1.5 to 9.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 remission 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 as explanatory variables were included in the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3085
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%
0.3 to 1.5
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 90 μg/kg/h
Hide Arm/Group Description:
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
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 53 51
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Change at Hour 60 Number Analyzed 52 participants 49 participants
-29.23  (2.248) -37.59  (2.276)
Change at Day 7 Number Analyzed 53 participants 50 participants
-25.05  (2.624) -34.80  (2.668)
Change at Day 30 Number Analyzed 52 participants 48 participants
-36.24  (2.345) -34.86  (2.390)
Show Statistical Analysis 1 Hide Statistical Analysis 1
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 was 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 were 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 0.0063
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -8.35
Confidence Interval (2-Sided) 95%
-14.29 to -2.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.989
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 Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was 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 were 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 0.0074
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -9.75
Confidence Interval (2-Sided) 95%
-16.83 to -2.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.566
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 was 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 were 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 0.6637
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
-4.88 to 7.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.149
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, Hours 2, 4, 8, 12, 24, 36, 48, 60, 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 90 μg/kg/h
Hide Arm/Group Description:
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
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 53 51
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Depressed Mood, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.35  (0.121) -0.45  (0.121)
Depressed Mood, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.67  (0.137) -0.92  (0.138)
Depressed Mood, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.90  (0.136) -1.20  (0.136)
Depressed Mood, Change at Hour 12 Number Analyzed 52 participants 50 participants
-1.05  (0.139) -1.18  (0.140)
Depressed Mood, Change at Hour 24 Number Analyzed 53 participants 50 participants
-1.01  (0.143) -1.34  (0.145)
Depressed Mood, Change at Hour 36 Number Analyzed 53 participants 49 participants
-1.35  (0.145) -1.64  (0.147)
Depressed Mood, Change at Hour 48 Number Analyzed 53 participants 49 participants
-1.33  (0.144) -1.74  (0.146)
Depressed Mood, Change at Hour 60 Number Analyzed 52 participants 49 participants
-1.62  (0.142) -1.91  (0.144)
Depressed Mood, Change at Hour 72 Number Analyzed 53 participants 49 participants
-1.63  (0.137) -1.93  (0.140)
Depressed Mood, Change at Day 7 Number Analyzed 53 participants 50 participants
-1.43  (0.159) -1.82  (0.161)
Depressed Mood, Change at Day 14 Number Analyzed 33 participants 31 participants
-1.42  (0.170) -1.59  (0.174)
Depressed Mood, Change at Day 21 Number Analyzed 33 participants 32 participants
-1.80  (0.168) -1.56  (0.170)
Depressed Mood, Change at Day 30 Number Analyzed 52 participants 48 participants
-2.07  (0.137) -1.89  (0.140)
Feelings of Guilt, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.37  (0.125) -0.59  (0.125)
Feelings of Guilt, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.56  (0.127) -1.00  (0.127)
Feelings of Guilt, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.81  (0.124) -1.04  (0.124)
Feelings of Guilt, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.69  (0.127) -0.98  (0.128)
Feelings of Guilt, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.86  (0.122) -1.16  (0.123)
Feelings of Guilt, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.75  (0.127) -1.09  (0.129)
Feelings of Guilt, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.90  (0.129) -1.11  (0.131)
Feelings of Guilt, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.99  (0.119) -1.28  (0.120)
Feelings of Guilt, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.94  (0.121) -1.34  (0.123)
Feelings of Guilt, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.82  (0.135) -1.14  (0.137)
Feelings of Guilt, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.90  (0.133) -1.00  (0.136)
Feelings of Guilt, Change at Day 21 Number Analyzed 33 participants 32 participants
-1.01  (0.126) -1.11  (0.128)
Feelings of Guilt, Change at Day 30 Number Analyzed 52 participants 48 participants
-1.31  (0.111) -1.20  (0.112)
Suicide, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.11  (0.062) -0.19  (0.062)
Suicide, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.20  (0.062) -0.28  (0.062)
Suicide, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.26  (0.062) -0.32  (0.062)
Suicide, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.27  (0.062) -0.36  (0.062)
Suicide, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.31  (0.062) -0.38  (0.062)
Suicide, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.29  (0.062) -0.38  (0.063)
Suicide, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.29  (0.062) -0.40  (0.063)
Suicide, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.33  (0.062) -0.40  (0.063)
Suicide, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.33  (0.062) -0.40  (0.063)
Suicide, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.29  (0.062) -0.30  (0.062)
Suicide, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.35  (0.068) -0.32  (0.069)
Suicide, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.36  (0.068) -0.36  (0.068)
Suicide, Change at Day 30 Number Analyzed 52 participants 48 participants
-0.37  (0.062) -0.38  (0.063)
Insomnia - Early, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.18  (0.077) -0.22  (0.077)
Insomnia - Early, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.35  (0.092) -0.26  (0.092)
Insomnia - Early, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.28  (0.085) -0.26  (0.085)
Insomnia - Early, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.36  (0.090) -0.25  (0.091)
Insomnia - Early, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.54  (0.111) -0.81  (0.113)
Insomnia - Early, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.62  (0.115) -0.80  (0.117)
Insomnia - Early, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.62  (0.122) -0.94  (0.125)
Insomnia - Early, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.87  (0.130) -0.96  (0.133)
Insomnia - Early, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.54  (0.119) -0.93  (0.122)
Insomnia - Early, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.69  (0.130) -0.95  (0.133)
Insomnia - Early, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.78  (0.142) -0.98  (0.145)
Insomnia - Early, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.98  (0.156) -0.95  (0.157)
Insomnia - Early, Change at Day 30 Number Analyzed 52 participants 48 participants
-1.05  (0.126) -0.96  (0.130)
Insomnia - Middle, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.18  (0.089) -0.08  (0.089)
Insomnia - Middle, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.20  (0.092) -0.22  (0.092)
Insomnia - Middle, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.28  (0.092) -0.22  (0.092)
Insomnia - Middle, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.30  (0.094) -0.15  (0.094)
Insomnia - Middle, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.52  (0.103) -0.84  (0.105)
Insomnia - Middle, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.64  (0.103) -0.91  (0.105)
Insomnia - Middle, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.58  (0.106) -0.88  (0.109)
Insomnia - Middle, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.67  (0.099) -0.96  (0.101)
Insomnia - Middle, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.77  (0.101) -1.00  (0.103)
Insomnia - Middle, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.67  (0.112) -0.89  (0.114)
Insomnia - Middle, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.62  (0.135) -0.85  (0.137)
Insomnia - Middle, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.81  (0.139) -0.79  (0.138)
Insomnia - Middle, Change at Day 30 Number Analyzed 52 participants 48 participants
-0.84  (0.120) -0.91  (0.123)
Insomnia - Late, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.14  (0.091) -0.03  (0.092)
Insomnia - Late, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.20  (0.095) -0.13  (0.096)
Insomnia - Late, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.20  (0.090) -0.23  (0.090)
Insomnia - Late, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.21  (0.091) -0.23  (0.092)
Insomnia - Late, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.54  (0.100) -0.59  (0.101)
Insomnia - Late, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.46  (0.102) -0.45  (0.105)
Insomnia - Late, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.56  (0.097) -0.61  (0.100)
Insomnia - Late, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.60  (0.098) -0.63  (0.100)
Insomnia - Late, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.50  (0.104) -0.76  (0.107)
Insomnia - Late, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.46  (0.100) -0.64  (0.102)
Insomnia - Late, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.27  (0.128) -0.66  (0.130)
Insomnia - Late, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.51  (0.125) -0.64  (0.126)
Insomnia - Late, Change at Day 30 Number Analyzed 52 participants 48 participants
-0.67  (0.099) -0.72  (0.101)
Work and Activities, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.26  (0.109) -0.41  (0.109)
Work and Activities, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.73  (0.130) -0.72  (0.131)
Work and Activities, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.77  (0.139) -1.02  (0.141)
Work and Activities, Change at Hour 12 Number Analyzed 52 participants 50 participants
-1.07  (0.151) -1.18  (0.152)
Work and Activities, Change at Hour 24 Number Analyzed 53 participants 50 participants
-1.34  (0.149) -1.33  (0.151)
Work and Activities, Change at Hour 36 Number Analyzed 53 participants 49 participants
-1.54  (0.146) -1.65  (0.149)
Work and Activities, Change at Hour 48 Number Analyzed 53 participants 49 participants
-1.45  (0.138) -1.71  (0.141)
Work and Activities, Change at Hour 60 Number Analyzed 52 participants 49 participants
-1.60  (0.134) -2.04  (0.136)
Work and Activities, Change at Hour 72 Number Analyzed 53 participants 49 participants
-1.68  (0.143) -2.06  (0.146)
Work and Activities, Change at Day 7 Number Analyzed 53 participants 50 participants
-1.66  (0.157) -1.94  (0.160)
Work and Activities, Change at Day 14 Number Analyzed 33 participants 31 participants
-1.40  (0.161) -1.84  (0.165)
Work and Activities, Change at Day 21 Number Analyzed 33 participants 32 participants
-1.75  (0.174) -1.70  (0.178)
Work and Activities, Change at Day 30 Number Analyzed 52 participants 48 participants
-2.04  (0.142) -2.00  (0.145)
Retardation, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.03  (0.088) 0.06  (0.089)
Retardation, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.20  (0.085) 0.00  (0.086)
Retardation, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.25  (0.085) -0.13  (0.086)
Retardation, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.27  (0.082) -0.29  (0.083)
Retardation, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.18  (0.090) -0.17  (0.092)
Retardation, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.35  (0.082) -0.38  (0.084)
Retardation, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.35  (0.079) -0.24  (0.081)
Retardation, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.46  (0.066) -0.55  (0.068)
Retardation, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.48  (0.073) -0.44  (0.075)
Retardation, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.33  (0.073) -0.55  (0.074)
Retardation, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.47  (0.061) -0.58  (0.060)
Retardation, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.51  (0.070) -0.57  (0.068)
Retardation, Change at Day 30 Number Analyzed 52 participants 48 participants
-0.54  (0.056) -0.55  (0.058)
Agitation, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.27  (0.078) -0.47  (0.078)
Agitation, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.42  (0.082) -0.65  (0.082)
Agitation, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.40  (0.081) -0.71  (0.081)
Agitation, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.32  (0.093) -0.62  (0.094)
Agitation, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.52  (0.081) -0.74  (0.083)
Agitation, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.40  (0.092) -0.66  (0.094)
Agitation, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.44  (0.087) -0.78  (0.089)
Agitation, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.42  (0.097) -0.64  (0.099)
Agitation, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.37  (0.092) -0.74  (0.094)
Agitation, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.39  (0.096) -0.65  (0.097)
Agitation, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.58  (0.107) -0.67  (0.108)
Agitation, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.56  (0.112) -0.65  (0.114)
Agitation, Change at Day 30 Number Analyzed 52 participants 48 participants
-0.60  (0.075) -0.73  (0.077)
Anxiety Psychic, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.45  (0.126) -0.67  (0.126)
Anxiety Psychic, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.81  (0.138) -0.93  (0.138)
Anxiety Psychic, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.89  (0.141) -1.05  (0.142)
Anxiety Psychic, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.89  (0.143) -1.01  (0.144)
Anxiety Psychic, Change at Hour 24 Number Analyzed 53 participants 50 participants
-1.00  (0.140) -1.13  (0.141)
Anxiety Psychic, Change at Hour 36 Number Analyzed 53 participants 49 participants
-1.06  (0.141) -1.20  (0.143)
Anxiety Psychic, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.92  (0.142) -1.24  (0.144)
Anxiety Psychic, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.98  (0.131) -1.51  (0.133)
Anxiety Psychic, Change at Hour 72 Number Analyzed 53 participants 49 participants
-1.08  (0.135) -1.36  (0.137)
Anxiety Psychic, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.70  (0.133) -1.21  (0.134)
Anxiety Psychic, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.76  (0.178) -0.82  (0.184)
Anxiety Psychic, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.94  (0.156) -0.83  (0.158)
Anxiety Psychic, Change at Day 30 Number Analyzed 52 participants 48 participants
-1.25  (0.138) -1.10  (0.141)
Anxiety Somatic, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.54  (0.100) -0.61  (0.101)
Anxiety Somatic, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.71  (0.098) -0.81  (0.099)
Anxiety Somatic, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.62  (0.102) -0.69  (0.103)
Anxiety Somatic, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.60  (0.099) -0.87  (0.100)
Anxiety Somatic, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.73  (0.103) -0.77  (0.105)
Anxiety Somatic, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.75  (0.098) -0.89  (0.100)
Anxiety Somatic, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.79  (0.100) -0.96  (0.103)
Anxiety Somatic, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.88  (0.101) -0.95  (0.104)
Anxiety Somatic, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.84  (0.088) -1.08  (0.090)
Anxiety Somatic, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.66  (0.112) -0.92  (0.114)
Anxiety Somatic, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.85  (0.139) -0.63  (0.139)
Anxiety Somatic, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.90  (0.119) -1.01  (0.118)
Anxiety Somatic, Change at Day 30 Number Analyzed 52 participants 48 participants
-0.88  (0.110) -0.97  (0.113)
Somatic Symptoms GI, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.22  (0.091) -0.15  (0.092)
Somatic Symptoms GI, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.33  (0.096) -0.39  (0.096)
Somatic Symptoms GI, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.56  (0.087) -0.37  (0.087)
Somatic Symptoms GI, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.56  (0.090) -0.45  (0.091)
Somatic Symptoms GI, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.48  (0.083) -0.54  (0.084)
Somatic Symptoms GI, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.60  (0.084) -0.51  (0.086)
Somatic Symptoms GI, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.56  (0.086) -0.59  (0.088)
Somatic Symptoms GI, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.73  (0.091) -0.71  (0.093)
Somatic Symptoms GI, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.77  (0.081) -0.75  (0.082)
Somatic Symptoms GI, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.47  (0.093) -0.67  (0.095)
Somatic Symptoms GI, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.64  (0.093) -0.79  (0.094)
Somatic Symptoms GI, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.61  (0.107) -0.83  (0.108)
Somatic Symptoms GI, Change at Day 30 Number Analyzed 52 participants 48 participants
-0.77  (0.085) -0.73  (0.087)
Somatic Symptoms General, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.18  (0.081) -0.15  (0.079)
Somatic Symptoms General, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.29  (0.095) -0.35  (0.094)
Somatic Symptoms General, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.38  (0.094) -0.45  (0.093)
Somatic Symptoms General, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.50  (0.094) -0.75  (0.093)
Somatic Symptoms General, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.65  (0.104) -0.73  (0.104)
Somatic Symptoms General, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.55  (0.097) -0.69  (0.098)
Somatic Symptoms General, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.61  (0.101) -0.69  (0.102)
Somatic Symptoms General, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.79  (0.105) -0.91  (0.105)
Somatic Symptoms General, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.80  (0.112) -1.05  (0.113)
Somatic Symptoms General, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.57  (0.102) -0.93  (0.103)
Somatic Symptoms General, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.66  (0.118) -0.94  (0.118)
Somatic Symptoms General, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.82  (0.124) -0.67  (0.123)
Somatic Symptoms General, Change at Day 30 Number Analyzed 52 participants 48 participants
-0.77  (0.104) -0.86  (0.106)
Genital Symptoms, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.05  (0.052) 0.07  (0.053)
Genital Symptoms, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.09  (0.065) -0.01  (0.066)
Genital Symptoms, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.07  (0.070) -0.03  (0.070)
Genital Symptoms, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.05  (0.083) -0.09  (0.085)
Genital Symptoms, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.11  (0.089) -0.13  (0.091)
Genital Symptoms, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.18  (0.091) -0.31  (0.094)
Genital Symptoms, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.18  (0.092) -0.39  (0.095)
Genital Symptoms, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.23  (0.084) -0.37  (0.086)
Genital Symptoms, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.22  (0.102) -0.59  (0.105)
Genital Symptoms, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.52  (0.112) -0.57  (0.115)
Genital Symptoms, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.56  (0.149) -0.66  (0.152)
Genital Symptoms, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.67  (0.147) -0.76  (0.149)
Genital Symptoms, Change at Day 30 Number Analyzed 52 participants 48 participants
-0.84  (0.131) -0.62  (0.135)
Hypochondriasis, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.14  (0.077) -0.30  (0.077)
Hypochondriasis, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.20  (0.071) -0.28  (0.071)
Hypochondriasis, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.22  (0.073) -0.26  (0.073)
Hypochondriasis, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.18  (0.076) -0.34  (0.076)
Hypochondriasis, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.37  (0.069) -0.32  (0.069)
Hypochondriasis, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.25  (0.079) -0.30  (0.080)
Hypochondriasis, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.35  (0.075) -0.30  (0.076)
Hypochondriasis, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.29  (0.075) -0.34  (0.075)
Hypochondriasis, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.31  (0.077) -0.36  (0.078)
Hypochondriasis, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.25  (0.088) -0.27  (0.089)
Hypochondriasis, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.14  (0.102) -0.33  (0.104)
Hypochondriasis, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.30  (0.093) -0.35  (0.094)
Hypochondriasis, Change at Day 30 Number Analyzed 52 participants 48 participants
-0.31  (0.069) -0.40  (0.070)
Loss of Weight, Change at Hour 2 Number Analyzed 53 participants 51 participants
-0.11  (0.055) -0.06  (0.055)
Loss of Weight, Change at Hour 4 Number Analyzed 53 participants 51 participants
-0.17  (0.063) -0.02  (0.063)
Loss of Weight, Change at Hour 8 Number Analyzed 53 participants 51 participants
-0.19  (0.053) -0.08  (0.053)
Loss of Weight, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.21  (0.067) -0.02  (0.067)
Loss of Weight, Change at Hour 24 Number Analyzed 53 participants 50 participants
-0.25  (0.067) -0.04  (0.067)
Loss of Weight, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.23  (0.066) -0.15  (0.067)
Loss of Weight, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.23  (0.074) -0.11  (0.076)
Loss of Weight, Change at Hour 60 Number Analyzed 51 participants 49 participants
-0.19  (0.065) -0.19  (0.065)
Loss of Weight, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.15  (0.076) -0.23  (0.078)
Loss of Weight, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.38  (0.091) -0.18  (0.093)
Loss of Weight, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.44  (0.125) -0.39  (0.127)
Loss of Weight, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.38  (0.130) -0.50  (0.132)
Loss of Weight, Change at Day 30 Number Analyzed 52 participants 48 participants
-0.46  (0.111) -0.42  (0.115)
Insight, Change at Hour 2 Number Analyzed 53 participants 51 participants
0.01  (0.034) -0.03  (0.034)
Insight, Change at Hour 4 Number Analyzed 53 participants 51 participants
0.01  (0.034) -0.05  (0.034)
Insight, Change at Hour 8 Number Analyzed 53 participants 51 participants
0.05  (0.034) -0.03  (0.034)
Insight, Change at Hour 12 Number Analyzed 52 participants 50 participants
-0.01  (0.034) -0.03  (0.034)
Insight, Change at Hour 24 Number Analyzed 53 participants 50 participants
0.01  (0.034) -0.05  (0.034)
Insight, Change at Hour 36 Number Analyzed 53 participants 49 participants
-0.01  (0.034) -0.01  (0.034)
Insight, Change at Hour 48 Number Analyzed 53 participants 49 participants
-0.01  (0.034) 0.01  (0.034)
Insight, Change at Hour 60 Number Analyzed 52 participants 49 participants
-0.04  (0.034) 0.01  (0.034)
Insight, Change at Hour 72 Number Analyzed 53 participants 49 participants
-0.01  (0.034) 0.01  (0.034)
Insight, Change at Day 7 Number Analyzed 53 participants 50 participants
-0.02  (0.034) -0.07  (0.034)
Insight, Change at Day 14 Number Analyzed 33 participants 31 participants
-0.02  (0.038) -0.02  (0.038)
Insight, Change at Day 21 Number Analyzed 33 participants 32 participants
-0.02  (0.038) -0.02  (0.038)
Insight, Change at Day 30 Number Analyzed 52 participants 48 participants
-0.02  (0.034) -0.01  (0.034)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.5132
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%
-0.41 to 0.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.154
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, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.1672
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.61 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.181
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0963
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%
-0.65 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.178
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, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.4803
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.49 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.183
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0844
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.71 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.191
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, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.1325
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.68 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.193
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0332
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.79 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.192
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, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.1273
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.67 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.189
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.1059
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%
-0.66 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.182
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, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0683
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.82 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.215
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.4458
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%
-0.64 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.232
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, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.2905
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-0.21 to 0.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.228
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Depressed Mood, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.3096
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-0.18 to 0.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.182
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 Feeling of Guilt, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.1925
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.55 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.165
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Feeling of Guilt, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0101
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%
-0.77 to -0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.168
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 Feeling of Guilt, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.1546
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%
-0.56 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.163
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Feeling of Guilt, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0901
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.62 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.168
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 Feeling of Guilt, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0717
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.62 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.162
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Feeling of Guilt, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0468
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.68 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.169
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 Feeling of Guilt, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.2222
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.56 to 0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.173
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Feeling of Guilt, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0682
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.60 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.156
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 Feeling of Guilt, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0147
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.72 to -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.160
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Feeling of Guilt, Day 7:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0837
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%
-0.68 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.182
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 Feeling of Guilt, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.5828
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%
-0.46 to 0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.179
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Feeling of Guilt, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.5674
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%
-0.43 to 0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.168
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 Feeling of Guilt, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.4613
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%
-0.18 to 0.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.145
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Suicide, Hour 2:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.3240
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%
-0.24 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.082
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 Suicide, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.3023
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%
-0.24 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.082
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Suicide, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.4127
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%
-0.23 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.082
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 Suicide, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.2819
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%
-0.25 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.082
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Suicide, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.3884
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%
-0.23 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.082
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 Suicide, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.2750
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%
-0.25 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.082
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Suicide, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.1811
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%
-0.27 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.082
Estimation Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Suicide, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.3854
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%
-0.23 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.082
Estimation Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Suicide, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.3822
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%
-0.23 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.082
Estimation Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Suicide, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.9255
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%
-0.17 to 0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.082
Estimation Comments [Not Specified]
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Suicide, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.6714
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.14 to 0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.091
Estimation Comments [Not Specified]
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Suicide, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.9838
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%
-0.18 to 0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.091
Estimation Comments [Not Specified]
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Suicide, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.8884
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%
-0.17 to 0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.083
Estimation Comments [Not Specified]
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.6996
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.23 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.097
Estimation Comments [Not Specified]
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.4426
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%
-0.15 to 0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.121
Estimation Comments [Not Specified]
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.8743
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%
-0.20 to 0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.110
Estimation Comments [Not Specified]
Show Statistical Analysis 43 Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.3498
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%
-0.12 to 0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.118
Estimation Comments [Not Specified]
Show Statistical Analysis 44 Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0839
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%
-0.56 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.151
Estimation Comments [Not Specified]
Show Statistical Analysis 45 Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.2595
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%
-0.49 to 0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.157
Estimation Comments [Not Specified]
Show Statistical Analysis 46 Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0560
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%
-0.66 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.168
Estimation Comments [Not Specified]
Show Statistical Analysis 47 Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.6187
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%
-0.45 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.180
Estimation Comments [Not Specified]
Show Statistical Analysis 48 Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Hour 72 MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0187
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.72 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.163
Estimation Comments [Not Specified]
Show Statistical Analysis 49 Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.1531
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%
-0.62 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.180
Estimation Comments [Not Specified]
Show Statistical Analysis 50 Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.3341
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.58 to 0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.197
Estimation Comments [Not Specified]
Show Statistical Analysis 51 Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.8969
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.40 to 0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.216
Estimation Comments [Not Specified]
Show Statistical Analysis 52 Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Early, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.5862
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%
-0.25 to 0.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.174
Estimation Comments [Not Specified]
Show Statistical Analysis 53 Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.3776
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%
-0.13 to 0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.117
Estimation Comments [Not Specified]
Show Statistical Analysis 54 Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.9029
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%
-0.26 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.121
Estimation Comments [Not Specified]
Show Statistical Analysis 55 Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.6173
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%
-0.18 to 0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.121
Estimation Comments [Not Specified]
Show Statistical Analysis 56 Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.2433
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%
-0.10 to 0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.124
Estimation Comments [Not Specified]
Show Statistical Analysis 57 Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Hour 24 MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0234
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%
-0.59 to -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.139
Estimation Comments [Not Specified]
Show Statistical Analysis 58 Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0540
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.55 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.139
Estimation Comments [Not Specified]
Show Statistical Analysis 59 Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0406
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%
-0.58 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.144
Estimation Comments [Not Specified]
Show Statistical Analysis 60 Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0295
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.56 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.132
Estimation Comments [Not Specified]
Show Statistical Analysis 61 Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.0925
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%
-0.50 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.135
Estimation Comments [Not Specified]
Show Statistical Analysis 62 Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.1631
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.52 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.152
Estimation Comments [Not Specified]
Show Statistical Analysis 63 Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.2213
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%
-0.60 to 0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.185
Estimation Comments [Not Specified]
Show Statistical Analysis 64 Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.9175
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%
-0.36 to 0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.189
Estimation Comments [Not Specified]
Show Statistical Analysis 65 Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Placebo, SAGE-547 90 μg/kg/h
Comments Insomnia-Middle, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score 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 0.6763
Comments [Not Specified]
Method MMRM