Trial Outcomes & Findings for A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C) (NCT NCT02942017)
NCT ID: NCT02942017
Last Updated: 2025-09-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
108 participants
Primary outcome timeframe
Baseline, Hour 60
Results posted on
2025-09-15
Participant Flow
Participants took part in the study at 32 centers in United States from 25 July 2016 to 11 October 2017.
A total of 108 participants were randomized into the study to receive either placebo or SAGE-547, 104 of whom received the study drug.
Participant milestones
| Measure |
Placebo
Participants received an infusion rate equivalent to the 90 micrograms per kilogram per hour (μg/kg/h) group.
|
SAGE-547 90 μg/kg/h
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 Study
STARTED
|
54
|
54
|
|
Overall Study
Treated
|
53
|
51
|
|
Overall Study
COMPLETED
|
52
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Participants received an infusion rate equivalent to the 90 micrograms per kilogram per hour (μg/kg/h) group.
|
SAGE-547 90 μg/kg/h
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 Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Randomized but not dosed
|
1
|
3
|
Baseline Characteristics
A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)
Baseline characteristics by cohort
| Measure |
Placebo
n=53 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 Participants
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
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.3 years
STANDARD_DEVIATION 5.90 • n=5 Participants
|
28.2 years
STANDARD_DEVIATION 6.09 • n=7 Participants
|
27.8 years
STANDARD_DEVIATION 5.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latina
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latina
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Hamilton Rating Scale for Depression (HAMD) Total Score
|
22.7 score on a scale
STANDARD_DEVIATION 1.59 • n=5 Participants
|
22.6 score on a scale
STANDARD_DEVIATION 1.56 • n=7 Participants
|
22.7 score on a scale
STANDARD_DEVIATION 1.57 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Hour 60Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=49 Participants
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).
|
|---|---|---|
|
Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score
|
-12.12 score on a scale
Standard Error 0.773
|
-14.62 score on a scale
Standard Error 0.782
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=52 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=48 Participants
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).
|
|---|---|---|
|
Change From Baseline in HAM-D Total Score at Day 30
|
-15.23 score on a scale
Standard Error 0.934
|
-14.69 score on a scale
Standard Error 0.955
|
SECONDARY outcome
Timeframe: Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14 and 21Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 Participants
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).
|
|---|---|---|
|
Change From Baseline in HAM-D Total Score
Change at Hour 48
|
-10.59 score on a scale
Standard Error 0.860
|
-13.00 score on a scale
Standard Error 0.873
|
|
Change From Baseline in HAM-D Total Score
Change at Hour 2
|
-4.00 score on a scale
Standard Error 0.598
|
-4.60 score on a scale
Standard Error 0.595
|
|
Change From Baseline in HAM-D Total Score
Change at Hour 4
|
-6.55 score on a scale
Standard Error 0.701
|
-7.32 score on a scale
Standard Error 0.702
|
|
Change From Baseline in HAM-D Total Score
Change at Hour 8
|
-7.44 score on a scale
Standard Error 0.738
|
-8.38 score on a scale
Standard Error 0.740
|
|
Change From Baseline in HAM-D Total Score
Change at Hour 12
|
-7.96 score on a scale
Standard Error 0.758
|
-9.10 score on a scale
Standard Error 0.762
|
|
Change From Baseline in HAM-D Total Score
Change at Hour 24
|
-9.81 score on a scale
Standard Error 0.820
|
-11.42 score on a scale
Standard Error 0.827
|
|
Change From Baseline in HAM-D Total Score
Change at Hour 36
|
-10.45 score on a scale
Standard Error 0.833
|
-12.31 score on a scale
Standard Error 0.843
|
|
Change From Baseline in HAM-D Total Score
Change at Hour 72
|
-11.83 score on a scale
Standard Error 0.829
|
-15.31 score on a scale
Standard Error 0.841
|
|
Change From Baseline in HAM-D Total Score
Change at Day 7
|
-10.74 score on a scale
Standard Error 1.042
|
-13.98 score on a scale
Standard Error 1.061
|
|
Change From Baseline in HAM-D Total Score
Change at Day 14
|
-11.40 score on a scale
Standard Error 0.989
|
-13.43 score on a scale
Standard Error 1.013
|
|
Change From Baseline in HAM-D Total Score
Change at Day 21
|
-13.26 score on a scale
Standard Error 1.022
|
-13.59 score on a scale
Standard Error 1.041
|
SECONDARY outcome
Timeframe: Hour 60, Days 7 and 30Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 Participants
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).
|
|---|---|---|
|
Percentage of Participants With HAM-D Response
Hour 60
|
59.6 percentage of participants
|
75.5 percentage of participants
|
|
Percentage of Participants With HAM-D Response
Day 7
|
50.9 percentage of participants
|
66.0 percentage of participants
|
|
Percentage of Participants With HAM-D Response
Day 30
|
78.8 percentage of participants
|
70.8 percentage of participants
|
SECONDARY outcome
Timeframe: Hour 60, Days 7 and 30Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 Participants
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).
|
|---|---|---|
|
Percentage of Participants With HAM-D Remission
Hour 60
|
38.5 percentage of participants
|
61.2 percentage of participants
|
|
Percentage of Participants With HAM-D Remission
Day 7
|
32.1 percentage of participants
|
56.0 percentage of participants
|
|
Percentage of Participants With HAM-D Remission
Day 30
|
61.5 percentage of participants
|
47.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Hour 60, Days 7 and 30Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 Participants
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).
|
|---|---|---|
|
Change From Baseline in HAM-D Bech 6 Subscale
Change at Hour 60
|
-29.23 score on a scale
Standard Error 2.248
|
-37.59 score on a scale
Standard Error 2.276
|
|
Change From Baseline in HAM-D Bech 6 Subscale
Change at Day 7
|
-25.05 score on a scale
Standard Error 2.624
|
-34.80 score on a scale
Standard Error 2.668
|
|
Change From Baseline in HAM-D Bech 6 Subscale
Change at Day 30
|
-36.24 score on a scale
Standard Error 2.345
|
-34.86 score on a scale
Standard Error 2.390
|
SECONDARY outcome
Timeframe: Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 60, 72, and Days 7, 14, 21, and 30Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 Participants
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).
|
|---|---|---|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Day 7
|
-0.38 score on a scale
Standard Error 0.091
|
-0.18 score on a scale
Standard Error 0.093
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Hour 4
|
0.01 score on a scale
Standard Error 0.034
|
-0.05 score on a scale
Standard Error 0.034
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Day 7
|
-1.43 score on a scale
Standard Error 0.159
|
-1.82 score on a scale
Standard Error 0.161
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Day 14
|
-1.42 score on a scale
Standard Error 0.170
|
-1.59 score on a scale
Standard Error 0.174
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Day 30
|
-2.07 score on a scale
Standard Error 0.137
|
-1.89 score on a scale
Standard Error 0.140
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Hour 60
|
-0.99 score on a scale
Standard Error 0.119
|
-1.28 score on a scale
Standard Error 0.120
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Hour 4
|
-0.20 score on a scale
Standard Error 0.085
|
0.00 score on a scale
Standard Error 0.086
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Day 14
|
-0.47 score on a scale
Standard Error 0.061
|
-0.58 score on a scale
Standard Error 0.060
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Hour 2
|
-0.45 score on a scale
Standard Error 0.126
|
-0.67 score on a scale
Standard Error 0.126
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Hour 24
|
-0.73 score on a scale
Standard Error 0.103
|
-0.77 score on a scale
Standard Error 0.105
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Hour 36
|
-0.18 score on a scale
Standard Error 0.091
|
-0.31 score on a scale
Standard Error 0.094
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Hour 60
|
-0.88 score on a scale
Standard Error 0.101
|
-0.95 score on a scale
Standard Error 0.104
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Day 7
|
-0.66 score on a scale
Standard Error 0.112
|
-0.92 score on a scale
Standard Error 0.114
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Day 14
|
-0.85 score on a scale
Standard Error 0.139
|
-0.63 score on a scale
Standard Error 0.139
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Day 21
|
-0.90 score on a scale
Standard Error 0.119
|
-1.01 score on a scale
Standard Error 0.118
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Day 30
|
-0.88 score on a scale
Standard Error 0.110
|
-0.97 score on a scale
Standard Error 0.113
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Hour 2
|
-0.22 score on a scale
Standard Error 0.091
|
-0.15 score on a scale
Standard Error 0.092
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Hour 24
|
-0.48 score on a scale
Standard Error 0.083
|
-0.54 score on a scale
Standard Error 0.084
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Hour 36
|
-0.60 score on a scale
Standard Error 0.084
|
-0.51 score on a scale
Standard Error 0.086
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Hour 60
|
-0.73 score on a scale
Standard Error 0.091
|
-0.71 score on a scale
Standard Error 0.093
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Day 21
|
-0.61 score on a scale
Standard Error 0.107
|
-0.83 score on a scale
Standard Error 0.108
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Day 30
|
-0.77 score on a scale
Standard Error 0.085
|
-0.73 score on a scale
Standard Error 0.087
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Hour 4
|
-0.29 score on a scale
Standard Error 0.095
|
-0.35 score on a scale
Standard Error 0.094
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Hour 24
|
-0.65 score on a scale
Standard Error 0.104
|
-0.73 score on a scale
Standard Error 0.104
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Hour 36
|
-0.55 score on a scale
Standard Error 0.097
|
-0.69 score on a scale
Standard Error 0.098
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Hour 48
|
-0.61 score on a scale
Standard Error 0.101
|
-0.69 score on a scale
Standard Error 0.102
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Hour 60
|
-0.79 score on a scale
Standard Error 0.105
|
-0.91 score on a scale
Standard Error 0.105
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Hour 72
|
-0.80 score on a scale
Standard Error 0.112
|
-1.05 score on a scale
Standard Error 0.113
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Day 7
|
-0.57 score on a scale
Standard Error 0.102
|
-0.93 score on a scale
Standard Error 0.103
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Day 14
|
-0.66 score on a scale
Standard Error 0.118
|
-0.94 score on a scale
Standard Error 0.118
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Day 21
|
-0.82 score on a scale
Standard Error 0.124
|
-0.67 score on a scale
Standard Error 0.123
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Day 30
|
-0.77 score on a scale
Standard Error 0.104
|
-0.86 score on a scale
Standard Error 0.106
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Hour 12
|
-0.05 score on a scale
Standard Error 0.083
|
-0.09 score on a scale
Standard Error 0.085
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Hour 24
|
-0.11 score on a scale
Standard Error 0.089
|
-0.13 score on a scale
Standard Error 0.091
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Hour 48
|
-0.18 score on a scale
Standard Error 0.092
|
-0.39 score on a scale
Standard Error 0.095
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Hour 60
|
-0.23 score on a scale
Standard Error 0.084
|
-0.37 score on a scale
Standard Error 0.086
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Hour 72
|
-0.22 score on a scale
Standard Error 0.102
|
-0.59 score on a scale
Standard Error 0.105
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Day 7
|
-0.52 score on a scale
Standard Error 0.112
|
-0.57 score on a scale
Standard Error 0.115
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Day 14
|
-0.56 score on a scale
Standard Error 0.149
|
-0.66 score on a scale
Standard Error 0.152
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Day 21
|
-0.67 score on a scale
Standard Error 0.147
|
-0.76 score on a scale
Standard Error 0.149
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Day 30
|
-0.84 score on a scale
Standard Error 0.131
|
-0.62 score on a scale
Standard Error 0.135
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Hour 2
|
-0.14 score on a scale
Standard Error 0.077
|
-0.30 score on a scale
Standard Error 0.077
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Hour 4
|
-0.20 score on a scale
Standard Error 0.071
|
-0.28 score on a scale
Standard Error 0.071
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Hour 8
|
-0.22 score on a scale
Standard Error 0.073
|
-0.26 score on a scale
Standard Error 0.073
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Hour 12
|
-0.18 score on a scale
Standard Error 0.076
|
-0.34 score on a scale
Standard Error 0.076
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Hour 24
|
-0.37 score on a scale
Standard Error 0.069
|
-0.32 score on a scale
Standard Error 0.069
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Hour 36
|
-0.25 score on a scale
Standard Error 0.079
|
-0.30 score on a scale
Standard Error 0.080
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Hour 48
|
-0.35 score on a scale
Standard Error 0.075
|
-0.30 score on a scale
Standard Error 0.076
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Hour 60
|
-0.29 score on a scale
Standard Error 0.075
|
-0.34 score on a scale
Standard Error 0.075
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Hour 72
|
-0.31 score on a scale
Standard Error 0.077
|
-0.36 score on a scale
Standard Error 0.078
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Day 7
|
-0.25 score on a scale
Standard Error 0.088
|
-0.27 score on a scale
Standard Error 0.089
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Day 14
|
-0.14 score on a scale
Standard Error 0.102
|
-0.33 score on a scale
Standard Error 0.104
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Day 21
|
-0.30 score on a scale
Standard Error 0.093
|
-0.35 score on a scale
Standard Error 0.094
|
|
Change From Baseline in HAM-D Individual Item Scores
Hypochondriasis, Change at Day 30
|
-0.31 score on a scale
Standard Error 0.069
|
-0.40 score on a scale
Standard Error 0.070
|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Hour 2
|
-0.11 score on a scale
Standard Error 0.055
|
-0.06 score on a scale
Standard Error 0.055
|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Hour 4
|
-0.17 score on a scale
Standard Error 0.063
|
-0.02 score on a scale
Standard Error 0.063
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Hour 36
|
-1.35 score on a scale
Standard Error 0.145
|
-1.64 score on a scale
Standard Error 0.147
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Hour 24
|
0.01 score on a scale
Standard Error 0.034
|
-0.05 score on a scale
Standard Error 0.034
|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Hour 8
|
-0.19 score on a scale
Standard Error 0.053
|
-0.08 score on a scale
Standard Error 0.053
|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Hour 12
|
-0.21 score on a scale
Standard Error 0.067
|
-0.02 score on a scale
Standard Error 0.067
|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Hour 24
|
-0.25 score on a scale
Standard Error 0.067
|
-0.04 score on a scale
Standard Error 0.067
|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Hour 36
|
-0.23 score on a scale
Standard Error 0.066
|
-0.15 score on a scale
Standard Error 0.067
|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Hour 48
|
-0.23 score on a scale
Standard Error 0.074
|
-0.11 score on a scale
Standard Error 0.076
|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Hour 60
|
-0.19 score on a scale
Standard Error 0.065
|
-0.19 score on a scale
Standard Error 0.065
|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Hour 72
|
-0.15 score on a scale
Standard Error 0.076
|
-0.23 score on a scale
Standard Error 0.078
|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Day 14
|
-0.44 score on a scale
Standard Error 0.125
|
-0.39 score on a scale
Standard Error 0.127
|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Day 21
|
-0.38 score on a scale
Standard Error 0.130
|
-0.50 score on a scale
Standard Error 0.132
|
|
Change From Baseline in HAM-D Individual Item Scores
Loss of Weight, Change at Day 30
|
-0.46 score on a scale
Standard Error 0.111
|
-0.42 score on a scale
Standard Error 0.115
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Hour 2
|
0.01 score on a scale
Standard Error 0.034
|
-0.03 score on a scale
Standard Error 0.034
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Hour 36
|
-0.01 score on a scale
Standard Error 0.034
|
-0.01 score on a scale
Standard Error 0.034
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Hour 48
|
-0.01 score on a scale
Standard Error 0.034
|
0.01 score on a scale
Standard Error 0.034
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Hour 60
|
-0.04 score on a scale
Standard Error 0.034
|
0.01 score on a scale
Standard Error 0.034
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Hour 72
|
-0.01 score on a scale
Standard Error 0.034
|
0.01 score on a scale
Standard Error 0.034
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Day 7
|
-0.02 score on a scale
Standard Error 0.034
|
-0.07 score on a scale
Standard Error 0.034
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Day 14
|
-0.02 score on a scale
Standard Error 0.038
|
-0.02 score on a scale
Standard Error 0.038
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Day 21
|
-0.02 score on a scale
Standard Error 0.038
|
-0.02 score on a scale
Standard Error 0.038
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Day 30
|
-0.02 score on a scale
Standard Error 0.034
|
-0.01 score on a scale
Standard Error 0.034
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Hour 8
|
0.05 score on a scale
Standard Error 0.034
|
-0.03 score on a scale
Standard Error 0.034
|
|
Change From Baseline in HAM-D Individual Item Scores
Insight, Change at Hour 12
|
-0.01 score on a scale
Standard Error 0.034
|
-0.03 score on a scale
Standard Error 0.034
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Hour 12
|
-1.05 score on a scale
Standard Error 0.139
|
-1.18 score on a scale
Standard Error 0.140
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Hour 24
|
-1.01 score on a scale
Standard Error 0.143
|
-1.34 score on a scale
Standard Error 0.145
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Hour 2
|
-0.35 score on a scale
Standard Error 0.121
|
-0.45 score on a scale
Standard Error 0.121
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Hour 4
|
-0.67 score on a scale
Standard Error 0.137
|
-0.92 score on a scale
Standard Error 0.138
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Hour 8
|
-0.90 score on a scale
Standard Error 0.136
|
-1.20 score on a scale
Standard Error 0.136
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Hour 48
|
-1.33 score on a scale
Standard Error 0.144
|
-1.74 score on a scale
Standard Error 0.146
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Hour 60
|
-1.62 score on a scale
Standard Error 0.142
|
-1.91 score on a scale
Standard Error 0.144
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Hour 72
|
-1.63 score on a scale
Standard Error 0.137
|
-1.93 score on a scale
Standard Error 0.140
|
|
Change From Baseline in HAM-D Individual Item Scores
Depressed Mood, Change at Day 21
|
-1.80 score on a scale
Standard Error 0.168
|
-1.56 score on a scale
Standard Error 0.170
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Hour 2
|
-0.37 score on a scale
Standard Error 0.125
|
-0.59 score on a scale
Standard Error 0.125
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Hour 4
|
-0.56 score on a scale
Standard Error 0.127
|
-1.00 score on a scale
Standard Error 0.127
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Hour 8
|
-0.81 score on a scale
Standard Error 0.124
|
-1.04 score on a scale
Standard Error 0.124
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Hour 12
|
-0.69 score on a scale
Standard Error 0.127
|
-0.98 score on a scale
Standard Error 0.128
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Hour 24
|
-0.86 score on a scale
Standard Error 0.122
|
-1.16 score on a scale
Standard Error 0.123
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Hour 36
|
-0.75 score on a scale
Standard Error 0.127
|
-1.09 score on a scale
Standard Error 0.129
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Hour 48
|
-0.90 score on a scale
Standard Error 0.129
|
-1.11 score on a scale
Standard Error 0.131
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Hour 72
|
-0.94 score on a scale
Standard Error 0.121
|
-1.34 score on a scale
Standard Error 0.123
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Day 7
|
-0.82 score on a scale
Standard Error 0.135
|
-1.14 score on a scale
Standard Error 0.137
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Day 14
|
-0.90 score on a scale
Standard Error 0.133
|
-1.00 score on a scale
Standard Error 0.136
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Day 21
|
-1.01 score on a scale
Standard Error 0.126
|
-1.11 score on a scale
Standard Error 0.128
|
|
Change From Baseline in HAM-D Individual Item Scores
Feelings of Guilt, Change at Day 30
|
-1.31 score on a scale
Standard Error 0.111
|
-1.20 score on a scale
Standard Error 0.112
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Hour 2
|
-0.11 score on a scale
Standard Error 0.062
|
-0.19 score on a scale
Standard Error 0.062
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Hour 4
|
-0.20 score on a scale
Standard Error 0.062
|
-0.28 score on a scale
Standard Error 0.062
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Hour 8
|
-0.26 score on a scale
Standard Error 0.062
|
-0.32 score on a scale
Standard Error 0.062
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Hour 12
|
-0.27 score on a scale
Standard Error 0.062
|
-0.36 score on a scale
Standard Error 0.062
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Hour 24
|
-0.31 score on a scale
Standard Error 0.062
|
-0.38 score on a scale
Standard Error 0.062
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Hour 36
|
-0.29 score on a scale
Standard Error 0.062
|
-0.38 score on a scale
Standard Error 0.063
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Hour 48
|
-0.29 score on a scale
Standard Error 0.062
|
-0.40 score on a scale
Standard Error 0.063
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Hour 60
|
-0.33 score on a scale
Standard Error 0.062
|
-0.40 score on a scale
Standard Error 0.063
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Hour 72
|
-0.33 score on a scale
Standard Error 0.062
|
-0.40 score on a scale
Standard Error 0.063
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Day 7
|
-0.29 score on a scale
Standard Error 0.062
|
-0.30 score on a scale
Standard Error 0.062
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Day 14
|
-0.35 score on a scale
Standard Error 0.068
|
-0.32 score on a scale
Standard Error 0.069
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Day 21
|
-0.36 score on a scale
Standard Error 0.068
|
-0.36 score on a scale
Standard Error 0.068
|
|
Change From Baseline in HAM-D Individual Item Scores
Suicide, Change at Day 30
|
-0.37 score on a scale
Standard Error 0.062
|
-0.38 score on a scale
Standard Error 0.063
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Hour 2
|
-0.18 score on a scale
Standard Error 0.077
|
-0.22 score on a scale
Standard Error 0.077
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Hour 4
|
-0.35 score on a scale
Standard Error 0.092
|
-0.26 score on a scale
Standard Error 0.092
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Hour 8
|
-0.28 score on a scale
Standard Error 0.085
|
-0.26 score on a scale
Standard Error 0.085
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Hour 12
|
-0.36 score on a scale
Standard Error 0.090
|
-0.25 score on a scale
Standard Error 0.091
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Hour 24
|
-0.54 score on a scale
Standard Error 0.111
|
-0.81 score on a scale
Standard Error 0.113
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Hour 36
|
-0.62 score on a scale
Standard Error 0.115
|
-0.80 score on a scale
Standard Error 0.117
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Hour 48
|
-0.62 score on a scale
Standard Error 0.122
|
-0.94 score on a scale
Standard Error 0.125
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Hour 60
|
-0.87 score on a scale
Standard Error 0.130
|
-0.96 score on a scale
Standard Error 0.133
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Hour 72
|
-0.54 score on a scale
Standard Error 0.119
|
-0.93 score on a scale
Standard Error 0.122
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Day 7
|
-0.69 score on a scale
Standard Error 0.130
|
-0.95 score on a scale
Standard Error 0.133
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Day 14
|
-0.78 score on a scale
Standard Error 0.142
|
-0.98 score on a scale
Standard Error 0.145
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Day 21
|
-0.98 score on a scale
Standard Error 0.156
|
-0.95 score on a scale
Standard Error 0.157
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Early, Change at Day 30
|
-1.05 score on a scale
Standard Error 0.126
|
-0.96 score on a scale
Standard Error 0.130
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Hour 2
|
-0.18 score on a scale
Standard Error 0.089
|
-0.08 score on a scale
Standard Error 0.089
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Hour 4
|
-0.20 score on a scale
Standard Error 0.092
|
-0.22 score on a scale
Standard Error 0.092
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Hour 8
|
-0.28 score on a scale
Standard Error 0.092
|
-0.22 score on a scale
Standard Error 0.092
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Hour 12
|
-0.30 score on a scale
Standard Error 0.094
|
-0.15 score on a scale
Standard Error 0.094
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Hour 24
|
-0.52 score on a scale
Standard Error 0.103
|
-0.84 score on a scale
Standard Error 0.105
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Hour 36
|
-0.64 score on a scale
Standard Error 0.103
|
-0.91 score on a scale
Standard Error 0.105
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Hour 48
|
-0.58 score on a scale
Standard Error 0.106
|
-0.88 score on a scale
Standard Error 0.109
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Hour 60
|
-0.67 score on a scale
Standard Error 0.099
|
-0.96 score on a scale
Standard Error 0.101
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Hour 72
|
-0.77 score on a scale
Standard Error 0.101
|
-1.00 score on a scale
Standard Error 0.103
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Day 7
|
-0.67 score on a scale
Standard Error 0.112
|
-0.89 score on a scale
Standard Error 0.114
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Day 14
|
-0.62 score on a scale
Standard Error 0.135
|
-0.85 score on a scale
Standard Error 0.137
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Day 21
|
-0.81 score on a scale
Standard Error 0.139
|
-0.79 score on a scale
Standard Error 0.138
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Middle, Change at Day 30
|
-0.84 score on a scale
Standard Error 0.120
|
-0.91 score on a scale
Standard Error 0.123
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Hour 2
|
-0.14 score on a scale
Standard Error 0.091
|
-0.03 score on a scale
Standard Error 0.092
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Hour 4
|
-0.20 score on a scale
Standard Error 0.095
|
-0.13 score on a scale
Standard Error 0.096
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Hour 8
|
-0.20 score on a scale
Standard Error 0.090
|
-0.23 score on a scale
Standard Error 0.090
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Hour 12
|
-0.21 score on a scale
Standard Error 0.091
|
-0.23 score on a scale
Standard Error 0.092
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Hour 24
|
-0.54 score on a scale
Standard Error 0.100
|
-0.59 score on a scale
Standard Error 0.101
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Hour 36
|
-0.46 score on a scale
Standard Error 0.102
|
-0.45 score on a scale
Standard Error 0.105
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Hour 48
|
-0.56 score on a scale
Standard Error 0.097
|
-0.61 score on a scale
Standard Error 0.100
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Hour 60
|
-0.60 score on a scale
Standard Error 0.098
|
-0.63 score on a scale
Standard Error 0.100
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Hour 72
|
-0.50 score on a scale
Standard Error 0.104
|
-0.76 score on a scale
Standard Error 0.107
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Day 7
|
-0.46 score on a scale
Standard Error 0.100
|
-0.64 score on a scale
Standard Error 0.102
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Day 14
|
-0.27 score on a scale
Standard Error 0.128
|
-0.66 score on a scale
Standard Error 0.130
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Day 21
|
-0.51 score on a scale
Standard Error 0.125
|
-0.64 score on a scale
Standard Error 0.126
|
|
Change From Baseline in HAM-D Individual Item Scores
Insomnia - Late, Change at Day 30
|
-0.67 score on a scale
Standard Error 0.099
|
-0.72 score on a scale
Standard Error 0.101
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Hour 2
|
-0.26 score on a scale
Standard Error 0.109
|
-0.41 score on a scale
Standard Error 0.109
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Hour 4
|
-0.73 score on a scale
Standard Error 0.130
|
-0.72 score on a scale
Standard Error 0.131
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Hour 8
|
-0.77 score on a scale
Standard Error 0.139
|
-1.02 score on a scale
Standard Error 0.141
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Hour 12
|
-1.07 score on a scale
Standard Error 0.151
|
-1.18 score on a scale
Standard Error 0.152
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Hour 24
|
-1.34 score on a scale
Standard Error 0.149
|
-1.33 score on a scale
Standard Error 0.151
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Hour 36
|
-1.54 score on a scale
Standard Error 0.146
|
-1.65 score on a scale
Standard Error 0.149
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Hour 48
|
-1.45 score on a scale
Standard Error 0.138
|
-1.71 score on a scale
Standard Error 0.141
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Hour 60
|
-1.60 score on a scale
Standard Error 0.134
|
-2.04 score on a scale
Standard Error 0.136
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Hour 72
|
-1.68 score on a scale
Standard Error 0.143
|
-2.06 score on a scale
Standard Error 0.146
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Day 7
|
-1.66 score on a scale
Standard Error 0.157
|
-1.94 score on a scale
Standard Error 0.160
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Day 14
|
-1.40 score on a scale
Standard Error 0.161
|
-1.84 score on a scale
Standard Error 0.165
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Day 21
|
-1.75 score on a scale
Standard Error 0.174
|
-1.70 score on a scale
Standard Error 0.178
|
|
Change From Baseline in HAM-D Individual Item Scores
Work and Activities, Change at Day 30
|
-2.04 score on a scale
Standard Error 0.142
|
-2.00 score on a scale
Standard Error 0.145
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Hour 2
|
-0.03 score on a scale
Standard Error 0.088
|
0.06 score on a scale
Standard Error 0.089
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Hour 8
|
-0.25 score on a scale
Standard Error 0.085
|
-0.13 score on a scale
Standard Error 0.086
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Hour 12
|
-0.27 score on a scale
Standard Error 0.082
|
-0.29 score on a scale
Standard Error 0.083
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Hour 24
|
-0.18 score on a scale
Standard Error 0.090
|
-0.17 score on a scale
Standard Error 0.092
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Hour 36
|
-0.35 score on a scale
Standard Error 0.082
|
-0.38 score on a scale
Standard Error 0.084
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Hour 48
|
-0.35 score on a scale
Standard Error 0.079
|
-0.24 score on a scale
Standard Error 0.081
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Hour 60
|
-0.46 score on a scale
Standard Error 0.066
|
-0.55 score on a scale
Standard Error 0.068
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Hour 72
|
-0.48 score on a scale
Standard Error 0.073
|
-0.44 score on a scale
Standard Error 0.075
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Day 7
|
-0.33 score on a scale
Standard Error 0.073
|
-0.55 score on a scale
Standard Error 0.074
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Day 21
|
-0.51 score on a scale
Standard Error 0.070
|
-0.57 score on a scale
Standard Error 0.068
|
|
Change From Baseline in HAM-D Individual Item Scores
Retardation, Change at Day 30
|
-0.54 score on a scale
Standard Error 0.056
|
-0.55 score on a scale
Standard Error 0.058
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Hour 2
|
-0.27 score on a scale
Standard Error 0.078
|
-0.47 score on a scale
Standard Error 0.078
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Hour 4
|
-0.42 score on a scale
Standard Error 0.082
|
-0.65 score on a scale
Standard Error 0.082
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Hour 8
|
-0.40 score on a scale
Standard Error 0.081
|
-0.71 score on a scale
Standard Error 0.081
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Hour 12
|
-0.32 score on a scale
Standard Error 0.093
|
-0.62 score on a scale
Standard Error 0.094
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Hour 24
|
-0.52 score on a scale
Standard Error 0.081
|
-0.74 score on a scale
Standard Error 0.083
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Hour 36
|
-0.40 score on a scale
Standard Error 0.092
|
-0.66 score on a scale
Standard Error 0.094
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Hour 48
|
-0.44 score on a scale
Standard Error 0.087
|
-0.78 score on a scale
Standard Error 0.089
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Hour 60
|
-0.42 score on a scale
Standard Error 0.097
|
-0.64 score on a scale
Standard Error 0.099
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Hour 72
|
-0.37 score on a scale
Standard Error 0.092
|
-0.74 score on a scale
Standard Error 0.094
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Day 7
|
-0.39 score on a scale
Standard Error 0.096
|
-0.65 score on a scale
Standard Error 0.097
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Day 14
|
-0.58 score on a scale
Standard Error 0.107
|
-0.67 score on a scale
Standard Error 0.108
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Day 21
|
-0.56 score on a scale
Standard Error 0.112
|
-0.65 score on a scale
Standard Error 0.114
|
|
Change From Baseline in HAM-D Individual Item Scores
Agitation, Change at Day 30
|
-0.60 score on a scale
Standard Error 0.075
|
-0.73 score on a scale
Standard Error 0.077
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Hour 4
|
-0.81 score on a scale
Standard Error 0.138
|
-0.93 score on a scale
Standard Error 0.138
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Hour 8
|
-0.89 score on a scale
Standard Error 0.141
|
-1.05 score on a scale
Standard Error 0.142
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Hour 12
|
-0.89 score on a scale
Standard Error 0.143
|
-1.01 score on a scale
Standard Error 0.144
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Hour 24
|
-1.00 score on a scale
Standard Error 0.140
|
-1.13 score on a scale
Standard Error 0.141
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Hour 36
|
-1.06 score on a scale
Standard Error 0.141
|
-1.20 score on a scale
Standard Error 0.143
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Hour 48
|
-0.92 score on a scale
Standard Error 0.142
|
-1.24 score on a scale
Standard Error 0.144
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Hour 60
|
-0.98 score on a scale
Standard Error 0.131
|
-1.51 score on a scale
Standard Error 0.133
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Hour 72
|
-1.08 score on a scale
Standard Error 0.135
|
-1.36 score on a scale
Standard Error 0.137
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Day 7
|
-0.70 score on a scale
Standard Error 0.133
|
-1.21 score on a scale
Standard Error 0.134
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Day 14
|
-0.76 score on a scale
Standard Error 0.178
|
-0.82 score on a scale
Standard Error 0.184
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Day 21
|
-0.94 score on a scale
Standard Error 0.156
|
-0.83 score on a scale
Standard Error 0.158
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Psychic, Change at Day 30
|
-1.25 score on a scale
Standard Error 0.138
|
-1.10 score on a scale
Standard Error 0.141
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Hour 2
|
-0.54 score on a scale
Standard Error 0.100
|
-0.61 score on a scale
Standard Error 0.101
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Hour 4
|
-0.71 score on a scale
Standard Error 0.098
|
-0.81 score on a scale
Standard Error 0.099
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Hour 8
|
-0.62 score on a scale
Standard Error 0.102
|
-0.69 score on a scale
Standard Error 0.103
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Hour 12
|
-0.60 score on a scale
Standard Error 0.099
|
-0.87 score on a scale
Standard Error 0.100
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Hour 36
|
-0.75 score on a scale
Standard Error 0.098
|
-0.89 score on a scale
Standard Error 0.100
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Hour 48
|
-0.79 score on a scale
Standard Error 0.100
|
-0.96 score on a scale
Standard Error 0.103
|
|
Change From Baseline in HAM-D Individual Item Scores
Anxiety Somatic, Change at Hour 72
|
-0.84 score on a scale
Standard Error 0.088
|
-1.08 score on a scale
Standard Error 0.090
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Hour 4
|
-0.33 score on a scale
Standard Error 0.096
|
-0.39 score on a scale
Standard Error 0.096
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Hour 8
|
-0.56 score on a scale
Standard Error 0.087
|
-0.37 score on a scale
Standard Error 0.087
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Hour 12
|
-0.56 score on a scale
Standard Error 0.090
|
-0.45 score on a scale
Standard Error 0.091
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Hour 48
|
-0.56 score on a scale
Standard Error 0.086
|
-0.59 score on a scale
Standard Error 0.088
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Hour 72
|
-0.77 score on a scale
Standard Error 0.081
|
-0.75 score on a scale
Standard Error 0.082
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Day 7
|
-0.47 score on a scale
Standard Error 0.093
|
-0.67 score on a scale
Standard Error 0.095
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms GI, Change at Day 14
|
-0.64 score on a scale
Standard Error 0.093
|
-0.79 score on a scale
Standard Error 0.094
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Hour 2
|
-0.18 score on a scale
Standard Error 0.081
|
-0.15 score on a scale
Standard Error 0.079
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Hour 8
|
-0.38 score on a scale
Standard Error 0.094
|
-0.45 score on a scale
Standard Error 0.093
|
|
Change From Baseline in HAM-D Individual Item Scores
Somatic Symptoms General, Change at Hour 12
|
-0.50 score on a scale
Standard Error 0.094
|
-0.75 score on a scale
Standard Error 0.093
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Hour 2
|
-0.05 score on a scale
Standard Error 0.052
|
0.07 score on a scale
Standard Error 0.053
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Hour 4
|
-0.09 score on a scale
Standard Error 0.065
|
-0.01 score on a scale
Standard Error 0.066
|
|
Change From Baseline in HAM-D Individual Item Scores
Genital Symptoms, Change at Hour 8
|
-0.07 score on a scale
Standard Error 0.070
|
-0.03 score on a scale
Standard Error 0.070
|
SECONDARY outcome
Timeframe: Baseline, Hour 60, Days 7 and 30Population: 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.
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicates more severe depression. A negative change from baseline indicates less severe depression. A positive change from baseline indicates more severe depression.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 Participants
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).
|
|---|---|---|
|
Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Day 7
|
-15.35 score on a scale
Standard Deviation 1.658
|
-18.91 score on a scale
Standard Deviation 1.676
|
|
Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Day 30
|
-20.52 score on a scale
Standard Deviation 1.489
|
-20.48 score on a scale
Standard Deviation 1.504
|
|
Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Hour 60
|
-15.66 score on a scale
Standard Deviation 1.329
|
-20.52 score on a scale
Standard Deviation 1.333
|
SECONDARY outcome
Timeframe: Hour 60, Days 7 and 30Population: 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.
The CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response
Day 30
|
78.8 percentage of participants
|
81.3 percentage of participants
|
|
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response
Hour 60
|
55.8 percentage of participants
|
79.6 percentage of participants
|
|
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response
Day 7
|
54.7 percentage of participants
|
70.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Hour 60, Days 7, 14, 21 and 30Population: 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.
The GAD-7 is a participant-rated, generalized anxiety symptom severity scale. Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = "not at all sure," 1 = "several days," 2 = "over half the days," and 3 = "nearly every day" to the response categories. The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety. The GAD-7 total score was calculated as the sum of the seven individual item scores. A negative change from baseline indicates less anxiety. A positive change from baseline indicates more anxiety.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 Participants
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).
|
|---|---|---|
|
Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score
Hour 60
|
-6.41 score on a scale
Standard Error 0.814
|
-7.58 score on a scale
Standard Error 0.850
|
|
Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score
Day 7
|
-7.67 score on a scale
Standard Error 0.858
|
-8.43 score on a scale
Standard Error 0.879
|
|
Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score
Day 14
|
-7.90 score on a scale
Standard Error 0.937
|
-9.76 score on a scale
Standard Error 0.961
|
|
Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score
Day 21
|
-8.92 score on a scale
Standard Error 1.053
|
-10.88 score on a scale
Standard Error 1.081
|
|
Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score
Day 30
|
-9.89 score on a scale
Standard Error 0.884
|
-10.20 score on a scale
Standard Error 0.913
|
SECONDARY outcome
Timeframe: Up to approximately 37 daysPopulation: The safety set included all randomized participants who started the study drug infusion.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Event (TEAE)
|
45.3 percentage of participants
|
49.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 37 daysPopulation: 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.
The time to first start or increase in the dose and time to first stop or decrease in the dose of any antidepressant medication.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 Participants
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).
|
|---|---|---|
|
Time to Change in Antidepressant Medication
Time to first start/increase in dose
|
8 days
Interval 4.0 to 13.0
|
10 days
Interval 7.0 to 17.0
|
|
Time to Change in Antidepressant Medication
Time to first stop/decrease in dose
|
—
|
18 days
Interval 18.0 to 18.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
SAGE-547 90 μg/kg/h
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=53 participants at risk
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 participants at risk
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).
|
|---|---|---|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/53 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
2.0%
1/51 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
|
Nervous system disorders
Syncope
|
0.00%
0/53 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
2.0%
1/51 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
Other adverse events
| Measure |
Placebo
n=53 participants at risk
Participants received an infusion rate equivalent to the 90 μg/kg/h group.
|
SAGE-547 90 μg/kg/h
n=51 participants at risk
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).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/53 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
9.8%
5/51 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
|
General disorders
Fatigue
|
3.8%
2/53 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
5.9%
3/51 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
|
General disorders
Infusion site pain
|
3.8%
2/53 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
9.8%
5/51 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
|
Nervous system disorders
Dizziness
|
7.5%
4/53 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
9.8%
5/51 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
|
Nervous system disorders
Headache
|
11.3%
6/53 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
17.6%
9/51 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
|
Nervous system disorders
Somnolence
|
3.8%
2/53 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
7.8%
4/51 • Up to approximately 37 days
The Safety Set included all randomized participants who started the study drug infusion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).
- Publication restrictions are in place
Restriction type: OTHER