Trial Outcomes & Findings for A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression (NCT NCT02978326)

Last Updated: 2023-12-15

Results Overview

The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. 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 HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

276 participants

Primary outcome timeframe

Parts A and B: Baseline, Day 15

Results posted on

2023-12-15

Participant Flow

Participants took part in the study at 27 investigative centers in the United States of America from 04 January 2017 to 11 December 2018. Study was conducted in 2 parts. In Part A, only 1 participant was enrolled and thus no analysis was performed for Part A. All analysis sets were defined only for Part B. For Part A, only adverse events incidence were captured.

A total of 276 participants were enrolled and consented of which 154 eligible participants were randomized and thus presented in participant flow. Rest of the 123 participants were not randomized and not part of any analyses. 152 randomized participants received study drug and 143 completed the study.

Participant milestones

Participant milestones
Measure	Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 milligrams (mg), oral solution, twice daily (BID) for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Part A (Up to 75 Days) STARTED	1	0	0
Part A (Up to 75 Days) COMPLETED	1	0	0
Part A (Up to 75 Days) NOT COMPLETED	0	0	0
Part B (Up to 45 Days) STARTED	0	76	77
Part B (Up to 45 Days) Received Study Drug	0	73	78
Part B (Up to 45 Days) Safety Set (Part B)	0	73	78
Part B (Up to 45 Days) Efficacy Set (Part B)	0	74	76
Part B (Up to 45 Days) COMPLETED	0	69	73
Part B (Up to 45 Days) NOT COMPLETED	0	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Part B: Placebo Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Part B (Up to 45 Days) Adverse Event	0	1
Part B (Up to 45 Days) Lost to Follow-up	3	0
Part B (Up to 45 Days) Non-compliance	2	0
Part B (Up to 45 Days) Withdrawal by Subject	2	3

Baseline Characteristics

Due to the low number of participants enrolled during Part A of the study, 0 participants are reported due to the risk of identification of a person.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Parts A and B: Baseline, Day 15

Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=74 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=76 Participants Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15	—	-13.6 score on a scale Standard Error 1.07	-17.8 score on a scale Standard Error 1.04

SECONDARY outcome

Timeframe: Part B: Baseline, Days 3, 8, 21 and 45

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=74 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=76 Participants Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 Change From Baseline at Day 3	—	-9.8 score on a scale Standard Error 0.95	-12.5 score on a scale Standard Error 0.93
Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 Change From Baseline at Day 8	—	-12.9 score on a scale Standard Error 1.03	-16.3 score on a scale Standard Error 1.00
Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 Change From Baseline at Day 21	—	-14.4 score on a scale Standard Error 1.11	-17.6 score on a scale Standard Error 1.09
Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 Change From Baseline at Day 45	—	-15.1 score on a scale Standard Error 1.06	-19.2 score on a scale Standard Error 1.02

SECONDARY outcome

Timeframe: Part B: Days 3, 8, 15, 21 and 45

HAM-D Response was defined as having a 50 percent (%) or greater reduction from Baseline in HAM-D total score. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours \[morning\]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=74 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=76 Participants Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Parts A and B: Percentage of Participants With HAM-D Response Day 3	—	27.0 percentage of participants	40.5 percentage of participants
Parts A and B: Percentage of Participants With HAM-D Response Day 8	—	44.6 percentage of participants	65.3 percentage of participants
Parts A and B: Percentage of Participants With HAM-D Response Day 15	—	47.9 percentage of participants	71.6 percentage of participants
Parts A and B: Percentage of Participants With HAM-D Response Day 21	—	56.2 percentage of participants	71.6 percentage of participants
Parts A and B: Percentage of Participants With HAM-D Response Day 45	—	56.5 percentage of participants	75.3 percentage of participants

SECONDARY outcome

Timeframe: Part B: Days 3, 8, 15, 21 and 45

HAM-D Remission was defined as a HAM-D total score of less than or equal to (\<=)7. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours \[morning\]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=74 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=76 Participants Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Parts A and B: Percentage of Participants With HAM-D Remission Day 3	—	5.4 percentage of participants	18.9 percentage of participants
Parts A and B: Percentage of Participants With HAM-D Remission Day 8	—	18.9 percentage of participants	32.0 percentage of participants
Parts A and B: Percentage of Participants With HAM-D Remission Day 15	—	23.3 percentage of participants	44.6 percentage of participants
Parts A and B: Percentage of Participants With HAM-D Remission Day 21	—	28.8 percentage of participants	41.9 percentage of participants
Parts A and B: Percentage of Participants With HAM-D Remission Day 45	—	30.4 percentage of participants	53.4 percentage of participants

SECONDARY outcome

Timeframe: Part B: Baseline, Days 3, 8, 15, 21 and 45

HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale (symptoms-depressed mood, feelings of guilt, suicide, work and activities, and retardation ); Anxiety subscale (symptoms-anxiety \[psychic and somatic\], somatic symptoms \[gastrointestinal and general\], hypochondriasis, loss of weight); Bech-6 subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general); Meier subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic). Each item was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicated more severe depression. A negative change from Baseline indicates less depression.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=74 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=76 Participants Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Parts A and B: Change From Baseline in HAM-D Subscales Scores Core: Change From Baseline at Day 3	—	-16.7 score on a scale Standard Error 1.91	-18.8 score on a scale Standard Error 1.88
Parts A and B: Change From Baseline in HAM-D Subscales Scores Core: Change From Baseline at Day 8	—	-23.4 score on a scale Standard Error 2.03	-28.7 score on a scale Standard Error 1.99
Parts A and B: Change From Baseline in HAM-D Subscales Scores Core: Change From Baseline at Day 15	—	-26.8 score on a scale Standard Error 2.10	-31.9 score on a scale Standard Error 2.06
Parts A and B: Change From Baseline in HAM-D Subscales Scores Core: Change From Baseline at Day 21	—	-27.3 score on a scale Standard Error 2.24	-33.7 score on a scale Standard Error 2.20
Parts A and B: Change From Baseline in HAM-D Subscales Scores Core: Change From Baseline at Day 45	—	-29.5 score on a scale Standard Error 2.11	-37.2 score on a scale Standard Error 2.05
Parts A and B: Change From Baseline in HAM-D Subscales Scores Anxiety: Change From Baseline at Day 3	—	-16.4 score on a scale Standard Error 1.98	-23.5 score on a scale Standard Error 1.93
Parts A and B: Change From Baseline in HAM-D Subscales Scores Anxiety: Change From Baseline at Day 8	—	-23.2 score on a scale Standard Error 2.15	-29.8 score on a scale Standard Error 2.09
Parts A and B: Change From Baseline in HAM-D Subscales Scores Anxiety: Change From Baseline at Day 15	—	-23.4 score on a scale Standard Error 2.19	-33.2 score on a scale Standard Error 2.13
Parts A and B: Change From Baseline in HAM-D Subscales Scores Anxiety: Change From Baseline at Day 21	—	-27.3 score on a scale Standard Error 2.17	-33.3 score on a scale Standard Error 2.11
Parts A and B: Change From Baseline in HAM-D Subscales Scores Anxiety: Change From Baseline at Day 45	—	-26.5 score on a scale Standard Error 2.19	-34.5 score on a scale Standard Error 2.11
Parts A and B: Change From Baseline in HAM-D Subscales Scores Bech-6: Change From Baseline at Day 3	—	-19.5 score on a scale Standard Error 2.45	-23.7 score on a scale Standard Error 2.41
Parts A and B: Change From Baseline in HAM-D Subscales Scores Bech-6: Change From Baseline at Day 8	—	-28.3 score on a scale Standard Error 2.58	-34.9 score on a scale Standard Error 2.53
Parts A and B: Change From Baseline in HAM-D Subscales Scores Bech-6: Change From Baseline at Day 15	—	-30.9 score on a scale Standard Error 2.61	-39.2 score on a scale Standard Error 2.56
Parts A and B: Change From Baseline in HAM-D Subscales Scores Bech-6: Change From Baseline at Day 21	—	-32.7 score on a scale Standard Error 2.72	-40.7 score on a scale Standard Error 2.68
Parts A and B: Change From Baseline in HAM-D Subscales Scores Bech-6: Change From Baseline at Day 45	—	-34.6 score on a scale Standard Error 2.61	-44.0 score on a scale Standard Error 2.54
Parts A and B: Change From Baseline in HAM-D Subscales Scores Meier: Change From Baseline at Day 3	—	-17.0 score on a scale Standard Error 2.17	-21.7 score on a scale Standard Error 2.13
Parts A and B: Change From Baseline in HAM-D Subscales Scores Meier: Change From Baseline at Day 8	—	-25.0 score on a scale Standard Error 2.30	-32.2 score on a scale Standard Error 2.24
Parts A and B: Change From Baseline in HAM-D Subscales Scores Meier: Change From Baseline at Day 15	—	-28.1 score on a scale Standard Error 2.35	-35.5 score on a scale Standard Error 2.30
Parts A and B: Change From Baseline in HAM-D Subscales Scores Meier: Change From Baseline at Day 21	—	-29.9 score on a scale Standard Error 2.42	-37.0 score on a scale Standard Error 2.37
Parts A and B: Change From Baseline in HAM-D Subscales Scores Meier: Change From Baseline at Day 45	—	-31.5 score on a scale Standard Error 2.32	-41.0 score on a scale Standard Error 2.25

SECONDARY outcome

Timeframe: Part B: Baseline, Days 3, 8, 15, 21 and 45

The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. 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 were 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 indicated a greater degree of depression. A negative change from Baseline indicates less depression.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=74 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=76 Participants Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Agitation: Change From Baseline at Day 21	—	-0.8 score on a scale Standard Error 0.09	-0.9 score on a scale Standard Error 0.08
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Agitation: Change From Baseline at Day 45	—	-0.8 score on a scale Standard Error 0.09	-1.1 score on a scale Standard Error 0.07
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Anxiety Psychic: Change From Baseline at Day 3	—	-0.7 score on a scale Standard Error 0.12	-1.1 score on a scale Standard Error 0.13
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Anxiety Psychic: Change From Baseline at Day 8	—	-1.1 score on a scale Standard Error 0.14	-1.5 score on a scale Standard Error 0.13
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Anxiety Psychic: Change From Baseline at Day 15	—	-1.2 score on a scale Standard Error 0.13	-1.6 score on a scale Standard Error 0.13
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Anxiety Psychic: Change From Baseline at Day 21	—	-1.3 score on a scale Standard Error 0.14	-1.6 score on a scale Standard Error 0.12
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Anxiety Psychic: Change From Baseline at Day 45	—	-1.3 score on a scale Standard Error 0.14	-1.7 score on a scale Standard Error 0.12
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Anxiety Somatic: Change From Baseline at Day 3	—	-0.6 score on a scale Standard Error 0.10	-0.7 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Anxiety Somatic: Change From Baseline at Day 8	—	-0.7 score on a scale Standard Error 0.10	-0.9 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Anxiety Somatic: Change From Baseline at Day 15	—	-0.8 score on a scale Standard Error 0.11	-0.9 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Anxiety Somatic: Change From Baseline at Day 21	—	-0.9 score on a scale Standard Error 0.11	-1.0 score on a scale Standard Error 0.11
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Anxiety Somatic: Change From Baseline at Day 45	—	-0.8 score on a scale Standard Error 0.11	-1.0 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Somatic Symptoms Gastrointestinal: Change From Baseline at Day 3	—	-0.3 score on a scale Standard Error 0.09	-0.6 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Somatic Symptoms Gastrointestinal: Change From Baseline at Day 8	—	-0.6 score on a scale Standard Error 0.10	-0.8 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Somatic Symptoms Gastrointestinal: Change From Baseline at Day 15	—	-0.7 score on a scale Standard Error 0.11	-1.0 score on a scale Standard Error 0.08
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Somatic Symptoms Gastrointestinal: Change From Baseline at Day 21	—	-0.8 score on a scale Standard Error 0.11	-0.9 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Somatic Symptoms Gastrointestinal: Change From Baseline at Day 45	—	-0.8 score on a scale Standard Error 0.10	-1.0 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores General Somatic Symptoms: Change From Baseline at Day 3	—	-0.6 score on a scale Standard Error 0.08	-0.7 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores General Somatic Symptoms: Change From Baseline at Day 8	—	-0.8 score on a scale Standard Error 0.09	-0.9 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores General Somatic Symptoms: Change From Baseline at Day 15	—	-0.6 score on a scale Standard Error 0.08	-1.1 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores General Somatic Symptoms: Change From Baseline at Day 21	—	-0.7 score on a scale Standard Error 0.10	-1.0 score on a scale Standard Error 0.08
Parts A and B: Change From Baseline in HAM-D Individual Item Scores General Somatic Symptoms: Change From Baseline at Day 45	—	-0.8 score on a scale Standard Error 0.09	-1.0 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Genital Symptoms: Change From Baseline at Day 3	—	-0.3 score on a scale Standard Error 0.08	-0.4 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Genital Symptoms: Change From Baseline at Day 8	—	-0.6 score on a scale Standard Error 0.10	-0.6 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Genital Symptoms: Change From Baseline at Day 15	—	-0.7 score on a scale Standard Error 0.10	-0.9 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Genital Symptoms: Change From Baseline at Day 21	—	-0.7 score on a scale Standard Error 0.10	-0.8 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Genital Symptoms: Change From Baseline at Day 45	—	-0.8 score on a scale Standard Error 0.10	-1.0 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Hypochondriasis: Change From Baseline at Day 3	—	-0.5 score on a scale Standard Error 0.09	-0.7 score on a scale Standard Error 0.08
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Hypochondriasis: Change From Baseline at Day 8	—	-0.6 score on a scale Standard Error 0.08	-0.8 score on a scale Standard Error 0.07
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Hypochondriasis: Change From Baseline at Day 15	—	-0.5 score on a scale Standard Error 0.10	-1.0 score on a scale Standard Error 0.06
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Hypochondriasis: Change From Baseline at Day 21	—	-0.6 score on a scale Standard Error 0.08	-0.9 score on a scale Standard Error 0.06
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Hypochondriasis: Change From Baseline at Day 45	—	-0.7 score on a scale Standard Error 0.09	-0.9 score on a scale Standard Error 0.07
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Loss of Weight According to Patient: Change From Baseline at Day 3	—	-0.3 score on a scale Standard Error 0.08	-0.5 score on a scale Standard Error 0.07
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Loss of Weight According to Patient: Change From Baseline at Day 8	—	-0.4 score on a scale Standard Error 0.07	-0.5 score on a scale Standard Error 0.07
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Loss of Weight According to Patient: Change From Baseline at Day 15	—	-0.5 score on a scale Standard Error 0.07	-0.5 score on a scale Standard Error 0.06
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Loss of Weight According to Patient: Change From Baseline at Day 21	—	-0.6 score on a scale Standard Error 0.06	-0.6 score on a scale Standard Error 0.05
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Loss of Weight According to Patient: Change From Baseline at Day 45	—	-0.5 score on a scale Standard Error 0.08	-0.6 score on a scale Standard Error 0.05
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insight: Change From Baseline at Day 3	—	0.0 score on a scale Standard Error 0.02	-0.1 score on a scale Standard Error 0.02
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insight: Change From Baseline at Day 8	—	0.0 score on a scale Standard Error 0.02	-0.1 score on a scale Standard Error 0.02
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insight: Change From Baseline at Day 15	—	0.0 score on a scale Standard Error 0.02	-0.1 score on a scale Standard Error 0.02
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insight: Change From Baseline at Day 21	—	0.0 score on a scale Standard Error 0.02	-0.1 score on a scale Standard Error 0.02
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insight: Change From Baseline at Day 45	—	0.0 score on a scale Standard Error 0.04	-0.1 score on a scale Standard Error 0.02
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Depressed Mood: Change From Baseline at Day 3	—	-0.8 score on a scale Standard Error 0.13	-1.1 score on a scale Standard Error 0.13
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Depressed Mood: Change From Baseline at Day 8	—	-1.3 score on a scale Standard Error 0.14	-1.7 score on a scale Standard Error 0.13
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Depressed Mood: Change From Baseline at Day 15	—	-1.5 score on a scale Standard Error 0.15	-1.8 score on a scale Standard Error 0.13
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Depressed Mood: Change From Baseline at Day 21	—	-1.5 score on a scale Standard Error 0.14	-2.1 score on a scale Standard Error 0.13
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Depressed Mood: Change From Baseline at Day 45	—	-1.7 score on a scale Standard Error 0.15	-2.1 score on a scale Standard Error 0.12
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Feelings of Guilt: Change From Baseline at Day 3	—	-0.9 score on a scale Standard Error 0.12	-1.0 score on a scale Standard Error 0.13
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Feelings of Guilt: Change From Baseline at Day 8	—	-1.1 score on a scale Standard Error 0.13	-1.4 score on a scale Standard Error 0.12
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Feelings of Guilt: Change From Baseline at Day 15	—	-1.3 score on a scale Standard Error 0.13	-1.5 score on a scale Standard Error 0.11
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Feelings of Guilt: Change From Baseline at Day 21	—	-1.2 score on a scale Standard Error 0.13	-1.6 score on a scale Standard Error 0.12
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Feelings of Guilt: Change From Baseline at Day 45	—	-1.5 score on a scale Standard Error 0.12	-1.8 score on a scale Standard Error 0.11
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Suicide: Change From Baseline at Day 3	—	-0.2 score on a scale Standard Error 0.05	-0.3 score on a scale Standard Error 0.04
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Suicide: Change From Baseline at Day 8	—	-0.2 score on a scale Standard Error 0.04	-0.4 score on a scale Standard Error 0.03
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Suicide: Change From Baseline at Day 15	—	-0.3 score on a scale Standard Error 0.04	-0.3 score on a scale Standard Error 0.04
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Suicide: Change From Baseline at Day 21	—	-0.2 score on a scale Standard Error 0.05	-0.3 score on a scale Standard Error 0.05
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Suicide: Change From Baseline at Day 45	—	-0.2 score on a scale Standard Error 0.05	-0.4 score on a scale Standard Error 0.03
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Early - Early Night: Change From Baseline at Day 3	—	-0.9 score on a scale Standard Error 0.11	-1.2 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Early - Early Night: Change From Baseline at Day 8	—	-0.9 score on a scale Standard Error 0.11	-1.3 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Early - Early Night: Change From Baseline at Day 15	—	-0.9 score on a scale Standard Error 0.11	-1.3 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Early - Early Night: Change From Baseline at Day 21	—	-0.9 score on a scale Standard Error 0.11	-1.1 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Early - Early Night: Change From Baseline at Day 45	—	-1.0 score on a scale Standard Error 0.12	-1.1 score on a scale Standard Error 0.11
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Middle - Middle Night: Change From Baseline at Day 3	—	-1.0 score on a scale Standard Error 0.11	-1.3 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Middle - Middle Night: Change From Baseline at Day 8	—	-1.0 score on a scale Standard Error 0.11	-1.3 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Middle - Middle Night: Change From Baseline at Day 15	—	-0.9 score on a scale Standard Error 0.11	-1.3 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Middle - Middle Night: Change From Baseline at Day 21	—	-0.8 score on a scale Standard Error 0.11	-1.2 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Middle - Middle Night: Change From Baseline at Day 45	—	-0.9 score on a scale Standard Error 0.11	-1.3 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Early Hours - Morning: Change From Baseline at Day 3	—	-0.8 score on a scale Standard Error 0.11	-1.1 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Early Hours - Morning: Change From Baseline at Day 8	—	-0.9 score on a scale Standard Error 0.10	-1.2 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Early Hours - Morning: Change From Baseline at Day 15	—	-1.0 score on a scale Standard Error 0.11	-1.2 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Early Hours - Morning: Change From Baseline at Day 21	—	-0.9 score on a scale Standard Error 0.11	-1.0 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Insomnia Early Hours - Morning: Change From Baseline at Day 45	—	-0.9 score on a scale Standard Error 0.10	-1.3 score on a scale Standard Error 0.08
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Work and Activities: Change From Baseline at Day 3	—	-0.8 score on a scale Standard Error 0.12	-0.9 score on a scale Standard Error 0.13
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Work and Activities: Change From Baseline at Day 8	—	-1.3 score on a scale Standard Error 0.14	-1.4 score on a scale Standard Error 0.14
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Work and Activities: Change From Baseline at Day 15	—	-1.4 score on a scale Standard Error 0.14	-1.8 score on a scale Standard Error 0.13
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Work and Activities: Change From Baseline at Day 21	—	-1.7 score on a scale Standard Error 0.16	-1.9 score on a scale Standard Error 0.14
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Work and Activities: Change From Baseline at Day 45	—	-1.7 score on a scale Standard Error 0.16	-2.1 score on a scale Standard Error 0.14
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Retardation: Change From Baseline at Day 3	—	-0.5 score on a scale Standard Error 0.07	-0.4 score on a scale Standard Error 0.10
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Retardation: Change From Baseline at Day 8	—	-0.7 score on a scale Standard Error 0.08	-0.8 score on a scale Standard Error 0.07
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Retardation: Change From Baseline at Day 15	—	-0.8 score on a scale Standard Error 0.07	-0.8 score on a scale Standard Error 0.07
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Retardation: Change From Baseline at Day 21	—	-0.8 score on a scale Standard Error 0.08	-0.8 score on a scale Standard Error 0.07
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Retardation: Change From Baseline at Day 45	—	-0.9 score on a scale Standard Error 0.07	-1.0 score on a scale Standard Error 0.07
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Agitation: Change From Baseline at Day 3	—	-0.4 score on a scale Standard Error 0.09	-0.7 score on a scale Standard Error 0.09
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Agitation: Change From Baseline at Day 8	—	-0.6 score on a scale Standard Error 0.09	-0.9 score on a scale Standard Error 0.08
Parts A and B: Change From Baseline in HAM-D Individual Item Scores Agitation: Change From Baseline at Day 15	—	-0.6 score on a scale Standard Error 0.09	-0.9 score on a scale Standard Error 0.09

SECONDARY outcome

Timeframe: Part B: Baseline, Days 3, 8, 15, 21 and 45

The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=74 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=76 Participants Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline at Day 3	—	-11.7 score on a scale Standard Error 1.36	-14.8 score on a scale Standard Error 1.33
Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline at Day 8	—	-16.3 score on a scale Standard Error 1.45	-20.3 score on a scale Standard Error 1.42
Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline at Day 15	—	-17.6 score on a scale Standard Error 1.48	-22.1 score on a scale Standard Error 1.45
Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline at Day 21	—	-17.8 score on a scale Standard Error 1.49	-22.1 score on a scale Standard Error 1.46
Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline at Day 45	—	-19.0 score on a scale Standard Error 1.44	-24.8 score on a scale Standard Error 1.39

SECONDARY outcome

Timeframe: Part B: Days 3, 8, 15, 21 and 45

The Clinical Global Impression - Improvement (CGI-I) item of the CGI scale uses a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 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. CGI response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved). The percentage of participants with overall improvement in post-treatment condition, rated by investigator as very much improved (CGI-I score of 1) or much improved (CGI-I score of 2) is reported.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=74 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=76 Participants Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response Day 3	—	28.4 percentage of participants	37.8 percentage of participants
Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response Day 8	—	50.0 percentage of participants	65.3 percentage of participants
Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response Day 15	—	52.1 percentage of participants	71.6 percentage of participants
Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response Day 21	—	54.8 percentage of participants	70.3 percentage of participants
Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response Day 45	—	55.9 percentage of participants	71.2 percentage of participants

SECONDARY outcome

Timeframe: Part B: Baseline, Days 3, 8, 15, 21 and 45

The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of \<17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity. A negative change from Baseline indicates less anxiety.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=74 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=76 Participants Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score Change From Baseline at Day 3	—	-8.9 score on a scale Standard Error 1.02	-12.0 score on a scale Standard Error 0.99
Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score Change From Baseline at Day 8	—	-11.7 score on a scale Standard Error 1.04	-16.1 score on a scale Standard Error 1.01
Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score Change From Baseline at Day 15	—	-12.7 score on a scale Standard Error 1.09	-16.6 score on a scale Standard Error 1.07
Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score Change From Baseline at Day 21	—	-13.1 score on a scale Standard Error 1.07	-16.6 score on a scale Standard Error 1.05
Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score Change From Baseline at Day 45	—	-13.6 score on a scale Standard Error 1.02	-18.6 score on a scale Standard Error 0.99

SECONDARY outcome

Timeframe: Part B: Days 3, 8, 15, 21 and 45

MADRS response was defined as having a 50% or greater reduction from Baseline in MADRS total score. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=74 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=76 Participants Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Parts A and B: Percentage of Participants With MADRS Response Day 3	—	27.0 percentage of participants	40.5 percentage of participants
Parts A and B: Percentage of Participants With MADRS Response Day 8	—	50.0 percentage of participants	64.0 percentage of participants
Parts A and B: Percentage of Participants With MADRS Response Day 15	—	47.9 percentage of participants	73.0 percentage of participants
Parts A and B: Percentage of Participants With MADRS Response Day 21	—	52.1 percentage of participants	70.3 percentage of participants
Parts A and B: Percentage of Participants With MADRS Response Day 45	—	56.5 percentage of participants	74.0 percentage of participants

SECONDARY outcome

Timeframe: Part B: Days 3, 8, 15, 21 and 45

Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.

MADRS Remission was defined as a MADRS total score of \<=10. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=74 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=76 Participants Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Parts A and B: Percentage of Participants With MADRS Remission Day 3	—	9.5 percentage of participants	24.3 percentage of participants
Parts A and B: Percentage of Participants With MADRS Remission Day 8	—	28.4 percentage of participants	37.3 percentage of participants
Parts A and B: Percentage of Participants With MADRS Remission Day 15	—	30.1 percentage of participants	54.1 percentage of participants
Parts A and B: Percentage of Participants With MADRS Remission Day 21	—	31.5 percentage of participants	52.7 percentage of participants
Parts A and B: Percentage of Participants With MADRS Remission Day 45	—	37.7 percentage of participants	58.9 percentage of participants

SECONDARY outcome

Timeframe: Part A: Up to Day 75; Part B: Up to Day 45

Population: Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.

An Adverse Event (AE) was 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 (example, 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 was defined as an AE with an onset that occurs after receiving study drug.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution n=1 Participants Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=73 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=78 Participants Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	1 Participants	38 Participants	47 Participants

SECONDARY outcome

Timeframe: Part B: From first dose of study drug up to 45 days

Population: Safety Set (Part B) included all participants who were administered study drug in Part B of the study and analyzed by treatment actually received.

Vital signs included assessments of supine and standing systolic blood pressure (SBP), supine and standing diastolic blood pressure (DBP), and heart rate.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution n=73 Participants Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=78 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Supine SBP: <90 millimeter of mercury (mmHg)	0 Participants	3 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Supine SBP: Decrease From Baseline of >=30	2 Participants	1 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Supine SBP: Increase From Baseline of >=30	1 Participants	0 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Standing SBP: <90 mmHg	5 Participants	4 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Standing SBP: Decrease From Baseline of >=30	4 Participants	1 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Standing SBP: Increase From Baseline of >=30	1 Participants	2 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Supine DBP: <50 mmHg	1 Participants	1 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Supine DBP: Decrease From Baseline of >=20	5 Participants	3 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Supine DBP: Increase From Baseline of >=20	1 Participants	5 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Standing DBP: <50 mmHg	1 Participants	1 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Standing DBP: >110 mmHg	0 Participants	1 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Standing DBP: Decrease From Baseline of >=20	3 Participants	7 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements Standing DBP: Increase From Baseline of >=20	3 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Part B: From first dose of study drug up to 45 days

Population: Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received.

Laboratory tests included tests of Hematology, Chemistry, and Urinalysis.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution n=73 Participants Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=78 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Hematology: Eosinophils >1.5 10^9/Liter(L)	0 Participants	1 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Hematology: Hematocrit <0.359	11 Participants	8 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Hematology: Hematocrit >0.446	10 Participants	12 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Hematology: Hemoglobin <110 g/L	12 Participants	6 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Hematology: Leukocytes <2.5 10^9/L	2 Participants	2 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Hematology: Neutrophils <1.5 10^9/L	15 Participants	11 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Serum Chemistry: Alanine Aminotransferase >3xUpper Limit of Normal Value (ULN)	1 Participants	0 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Serum Chemistry: Calcium <2.0 millimoles (mmol)/L	0 Participants	1 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Serum Chemistry: Chloride <90 mmol/L	1 Participants	2 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Serum Chemistry: Glucose <2.8 mmol/L	0 Participants	1 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Serum Chemistry: Glucose >13.9 mmol/L	0 Participants	1 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Serum Chemistry: Phosphate >5 milligrams/deciliter (mg/dL)	2 Participants	1 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Serum Chemistry: Potassium <3.5 mmol/L	0 Participants	1 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Serum Chemistry: Potassium >5.2 mmol/L	6 Participants	5 Participants	—
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations Serum Chemistry: Sodium >145 mmol/L	3 Participants	5 Participants	—

SECONDARY outcome

Timeframe: Part B: Baseline, Days 8, 15, and 21

Population: Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.

ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Heart rate was measured in terms of beats per minute. Change from Baseline in heart rate at specified time points were reported.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution n=73 Participants Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=78 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate Baseline	68.2 beats per minute Standard Deviation 9.55	69.9 beats per minute Standard Deviation 10.85	—
Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate Change From Baseline at Day 8	0.8 beats per minute Standard Deviation 9.91	1.5 beats per minute Standard Deviation 12.62	—
Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate Change From Baseline at Day 15	-0.1 beats per minute Standard Deviation 8.16	0.9 beats per minute Standard Deviation 12.69	—
Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate Change From Baseline at Day 21	2.5 beats per minute Standard Deviation 8.93	-0.6 beats per minute Standard Deviation 11.33	—

SECONDARY outcome

Timeframe: Part B: Baseline, Days 8, 15, and 21

Population: Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received.

ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Change from Baseline in PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval is reported.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution n=73 Participants Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=78 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval PR Interval: Baseline	151.4 milliseconds Standard Deviation 20.38	151.7 milliseconds Standard Deviation 17.12	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval PR Interval: Change From Baseline at Day 8	3.4 milliseconds Standard Deviation 26.97	0.6 milliseconds Standard Deviation 11.95	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval PR Interval: Change From Baseline at Day 15	1.1 milliseconds Standard Deviation 11.81	0.8 milliseconds Standard Deviation 11.02	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval PR Interval: Change From Baseline at Day 21	2.5 milliseconds Standard Deviation 14.66	2.5 milliseconds Standard Deviation 11.82	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval RR Interval: Baseline	892.2 milliseconds Standard Deviation 131.63	871.6 milliseconds Standard Deviation 124.16	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval RR Interval: Change From Baseline at Day 8	-9.9 milliseconds Standard Deviation 137.12	-16.9 milliseconds Standard Deviation 149.42	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval RR Interval: Change From Baseline at Day 15	-1.9 milliseconds Standard Deviation 107.37	-8.4 milliseconds Standard Deviation 147.36	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval RR Interval: Change From Baseline at Day 21	-32.0 milliseconds Standard Deviation 113.89	13.9 milliseconds Standard Deviation 141.69	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval QRS Duration: Baseline	87.3 milliseconds Standard Deviation 9.50	90.2 milliseconds Standard Deviation 9.81	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval QRS Duration: Change From Baseline at Day 8	0.0 milliseconds Standard Deviation 8.19	-0.3 milliseconds Standard Deviation 6.98	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval QRS Duration: Change From Baseline at Day 15	-0.7 milliseconds Standard Deviation 7.14	-0.3 milliseconds Standard Deviation 6.69	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval QRS Duration: Change From Baseline at Day 21	0.1 milliseconds Standard Deviation 7.58	0.0 milliseconds Standard Deviation 6.84	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval QT Interval: Baseline	395.1 milliseconds Standard Deviation 28.85	393.0 milliseconds Standard Deviation 28.66	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval QT Interval: Change From Baseline at Day 8	-5.5 milliseconds Standard Deviation 24.23	-4.3 milliseconds Standard Deviation 29.89	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval QT Interval: Change From Baseline at Day 15	-1.4 milliseconds Standard Deviation 22.96	-2.7 milliseconds Standard Deviation 28.53	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval QT Interval: Change From Baseline at Day 21	-5.9 milliseconds Standard Deviation 23.70	0.1 milliseconds Standard Deviation 30.60	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval QTcF Interval: Baseline	411.3 milliseconds Standard Deviation 20.92	412.2 milliseconds Standard Deviation 18.83	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval QTcF Interval: Change From Baseline at Day 8	-4.1 milliseconds Standard Deviation 15.80	-1.7 milliseconds Standard Deviation 15.57	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval QTcF Interval: Change From Baseline at Day 15	-1.2 milliseconds Standard Deviation 14.75	-1.5 milliseconds Standard Deviation 14.94	—
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval QTcF Interval: Change From Baseline at Day 21	-1.1 milliseconds Standard Deviation 19.39	-1.8 milliseconds Standard Deviation 20.77	—

SECONDARY outcome

Timeframe: Part B: Up to Day 45

Population: Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received.

C-SSRS was used to assess the suicidality of participants during the study. The assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for severity of ideation (if present), from 1 to 5, with 5 being the most severe. Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported.

Outcome measures

Outcome measures
Measure	Part A: SAGE-217 15/20 mg Oral Solution n=73 Participants Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=78 Participants Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Part B: Number of Participants With a Response of "Yes" to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation	13 Participants	6 Participants	—
Part B: Number of Participants With a Response of "Yes" to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Behavior	0 Participants	0 Participants	—

Adverse Events

Part A: SAGE-217 15/20 mg Oral Solution

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Placebo

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Part B: SAGE 217 30 mg Capsules

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: SAGE-217 15/20 mg Oral Solution n=1 participants at risk Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=73 participants at risk Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=78 participants at risk Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Psychiatric disorders Confusional state	0.00% 0/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	0.00% 0/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	1.3% 1/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.
Gastrointestinal disorders Pancreatitis	0.00% 0/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	1.4% 1/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	0.00% 0/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.

Other adverse events

Other adverse events
Measure	Part A: SAGE-217 15/20 mg Oral Solution n=1 participants at risk Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.	Part B: Placebo n=73 participants at risk Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.	Part B: SAGE 217 30 mg Capsules n=78 participants at risk Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Nervous system disorders Somnolence	0.00% 0/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	11.0% 8/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	15.4% 12/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.
Nervous system disorders Headache	0.00% 0/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	12.3% 9/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	9.0% 7/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.
Nervous system disorders Dizziness	0.00% 0/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	5.5% 4/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	7.7% 6/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.
Infections and infestations Upper respiratory tract infection	0.00% 0/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	1.4% 1/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	7.7% 6/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	2.7% 2/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	6.4% 5/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.
Nervous system disorders Sedation	0.00% 0/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	0.00% 0/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	5.1% 4/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.
Gastrointestinal disorders Nausea	0.00% 0/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	8.2% 6/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	3.8% 3/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	5.5% 4/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	1.3% 1/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.
Psychiatric disorders Abnormal dreams	0.00% 0/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	5.5% 4/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	0.00% 0/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	5.5% 4/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	0.00% 0/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.
Psychiatric disorders Insomnia	100.0% 1/1 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	0.00% 0/73 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.	0.00% 0/78 • Part A: Up to Day 75; Part B: Up to Day 45 Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.

Additional Information

US Biogen Clinical Trial Center

Biogen

Phone: 866-633-4636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Publication restrictions are in place

Restriction type: OTHER