Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in the 17-item HAM-D Total Score at Day 15Primary· Baseline (BL), Day 15
The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D total score comprises a sum of the 17 individual item scores. 8 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 9 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. Total HAM-D score can range from 0 to 52,
Group
Value
95% CI
SAGE-217 Matched Placebo
-11.1
± 0.59
SAGE-217 20 mg
-11.5
± 0.62
SAGE-217 30 mg
-12.5
± 0.68
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 15Secondary· Baseline, Day 15
The CGI-S uses a 7-point Likert scale to rate the severity of the participant's illness relative to the clinician's past experience with participants who had the same diagnosis. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=extremely ill. A higher score indicates extreme illness/more severity. A negative change from baseline indicates less severe illness.
Group
Value
95% CI
SAGE-217 Matched Placebo
-1.5
± 0.10
SAGE-217 20 mg
-1.6
± 0.11
SAGE-217 30 mg
-1.7
± 0.11
Change From Baseline in the 17-item HAM-D Total ScoreSecondary· Baseline, Days 3, 8, 42, and 182
The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D total score comprises a sum of the 17 individual item scores. 8 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 9 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. Total HAM-D score can range from 0 to 52,
Change from Baseline at Day 3
Group
Value
95% CI
SAGE-217 Matched Placebo
-6.7
± 0.46
SAGE-217 20 mg
-7.1
± 0.48
SAGE-217 30 mg
-8.3
± 0.47
Change from Baseline at Day 8
Group
Value
95% CI
SAGE-217 Matched Placebo
-7.8
± 0.53
SAGE-217 20 mg
-8.4
± 0.54
SAGE-217 30 mg
-9.9
± 0.60
Change from Baseline at Day 42
Group
Value
95% CI
SAGE-217 Matched Placebo
-11.7
± 0.64
SAGE-217 20 mg
-11.5
± 0.70
SAGE-217 30 mg
-11.9
± 0.67
Change from Baseline at Day 182
Group
Value
95% CI
SAGE-217 Matched Placebo
-13.2
± 0.74
SAGE-217 20 mg
-13.4
± 0.83
SAGE-217 30 mg
-13.9
± 0.72
Number of Participants Achieving HAM-D ResponseSecondary· Days 15, 42, and 182
HAM-D response is defined as a ≥50% reduction in HAM-D score from baseline. The HAM-D total score comprises a sum of the 17 individual item scores. 8 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 9 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. Total HAM-D score can range from 0 to 52, and higher scores indicate severe depress
Day 15
Group
Value
95% CI
SAGE-217 Matched Placebo
60
SAGE-217 20 mg
65
SAGE-217 30 mg
77
Day 42
Group
Value
95% CI
SAGE-217 Matched Placebo
56
SAGE-217 20 mg
59
SAGE-217 30 mg
59
Day 182
Group
Value
95% CI
SAGE-217 Matched Placebo
51
SAGE-217 20 mg
39
SAGE-217 30 mg
51
Number of Participants Achieving HAM-D RemissionSecondary· Days 15, 42, and 182
HAM-D remission is defined as HAM-D total score ≤7. The HAM-D total score comprises a sum of the 17 individual item scores. 8 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 9 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. Total HAM-D score can range from 0 to 52, and higher scores indicate severe depression.
Day 15
Group
Value
95% CI
SAGE-217 Matched Placebo
33
SAGE-217 20 mg
35
SAGE-217 30 mg
48
Day 42
Group
Value
95% CI
SAGE-217 Matched Placebo
35
SAGE-217 20 mg
39
SAGE-217 30 mg
33
Day 182
Group
Value
95% CI
SAGE-217 Matched Placebo
32
SAGE-217 20 mg
29
SAGE-217 30 mg
34
Number of Participants Achieving Clinical Global Impression - Improvement (CGI-I) Response at Day 15Secondary· Day 15
CGI-I response is defined as a CGI-I score of very much improved or much improved. The CGI-I 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 included: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.
Group
Value
95% CI
SAGE-217 Matched Placebo
65
SAGE-217 20 mg
71
SAGE-217 30 mg
84
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Day 15Secondary· Baseline, Day 15
The 14-item HAM-A is used to rate the severity of symptoms of anxiety. Each of the 14 items is defined by a series of symptoms and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe) to each item. Total HAM-A score is calculated as the sum of the 14 individual item scores with a total score range of 0 to 56, where the score of \<17 indicates mild severity, 18 to 24 indicates mild to moderate severity, and 25 to 30 indica
Group
Value
95% CI
SAGE-217 Matched Placebo
-8.7
± 0.49
SAGE-217 20 mg
-9.1
± 0.54
SAGE-217 30 mg
-9.4
± 0.53
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 15Secondary· Baseline, Day 15
The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. Each item is rated on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). Total MADRS score, calculated as the sum of the 10 individual items, ranges from 0 to 60 with a higher score indicating more depression. A negative change from baseline indicates less severe symptoms.
Group
Value
95% CI
SAGE-217 Matched Placebo
-16.0
± 0.93
SAGE-217 20 mg
-16.7
± 1.00
SAGE-217 30 mg
-18.0
± 1.03
Change From Baseline in HAM-D Core Subscale ScoreSecondary· Baseline, Days 15, and 42
The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. HAM-D subscale scores are calculated as the sum of the items comprising each subscale. The core subscale score is the sum of the following symptom scores, scored in a range of 0 to 4: Depressed mood, feelings of guilt, suicide, work and activities, and retardation. Total HAM-D core subscale scores were transformed to a scale of 0 to 100. Higher scores indicate more severe depression. A negative change from baseline indicates less depression.
Change from Baseline at Day 15
Group
Value
95% CI
SAGE-217 Matched Placebo
-21.7
± 1.33
SAGE-217 20 mg
-21.3
± 1.31
SAGE-217 30 mg
-22.6
± 1.38
Change from Baseline at Day 42
Group
Value
95% CI
SAGE-217 Matched Placebo
-23.1
± 1.36
SAGE-217 20 mg
-22.4
± 1.44
SAGE-217 30 mg
-23.6
± 1.40
Change From Baseline in HAM-D Anxiety Subscale ScoreSecondary· Baseline, Days 15, and 42
The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. HAM-D subscale scores are calculated as the sum of the items comprising each subscale. The anxiety subscale score is the sum of the following symptom scores: Anxiety (psychic and somatic) \[scored in a range of 0 to 4\], somatic symptoms (gastrointestinal and general) \[scored in a range of 0 to 2\], hypochondriasis \[scored in a range of 0 to 4\], and loss of weight \[scored in a range of 0 to 2\]. Total HAM-D anxiety subscale scores were transformed to a scale of 0 to 100. Hi
Change from Baseline at Day 15
Group
Value
95% CI
SAGE-217 Matched Placebo
-19.4
± 1.19
SAGE-217 20 mg
-20.1
± 1.28
SAGE-217 30 mg
-22.1
± 1.30
Change from Baseline at Day 42
Group
Value
95% CI
SAGE-217 Matched Placebo
-22.0
± 1.27
SAGE-217 20 mg
-20.7
± 1.38
SAGE-217 30 mg
-21.7
± 1.29
Change From Baseline in HAM-D Bech-6 Subscale ScoreSecondary· Baseline, Days 15, and 42
The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. HAM-D subscale scores are calculated as the sum of the items comprising each subscale. The Bech-6 subscale score is the sum of the following symptom scores, scored in a range of 0 to 4: Depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general. Total HAM-D Bech-6 subscale scores were transformed to a scale of 0 to 100. Higher scores indicate more severe depression. A negative change from baseline indicates less depression
Change from Baseline at Day 15
Group
Value
95% CI
SAGE-217 Matched Placebo
-26.2
± 1.57
SAGE-217 20 mg
-26.3
± 1.62
SAGE-217 30 mg
-28.7
± 1.70
Change from Baseline at Day 42
Group
Value
95% CI
SAGE-217 Matched Placebo
-28.0
± 1.66
SAGE-217 20 mg
-27.4
± 1.77
SAGE-217 30 mg
-28.7
± 1.70
Change From Baseline in HAM-D Maier Subscale ScoreSecondary· Baseline, Days 15, and 42
The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. HAM-D subscale scores are calculated as the sum of the items comprising each subscale. The Maier subscale score is the sum of the following symptom scores, scored in a range of 0 to 4: Depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic. Total HAM-D Maier subscale scores were transformed to a scale of 0 to 100. Higher scores indicate more severe depression. A negative change from baseline indicates less depression.
Change from Baseline at Day 15
Group
Value
95% CI
SAGE-217 Matched Placebo
-23.4
± 1.34
SAGE-217 20 mg
-23.1
± 1.37
SAGE-217 30 mg
-25.9
± 1.45
Change from Baseline at Day 42
Group
Value
95% CI
SAGE-217 Matched Placebo
-25.0
± 1.42
SAGE-217 20 mg
-24.8
± 1.53
SAGE-217 30 mg
-26.2
± 1.49
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment period: Up to 14 days; FU period: Day 15 to 42; Extended FU Period: Day 43 to 182.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (MDD).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04476030 — A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive
· Phase 3
· completed
NCT04442503 — A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)
· Phase 3
· completed
NCT04442490 — A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)
· Phase 3
· completed
NCT04007367 — A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder
· Phase 3
· terminated
NCT03864614 — A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biogen
Last refreshed: 29 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03672175.