A Phase 3 interventional study of SAGE-217 in Major Depressive Disorder, sponsored by Biogen. Completed at 52 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Biogen · Phase 3, Interventional, and Treatment
This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.
This study was previously posted by Sage Therapeutics. In July 2024, sponsorship of the trial was transferred to Biogen.
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Exclusion Criteria:
Drug: SAGE-217
SAGE-217
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. For Part A, a TEAE was defined as an AE with onset after the first dose of SAGE-217.
Time frame: Up to 52 Weeks
Part B: Number of Participants With TEAEs
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. For Part B, a TEAE was defined as an AE with onset on or after the first dose of SAGE-217 in MDD-303B for the participants who received placebo + ADT in parent study, or an AE with onset on or after the ICF signoff in MDD-303B for the participants who received SAGE-217 + ADT in parent study.
Time frame: Up to 46 Weeks
Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS scale consisted of a baseline evaluation that assessed lifetime experience as well as past 24-month experience of participants for SI and SB and a postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation, if present. The C-SSRS SI items included: 1. wish to be dead, 2. non-specific active suicidal thoughts, 3. active SI with any methods, 4. active SI with some intent, and 5. active SI with a specific plan (5 being the most severe). C-SSRS SB items included 1. preparatory acts or behavior, 2. aborted attempt, 3. interrupted attempt, 4. actual attempt (non-fatal), and 5. completed suicide (5 being worst). Participants with at least one SI question answered Yes or at least one SB question answered Yes post-baseline for the specific period is counted under SI or SB respectively.
Time frame: Baseline up to 52 Weeks (Study Period 1-5)
Part B: Number of Participants With Suicidal Ideation (SI) and Suicidal Behavior (SB) as Assessed by the C-SSRS
C-SSRS scale consisted of a baseline evaluation that assessed lifetime experience as well as past 24-month experience of participants for SI and SB and a postbaseline (PB) evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation, if present. The C-SSRS SI items included: 1. wish to be dead, 2. non-specific active suicidal thoughts, 3. active SI with any methods, 4. active SI with some intent, and 5. active SI with a specific plan (5 being the most severe). C-SSRS SB items included 1. preparatory acts or behavior, 2. aborted attempt, 3. interrupted attempt, 4. actual attempt (non-fatal), and 5. completed suicide (5 being worst). Participants with at least one SI question answered Yes or at least one SB question answered Yes post-baseline for the specific period is counted under SI or SB respectively.
Time frame: Baseline up to 46 Weeks (Study Period 1-5)
Parts A and B: Time to First Repeat Treatment With SAGE-217
For Part A, the first day of the first repeat treatment is Treatment Cycle 2 Day 1. For Part B, participants who had "placebo + ADT" in the parent study (217-MDD-305), the first repeat treatment of SAGE-217 was the second treatment within MDD-303B. Participants who had SAGE-217 + ADT in the parent study (217-MDD-305), the first repeat treatment of SAGE-217 was the first treatment within MDD-303B. For Part A, as prespecified, data for this outcome measure was collected for Sage-217 High-dose Cohort and Sage-217 30 mg Cohort (Low Dose + Dose Switch). For Part B, data for this outcome measure is presented as per the designated arms in the parent study (217-MDD-305). Analysis used Kaplan-Meier estimates where the participants with no repeat treatment were censored.
Time frame: Up to 52 Weeks
Parts A and B: Number of Participants Who Achieved the Requirements for Repeat Treatment for SAGE-217
Participants who continued in the study beyond 56 days from the last study drug dose (in parent study for Part B) and had a HAMD-17 total score ≥20 between the end of first treatment cycle and start of next treatment cycle qualified for repeat treatment for SAGE-217. The 17-item HAM-D was used for measuring severity of depression. It comprised individual ratings of 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. For Part B, data for this outcome measure is presented as per the designated arms in the parent study (217-MDD-305).
Time frame: Up to 52 Weeks
Parts A and B: Number of Repeat Treatment Cycles of SAGE-217 for Each Participant
The response of initial treatment and/or repeat treatment was assessed by HAMD-17. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised individual ratings of following symptoms scored in range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Following symptoms were scored in range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. total score range=0 to 52, and higher scores indicated greater degree of depression. Participants who had a HAM-D total score \>=20 within the protocol were eligible for at least 1 repeat treatment in study. For Part B, data for this outcome measure is presented as per the designated arms in parent study (217-MDD-305). Participants who did not have any re-treatment were included with number of re-treatments equal to 0.
Time frame: Up to 52 Weeks
Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 in Study Period 1
The 17-item HAM-D scale was used for measuring severity of depression. The 17-item HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), 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. Each item is scored in a range of 0 to 2 or 0 to 4. The total score ranges from 0 to 52 with higher scores indicating a greater degree of depression. A negative change from baseline indicates improvement. A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it.
Time frame: Baseline, Day 15 in Study Period 1
Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 of Each Treatment Cycle
The 17-item HAM-D scale was used for measuring severity of depression. The 17-item HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), 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. Each item is scored in a range of 0 to 2 or 0 to 4. The total score ranges from 0 to 52 with higher scores indicating a greater degree of depression. A negative change from baseline indicates improvement. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle.
Time frame: Baseline, Day 15 of treatment cycles 2, 3, 4, and 5
Part B: Change From Baseline in the HAMD-17 Total Score at Day 15 of Each Treatment (Initial and/or Repeat Treatment) Cycle
The 17-item HAM-D scale was used to measure the severity of depression. The 17-item HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), 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. Each item is scored in a range of 0 to 2 or 0 to 4. The total score ranges from 0 to 52 with higher scores indicating a greater degree of depression. A negative change from baseline indicates improvement. Study period is defined as treatment cycle (28 days) followed by immediate observation period (maximum 46 weeks), until the first dose of the subsequent treatment cycle.
Time frame: Baseline, Day 15 of Study Period 1, 2, 3, 4, and 5
Part A: Percentage of Participants Who Achieved HAM-D Response During Treatment Cycle 1
HAM-D response was defined as a ≥50% reduction in HAM-D score from baseline, at the end of each 14-day treatment period. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Percentage are rounded off.
Time frame: Day 15 of treatment cycle 1
Part A: Percentage of Participants Who Achieved HAM-D Response During Each Study Period
HAM-D response was defined as a ≥50% reduction in HAM-D score from baseline, at the end of each 14-day treatment period. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it. Percentage are rounded off.
Time frame: Day 15 of Study Period 2, 3, 4, and 5
Part B: Percentage of Participants Who Achieved HAM-D Response
HAM-D response was defined as a ≥50% reduction in HAM-D score from baseline, at the end of each 14-day treatment period. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. A study period is defined as treatment cycle (28 days) followed by immediate observation period (maximum 46 weeks), until the first dose of the subsequent treatment cycle. Percentage are rounded off.
Time frame: Day 15 of Study Period 1, 2, 3, 4, and 5
Part A: Percentage of Participants Who Achieved HAM-D Remission During Treatment Cycle 1
Remission was defined as having a HAM-D total score of ≤7. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Percentage are rounded off.
Time frame: Day 15 of treatment cycle 1
Part A: Percentage of Participants Who Achieved HAM-D Remission During Each Study Period
Remission was defined as having a HAM-D total score of ≤7. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it. Percentage are rounded off.
Time frame: Day 15 of Study Periods 2, 3, 4, and 5
Part B: Percentage of Participants Who Achieved HAM-D Remission
Remission was defined as having a HAM-D total score of ≤7. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. A Study Period is defined as Treatment Cycle (28 days) followed by the immediate observational period (maximum 46 weeks), until the first dose of the subsequent treatment cycle. Percentage are rounded off.
Time frame: Day 15 of Study Period 1, 2, 3, 4, and 5
Part A: Percentage of Participants Who Achieved Clinical Global Impression - Improvement (CGI-I) Response During Treatment Cycle 1
The CGI scale consists of 3 items. Only the first 2 items are being used in this study. The CGI-I employed a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The Investigator rated the participant's total improvement compared to baseline, 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. The CGI-I is only rated at posttreatment assessments. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved." Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Percentage are rounded off.
Time frame: Day 15 of treatment cycle 1
Part A: Percentage of Participants Who Achieved CGI-I Response During Each Study Period
The CGI scale consists of 3 items. Only the first 2 items are being used in this study. The CGI-I employed a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The Investigator rated the participant's total improvement compared to baseline, 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. The CGI-I is only rated at posttreatment assessments. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved." A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it. Percentage are rounded off.
Time frame: Day 15 of Study Periods 2, 3, 4, and 5
Part B: Percentage of Participants Who Achieved CGI-I Response
The CGI scale consists of 3 items. Only the first 2 items are being used in this study. The CGI-I employed a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The Investigator rated the participant's total improvement compared to baseline, 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. The CGI-I is only rated at posttreatment assessments. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved." A Study Period is defined as Treatment Cycle (28 days) followed by the immediate observational period (maximum 46 weeks), until the first dose of the subsequent treatment cycle. Percentage are rounded off.
Time frame: Day 15 of Study Period 1, 2, 3, 4, and 5
Part A: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Treatment Cycle 1
The CGI-S uses a 7-point Likert scale to rate the severity of the participant's mental illness at the time of assessment, 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 indicated extreme illness. A negative change from baseline indicated improvement. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle.
Time frame: Baseline, Day 15 of treatment cycle 1
Part A: Change From Baseline in CGI-S Score During Each Treatment Cycle
The CGI-S uses a 7-point Likert scale to rate the severity of the participant's mental illness at the time of assessment, 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 indicated extreme illness. A negative change from baseline indicated improvement. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle.
Time frame: Baseline, Day 15 of treatment cycles 2, 3, 4, and 5
Part B: Change From Baseline in CGI-S Score
The CGI-S uses a 7-point Likert scale to rate the severity of the participant's mental illness at the time of assessment, 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 indicated extreme illness. A negative change from baseline indicated improvement. A Study Period is defined as Treatment Cycle (28 days) followed by the immediate observational period (maximum 46 weeks), until the first dose of the subsequent treatment cycle.
Time frame: Baseline Day 15 of Study Period 1, 2, 3, 4, and 5
Participants were enrolled at 38 study sites in Part A and 52 study sites in Part B in the United States.
| Milestone | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort | Part B: Sage-217 |
|---|---|---|---|---|
| Started | 513 | 645 | 80 | 277 |
| Dosed with sage-217 within this study | 513 | 645 | 80 | 118 |
| Completed | 213 | 236 | 76 | 69 |
| Not completed | 300 | 409 | 4 | 208 |
| Withdrew: Participant did not meet 50% reduction in hamd-17 | 116 | 173 | 0 | 0 |
| Withdrew: Withdrawal by subject | 72 | 100 | 1 | 21 |
| Withdrew: Lost to follow-up | 45 | 54 | 0 | 9 |
| Withdrew: Adverse event | 42 | 30 | 1 | 9 |
| Withdrew: Protocol deviation | 6 | 26 | 0 | 1 |
| Withdrew: Physician decision | 7 | 10 | 1 | 5 |
| Withdrew: Non-compliance with investigational drug | 4 | 4 | 0 | 0 |
| Withdrew: Sponsor decision | 1 | 2 | 0 | 0 |
| Withdrew: Pregnancy | 0 | 1 | 0 | 0 |
| Withdrew: Other | 7 | 9 | 1 | 4 |
| Withdrew: Enrolled but did not receive sage-217 | 0 | 0 | 0 | 159 |
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. For Part A, a TEAE was defined as an AE with onset after the first dose of SAGE-217.
| Participants | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort |
|---|---|---|---|
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 374 | 437 | 57 |
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. For Part B, a TEAE was defined as an AE with onset on or after the first dose of SAGE-217 in MDD-303B for the participants who received placebo + ADT in parent study, or an AE with onset on or after the ICF signoff in MDD-303B for the participants who received SAGE-217 + ADT in parent study.
| Participants | Part B: Sage-217 |
|---|---|
| Part B: Number of Participants With TEAEs | 87 |
C-SSRS scale consisted of a baseline evaluation that assessed lifetime experience as well as past 24-month experience of participants for SI and SB and a postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation, if present. The C-SSRS SI items included: 1. wish to be dead, 2. non-specific active suicidal thoughts, 3. active SI with any methods, 4. active SI with some intent, and 5. active SI with a specific plan (5 being the most severe). C-SSRS SB items included 1. preparatory acts or behavior, 2. aborted attempt, 3. interrupted attempt, 4. actual attempt (non-fatal), and 5. completed suicide (5 being worst). Participants with at least one SI question answered Yes or at least one SB question answered Yes post-baseline for the specific period is counted under SI or SB respectively.
| Participants | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort |
|---|---|---|---|
| Study Period 1: SI: Baseline | 262 | 264 | 29 |
| Study Period 1: SI: Post-baseline | 128 | 141 | 14 |
| Study Period 1: SB: Baseline | 6 | 8 | 0 |
| Study Period 1: SB: Post-baseline | 3 | 1 | 0 |
| Study Period 2: SI: Baseline | 52 | 57 | 16 |
| Study Period 2: SI: Post-baseline | 44 | 51 | 10 |
| Study Period 2: SB: Baseline | 1 | 0 | 0 |
| Study Period 2: SB: Post-baseline | 0 | 0 | 0 |
| Study Period 3: SI: Baseline | 16 | 23 | 12 |
| Study Period 3: SI: Post-baseline | 17 | 22 | 11 |
| Study Period 3: SB: Baseline | 0 | 0 | 0 |
| Study Period 3: SB: Post-baseline | 0 | 0 | 0 |
| Study Period 4: SI: Baseline | 11 | 8 | 10 |
| Study Period 4: SI: Post-baseline | 10 | 9 | 9 |
| Study Period 4: SB: Baseline | 0 | 0 | 0 |
| Study Period 4: SB: Post-baseline | 1 | 0 | 0 |
| Study Period 5: SI: Baseline | 3 | 1 | 1 |
| Study Period 5: SI: Post-baseline | 6 | 3 | 2 |
| Study Period 5: SB: Baseline | 0 | 0 | 0 |
| Study Period 5: SB: Post-baseline | 0 | 0 | 0 |
C-SSRS scale consisted of a baseline evaluation that assessed lifetime experience as well as past 24-month experience of participants for SI and SB and a postbaseline (PB) evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation, if present. The C-SSRS SI items included: 1. wish to be dead, 2. non-specific active suicidal thoughts, 3. active SI with any methods, 4. active SI with some intent, and 5. active SI with a specific plan (5 being the most severe). C-SSRS SB items included 1. preparatory acts or behavior, 2. aborted attempt, 3. interrupted attempt, 4. actual attempt (non-fatal), and 5. completed suicide (5 being worst). Participants with at least one SI question answered Yes or at least one SB question answered Yes post-baseline for the specific period is counted under SI or SB respectively.
| Participants | Part B: Sage-217 All Participants |
|---|---|
| Study Period 1: SI: Baseline | 17 |
| Study Period 1: SI: Post-baseline | 16 |
| Study Period 1: SB: Baseline | 0 |
| Study Period 1: SB: Post-baseline | 1 |
| Study Period 2: SI: Baseline | 19 |
| Study Period 2: SI: Post-baseline | 24 |
| Study Period 2: SB: Baseline | 0 |
| Study Period 2: SB: Post-baseline | 0 |
| Study Period 3: SI: Baseline | 9 |
| Study Period 3: SI: Post-baseline | 9 |
| Study Period 3: SB: Baseline | 0 |
| Study Period 3: SB: Post-baseline | 0 |
| Study Period 4: SI: Baseline | 5 |
| Study Period 4: SI: Post-baseline | 6 |
| Study Period 4: SB: Baseline | 0 |
| Study Period 4: SB: Post-baseline | 0 |
| Study Period 5: SI: Baseline | 1 |
| Study Period 5: SI: Post-baseline | 1 |
| Study Period 5: SB: Baseline | 0 |
| Study Period 5: SB: Post-baseline | 0 |
For Part A, the first day of the first repeat treatment is Treatment Cycle 2 Day 1. For Part B, participants who had "placebo + ADT" in the parent study (217-MDD-305), the first repeat treatment of SAGE-217 was the second treatment within MDD-303B. Participants who had SAGE-217 + ADT in the parent study (217-MDD-305), the first repeat treatment of SAGE-217 was the first treatment within MDD-303B. For Part A, as prespecified, data for this outcome measure was collected for Sage-217 High-dose Cohort and Sage-217 30 mg Cohort (Low Dose + Dose Switch). For Part B, data for this outcome measure is presented as per the designated arms in the parent study (217-MDD-305). Analysis used Kaplan-Meier estimates where the participants with no repeat treatment were censored.
| days | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 30 mg Cohort (Low Dose + Dose Switch) | Part B: Placebo + ADT | Part B: SAGE-217 + ADT |
|---|---|---|---|---|
| Parts A and B: Time to First Repeat Treatment With SAGE-217 | 281 (191 to NA) | 135 (121 to 166) | 79 (64 to NA) | 233 (121 to NA) |
Participants who continued in the study beyond 56 days from the last study drug dose (in parent study for Part B) and had a HAMD-17 total score ≥20 between the end of first treatment cycle and start of next treatment cycle qualified for repeat treatment for SAGE-217. The 17-item HAM-D was used for measuring severity of depression. It comprised individual ratings of 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. For Part B, data for this outcome measure is presented as per the designated arms in the parent study (217-MDD-305).
| Participants | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Dose-switch Cohort | Part B: Placebo + ADT | Part B: SAGE-217 + ADT |
|---|---|---|---|---|---|
| Parts A and B: Number of Participants Who Achieved the Requirements for Repeat Treatment for SAGE-217 | 174 | 224 | 80 | 28 | 61 |
The response of initial treatment and/or repeat treatment was assessed by HAMD-17. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised individual ratings of following symptoms scored in range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Following symptoms were scored in range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. total score range=0 to 52, and higher scores indicated greater degree of depression. Participants who had a HAM-D total score \>=20 within the protocol were eligible for at least 1 repeat treatment in study. For Part B, data for this outcome measure is presented as per the designated arms in parent study (217-MDD-305). Participants who did not have any re-treatment were included with number of re-treatments equal to 0.
| repeat treatment cycles | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort | Part B: Placebo + ADT | Part B: SAGE-217 + ADT |
|---|---|---|---|---|---|
| Parts A and B: Number of Repeat Treatment Cycles of SAGE-217 for Each Participant | 0.8 ± 1.11 | 0.9 ± 1.13 | 2.8 ± 0.97 | 1.6 ± 0.80 | 1.9 ± 0.97 |
The 17-item HAM-D scale was used for measuring severity of depression. The 17-item HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), 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. Each item is scored in a range of 0 to 2 or 0 to 4. The total score ranges from 0 to 52 with higher scores indicating a greater degree of depression. A negative change from baseline indicates improvement. A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it.
| score on a scale | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort |
|---|---|---|---|
| Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 in Study Period 1 | -15.3 ± 6.58 | -14.6 ± 7.09 | -20.1 ± 4.61 |
The 17-item HAM-D scale was used for measuring severity of depression. The 17-item HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), 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. Each item is scored in a range of 0 to 2 or 0 to 4. The total score ranges from 0 to 52 with higher scores indicating a greater degree of depression. A negative change from baseline indicates improvement. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle.
| score on a scale | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort |
|---|---|---|---|
| Treatment cycle 2: CFB at Day 15 | -13.3 ± 6.36 | -12.3 ± 6.49 | -15.4 ± 7.21 |
| Treatment cycle 3: CFB at Day 15 | -12.2 ± 8.06 | -12.5 ± 6.26 | -15.1 ± 6.24 |
| Treatment cycle 4: CFB at Day 15 | -11.1 ± 6.42 | -11.7 ± 7.52 | -15.8 ± 7.12 |
| Treatment cycle 5: CFB at Day 15 | -9.0 ± 7.17 | -11.6 ± 6.65 | -17.5 ± 8.47 |
The 17-item HAM-D scale was used to measure the severity of depression. The 17-item HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), 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. Each item is scored in a range of 0 to 2 or 0 to 4. The total score ranges from 0 to 52 with higher scores indicating a greater degree of depression. A negative change from baseline indicates improvement. Study period is defined as treatment cycle (28 days) followed by immediate observation period (maximum 46 weeks), until the first dose of the subsequent treatment cycle.
| score on a scale | Part B: Study Period 1 | Part B: Study Period 2 | Part B: Study Period 3 | Part B: Study Period 4 | Part B: Study Period 5 |
|---|---|---|---|---|---|
| Part B: Change From Baseline in the HAMD-17 Total Score at Day 15 of Each Treatment (Initial and/or Repeat Treatment) Cycle | -10.1 ± 6.43 | -10.7 ± 6.49 | -9.6 ± 7.53 | -9.7 ± 7.60 | -10.8 ± 9.26 |
HAM-D response was defined as a ≥50% reduction in HAM-D score from baseline, at the end of each 14-day treatment period. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Percentage are rounded off.
| percentage of participants | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort |
|---|---|---|---|
| Part A: Percentage of Participants Who Achieved HAM-D Response During Treatment Cycle 1 | 67.3 | 65.9 | 100 |
HAM-D response was defined as a ≥50% reduction in HAM-D score from baseline, at the end of each 14-day treatment period. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it. Percentage are rounded off.
| percentage of participants | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort |
|---|---|---|---|
| Study Period 2: Day 15 | 65.3 | 62.8 | 67.9 |
| Study Period 3: Day 15 | 58.0 | 59.3 | 68.6 |
| Study Period 4: Day 15 | 38.2 | 55.0 | 75.5 |
| Study Period 5: Day 15 | 25.0 | 58.8 | 81.8 |
HAM-D response was defined as a ≥50% reduction in HAM-D score from baseline, at the end of each 14-day treatment period. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. A study period is defined as treatment cycle (28 days) followed by immediate observation period (maximum 46 weeks), until the first dose of the subsequent treatment cycle. Percentage are rounded off.
| percentage of participants | Part B: Study Period 1 | Part B: Study Period 2 | Part B: Study Period 3 | Part B: Study Period 4 | Part B: Study Period 5 |
|---|---|---|---|---|---|
| Part B: Percentage of Participants Who Achieved HAM-D Response | 46.2 | 47.1 | 38.1 | 30.0 | 60.0 |
Remission was defined as having a HAM-D total score of ≤7. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Percentage are rounded off.
| percentage of participants | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort |
|---|---|---|---|
| Part A: Percentage of Participants Who Achieved HAM-D Remission During Treatment Cycle 1 | 40.9 | 40.2 | 40.0 |
Remission was defined as having a HAM-D total score of ≤7. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it. Percentage are rounded off.
| percentage of participants | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort |
|---|---|---|---|
| Study Period 2: Day 15 | 38.7 | 31.9 | 37.2 |
| Study Period 3: Day 15 | 34.8 | 29.6 | 32.9 |
| Study Period 4: Day 15 | 23.5 | 32.5 | 43.4 |
| Study Period 5: Day 15 | 16.7 | 29.4 | 63.6 |
Remission was defined as having a HAM-D total score of ≤7. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. A Study Period is defined as Treatment Cycle (28 days) followed by the immediate observational period (maximum 46 weeks), until the first dose of the subsequent treatment cycle. Percentage are rounded off.
| percentage of participants | Part B: Study Period 1 | Part B: Study Period 2 | Part B: Study Period 3 | Part B: Study Period 4 | Part B: Study Period 5 |
|---|---|---|---|---|---|
| Part B: Percentage of Participants Who Achieved HAM-D Remission | 19.2 | 29.4 | 26.2 | 20.0 | 40.0 |
The CGI scale consists of 3 items. Only the first 2 items are being used in this study. The CGI-I employed a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The Investigator rated the participant's total improvement compared to baseline, 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. The CGI-I is only rated at posttreatment assessments. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved." Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Percentage are rounded off.
| percentage of participants | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort |
|---|---|---|---|
| Part A: Percentage of Participants Who Achieved Clinical Global Impression - Improvement (CGI-I) Response During Treatment Cycle 1 | 78.9 | 75.0 | 96.3 |
The CGI scale consists of 3 items. Only the first 2 items are being used in this study. The CGI-I employed a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The Investigator rated the participant's total improvement compared to baseline, 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. The CGI-I is only rated at posttreatment assessments. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved." A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it. Percentage are rounded off.
| percentage of participants | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort |
|---|---|---|---|
| Study Period 2: Day 15 | 76.7 | 75.0 | 79.5 |
| Study Period 3: Day 15 | 65.2 | 73.2 | 80.9 |
| Study Period 4: Day 15 | 52.9 | 60.0 | 84.9 |
| Study Period 5: Day 15 | 33.3 | 68.8 | 90.9 |
The CGI scale consists of 3 items. Only the first 2 items are being used in this study. The CGI-I employed a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The Investigator rated the participant's total improvement compared to baseline, 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. The CGI-I is only rated at posttreatment assessments. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved." A Study Period is defined as Treatment Cycle (28 days) followed by the immediate observational period (maximum 46 weeks), until the first dose of the subsequent treatment cycle. Percentage are rounded off.
| percentage of participants | Part B: Study Period 1 | Part B: Study Period 2 | Part B: Study Period 3 | Part B: Study Period 4 | Part B: Study Period 5 |
|---|---|---|---|---|---|
| Part B: Percentage of Participants Who Achieved CGI-I Response | 53.8 | 63.5 | 64.3 | 55.0 | 60.0 |
The CGI-S uses a 7-point Likert scale to rate the severity of the participant's mental illness at the time of assessment, 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 indicated extreme illness. A negative change from baseline indicated improvement. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle.
| score on a scale | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort |
|---|---|---|---|
| Part A: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Treatment Cycle 1 | -2.3 ± 1.22 | -2.1 ± 1.25 | -2.4 ± 1.01 |
The CGI-S uses a 7-point Likert scale to rate the severity of the participant's mental illness at the time of assessment, 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 indicated extreme illness. A negative change from baseline indicated improvement. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle.
| score on a scale | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort |
|---|---|---|---|
| Treatment Cycle 2: CFB at Day 15 | -2.0 ± 1.15 | -1.9 ± 1.23 | -2.2 ± 1.43 |
| Treatment Cycle 3: CFB at Day 15 | -1.8 ± 1.32 | -1.8 ± 1.21 | -2.1 ± 1.35 |
| Treatment Cycle 4: CFB at Day 15 | -1.8 ± 1.16 | -1.7 ± 1.33 | -2.4 ± 1.64 |
| Treatment Cycle 5: CFB at Day 15 | -1.2 ± 1.27 | -1.9 ± 1.09 | -2.7 ± 1.83 |
The CGI-S uses a 7-point Likert scale to rate the severity of the participant's mental illness at the time of assessment, 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 indicated extreme illness. A negative change from baseline indicated improvement. A Study Period is defined as Treatment Cycle (28 days) followed by the immediate observational period (maximum 46 weeks), until the first dose of the subsequent treatment cycle.
| score on a scale | Part B: Study Period 1 | Part B: Study Period 2 | Part B: Study Period 3 | Part B: Study Period 4 | Part B: Study Period 5 |
|---|---|---|---|---|---|
| Part B: Change From Baseline in CGI-S Score | -1.5 ± 1.18 | -1.8 ± 1.15 | -1.7 ± 1.26 | -1.4 ± 1.39 | -1.4 ± 1.52 |
Collected over For Part A: Up to 52 Weeks; For Part B: Up to 46 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: Sage-217 High-dose Cohort | 0/513 (0%) | 18/513 (3.5%) | 371/513 (72.3%) |
| Part A: Sage-217 Low-dose Cohort | 1/645 (0.2%) | 19/645 (2.9%) | 435/645 (67.4%) |
| Part A: Sage-217 Dose-switch Cohort | 0/80 (0%) | 1/80 (1.3%) | 57/80 (71.3%) |
| Part B: Sage-217 All Participants | 0/118 (0%) | 4/118 (3.4%) | 87/118 (73.7%) |
| Event | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort | Part B: Sage-217 All Participants |
|---|---|---|---|---|
| DiverticulitisInfections and infestations | 0/513 | 1/645 | 1/80 | 0/118 |
| Suicidal ideationPsychiatric disorders | 2/513 | 1/645 | 0/80 | 1/118 |
| Suicide attemptPsychiatric disorders | 1/513 | 2/645 | 0/80 | 1/118 |
| DysphagiaGastrointestinal disorders | 0/513 | 0/645 | 0/80 | 1/118 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/513 | 0/645 | 0/80 | 1/118 |
| BronchospasmRespiratory, thoracic and mediastinal disorders | 0/513 | 0/645 | 0/80 | 1/118 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/513 | 3/645 | 0/80 | 0/118 |
| AstheniaGeneral disorders | 2/513 | 0/645 | 0/80 | 0/118 |
| Confusional statePsychiatric disorders | 1/513 | 0/645 | 0/80 | 0/118 |
| DeliriumPsychiatric disorders | 1/513 | 0/645 | 0/80 | 0/118 |
| Event | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort | Part B: Sage-217 All Participants |
|---|---|---|---|---|
| SomnolenceNervous system disorders | 102/513 | 76/645 | 10/80 | 19/118 |
| HeadacheNervous system disorders | 61/513 | 90/645 | 13/80 | 13/118 |
| DizzinessNervous system disorders | 78/513 | 47/645 | 7/80 | 13/118 |
| SedationNervous system disorders | 57/513 | 29/645 | 11/80 | 8/118 |
| DiarrhoeaGastrointestinal disorders | 26/513 | 43/645 | 11/80 | 6/118 |
| FatigueGeneral disorders | 22/513 | 27/645 | 8/80 | 13/118 |
| COVID-19Infections and infestations | 44/513 | 2/645 | 3/80 | 9/118 |
| Upper respiratory tract infectionInfections and infestations | 23/513 | 52/645 | 5/80 | 9/118 |
| NauseaGastrointestinal disorders | 28/513 | 25/645 | 3/80 | 9/118 |
| InsomniaPsychiatric disorders | 23/513 | 31/645 | 5/80 | 8/118 |
For Part A: Safety Set included all participants who were administered SAGE-217. For Part B: Safety Set included participants who signed the informed consent form (ICF) for MDD-303B and had at least 1 dosing of SAGE-217 in the parent study or within MDD-303B.
| Age, Continuous(years) | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort | Part B: Sage-217 | Total |
|---|---|---|---|---|---|
| Mean | 43.7 ± 15.01 | 44.7 ± 14.31 | 47.5 ± 12.71 | 38.9 ± 12.39 | 43.7 ± 14.38 |
| Sex: Female, Male(Participants) | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort | Part B: Sage-217 | Total |
|---|---|---|---|---|---|
| Female | 331 | 423 | 66 | 127 | 947 |
| Male | 182 | 222 | 14 | 63 | 481 |
| Ethnicity (NIH/OMB)(Participants) | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort | Part B: Sage-217 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 111 | 139 | 37 | 40 | 327 |
| Not Hispanic or Latino | 402 | 506 | 43 | 150 | 1101 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort | Part B: Sage-217 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 6 | 1 | 0 | 0 | 7 |
| Asian | 18 | 22 | 1 | 5 | 46 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 0 | 0 | 2 |
| Black or African American | 45 | 108 | 7 | 31 | 191 |
| White | 432 | 499 | 72 | 153 | 1156 |
| More than one race | 7 | 11 | 0 | 0 | 18 |
| Unknown or Not Reported | 4 | 3 | 0 | 1 | 8 |
| Region of Enrollment(participants) | Part A: Sage-217 High-dose Cohort | Part A: Sage-217 Low-dose Cohort | Part A: Sage-217 Dose-switch Cohort | Part B: Sage-217 | Total |
|---|---|---|---|---|---|
| United States | 513 | 645 | 80 | 190 | 1428 |
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