{"protocolSection":{"identificationModule":{"nctId":"NCT03864614","orgStudyIdInfo":{"id":"217-MDD-303"},"organization":{"fullName":"Biogen","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)","officialTitle":"A Phase 3, Open-Label, 1-Year Study of the Safety, Tolerability, and Need for Re-Treatment With SAGE-217 in Adult Subjects With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2024-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-02-27","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-06-22","type":"ACTUAL"},"completionDateStruct":{"date":"2023-06-22","type":"ACTUAL"},"studyFirstSubmitDate":"2019-02-05","studyFirstSubmitQcDate":"2019-03-04","studyFirstPostDateStruct":{"date":"2019-03-06","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-06-21","resultsFirstSubmitQcDate":"2024-06-21","resultsFirstPostDateStruct":{"date":"2024-07-18","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-08-08","lastUpdatePostDateStruct":{"date":"2024-08-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Biogen","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"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.","detailedDescription":"This study was previously posted by Sage Therapeutics. In July 2024, sponsorship of the trial was transferred to Biogen."},"conditionsModule":{"conditions":["Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":1515,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"SAGE-217","type":"EXPERIMENTAL","interventionNames":["Drug: SAGE-217"]}],"interventions":[{"type":"DRUG","name":"SAGE-217","description":"SAGE-217","armGroupLabels":["SAGE-217"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)","description":"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.","timeFrame":"Up to 52 Weeks"},{"measure":"Part B: Number of Participants With TEAEs","description":"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.","timeFrame":"Up to 46 Weeks"},{"measure":"Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)","description":"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.","timeFrame":"Baseline up to 52 Weeks (Study Period 1-5)"},{"measure":"Part B: Number of Participants With Suicidal Ideation (SI) and Suicidal Behavior (SB) as Assessed by the C-SSRS","description":"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.","timeFrame":"Baseline up to 46 Weeks (Study Period 1-5)"}],"secondaryOutcomes":[{"measure":"Parts A and B: Time to First Repeat Treatment With SAGE-217","description":"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).\n\nAnalysis used Kaplan-Meier estimates where the participants with no repeat treatment were censored.","timeFrame":"Up to 52 Weeks"},{"measure":"Parts A and B: Number of Participants Who Achieved the Requirements for Repeat Treatment for SAGE-217","description":"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).","timeFrame":"Up to 52 Weeks"},{"measure":"Parts A and B: Number of Repeat Treatment Cycles of SAGE-217 for Each Participant","description":"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.","timeFrame":"Up to 52 Weeks"},{"measure":"Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 in Study Period 1","description":"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.","timeFrame":"Baseline, Day 15 in Study Period 1"},{"measure":"Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 of Each Treatment Cycle","description":"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.","timeFrame":"Baseline, Day 15 of treatment cycles 2, 3, 4, and 5"},{"measure":"Part B: Change From Baseline in the HAMD-17 Total Score at Day 15 of Each Treatment (Initial and/or Repeat Treatment) Cycle","description":"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.","timeFrame":"Baseline, Day 15 of Study Period 1, 2, 3, 4, and 5"},{"measure":"Part A: Percentage of Participants Who Achieved HAM-D Response During Treatment Cycle 1","description":"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.","timeFrame":"Day 15 of treatment cycle 1"},{"measure":"Part A: Percentage of Participants Who Achieved HAM-D Response During Each Study Period","description":"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.","timeFrame":"Day 15 of Study Period 2, 3, 4, and 5"},{"measure":"Part B: Percentage of Participants Who Achieved HAM-D Response","description":"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.","timeFrame":"Day 15 of Study Period 1, 2, 3, 4, and 5"},{"measure":"Part A: Percentage of Participants Who Achieved HAM-D Remission During Treatment Cycle 1","description":"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.","timeFrame":"Day 15 of treatment cycle 1"},{"measure":"Part A: Percentage of Participants Who Achieved HAM-D Remission During Each Study Period","description":"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.","timeFrame":"Day 15 of Study Periods 2, 3, 4, and 5"},{"measure":"Part B: Percentage of Participants Who Achieved HAM-D Remission","description":"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.","timeFrame":"Day 15 of Study Period 1, 2, 3, 4, and 5"},{"measure":"Part A: Percentage of Participants Who Achieved Clinical Global Impression - Improvement (CGI-I) Response During Treatment Cycle 1","description":"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.","timeFrame":"Day 15 of treatment cycle 1"},{"measure":"Part A: Percentage of Participants Who Achieved CGI-I Response During Each Study Period","description":"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.","timeFrame":"Day 15 of Study Periods 2, 3, 4, and 5"},{"measure":"Part B: Percentage of Participants Who Achieved CGI-I Response","description":"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.","timeFrame":"Day 15 of Study Period 1, 2, 3, 4, and 5"},{"measure":"Part A: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Treatment Cycle 1","description":"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.","timeFrame":"Baseline, Day 15 of treatment cycle 1"},{"measure":"Part A: Change From Baseline in CGI-S Score During Each Treatment Cycle","description":"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.","timeFrame":"Baseline, Day 15 of treatment cycles 2, 3, 4, and 5"},{"measure":"Part B: Change From Baseline in CGI-S Score","description":"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.","timeFrame":"Baseline Day 15 of Study Period 1, 2, 3, 4, and 5"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Participant has a diagnosis of MDD as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period.\n2. Participant is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests.\n3. Participant has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥28 and a HAM-D total score of ≥20 at Screening and Day 1 (prior to dosing).\n\nExclusion Criteria:\n\n1. Participant has attempted suicide associated with the current episode of MDD.\n2. Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.\n3. Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Sage Investigational Site","city":"Dothan","state":"Alabama","zip":"36303","country":"United States","geoPoint":{"lat":31.22323,"lon":-85.39049}},{"facility":"Sage Investigational Site","city":"Phoenix","state":"Arizona","zip":"85012","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Sage Investigational Site","city":"Anaheim","state":"California","zip":"92805","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"Sage Investigational Site","city":"Costa Mesa","state":"California","zip":"92626","country":"United States","geoPoint":{"lat":33.64113,"lon":-117.91867}},{"facility":"Sage 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site","city":"Cincinnati","state":"Ohio","zip":"45215","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Sage Investigational Site","city":"Cincinnati","state":"Ohio","zip":"45219","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Sage Investigational Site","city":"North Canton","state":"Ohio","zip":"44720","country":"United States","geoPoint":{"lat":40.87589,"lon":-81.40234}},{"facility":"Sage Investigational Site","city":"Oklahoma City","state":"Oklahoma","zip":"73112","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"Sage Investigational Site","city":"Plymouth Meeting","state":"Pennsylvania","zip":"19462","country":"United States","geoPoint":{"lat":40.10233,"lon":-75.27435}},{"facility":"Sage Investigational Site","city":"Austin","state":"Texas","zip":"78759","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"Sage Investigational Site","city":"Dallas","state":"Texas","zip":"75231","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"Sage Investigational Site","city":"Houston","state":"Texas","zip":"77030","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Sage Investigational Site","city":"Houston","state":"Texas","zip":"77081","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Sage Investigational Site","city":"Newport","state":"Texas","zip":"78712","country":"United States","geoPoint":{"lat":33.46789,"lon":-98.01643}},{"facility":"Sage Investigational Site","city":"Wichita Falls","state":"Texas","zip":"76309","country":"United States","geoPoint":{"lat":33.91371,"lon":-98.49339}},{"facility":"Sage Investigational Site","city":"Bellevue","state":"Washington","zip":"98007","country":"United States","geoPoint":{"lat":47.61038,"lon":-122.20068}}]},"referencesModule":{"references":[{"pmid":"38153320","type":"DERIVED","citation":"Cutler AJ, Mattingly GW, Kornstein SG, Aaronson ST, Lasser R, Zhang H, Rana N, Brown C, Levin S, Miller C, Kotecha M, Forrestal F, Doherty J. Long-Term Safety and Efficacy of Initial and Repeat Treatment Courses With Zuranolone in Adult Patients With Major Depressive Disorder: Interim Results From the Open-Label, Phase 3 SHORELINE Study. J Clin Psychiatry. 2023 Dec 27;85(1):23m14845. doi: 10.4088/JCP.23m14845."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/","url":"https://vivli.org/"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants with Major Depressive Disorder (MDD) were enrolled in this study. This study was conducted in 2 parts, Part A enrolled de novo MDD participants and Part B enrolled MDD participants from the parent study 217- MDD-305 (NCT04476030). Data for Part B was collected and reported in a single arm for each participant who signed informed consent to enroll into this study to be treated with SAGE-217 if and when eligible to be treated.","recruitmentDetails":"Participants were enrolled at 38 study sites in Part A and 52 study sites in Part B in the United States.","groups":[{"id":"FG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the investigational product (IP), the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period"},{"id":"FG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"FG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period"},{"id":"FG003","title":"Part B: Sage-217","description":"Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"513"},{"groupId":"FG001","numSubjects":"645"},{"groupId":"FG002","numSubjects":"80"},{"groupId":"FG003","numSubjects":"277"}]},{"type":"Dosed With SAGE-217 Within This Study","achievements":[{"groupId":"FG000","numSubjects":"513"},{"groupId":"FG001","numSubjects":"645"},{"groupId":"FG002","numSubjects":"80"},{"groupId":"FG003","numSubjects":"118"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"213"},{"groupId":"FG001","numSubjects":"236"},{"groupId":"FG002","numSubjects":"76"},{"groupId":"FG003","numSubjects":"69"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"300"},{"groupId":"FG001","numSubjects":"409"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"208"}]}],"dropWithdraws":[{"type":"Participant Did Not Meet 50% Reduction in HAMD-17","reasons":[{"groupId":"FG000","numSubjects":"116"},{"groupId":"FG001","numSubjects":"173"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"72"},{"groupId":"FG001","numSubjects":"100"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"21"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"54"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"9"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"30"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"9"}]},{"type":"Protocol Deviation","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"5"}]},{"type":"Non-compliance With Investigational Drug","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"4"}]},{"type":"Enrolled but did not receive SAGE-217","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"159"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"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.","groups":[{"id":"BG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the investigational product (IP), the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"BG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"BG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"BG003","title":"Part B: Sage-217","description":"Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"513"},{"groupId":"BG001","value":"645"},{"groupId":"BG002","value":"80"},{"groupId":"BG003","value":"190"},{"groupId":"BG004","value":"1428"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"43.7","spread":"15.01"},{"groupId":"BG001","value":"44.7","spread":"14.31"},{"groupId":"BG002","value":"47.5","spread":"12.71"},{"groupId":"BG003","value":"38.9","spread":"12.39"},{"groupId":"BG004","value":"43.7","spread":"14.38"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"331"},{"groupId":"BG001","value":"423"},{"groupId":"BG002","value":"66"},{"groupId":"BG003","value":"127"},{"groupId":"BG004","value":"947"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"182"},{"groupId":"BG001","value":"222"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"63"},{"groupId":"BG004","value":"481"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"111"},{"groupId":"BG001","value":"139"},{"groupId":"BG002","value":"37"},{"groupId":"BG003","value":"40"},{"groupId":"BG004","value":"327"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"402"},{"groupId":"BG001","value":"506"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"150"},{"groupId":"BG004","value":"1101"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"7"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"46"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"2"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"108"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"31"},{"groupId":"BG004","value":"191"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"432"},{"groupId":"BG001","value":"499"},{"groupId":"BG002","value":"72"},{"groupId":"BG003","value":"153"},{"groupId":"BG004","value":"1156"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"18"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"8"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"513"},{"groupId":"BG001","value":"645"},{"groupId":"BG002","value":"80"},{"groupId":"BG003","value":"190"},{"groupId":"BG004","value":"1428"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)","description":"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.","populationDescription":"Safety Set included all participants who were administered SAGE-217.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to 52 Weeks","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"513"},{"groupId":"OG001","value":"645"},{"groupId":"OG002","value":"80"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"374"},{"groupId":"OG001","value":"437"},{"groupId":"OG002","value":"57"}]}]}]},{"type":"PRIMARY","title":"Part B: Number of Participants With TEAEs","description":"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.","populationDescription":"Study-specific Safety Set included all participants who signed the ICF for 217-MDD-303B and had at least 1 dosing of SAGE-217 within 217-MDD-303B. Data for Part B was collected and reported in a single arm for each participant who started treatment as specified.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to 46 Weeks","groups":[{"id":"OG000","title":"Part B: Sage-217","description":"Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"87"}]}]}]},{"type":"PRIMARY","title":"Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)","description":"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.","populationDescription":"Safety Set included all participants who were administered SAGE-217. For Baseline: Number analyzed is participants of safety set who received SAGE-217 in corresponding study period; For Post-baseline: Number analyzed is participants with data available for analysis at a specific timepoint. 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.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline up to 52 Weeks (Study Period 1-5)","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"513"},{"groupId":"OG001","value":"645"},{"groupId":"OG002","value":"80"}]}],"classes":[{"title":"Study Period 1: SI: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"513"},{"groupId":"OG001","value":"645"},{"groupId":"OG002","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"264"},{"groupId":"OG002","value":"29"}]}]},{"title":"Study Period 1: SI: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"505"},{"groupId":"OG001","value":"642"},{"groupId":"OG002","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"128"},{"groupId":"OG001","value":"141"},{"groupId":"OG002","value":"14"}]}]},{"title":"Study Period 1: SB: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"513"},{"groupId":"OG001","value":"642"},{"groupId":"OG002","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"0"}]}]},{"title":"Study Period 1: SB: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"505"},{"groupId":"OG001","value":"645"},{"groupId":"OG002","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Study Period 2: SI: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"206"},{"groupId":"OG002","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"16"}]}]},{"title":"Study Period 2: SI: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"204"},{"groupId":"OG002","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"10"}]}]},{"title":"Study Period 2: SB: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"206"},{"groupId":"OG002","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Study Period 2: SB: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"204"},{"groupId":"OG002","value":"80"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Study Period 3: SI: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"12"}]}]},{"title":"Study Period 3: SI: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"11"}]}]},{"title":"Study Period 3: SB: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Study Period 3: SB: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"71"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Study Period 4: SI: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"53"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"10"}]}]},{"title":"Study Period 4: SI: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"53"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"9"}]}]},{"title":"Study Period 4: SB: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"53"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Study Period 4: SB: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"53"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Study Period 5: SI: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"23"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"Study Period 5: SI: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"23"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"}]}]},{"title":"Study Period 5: SB: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"23"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Study Period 5: SB: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"23"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"PRIMARY","title":"Part B: Number of Participants With Suicidal Ideation (SI) and Suicidal Behavior (SB) as Assessed by the C-SSRS","description":"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.","populationDescription":"Period-Specific Safety Set included all participants who signed ICF for 217-MDD-303B and were dosed in respective Study Period. A Study Period is a treatment cycle followed by the immediate observation period until the first dose of the subsequent treatment cycle. Data for Part B was collected and reported in a single arm for each participant who started treatment as specified.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline up to 46 Weeks (Study Period 1-5)","groups":[{"id":"OG000","title":"Part B: Sage-217 All Participants","description":"Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"}]}],"classes":[{"title":"Study Period 1: SI: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}]},{"title":"Study Period 1: SI: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}]},{"title":"Study Period 1: SB: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Study Period 1: SB: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"57"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Study Period 2: SI: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"87"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}]},{"title":"Study Period 2: SI: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"87"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"24"}]}]},{"title":"Study Period 2: SB: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"87"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Study Period 2: SB: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"87"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Study Period 3: SI: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}]},{"title":"Study Period 3: SI: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}]},{"title":"Study Period 3: SB: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Study Period 3: SB: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Study Period 4: SI: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}]},{"title":"Study Period 4: SI: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]},{"title":"Study Period 4: SB: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Study Period 4: SB: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Study Period 5: SI: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Study Period 5: SI: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Study Period 5: SB: Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Study Period 5: SB: Post-baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Parts A and B: Time to First Repeat Treatment With SAGE-217","description":"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).\n\nAnalysis used Kaplan-Meier estimates where the participants with no repeat treatment were censored.","populationDescription":"For Part A: FAS included all participants in the Safety Set who had HAMD-17 (change from baseline \\>=50%) response at Treatment Cycle 1 Day 15 and the discontinuation from study date, if it existed, was after the end of Treatment Cycle 1. For Part B: Safety Set included all participants who received a dose of SAGE-217 either in the parent study 217-MDD-305 or within this protocol 217-MDD-303B.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"days","timeFrame":"Up to 52 Weeks","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 30 mg Cohort (Low Dose + Dose Switch)","description":"Participants from low-dose cohort (who received 30 mg as first and last dose) and dose-switch cohort (who received 30 mg as their first dose) were included in the 30 mg cohort arm."},{"id":"OG002","title":"Part B: Placebo + ADT","description":"Participants in the parent study (217-MDD-305) received SAGE-217-matching placebo capsules, orally, once daily along with an assigned anti-depressant therapy (ADT). Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle."},{"id":"OG003","title":"Part B: SAGE-217 + ADT","description":"Participants in the parent study (217-MDD-305) received SAGE-217 capsules, orally, once daily along with an assigned ADT. Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"338"},{"groupId":"OG001","value":"489"},{"groupId":"OG002","value":"57"},{"groupId":"OG003","value":"133"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"281","lowerLimit":"191","upperLimit":"NA","comment":"There was no observed failure time (i.e. time to repeat treatment) for which the upper bound of the confidence interval for the Kaplan-Meier estimate is less than 0.5, hence the upper limit of confidence interval remains not estimable."},{"groupId":"OG001","value":"135","lowerLimit":"121","upperLimit":"166"},{"groupId":"OG002","value":"79","lowerLimit":"64","upperLimit":"NA","comment":"There was no observed failure time (i.e. time to repeat treatment) for which the upper bound of the confidence interval for the Kaplan-Meier estimate is less than 0.5, hence the upper limit of confidence interval remains not estimable."},{"groupId":"OG003","value":"233","lowerLimit":"121","upperLimit":"NA","comment":"There was no observed failure time (i.e. time to repeat treatment) for which the upper bound of the confidence interval for the Kaplan-Meier estimate is less than 0.5, hence the upper limit of confidence interval remains not estimable."}]}]}]},{"type":"SECONDARY","title":"Parts A and B: Number of Participants Who Achieved the Requirements for Repeat Treatment for SAGE-217","description":"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).","populationDescription":"For Part A: FAS included all participants in the Safety Set who had HAMD-17 response at Treatment Cycle 1 Day 15 and the discontinuation from study date, if it existed, was after the end of Treatment Cycle 1. For Part B: FAS included all participants in the study-specific safety set (dosed at least once within this protocol) who had at least 1 HAMD-17 total score available after the first dose of SAGE-217 within 217-MDD-303B.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to 52 Weeks","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG003","title":"Part B: Placebo + ADT","description":"Participants in the parent study (217-MDD-305) received SAGE-217-matching placebo capsules, orally, once daily along with an assigned ADT. Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle."},{"id":"OG004","title":"Part B: SAGE-217 + ADT","description":"Participants in the parent study (217-MDD-305) received SAGE-217 capsules, orally, once daily along with an assigned ADT. Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"338"},{"groupId":"OG001","value":"409"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"57"},{"groupId":"OG004","value":"61"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"174"},{"groupId":"OG001","value":"224"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"28"},{"groupId":"OG004","value":"61"}]}]}]},{"type":"SECONDARY","title":"Parts A and B: Number of Repeat Treatment Cycles of SAGE-217 for Each Participant","description":"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.","populationDescription":"For Part A: FAS included all participants in safety set who had HAMD-17 response at Treatment Cycle 1 Day 15 and discontinuation from study date, if it existed, was after end of Treatment Cycle 1. For Part B: FAS included all participants in study-specific safety set (dosed at least once within this protocol) who had at least 1 HAMD-17 total score available after first dose of SAGE-217 within 217-MDD-303B.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"repeat treatment cycles","timeFrame":"Up to 52 Weeks","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG003","title":"Part B: Placebo + ADT","description":"Participants in the parent study (217-MDD-305) received SAGE-217-matching placebo capsules, orally, once daily along with an assigned ADT. Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle."},{"id":"OG004","title":"Part B: SAGE-217 + ADT","description":"Participants in the parent study (217-MDD-305) received SAGE-217 capsules, orally, once daily along with an assigned ADT. Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"338"},{"groupId":"OG001","value":"409"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"57"},{"groupId":"OG004","value":"61"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"1.11"},{"groupId":"OG001","value":"0.9","spread":"1.13"},{"groupId":"OG002","value":"2.8","spread":"0.97"},{"groupId":"OG003","value":"1.6","spread":"0.80"},{"groupId":"OG004","value":"1.9","spread":"0.97"}]}]}]},{"type":"SECONDARY","title":"Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 in Study Period 1","description":"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.","populationDescription":"The Safety Set was defined as all participants who received SAGE-217. Overall number analyzed is the number of participants with data available for analysis at a specified timepoint.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Day 15 in Study Period 1","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"465"},{"groupId":"OG001","value":"607"},{"groupId":"OG002","value":"80"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.3","spread":"6.58"},{"groupId":"OG001","value":"-14.6","spread":"7.09"},{"groupId":"OG002","value":"-20.1","spread":"4.61"}]}]}]},{"type":"SECONDARY","title":"Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 of Each Treatment Cycle","description":"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.","populationDescription":"FAS included all participants in the Safety Set who had HAMD-17 response at Treatment Cycle 1 Day 15 and a discontinuation from study date, if it existed, was after the end of Treatment Cycle 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a specific timepoint.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Day 15 of treatment cycles 2, 3, 4, and 5","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"188"},{"groupId":"OG002","value":"78"}]}],"classes":[{"title":"Treatment cycle 2: CFB at Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"188"},{"groupId":"OG002","value":"78"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-13.3","spread":"6.36"},{"groupId":"OG001","value":"-12.3","spread":"6.49"},{"groupId":"OG002","value":"-15.4","spread":"7.21"}]}]},{"title":"Treatment cycle 3: CFB at Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"81"},{"groupId":"OG002","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-12.2","spread":"8.06"},{"groupId":"OG001","value":"-12.5","spread":"6.26"},{"groupId":"OG002","value":"-15.1","spread":"6.24"}]}]},{"title":"Treatment cycle 4: CFB at Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"53"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-11.1","spread":"6.42"},{"groupId":"OG001","value":"-11.7","spread":"7.52"},{"groupId":"OG002","value":"-15.8","spread":"7.12"}]}]},{"title":"Treatment cycle 5: CFB at Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-9.0","spread":"7.17"},{"groupId":"OG001","value":"-11.6","spread":"6.65"},{"groupId":"OG002","value":"-17.5","spread":"8.47"}]}]}]},{"type":"SECONDARY","title":"Part B: Change From Baseline in the HAMD-17 Total Score at Day 15 of Each Treatment (Initial and/or Repeat Treatment) Cycle","description":"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.","populationDescription":"FAS included all participants who signed the ICF for 217-MDD-303B and had at least 1 dosing of SAGE-217 within 217-MDD-303B and had at least 1 HAMD-17 total score available after the first dose of SAGE-217 within 217-MDD-303B. Overall number of participants analyzed is participants in FAS who were dosed in the specific period. Data for this outcome measure was collected and analyzed as per study period.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Day 15 of Study Period 1, 2, 3, 4, and 5","groups":[{"id":"OG000","title":"Part B: Study Period 1","description":"Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Study Period 1 included only placebo + ADT participants from the parent study (217-MDD-305)."},{"id":"OG001","title":"Part B: Study Period 2","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 2 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG002","title":"Part B: Study Period 3","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 3 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG003","title":"Part B: Study Period 4","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 4 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG004","title":"Part B: Study Period 5","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 5 included only SAGE 217 + ADT participants from the parent study (217-MDD-305)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"85"},{"groupId":"OG002","value":"42"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-10.1","spread":"6.43"},{"groupId":"OG001","value":"-10.7","spread":"6.49"},{"groupId":"OG002","value":"-9.6","spread":"7.53"},{"groupId":"OG003","value":"-9.7","spread":"7.60"},{"groupId":"OG004","value":"-10.8","spread":"9.26"}]}]}]},{"type":"SECONDARY","title":"Part A: Percentage of Participants Who Achieved HAM-D Response During Treatment Cycle 1","description":"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.","populationDescription":"The Safety Set was defined as all participants who received SAGE-217. Overall number analyzed is the number of participants with data available for analysis at a specified timepoint.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Day 15 of treatment cycle 1","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"513"},{"groupId":"OG001","value":"645"},{"groupId":"OG002","value":"80"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"67.3"},{"groupId":"OG001","value":"65.9"},{"groupId":"OG002","value":"100"}]}]}]},{"type":"SECONDARY","title":"Part A: Percentage of Participants Who Achieved HAM-D Response During Each Study Period","description":"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.","populationDescription":"FAS included all participants in the Safety Set who had HAMD-17 response at Treatment Cycle 1 Day 15 and the discontinuation from study date, if it existed, was after the end of Treatment Cycle 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at given timepoint.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Day 15 of Study Period 2, 3, 4, and 5","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"188"},{"groupId":"OG002","value":"78"}]}],"classes":[{"title":"Study Period 2: Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"188"},{"groupId":"OG002","value":"78"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"65.3"},{"groupId":"OG001","value":"62.8"},{"groupId":"OG002","value":"67.9"}]}]},{"title":"Study Period 3: Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"81"},{"groupId":"OG002","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"58.0"},{"groupId":"OG001","value":"59.3"},{"groupId":"OG002","value":"68.6"}]}]},{"title":"Study Period 4: Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"53"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"38.2"},{"groupId":"OG001","value":"55.0"},{"groupId":"OG002","value":"75.5"}]}]},{"title":"Study Period 5: Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"25.0"},{"groupId":"OG001","value":"58.8"},{"groupId":"OG002","value":"81.8"}]}]}]},{"type":"SECONDARY","title":"Part B: Percentage of Participants Who Achieved HAM-D Response","description":"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.","populationDescription":"FAS included all participants who signed the ICF for 217-MDD-303B and had at least 1 dosing of SAGE-217 within 217-MDD-303B and had at least 1 HAMD-17 total score available after the first dose of SAGE-217 within 217-MDD-303B. Overall number of participants analyzed is participants in FAS who were dosed in the specific period. Data for this outcome measure was collected and analyzed as per study period.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Day 15 of Study Period 1, 2, 3, 4, and 5","groups":[{"id":"OG000","title":"Part B: Study Period 1","description":"Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Study Period 1 included only placebo + ADT participants from the parent study (217-MDD-305)."},{"id":"OG001","title":"Part B: Study Period 2","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 2 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG002","title":"Part B: Study Period 3","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 3 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG003","title":"Part B: Study Period 4","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 4 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG004","title":"Part B: Study Period 5","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 5 included only SAGE 217 + ADT participants from the parent study (217-MDD-305)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"85"},{"groupId":"OG002","value":"42"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"46.2"},{"groupId":"OG001","value":"47.1"},{"groupId":"OG002","value":"38.1"},{"groupId":"OG003","value":"30.0"},{"groupId":"OG004","value":"60.0"}]}]}]},{"type":"SECONDARY","title":"Part A: Percentage of Participants Who Achieved HAM-D Remission During Treatment Cycle 1","description":"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.","populationDescription":"The Safety Set was defined as all participants who received SAGE-217. Overall number analyzed is the number of participants with data available for analysis at a specified timepoint.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Day 15 of treatment cycle 1","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"465"},{"groupId":"OG001","value":"607"},{"groupId":"OG002","value":"80"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"40.9"},{"groupId":"OG001","value":"40.2"},{"groupId":"OG002","value":"40.0"}]}]}]},{"type":"SECONDARY","title":"Part A: Percentage of Participants Who Achieved HAM-D Remission During Each Study Period","description":"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.","populationDescription":"FAS included all participants in the Safety Set who had HAMD-17 response at Treatment Cycle 1 Day 15 and the discontinuation from study date, if it existed, was after the end of Treatment Cycle 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available at a given timepoint.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Day 15 of Study Periods 2, 3, 4, and 5","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"188"},{"groupId":"OG002","value":"78"}]}],"classes":[{"title":"Study Period 2: Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"188"},{"groupId":"OG002","value":"78"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"38.7"},{"groupId":"OG001","value":"31.9"},{"groupId":"OG002","value":"37.2"}]}]},{"title":"Study Period 3: Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"81"},{"groupId":"OG002","value":"70"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"34.8"},{"groupId":"OG001","value":"29.6"},{"groupId":"OG002","value":"32.9"}]}]},{"title":"Study Period 4: Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"53"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"23.5"},{"groupId":"OG001","value":"32.5"},{"groupId":"OG002","value":"43.4"}]}]},{"title":"Study Period 5: Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"16.7"},{"groupId":"OG001","value":"29.4"},{"groupId":"OG002","value":"63.6"}]}]}]},{"type":"SECONDARY","title":"Part B: Percentage of Participants Who Achieved HAM-D Remission","description":"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.","populationDescription":"FAS included all participants who signed the ICF for 217-MDD-303B and had at least 1 dosing of SAGE-217 within 217-MDD-303B and had at least 1 HAMD-17 total score available after the first dose of SAGE-217 within 217-MDD-303B. Overall number of participants analyzed is participants in FAS who were dosed in the specific period. Data for this outcome measure was collected and analyzed as per study period.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Day 15 of Study Period 1, 2, 3, 4, and 5","groups":[{"id":"OG000","title":"Part B: Study Period 1","description":"Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Study Period 1 included only placebo + ADT participants from the parent study (217-MDD-305)."},{"id":"OG001","title":"Part B: Study Period 2","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 2 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG002","title":"Part B: Study Period 3","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 3 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG003","title":"Part B: Study Period 4","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 4 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG004","title":"Part B: Study Period 5","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 5 included only SAGE 217 + ADT participants from the parent study (217-MDD-305)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"85"},{"groupId":"OG002","value":"42"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19.2"},{"groupId":"OG001","value":"29.4"},{"groupId":"OG002","value":"26.2"},{"groupId":"OG003","value":"20.0"},{"groupId":"OG004","value":"40.0"}]}]}]},{"type":"SECONDARY","title":"Part A: Percentage of Participants Who Achieved Clinical Global Impression - Improvement (CGI-I) Response During Treatment Cycle 1","description":"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.","populationDescription":"The Safety Set was defined as all participants who received SAGE-217. Overall number analyzed is the number of participants with data available for analysis at a specified timepoint.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Day 15 of treatment cycle 1","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"464"},{"groupId":"OG001","value":"608"},{"groupId":"OG002","value":"80"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"78.9"},{"groupId":"OG001","value":"75.0"},{"groupId":"OG002","value":"96.3"}]}]}]},{"type":"SECONDARY","title":"Part A: Percentage of Participants Who Achieved CGI-I Response During Each Study Period","description":"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.","populationDescription":"FAS included all participants in the Safety Set who had HAMD-17 response at Treatment Cycle 1 Day 15 and the discontinuation from study date, if it existed, was after the end of Treatment Cycle 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specific timepoint.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Day 15 of Study Periods 2, 3, 4, and 5","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"188"},{"groupId":"OG002","value":"78"}]}],"classes":[{"title":"Study Period 2: Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"188"},{"groupId":"OG002","value":"78"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"76.7"},{"groupId":"OG001","value":"75.0"},{"groupId":"OG002","value":"79.5"}]}]},{"title":"Study Period 3: Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"82"},{"groupId":"OG002","value":"68"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"65.2"},{"groupId":"OG001","value":"73.2"},{"groupId":"OG002","value":"80.9"}]}]},{"title":"Study Period 4: Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"53"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"52.9"},{"groupId":"OG001","value":"60.0"},{"groupId":"OG002","value":"84.9"}]}]},{"title":"Study Period 5: Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"33.3"},{"groupId":"OG001","value":"68.8"},{"groupId":"OG002","value":"90.9"}]}]}]},{"type":"SECONDARY","title":"Part B: Percentage of Participants Who Achieved CGI-I Response","description":"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.","populationDescription":"FAS included all participants who signed the ICF for 217-MDD-303B and had at least 1 dosing of SAGE-217 within 217-MDD-303B and had at least 1 HAMD-17 total score available after the first dose of SAGE-217 within 217-MDD-303B. Overall number of participants analyzed is participants in FAS who were dosed in the specific period. Data for this outcome measure was collected and analyzed as per study period.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Day 15 of Study Period 1, 2, 3, 4, and 5","groups":[{"id":"OG000","title":"Part B: Study Period 1","description":"Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Study Period 1 included only placebo + ADT participants from the parent study (217-MDD-305)."},{"id":"OG001","title":"Part B: Study Period 2","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 2 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG002","title":"Part B: Study Period 3","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 3 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG003","title":"Part B: Study Period 4","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 4 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG004","title":"Part B: Study Period 5","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 5 included only SAGE 217 + ADT participants from the parent study (217-MDD-305)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"85"},{"groupId":"OG002","value":"42"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"53.8"},{"groupId":"OG001","value":"63.5"},{"groupId":"OG002","value":"64.3"},{"groupId":"OG003","value":"55.0"},{"groupId":"OG004","value":"60.0"}]}]}]},{"type":"SECONDARY","title":"Part A: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Treatment Cycle 1","description":"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.","populationDescription":"The Safety Set was defined as all participants who received SAGE-217. Overall number analyzed is the number of participants with data available for analysis at a specified timepoint.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Day 15 of treatment cycle 1","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"464"},{"groupId":"OG001","value":"608"},{"groupId":"OG002","value":"80"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.3","spread":"1.22"},{"groupId":"OG001","value":"-2.1","spread":"1.25"},{"groupId":"OG002","value":"-2.4","spread":"1.01"}]}]}]},{"type":"SECONDARY","title":"Part A: Change From Baseline in CGI-S Score During Each Treatment Cycle","description":"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.","populationDescription":"FAS included all participants in the Safety Set who had HAMD-17 response at Treatment Cycle 1 Day 15 and the discontinuation from study date, if it existed, was after the end of Treatment Cycle 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specific timepoints.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Day 15 of treatment cycles 2, 3, 4, and 5","groups":[{"id":"OG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 milligrams (mg), orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in Hamilton Rating Scale for Depression \\[HAMD\\]-17 total score by Day 15) entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item Patient Health Questionnaire (PHQ-9); participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."},{"id":"OG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of the IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"188"},{"groupId":"OG002","value":"78"}]}],"classes":[{"title":"Treatment Cycle 2: CFB at Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"188"},{"groupId":"OG002","value":"78"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.0","spread":"1.15"},{"groupId":"OG001","value":"-1.9","spread":"1.23"},{"groupId":"OG002","value":"-2.2","spread":"1.43"}]}]},{"title":"Treatment Cycle 3: CFB at Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"82"},{"groupId":"OG002","value":"68"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"1.32"},{"groupId":"OG001","value":"-1.8","spread":"1.21"},{"groupId":"OG002","value":"-2.1","spread":"1.35"}]}]},{"title":"Treatment Cycle 4: CFB at Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"53"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.8","spread":"1.16"},{"groupId":"OG001","value":"-1.7","spread":"1.33"},{"groupId":"OG002","value":"-2.4","spread":"1.64"}]}]},{"title":"Treatment Cycle 5: CFB at Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"22"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"1.27"},{"groupId":"OG001","value":"-1.9","spread":"1.09"},{"groupId":"OG002","value":"-2.7","spread":"1.83"}]}]}]},{"type":"SECONDARY","title":"Part B: Change From Baseline in CGI-S Score","description":"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.","populationDescription":"FAS included all participants who signed the ICF for 217-MDD-303B and had at least 1 dosing of SAGE-217 within 217-MDD-303B and had at least 1 HAMD-17 total score available after the first dose of SAGE-217 within 217-MDD-303B. Overall number of participants analyzed is participants in FAS who were dosed in the specific period. Data for this outcome measure was collected and analyzed as per study period.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline Day 15 of Study Period 1, 2, 3, 4, and 5","groups":[{"id":"OG000","title":"Part B: Study Period 1","description":"Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. Study Period 1 included only placebo + ADT participants from the parent study (217-MDD-305)."},{"id":"OG001","title":"Part B: Study Period 2","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 2 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG002","title":"Part B: Study Period 3","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 3 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG003","title":"Part B: Study Period 4","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 4 included both placebo + ADT and SAGE 217 + ADT participants from the parent study (217-MDD-305)."},{"id":"OG004","title":"Part B: Study Period 5","description":"Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 46-week observational period. During the 46-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment. Study Period 5 included only SAGE 217 + ADT participants from the parent study (217-MDD-305)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"85"},{"groupId":"OG002","value":"42"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"1.18"},{"groupId":"OG001","value":"-1.8","spread":"1.15"},{"groupId":"OG002","value":"-1.7","spread":"1.26"},{"groupId":"OG003","value":"-1.4","spread":"1.39"},{"groupId":"OG004","value":"-1.4","spread":"1.52"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"For Part A: Up to 52 Weeks; For Part B: Up to 46 Weeks","description":"For Part A: Safety Set included all participants who were administered SAGE-217; For Part B: Study-specific Safety Set included all participants who were administered SAGE-217 within 217-MDD-303B. Data for Part B was collected and reported in a single arm for each participant who started treatment as specified.","eventGroups":[{"id":"EG000","title":"Part A: Sage-217 High-dose Cohort","description":"Participants received SAGE-217, 50 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment.","deathsNumAffected":0,"deathsNumAtRisk":513,"seriousNumAffected":18,"seriousNumAtRisk":513,"otherNumAffected":371,"otherNumAtRisk":513},{"id":"EG001","title":"Part A: Sage-217 Low-dose Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily from Day 1 through 14 followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment.","deathsNumAffected":1,"deathsNumAtRisk":645,"seriousNumAffected":19,"seriousNumAtRisk":645,"otherNumAffected":435,"otherNumAtRisk":645},{"id":"EG002","title":"Part A: Sage-217 Dose-switch Cohort","description":"Participants received SAGE-217, 30 mg, orally, once daily in treatment Cycle 1 Day 1 through Day 14 followed by 14-day follow-up period and switched to 50 mg orally, once daily in a subsequent treatment cycle. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. After the treatment period participants who had a response (a ≥50% reduction from baseline in HAMD-17 total score by Day 15) or remission entered a 48-week observational period. During the 48-week observational period, HAMD-17 responders returned to the site every 8 weeks for clinical assessments. Participants were assessed remotely every 14 days via the participant reported 9-item PHQ-9; participants with PHQ-9 score ≥10 returned to the site to be assessed by the clinician administered HAMD-17. At Day 70 or later, participants with a HAMD-17 total score ≥20, assessed approximately 1 week from the PHQ-9 score ≥10, were eligible for repeat treatment.","deathsNumAffected":0,"deathsNumAtRisk":80,"seriousNumAffected":1,"seriousNumAtRisk":80,"otherNumAffected":57,"otherNumAtRisk":80},{"id":"EG003","title":"Part B: Sage-217 All Participants","description":"Participants who were eligible to enter the current study from parent study 217-MDD-305 entered the 46-week observational period. Participants were followed with remote assessment of the participant-reported PHQ-9 every 2 weeks; if the PHQ-9 score was ≥10, the participant returned to the site approximately 1 week later and was assessed for the clinician administered HAMD-17. If the HAMD-17 total score was ≥20 and 56 days had elapsed since the last dose of IP, the participant began a 14-day SAGE-217 treatment period, which was followed by a 14-day follow-up period. Participants received SAGE-217 50 mg or 40 mg at the discretion of the investigator, orally, once daily for 14 days followed by 14-day follow-up period. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle.","deathsNumAffected":0,"deathsNumAtRisk":118,"seriousNumAffected":4,"seriousNumAtRisk":118,"otherNumAffected":87,"otherNumAtRisk":118}],"seriousEvents":[{"term":"Suicidal ideation","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":513},{"groupId":"EG001","numAffected":1,"numAtRisk":645},{"groupId":"EG002","numAffected":0,"numAtRisk":80},{"groupId":"EG003","numAffected":1,"numAtRisk":118}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":513},{"groupId":"EG001","numAffected":2,"numAtRisk":645},{"groupId":"EG002","numAffected":0,"numAtRisk":80},{"groupId":"EG003","numAffected":1,"numAtRisk":118}]},{"term":"Dysphagia","organSystem":"Gastrointestinal 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