{"protocolSection":{"identificationModule":{"nctId":"NCT02978326","orgStudyIdInfo":{"id":"217-PPD-201"},"organization":{"fullName":"Biogen","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression","officialTitle":"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-217 in the Treatment of Adult Female Subjects With Severe Postpartum Depression"},"statusModule":{"statusVerifiedDate":"2023-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-01-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-11-15","type":"ACTUAL"},"completionDateStruct":{"date":"2018-12-11","type":"ACTUAL"},"studyFirstSubmitDate":"2016-11-28","studyFirstSubmitQcDate":"2016-11-28","studyFirstPostDateStruct":{"date":"2016-11-30","type":"ESTIMATED"},"resultsFirstSubmitDate":"2021-11-15","resultsFirstSubmitQcDate":"2021-11-15","resultsFirstPostDateStruct":{"date":"2021-12-16","type":"ACTUAL"},"dispFirstSubmitDate":"2019-11-15","dispFirstSubmitQcDate":"2019-11-15","dispFirstPostDateStruct":{"date":"2019-11-20","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-11-27","lastUpdatePostDateStruct":{"date":"2023-12-15","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Biogen","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the Columbia Suicide Severity Rating Scale (C-SSRS).","detailedDescription":"This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen."},"conditionsModule":{"conditions":["Postpartum Depression"],"keywords":["Postpartum Care"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":276,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Part A: SAGE-217 15/20 mg Oral Solution","type":"EXPERIMENTAL","description":"Participants received SAGE-217, 15 milligrams (mg), oral solution, twice daily (BID) for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.","interventionNames":["Drug: SAGE-217 15/20 mg Oral Solution"]},{"label":"Part B: Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.","interventionNames":["Drug: Placebo"]},{"label":"Part B: SAGE 217 30 mg Capsules","type":"EXPERIMENTAL","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.","interventionNames":["Drug: SAGE 217 30 mg Capsules"]}],"interventions":[{"type":"DRUG","name":"SAGE-217 15/20 mg Oral Solution","description":"SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).","armGroupLabels":["Part A: SAGE-217 15/20 mg Oral Solution"]},{"type":"DRUG","name":"Placebo","description":"SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.","armGroupLabels":["Part B: Placebo"]},{"type":"DRUG","name":"SAGE 217 30 mg Capsules","description":"SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.","armGroupLabels":["Part B: SAGE 217 30 mg Capsules"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15","description":"The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.","timeFrame":"Parts A and B: Baseline, Day 15"}],"secondaryOutcomes":[{"measure":"Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45","description":"The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.","timeFrame":"Part B: Baseline, Days 3, 8, 21 and 45"},{"measure":"Parts A and B: Percentage of Participants With HAM-D Response","description":"HAM-D Response was defined as having a 50 percent (%) or greater reduction from Baseline in HAM-D total score. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours \\[morning\\]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.","timeFrame":"Part B: Days 3, 8, 15, 21 and 45"},{"measure":"Parts A and B: Percentage of Participants With HAM-D Remission","description":"HAM-D Remission was defined as a HAM-D total score of less than or equal to (\\<=)7. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours \\[morning\\]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.","timeFrame":"Part B: Days 3, 8, 15, 21 and 45"},{"measure":"Parts A and B: Change From Baseline in HAM-D Subscales Scores","description":"HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale (symptoms-depressed mood, feelings of guilt, suicide, work and activities, and retardation ); Anxiety subscale (symptoms-anxiety \\[psychic and somatic\\], somatic symptoms \\[gastrointestinal and general\\], hypochondriasis, loss of weight); Bech-6 subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general); Meier subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic). Each item was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicated more severe depression. A negative change from Baseline indicates less depression.","timeFrame":"Part B: Baseline, Days 3, 8, 15, 21 and 45"},{"measure":"Parts A and B: Change From Baseline in HAM-D Individual Item Scores","description":"The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. Symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from Baseline indicates less depression.","timeFrame":"Part B: Baseline, Days 3, 8, 15, 21 and 45"},{"measure":"Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score","description":"The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.","timeFrame":"Part B: Baseline, Days 3, 8, 15, 21 and 45"},{"measure":"Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response","description":"The Clinical Global Impression - Improvement (CGI-I) item of the CGI scale uses a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. CGI response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved). The percentage of participants with overall improvement in post-treatment condition, rated by investigator as very much improved (CGI-I score of 1) or much improved (CGI-I score of 2) is reported.","timeFrame":"Part B: Days 3, 8, 15, 21 and 45"},{"measure":"Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score","description":"The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of \\<17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity. A negative change from Baseline indicates less anxiety.","timeFrame":"Part B: Baseline, Days 3, 8, 15, 21 and 45"},{"measure":"Parts A and B: Percentage of Participants With MADRS Response","description":"MADRS response was defined as having a 50% or greater reduction from Baseline in MADRS total score. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.","timeFrame":"Part B: Days 3, 8, 15, 21 and 45"},{"measure":"Parts A and B: Percentage of Participants With MADRS Remission","description":"MADRS Remission was defined as a MADRS total score of \\<=10. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.","timeFrame":"Part B: Days 3, 8, 15, 21 and 45"},{"measure":"Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)","description":"An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.","timeFrame":"Part A: Up to Day 75; Part B: Up to Day 45"},{"measure":"Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements","description":"Vital signs included assessments of supine and standing systolic blood pressure (SBP), supine and standing diastolic blood pressure (DBP), and heart rate.","timeFrame":"Part B: From first dose of study drug up to 45 days"},{"measure":"Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations","description":"Laboratory tests included tests of Hematology, Chemistry, and Urinalysis.","timeFrame":"Part B: From first dose of study drug up to 45 days"},{"measure":"Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate","description":"ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Heart rate was measured in terms of beats per minute. Change from Baseline in heart rate at specified time points were reported.","timeFrame":"Part B: Baseline, Days 8, 15, and 21"},{"measure":"Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval","description":"ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Change from Baseline in PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval is reported.","timeFrame":"Part B: Baseline, Days 8, 15, and 21"},{"measure":"Part B: Number of Participants With a Response of \"Yes\" to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS)","description":"C-SSRS was used to assess the suicidality of participants during the study. The assessment included \"yes\" or \"no\" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for severity of ideation (if present), from 1 to 5, with 5 being the most severe. Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported.","timeFrame":"Part B: Up to Day 45"}]},"eligibilityModule":{"eligibilityCriteria":"Key Inclusion Criteria:\n\n* Participant either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s)\n* Participant has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Axis I Disorders (SCID-I)\n* Participant was \\<=six months postpartum.\n\nKey Exclusion Criteria:\n\n* Active psychosis\n* Attempted suicide associated with current episode of postpartum depression\n* Medical history of seizures\n* Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.\n\nNote: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion criteria might apply.","healthyVolunteers":false,"sex":"FEMALE","genderBased":true,"minimumAge":"18 Years","maximumAge":"45 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Sage Investigational Site","city":"Little Rock","state":"Arkansas","zip":"72209","country":"United States","geoPoint":{"lat":34.74648,"lon":-92.28959}},{"facility":"Sage Investigational Site","city":"Beverly Hills","state":"California","zip":"90212","country":"United States","geoPoint":{"lat":34.07362,"lon":-118.40036}},{"facility":"Sage Investigational Site","city":"Oceanside","state":"California","zip":"92056","country":"United States","geoPoint":{"lat":33.19587,"lon":-117.37948}},{"facility":"Sage Investigational Site","city":"Wildomar","state":"California","zip":"92595","country":"United States","geoPoint":{"lat":33.59891,"lon":-117.28004}},{"facility":"Sage Investigational Site","city":"Washington D.C.","state":"District of Columbia","zip":"20011","country":"United States","geoPoint":{"lat":38.89511,"lon":-77.03637}},{"facility":"Sage Investigational Site","city":"Aventura","state":"Florida","zip":"33027","country":"United States","geoPoint":{"lat":25.95648,"lon":-80.13921}},{"facility":"Sage Investigational Site","city":"Miami","state":"Florida","zip":"33173","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Sage Investigational Site","city":"Orlando","state":"Florida","zip":"32807","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Sage Investigational Site","city":"Pensacola","state":"Florida","zip":"32502","country":"United States","geoPoint":{"lat":30.42131,"lon":-87.21691}},{"facility":"Sage Investigational SIte","city":"Pinellas Park","state":"Florida","zip":"33782","country":"United States","geoPoint":{"lat":27.8428,"lon":-82.69954}},{"facility":"Sage Investigational Site","city":"Atlanta","state":"Georgia","zip":"30331","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Sage Investigational Site","city":"Decatur","state":"Georgia","zip":"30030","country":"United States","geoPoint":{"lat":33.77483,"lon":-84.29631}},{"facility":"Sage Investigational Site","city":"Hoffman Estates","state":"Illinois","zip":"60169","country":"United States","geoPoint":{"lat":42.04281,"lon":-88.0798}},{"facility":"Sage Investigational Site","city":"Owensboro","state":"Kentucky","zip":"42303","country":"United States","geoPoint":{"lat":37.77422,"lon":-87.11333}},{"facility":"Sage Investigational Site","city":"Lake Charles","state":"Louisiana","zip":"70629","country":"United States","geoPoint":{"lat":30.21309,"lon":-93.2044}},{"facility":"Sage Investigational Site","city":"New Orleans","state":"Louisiana","zip":"70115","country":"United States","geoPoint":{"lat":29.95465,"lon":-90.07507}},{"facility":"Sage Investigational Site","city":"Saint Charles","state":"Missouri","zip":"63304","country":"United States","geoPoint":{"lat":38.78394,"lon":-90.48123}},{"facility":"Sage Investigational Site","city":"Las Vegas","state":"Nevada","zip":"89102","country":"United States","geoPoint":{"lat":36.17497,"lon":-115.13722}},{"facility":"Sage Investigational Site","city":"Manhasset","state":"New York","zip":"11030","country":"United States","geoPoint":{"lat":40.79788,"lon":-73.69957}},{"facility":"Sage Investigational Site","city":"New York","state":"New York","zip":"10036","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Sage Investigational Site","city":"Chapel Hill","state":"North Carolina","zip":"27599","country":"United States","geoPoint":{"lat":35.9132,"lon":-79.05584}},{"facility":"Sage Investigational Site","city":"Raleigh","state":"North Carolina","zip":"27612","country":"United States","geoPoint":{"lat":35.7721,"lon":-78.63861}},{"facility":"Sage Investigational Site","city":"Providence","state":"Rhode Island","zip":"02904","country":"United States","geoPoint":{"lat":41.82399,"lon":-71.41283}},{"facility":"Sage Investigational Site","city":"Fort Worth","state":"Texas","zip":"76060","country":"United States","geoPoint":{"lat":32.72541,"lon":-97.32085}},{"facility":"Sage Investigational Site","city":"Houston","state":"Texas","zip":"77058","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Sage Investigational Site","city":"Richardson","state":"Texas","zip":"75080","country":"United States","geoPoint":{"lat":32.94818,"lon":-96.72972}},{"facility":"Sage Investigational Site","city":"Orem","state":"Utah","zip":"84058","country":"United States","geoPoint":{"lat":40.2969,"lon":-111.69465}}]},"referencesModule":{"references":[{"type":"RESULT","citation":"Deligiannidis K, Lasser R, Gunduz-Bruce H, Silber C, Sankoh AJ, Li Si, et al. A Phase 3, Double-Blind, Placebo- Controlled Trial of SAGE-217 in Postpartum Depression: Assessment of Depressive Symptoms Across Multiple Measures. Abstract presented at: American Society of Clinical Psychopharmacology 2019 Annual Meeting; May 28-31, 2019; Scottsdale, AZ."},{"type":"RESULT","citation":"Lasser R, Deligiannidis K, Gunduz-Bruce H, Silber C, Sankoh AJ, Li Si, et al. A Phase 3, Double-Blind, Placebo- Controlled Trial of SAGE-217 in Postpartum Depression: Topline Assessment of Secondary Efficacy Measures of Anxiety and Depression. Abstract presented at: American Society of Clinical Psychopharmacology 2019 Annual Meeting; May 28-31, 2019; Scottsdale, AZ."},{"pmid":"34190962","type":"RESULT","citation":"Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, Doherty J, Jonas J, Li S, Sankoh AJ, Silber C, Campbell AD, Werneburg B, Kanes SJ, Lasser R. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):951-959. doi: 10.1001/jamapsychiatry.2021.1559."},{"pmid":"36724109","type":"DERIVED","citation":"Deligiannidis KM, Citrome L, Huang MY, Acaster S, Fridman M, Bonthapally V, Lasser R, Kanes SJ. Effect of Zuranolone on Concurrent Anxiety and Insomnia Symptoms in Women With Postpartum Depression. J Clin Psychiatry. 2023 Jan 30;84(1):22m14475. doi: 10.4088/JCP.22m14475."}],"seeAlsoLinks":[{"label":"Related Info","url":"http://www.sagerx.com"}]},"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":"A total of 276 participants were enrolled and consented of which 154 eligible participants were randomized and thus presented in participant flow. Rest of the 123 participants were not randomized and not part of any analyses. 152 randomized participants received study drug and 143 completed the study.","recruitmentDetails":"Participants took part in the study at 27 investigative centers in the United States of America from 04 January 2017 to 11 December 2018. Study was conducted in 2 parts. In Part A, only 1 participant was enrolled and thus no analysis was performed for Part A. All analysis sets were defined only for Part B. For Part A, only adverse events incidence were captured.","groups":[{"id":"FG000","title":"Part A: SAGE-217 15/20 mg Oral Solution","description":"Participants received SAGE-217, 15 milligrams (mg), oral solution, twice daily (BID) for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated."},{"id":"FG001","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"FG002","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days."}],"periods":[{"title":"Part A (Up to 75 Days)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"COMPLETED","comment":"Completed = Number of participants who completed Part A of the study.","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]},{"title":"Part B (Up to 45 Days)","milestones":[{"type":"STARTED","comment":"Started = Number of participants who were randomized to receive study drug in Part B of the study.","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"76"},{"groupId":"FG002","numSubjects":"77"}]},{"type":"Received Study Drug","comment":"Two participants were randomized but did not receive study drug (1 in each treatment group).","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"73"},{"groupId":"FG002","comment":"Two participants were randomized to placebo but received at least 1 dose of SAGE-217 in error and were included in the SAGE-217 group for 'Received Study Drug' and for 'Safety Analysis'.","numSubjects":"78"}]},{"type":"Safety Set (Part B)","comment":"Safety Set (Part B) included all participants who were administered study drug in Part B and summarized by actual treatment received.","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"73"},{"groupId":"FG002","numSubjects":"78"}]},{"type":"Efficacy Set (Part B)","comment":"Efficacy Set (Part B) included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"74"},{"groupId":"FG002","numSubjects":"76"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"69"},{"groupId":"FG002","numSubjects":"73"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Non-compliance","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Part A: All randomized participants; Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.","groups":[{"id":"BG000","title":"Part A: SAGE-217 15/20 mg Oral Solution","description":"Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated."},{"id":"BG001","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"BG002","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"151"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"151"}]}],"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"151"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"151"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"151"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","populationDescription":"Due to the low number of participants enrolled during Part A of the study, 0 participants are reported due to the risk of identification of a person.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"34"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"116"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","populationDescription":"Due to the low number of participants enrolled during Part A of the study, 0 participants are reported due to the risk of identification of a person.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"31"},{"groupId":"BG003","value":"62"}]},{"title":"White","measurements":[{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"44"},{"groupId":"BG003","value":"84"}]},{"title":"More than one race","measurements":[{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score","description":"The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Items 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. HAM-D total score=sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study.","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"score on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"28.8","lowerLimit":"26","upperLimit":"40"},{"groupId":"BG002","value":"28.4","lowerLimit":"26","upperLimit":"34"},{"groupId":"BG003","value":"28.6","lowerLimit":"26","upperLimit":"40"}]}]}]},{"title":"HAM-D Subscales Scores","description":"HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale; Anxiety subscale; Bech-6 subscale; Meier subscale. Each item in the subscale was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicating more severe depression.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study.","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"score on a scale","classes":[{"title":"Core","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"50.1","lowerLimit":"40","upperLimit":"80"},{"groupId":"BG002","value":"51.3","lowerLimit":"40","upperLimit":"70"},{"groupId":"BG003","value":"50.7","lowerLimit":"40","upperLimit":"80"}]}]},{"title":"Anxiety","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"56.3","lowerLimit":"28","upperLimit":"78"},{"groupId":"BG002","value":"53.1","lowerLimit":"39","upperLimit":"78"},{"groupId":"BG003","value":"54.7","lowerLimit":"28","upperLimit":"78"}]}]},{"title":"Bech-6","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"64.5","lowerLimit":"50","upperLimit":"86"},{"groupId":"BG002","value":"66.3","lowerLimit":"50","upperLimit":"82"},{"groupId":"BG003","value":"65.4","lowerLimit":"50","upperLimit":"86"}]}]},{"title":"Meier","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"57.1","lowerLimit":"46","upperLimit":"79"},{"groupId":"BG002","value":"59.1","lowerLimit":"42","upperLimit":"83"},{"groupId":"BG003","value":"58.1","lowerLimit":"42","upperLimit":"83"}]}]}]},{"title":"HAM-D Individual Item Scores","description":"The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. Symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Symptoms scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study.","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"score on a scale","classes":[{"title":"Depressed Mood","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"3.1","lowerLimit":"2","upperLimit":"4"},{"groupId":"BG002","value":"3.1","lowerLimit":"3","upperLimit":"4"},{"groupId":"BG003","value":"3.1","lowerLimit":"2","upperLimit":"4"}]}]},{"title":"Feelings of Guilt","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"2.2","lowerLimit":"1","upperLimit":"3"},{"groupId":"BG002","value":"2.5","lowerLimit":"1","upperLimit":"3"},{"groupId":"BG003","value":"2.35","lowerLimit":"1","upperLimit":"3"}]}]},{"title":"Suicide","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"0.4","lowerLimit":"0","upperLimit":"3"},{"groupId":"BG002","value":"0.4","lowerLimit":"0","upperLimit":"2"},{"groupId":"BG003","value":"0.4","lowerLimit":"0","upperLimit":"3"}]}]},{"title":"Insomnia Early - Early Night","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"1.8","lowerLimit":"0","upperLimit":"2"},{"groupId":"BG002","value":"1.8","lowerLimit":"0","upperLimit":"2"},{"groupId":"BG003","value":"1.8","lowerLimit":"0","upperLimit":"2"}]}]},{"title":"Insomnia Middle - Middle Night","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"1.9","lowerLimit":"1","upperLimit":"2"},{"groupId":"BG002","value":"1.7","lowerLimit":"0","upperLimit":"2"},{"groupId":"BG003","value":"1.8","lowerLimit":"0","upperLimit":"2"}]}]},{"title":"Insomnia Early Hours - Morning","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"1.5","lowerLimit":"0","upperLimit":"2"},{"groupId":"BG002","value":"1.6","lowerLimit":"0","upperLimit":"2"},{"groupId":"BG003","value":"1.55","lowerLimit":"0","upperLimit":"2"}]}]},{"title":"Work and Activities","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"3.1","lowerLimit":"1","upperLimit":"4"},{"groupId":"BG002","value":"3.0","lowerLimit":"2","upperLimit":"4"},{"groupId":"BG003","value":"3.05","lowerLimit":"1","upperLimit":"4"}]}]},{"title":"Retardation","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"1.2","lowerLimit":"0","upperLimit":"3"},{"groupId":"BG002","value":"1.2","lowerLimit":"0","upperLimit":"3"},{"groupId":"BG003","value":"1.2","lowerLimit":"0","upperLimit":"3"}]}]},{"title":"Agitation","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"1.4","lowerLimit":"0","upperLimit":"3"},{"groupId":"BG002","value":"1.4","lowerLimit":"0","upperLimit":"4"},{"groupId":"BG003","value":"1.4","lowerLimit":"0","upperLimit":"4"}]}]},{"title":"Anxiety Psychic","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"2.7","lowerLimit":"2","upperLimit":"4"},{"groupId":"BG002","value":"2.9","lowerLimit":"1","upperLimit":"4"},{"groupId":"BG003","value":"2.8","lowerLimit":"1","upperLimit":"4"}]}]},{"title":"Anxiety Somatic","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"1.9","lowerLimit":"0","upperLimit":"3"},{"groupId":"BG002","value":"1.9","lowerLimit":"0","upperLimit":"3"},{"groupId":"BG003","value":"1.9","lowerLimit":"0","upperLimit":"3"}]}]},{"title":"Somatic Symptoms Gastrointestinal","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"1.5","lowerLimit":"0","upperLimit":"2"},{"groupId":"BG002","value":"1.3","lowerLimit":"0","upperLimit":"2"},{"groupId":"BG003","value":"1.4","lowerLimit":"0","upperLimit":"2"}]}]},{"title":"General Somatic Symptoms","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"1.8","lowerLimit":"1","upperLimit":"2"},{"groupId":"BG002","value":"1.8","lowerLimit":"0","upperLimit":"2"},{"groupId":"BG003","value":"1.8","lowerLimit":"0","upperLimit":"2"}]}]},{"title":"Genital Symptoms","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"1.9","lowerLimit":"1","upperLimit":"2"},{"groupId":"BG002","value":"1.9","lowerLimit":"0","upperLimit":"2"},{"groupId":"BG003","value":"1.9","lowerLimit":"0","upperLimit":"2"}]}]},{"title":"Hypochondriasis","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"1.3","lowerLimit":"0","upperLimit":"3"},{"groupId":"BG002","value":"1.0","lowerLimit":"0","upperLimit":"3"},{"groupId":"BG003","value":"1.15","lowerLimit":"0","upperLimit":"3"}]}]},{"title":"Loss of Weight According to Patient","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"0.9","lowerLimit":"0","upperLimit":"2"},{"groupId":"BG002","value":"0.6","lowerLimit":"0","upperLimit":"2"},{"groupId":"BG003","value":"0.75","lowerLimit":"0","upperLimit":"2"}]}]},{"title":"Insight","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"0.1","lowerLimit":"0","upperLimit":"1"},{"groupId":"BG002","value":"0.1","lowerLimit":"0","upperLimit":"1"},{"groupId":"BG003","value":"0.1","lowerLimit":"0","upperLimit":"1"}]}]}]},{"title":"Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score","description":"The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). MADRS total score was calculated as sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study.","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"score on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"36.3","lowerLimit":"27","upperLimit":"50"},{"groupId":"BG002","value":"34.9","lowerLimit":"26","upperLimit":"45"},{"groupId":"BG003","value":"35.6","lowerLimit":"26","upperLimit":"50"}]}]}]},{"title":"Hamilton Anxiety Rating Scale (HAM-A) Total Score","description":"The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of \\<17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study.","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"score on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"74"},{"groupId":"BG002","value":"76"},{"groupId":"BG003","value":"150"}]}],"categories":[{"measurements":[{"groupId":"BG001","value":"27.2","lowerLimit":"17","upperLimit":"40"},{"groupId":"BG002","value":"26.1","lowerLimit":"14","upperLimit":"40"},{"groupId":"BG003","value":"26.65","lowerLimit":"14","upperLimit":"40"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15","description":"The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Parts A and B: Baseline, Day 15","groups":[{"id":"OG000","title":"Part A: SAGE-217 15/20 mg Oral Solution","description":"Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated."},{"id":"OG001","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"OG002","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"76"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","value":"-13.6","spread":"1.07"},{"groupId":"OG002","value":"-17.8","spread":"1.04"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0028","pValueComment":"Mixed Model for Repeated Measures (MMRM) was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"Least Squares (LS) Mean Difference","paramValue":"-4.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.9","ciUpperLimit":"-1.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.37"}]},{"type":"SECONDARY","title":"Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45","description":"The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Part B: Baseline, Days 3, 8, 21 and 45","groups":[{"id":"OG000","title":"Part A: SAGE-217 15/20 mg Oral Solution","description":"Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated."},{"id":"OG001","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"OG002","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"76"}]}],"classes":[{"title":"Change From Baseline at Day 3","categories":[{"measurements":[{"groupId":"OG001","value":"-9.8","spread":"0.95"},{"groupId":"OG002","value":"-12.5","spread":"0.93"}]}]},{"title":"Change From Baseline at Day 8","categories":[{"measurements":[{"groupId":"OG001","value":"-12.9","spread":"1.03"},{"groupId":"OG002","value":"-16.3","spread":"1.00"}]}]},{"title":"Change From Baseline at Day 21","categories":[{"measurements":[{"groupId":"OG001","value":"-14.4","spread":"1.11"},{"groupId":"OG002","value":"-17.6","spread":"1.09"}]}]},{"title":"Change From Baseline at Day 45","categories":[{"measurements":[{"groupId":"OG001","value":"-15.1","spread":"1.06"},{"groupId":"OG002","value":"-19.2","spread":"1.02"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"Change From Baseline in the HAM-D Total Score at Day 3","nonInferiorityType":"SUPERIORITY","pValue":"0.0252","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-2.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.1","ciUpperLimit":"-0.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.19"},{"groupIds":["OG001","OG002"],"groupDescription":"Change From Baseline in the HAM-D Total Score at Day 8","nonInferiorityType":"SUPERIORITY","pValue":"0.0106","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-3.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.0","ciUpperLimit":"-0.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.31"},{"groupIds":["OG001","OG002"],"groupDescription":"Change From Baseline in the HAM-D Total Score at Day 21","nonInferiorityType":"SUPERIORITY","pValue":"0.0321","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-3.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.0","ciUpperLimit":"-0.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.44"},{"groupIds":["OG001","OG002"],"groupDescription":"Change From Baseline in the HAM-D Total Score at Day 45","nonInferiorityType":"SUPERIORITY","pValue":"0.0027","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-4.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.7","ciUpperLimit":"-1.4","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.34"}]},{"type":"SECONDARY","title":"Parts A and B: Percentage of Participants With HAM-D Response","description":"HAM-D Response was defined as having a 50 percent (%) or greater reduction from Baseline in HAM-D total score. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours \\[morning\\]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Part B: Days 3, 8, 15, 21 and 45","groups":[{"id":"OG000","title":"Part A: SAGE-217 15/20 mg Oral Solution","description":"Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated."},{"id":"OG001","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"OG002","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"76"}]}],"classes":[{"title":"Day 3","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"27.0"},{"groupId":"OG002","value":"40.5"}]}]},{"title":"Day 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"44.6"},{"groupId":"OG002","value":"65.3"}]}]},{"title":"Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"47.9"},{"groupId":"OG002","value":"71.6"}]}]},{"title":"Day 21","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"56.2"},{"groupId":"OG002","value":"71.6"}]}]},{"title":"Day 45","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"73"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"56.5"},{"groupId":"OG002","value":"75.3"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With HAM-D Response at Day 3","nonInferiorityType":"SUPERIORITY","pValue":"0.1004","pValueComment":"Generalized estimating equations (GEE) for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"1.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.89","ciUpperLimit":"3.60"},{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With HAM-D Response at Day 8","nonInferiorityType":"SUPERIORITY","pValue":"0.0127","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"2.31","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.20","ciUpperLimit":"4.45"},{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With HAM-D Response at Day 15","nonInferiorityType":"SUPERIORITY","pValue":"0.0049","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"2.63","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.34","ciUpperLimit":"5.16"},{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With HAM-D Response at Day 21","nonInferiorityType":"SUPERIORITY","pValue":"0.0763","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"1.85","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.94","ciUpperLimit":"3.64"},{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With HAM-D Response at Day 45","nonInferiorityType":"SUPERIORITY","pValue":"0.0216","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"2.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.13","ciUpperLimit":"4.60"}]},{"type":"SECONDARY","title":"Parts A and B: Percentage of Participants With HAM-D Remission","description":"HAM-D Remission was defined as a HAM-D total score of less than or equal to (\\<=)7. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours \\[morning\\]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Part B: Days 3, 8, 15, 21 and 45","groups":[{"id":"OG000","title":"Part A: SAGE-217 15/20 mg Oral Solution","description":"Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated."},{"id":"OG001","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"OG002","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"76"}]}],"classes":[{"title":"Day 3","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"5.4"},{"groupId":"OG002","value":"18.9"}]}]},{"title":"Day 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"18.9"},{"groupId":"OG002","value":"32.0"}]}]},{"title":"Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"23.3"},{"groupId":"OG002","value":"44.6"}]}]},{"title":"Day 21","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"28.8"},{"groupId":"OG002","value":"41.9"}]}]},{"title":"Day 45","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"73"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"30.4"},{"groupId":"OG002","value":"53.4"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With HAM-D Remission at Day 3","nonInferiorityType":"SUPERIORITY","pValue":"0.0200","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"3.89","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.24","ciUpperLimit":"12.23"},{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With HAM-D Remission at Day 8","nonInferiorityType":"SUPERIORITY","pValue":"0.0990","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"1.91","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.89","ciUpperLimit":"4.13"},{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With HAM-D Remission at Day 15","nonInferiorityType":"SUPERIORITY","pValue":"0.0110","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"2.53","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.24","ciUpperLimit":"5.17"},{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With HAM-D Remission at Day 21","nonInferiorityType":"SUPERIORITY","pValue":"0.1982","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"1.58","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.79","ciUpperLimit":"3.19"},{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With HAM-D Remission at Day 45","nonInferiorityType":"SUPERIORITY","pValue":"0.0091","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"2.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.26","ciUpperLimit":"5.03"}]},{"type":"SECONDARY","title":"Parts A and B: Change From Baseline in HAM-D Subscales Scores","description":"HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale (symptoms-depressed mood, feelings of guilt, suicide, work and activities, and retardation ); Anxiety subscale (symptoms-anxiety \\[psychic and somatic\\], somatic symptoms \\[gastrointestinal and general\\], hypochondriasis, loss of weight); Bech-6 subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general); Meier subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic). Each item was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicated more severe depression. A negative change from Baseline indicates less depression.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Part B: Baseline, Days 3, 8, 15, 21 and 45","groups":[{"id":"OG000","title":"Part A: SAGE-217 15/20 mg Oral Solution","description":"Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated."},{"id":"OG001","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"OG002","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"76"}]}],"classes":[{"title":"Core: Change From Baseline at Day 3","categories":[{"measurements":[{"groupId":"OG001","value":"-16.7","spread":"1.91"},{"groupId":"OG002","value":"-18.8","spread":"1.88"}]}]},{"title":"Core: Change From Baseline at Day 8","categories":[{"measurements":[{"groupId":"OG001","value":"-23.4","spread":"2.03"},{"groupId":"OG002","value":"-28.7","spread":"1.99"}]}]},{"title":"Core: Change From Baseline at Day 15","categories":[{"measurements":[{"groupId":"OG001","value":"-26.8","spread":"2.10"},{"groupId":"OG002","value":"-31.9","spread":"2.06"}]}]},{"title":"Core: Change From Baseline at Day 21","categories":[{"measurements":[{"groupId":"OG001","value":"-27.3","spread":"2.24"},{"groupId":"OG002","value":"-33.7","spread":"2.20"}]}]},{"title":"Core: Change From Baseline at Day 45","categories":[{"measurements":[{"groupId":"OG001","value":"-29.5","spread":"2.11"},{"groupId":"OG002","value":"-37.2","spread":"2.05"}]}]},{"title":"Anxiety: Change From Baseline at Day 3","categories":[{"measurements":[{"groupId":"OG001","value":"-16.4","spread":"1.98"},{"groupId":"OG002","value":"-23.5","spread":"1.93"}]}]},{"title":"Anxiety: Change From Baseline at Day 8","categories":[{"measurements":[{"groupId":"OG001","value":"-23.2","spread":"2.15"},{"groupId":"OG002","value":"-29.8","spread":"2.09"}]}]},{"title":"Anxiety: Change From Baseline at Day 15","categories":[{"measurements":[{"groupId":"OG001","value":"-23.4","spread":"2.19"},{"groupId":"OG002","value":"-33.2","spread":"2.13"}]}]},{"title":"Anxiety: Change From Baseline at Day 21","categories":[{"measurements":[{"groupId":"OG001","value":"-27.3","spread":"2.17"},{"groupId":"OG002","value":"-33.3","spread":"2.11"}]}]},{"title":"Anxiety: Change From Baseline at Day 45","categories":[{"measurements":[{"groupId":"OG001","value":"-26.5","spread":"2.19"},{"groupId":"OG002","value":"-34.5","spread":"2.11"}]}]},{"title":"Bech-6: Change From Baseline at Day 3","categories":[{"measurements":[{"groupId":"OG001","value":"-19.5","spread":"2.45"},{"groupId":"OG002","value":"-23.7","spread":"2.41"}]}]},{"title":"Bech-6: Change From Baseline at Day 8","categories":[{"measurements":[{"groupId":"OG001","value":"-28.3","spread":"2.58"},{"groupId":"OG002","value":"-34.9","spread":"2.53"}]}]},{"title":"Bech-6: Change From Baseline at Day 15","categories":[{"measurements":[{"groupId":"OG001","value":"-30.9","spread":"2.61"},{"groupId":"OG002","value":"-39.2","spread":"2.56"}]}]},{"title":"Bech-6: Change From Baseline at Day 21","categories":[{"measurements":[{"groupId":"OG001","value":"-32.7","spread":"2.72"},{"groupId":"OG002","value":"-40.7","spread":"2.68"}]}]},{"title":"Bech-6: Change From Baseline at Day 45","categories":[{"measurements":[{"groupId":"OG001","value":"-34.6","spread":"2.61"},{"groupId":"OG002","value":"-44.0","spread":"2.54"}]}]},{"title":"Meier: Change From Baseline at Day 3","categories":[{"measurements":[{"groupId":"OG001","value":"-17.0","spread":"2.17"},{"groupId":"OG002","value":"-21.7","spread":"2.13"}]}]},{"title":"Meier: Change From Baseline at Day 8","categories":[{"measurements":[{"groupId":"OG001","value":"-25.0","spread":"2.30"},{"groupId":"OG002","value":"-32.2","spread":"2.24"}]}]},{"title":"Meier: Change From Baseline at Day 15","categories":[{"measurements":[{"groupId":"OG001","value":"-28.1","spread":"2.35"},{"groupId":"OG002","value":"-35.5","spread":"2.30"}]}]},{"title":"Meier: Change From Baseline at Day 21","categories":[{"measurements":[{"groupId":"OG001","value":"-29.9","spread":"2.42"},{"groupId":"OG002","value":"-37.0","spread":"2.37"}]}]},{"title":"Meier: Change From Baseline at Day 45","categories":[{"measurements":[{"groupId":"OG001","value":"-31.5","spread":"2.32"},{"groupId":"OG002","value":"-41.0","spread":"2.25"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"Core: Change from Baseline in HAM-D Subscale Score at Day 3","nonInferiorityType":"SUPERIORITY","pValue":"0.3832","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-2.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.9","ciUpperLimit":"2.7","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.41"},{"groupIds":["OG001","OG002"],"groupDescription":"Core: Change from Baseline in HAM-D Subscale Score at Day 8","nonInferiorityType":"SUPERIORITY","pValue":"0.0415","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-5.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-10.5","ciUpperLimit":"-0.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.60"},{"groupIds":["OG001","OG002"],"groupDescription":"Core: Change from Baseline in HAM-D Subscale Score at Day 15","nonInferiorityType":"SUPERIORITY","pValue":"0.0606","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-5.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-10.5","ciUpperLimit":"0.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.71"},{"groupIds":["OG001","OG002"],"groupDescription":"Core: Change from Baseline in HAM-D Subscale Score at Day 21","nonInferiorityType":"SUPERIORITY","pValue":"0.0318","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-6.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-12.1","ciUpperLimit":"-0.6","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.91"},{"groupIds":["OG001","OG002"],"groupDescription":"Core: Change from Baseline in HAM-D Subscale Score at Day 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Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. Symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from Baseline indicates less depression.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Part B: Baseline, Days 3, 8, 15, 21 and 45","groups":[{"id":"OG000","title":"Part A: SAGE-217 15/20 mg Oral Solution","description":"Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated."},{"id":"OG001","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"OG002","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 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Repeated Measures","paramType":"LS Mean Difference","paramValue":"-0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.2","ciUpperLimit":"0.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.08"},{"groupIds":["OG001","OG002"],"groupDescription":"Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 21","nonInferiorityType":"SUPERIORITY","pValue":"0.9085","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"0.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.1","ciUpperLimit":"0.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.07"},{"groupIds":["OG001","OG002"],"groupDescription":"Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 45","nonInferiorityType":"SUPERIORITY","pValue":"0.1820","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.3","ciUpperLimit":"0.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.09"},{"groupIds":["OG001","OG002"],"groupDescription":"Insight: Change From Baseline in HAM-D Individual Item Score at Day 3","nonInferiorityType":"SUPERIORITY","pValue":"0.1593","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"0.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.1","ciUpperLimit":"0.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.03"},{"groupIds":["OG001","OG002"],"groupDescription":"Insight: Change From Baseline in HAM-D Individual Item Score at Day 8","nonInferiorityType":"SUPERIORITY","pValue":"0.6555","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"0.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.1","ciUpperLimit":"0.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.03"},{"groupIds":["OG001","OG002"],"groupDescription":"Insight: Change From Baseline in HAM-D Individual Item Score at Day 15","nonInferiorityType":"SUPERIORITY","pValue":"0.0170","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.1","ciUpperLimit":"0.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.03"},{"groupIds":["OG001","OG002"],"groupDescription":"Insight: Change From Baseline in HAM-D Individual Item Score at Day 21","nonInferiorityType":"SUPERIORITY","pValue":"0.0188","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.1","ciUpperLimit":"0.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.03"},{"groupIds":["OG001","OG002"],"groupDescription":"Insight: Change From Baseline in HAM-D Individual Item Score at Day 45","nonInferiorityType":"SUPERIORITY","pValue":"0.0726","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.2","ciUpperLimit":"0.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.05"}]},{"type":"SECONDARY","title":"Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score","description":"The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Part B: Baseline, Days 3, 8, 15, 21 and 45","groups":[{"id":"OG000","title":"Part A: SAGE-217 15/20 mg Oral Solution","description":"Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated."},{"id":"OG001","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"OG002","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"76"}]}],"classes":[{"title":"Change From Baseline at Day 3","categories":[{"measurements":[{"groupId":"OG001","value":"-11.7","spread":"1.36"},{"groupId":"OG002","value":"-14.8","spread":"1.33"}]}]},{"title":"Change From Baseline at Day 8","categories":[{"measurements":[{"groupId":"OG001","value":"-16.3","spread":"1.45"},{"groupId":"OG002","value":"-20.3","spread":"1.42"}]}]},{"title":"Change From Baseline at Day 15","categories":[{"measurements":[{"groupId":"OG001","value":"-17.6","spread":"1.48"},{"groupId":"OG002","value":"-22.1","spread":"1.45"}]}]},{"title":"Change From Baseline at Day 21","categories":[{"measurements":[{"groupId":"OG001","value":"-17.8","spread":"1.49"},{"groupId":"OG002","value":"-22.1","spread":"1.46"}]}]},{"title":"Change From Baseline at Day 45","categories":[{"measurements":[{"groupId":"OG001","value":"-19.0","spread":"1.44"},{"groupId":"OG002","value":"-24.8","spread":"1.39"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"Change From Baseline in MADRS Total Score at Day 3","nonInferiorityType":"SUPERIORITY","pValue":"0.0791","pValueComment":"MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-3.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.5","ciUpperLimit":"0.4","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.72"},{"groupIds":["OG001","OG002"],"groupDescription":"Change From Baseline in MADRS Total Score at Day 8","nonInferiorityType":"SUPERIORITY","pValue":"0.0322","pValueComment":"MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-4.0","ciPctValue":"1.86","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.7","ciUpperLimit":"-0.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.86"},{"groupIds":["OG001","OG002"],"groupDescription":"Change From Baseline in MADRS Total Score at Day 15","nonInferiorityType":"SUPERIORITY","pValue":"0.0180","pValueComment":"MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-4.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.3","ciUpperLimit":"-0.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.91"},{"groupIds":["OG001","OG002"],"groupDescription":"Change from Baseline in MADRS Total Score at 21","nonInferiorityType":"SUPERIORITY","pValue":"0.0271","pValueComment":"MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-4.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.1","ciUpperLimit":"-0.5","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.92"},{"groupIds":["OG001","OG002"],"groupDescription":"Change from Baseline in MADRS Total Score at 45","nonInferiorityType":"SUPERIORITY","pValue":"0.0018","pValueComment":"MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-5.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.4","ciUpperLimit":"-2.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.82"}]},{"type":"SECONDARY","title":"Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response","description":"The Clinical Global Impression - Improvement (CGI-I) item of the CGI scale uses a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. CGI response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved). The percentage of participants with overall improvement in post-treatment condition, rated by investigator as very much improved (CGI-I score of 1) or much improved (CGI-I score of 2) is reported.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Part B: Days 3, 8, 15, 21 and 45","groups":[{"id":"OG000","title":"Part A: SAGE-217 15/20 mg Oral Solution","description":"Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated."},{"id":"OG001","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"OG002","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"76"}]}],"classes":[{"title":"Day 3","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"28.4"},{"groupId":"OG002","value":"37.8"}]}]},{"title":"Day 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"50.0"},{"groupId":"OG002","value":"65.3"}]}]},{"title":"Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"52.1"},{"groupId":"OG002","value":"71.6"}]}]},{"title":"Day 21","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"54.8"},{"groupId":"OG002","value":"70.3"}]}]},{"title":"Day 45","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"73"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"55.9"},{"groupId":"OG002","value":"71.2"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With CGI-I Response at Day 3","nonInferiorityType":"SUPERIORITY","pValue":"0.3372","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"1.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.70","ciUpperLimit":"2.81"},{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With CGI-I Response at Day 8","nonInferiorityType":"SUPERIORITY","pValue":"0.0935","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"1.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.91","ciUpperLimit":"3.47"},{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With CGI-I Response at Day 15","nonInferiorityType":"SUPERIORITY","pValue":"0.0276","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"2.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.09","ciUpperLimit":"4.28"},{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With CGI-I Response at Day 21","nonInferiorityType":"SUPERIORITY","pValue":"0.0920","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment: Baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"1.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.91","ciUpperLimit":"3.54"},{"groupIds":["OG001","OG002"],"groupDescription":"Percentage of Participants With CGI-I Response at Day 45","nonInferiorityType":"SUPERIORITY","pValue":"0.1109","pValueComment":"Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.","statisticalMethod":"GEE for binary response model","paramType":"Odds Ratio (OR)","paramValue":"1.76","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.88","ciUpperLimit":"3.51"}]},{"type":"SECONDARY","title":"Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score","description":"The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of \\<17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity. A negative change from Baseline indicates less anxiety.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Part B: Baseline, Days 3, 8, 15, 21 and 45","groups":[{"id":"OG000","title":"Part A: SAGE-217 15/20 mg Oral Solution","description":"Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated."},{"id":"OG001","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"OG002","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"76"}]}],"classes":[{"title":"Change From Baseline at Day 3","categories":[{"measurements":[{"groupId":"OG001","value":"-8.9","spread":"1.02"},{"groupId":"OG002","value":"-12.0","spread":"0.99"}]}]},{"title":"Change From Baseline at Day 8","categories":[{"measurements":[{"groupId":"OG001","value":"-11.7","spread":"1.04"},{"groupId":"OG002","value":"-16.1","spread":"1.01"}]}]},{"title":"Change From Baseline at Day 15","categories":[{"measurements":[{"groupId":"OG001","value":"-12.7","spread":"1.09"},{"groupId":"OG002","value":"-16.6","spread":"1.07"}]}]},{"title":"Change From Baseline at Day 21","categories":[{"measurements":[{"groupId":"OG001","value":"-13.1","spread":"1.07"},{"groupId":"OG002","value":"-16.6","spread":"1.05"}]}]},{"title":"Change From Baseline at Day 45","categories":[{"measurements":[{"groupId":"OG001","value":"-13.6","spread":"1.02"},{"groupId":"OG002","value":"-18.6","spread":"0.99"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"Change from Baseline in HAM-A Total Score at Day 3","nonInferiorityType":"SUPERIORITY","pValue":"0.0169","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-3.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.7","ciUpperLimit":"-0.6","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.29"},{"groupIds":["OG001","OG002"],"groupDescription":"Change from Baseline in HAM-A Total Score at Day 8","nonInferiorityType":"SUPERIORITY","pValue":"0.0010","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-4.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.0","ciUpperLimit":"-1.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.32"},{"groupIds":["OG001","OG002"],"groupDescription":"Change from Baseline in HAM-A Total Score at Day 15","nonInferiorityType":"SUPERIORITY","pValue":"0.0063","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-3.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.7","ciUpperLimit":"-1.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.41"},{"groupIds":["OG001","OG002"],"groupDescription":"Change from Baseline in HAM-A Total Score at Day 21","nonInferiorityType":"SUPERIORITY","pValue":"0.0119","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-3.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.2","ciUpperLimit":"-0.8","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.37"},{"groupIds":["OG001","OG002"],"groupDescription":"Change from Baseline in HAM-A Total Score at Day 45","nonInferiorityType":"SUPERIORITY","pValue":"0.0002","pValueComment":"MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.","statisticalMethod":"Mixed Model for Repeated Measures","paramType":"LS Mean Difference","paramValue":"-5.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.5","ciUpperLimit":"-2.4","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.28"}]},{"type":"SECONDARY","title":"Parts A and B: Percentage of Participants With MADRS Response","description":"MADRS response was defined as having a 50% or greater reduction from Baseline in MADRS total score. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.","populationDescription":"Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Part B: Days 3, 8, 15, 21 and 45","groups":[{"id":"OG000","title":"Part A: SAGE-217 15/20 mg Oral Solution","description":"Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated."},{"id":"OG001","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"OG002","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"76"}]}],"classes":[{"title":"Day 3","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"27.0"},{"groupId":"OG002","value":"40.5"}]}]},{"title":"Day 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"50.0"},{"groupId":"OG002","value":"64.0"}]}]},{"title":"Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"74"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"47.9"},{"groupId":"OG002","value":"73.0"}]}]},{"title":"Day 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Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"beats per minute","timeFrame":"Part B: Baseline, Days 8, 15, and 21","groups":[{"id":"OG000","title":"Part B: Placebo","description":"Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days."},{"id":"OG001","title":"Part B: SAGE 217 30 mg Capsules","description":"Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"78"}]}],"classes":[{"title":"Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"78"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"68.2","spread":"9.55"},{"groupId":"OG001","value":"69.9","spread":"10.85"}]}]},{"title":"Change From Baseline at Day 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"76"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"9.91"},{"groupId":"OG001","value":"1.5","spread":"12.62"}]}]},{"title":"Change From Baseline at Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"75"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.1","spread":"8.16"},{"groupId":"OG001","value":"0.9","spread":"12.69"}]}]},{"title":"Change From Baseline at Day 21","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"76"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.5","spread":"8.93"},{"groupId":"OG001","value":"-0.6","spread":"11.33"}]}]}]},{"type":"SECONDARY","title":"Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval","description":"ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. 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