{"protocolSection":{"identificationModule":{"nctId":"NCT04442490","orgStudyIdInfo":{"id":"217-MDD-301B"},"organization":{"fullName":"Biogen","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)","officialTitle":"A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2023-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-05-12","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-03-26","type":"ACTUAL"},"completionDateStruct":{"date":"2021-04-21","type":"ACTUAL"},"studyFirstSubmitDate":"2020-06-18","studyFirstSubmitQcDate":"2020-06-18","studyFirstPostDateStruct":{"date":"2020-06-22","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-08-25","resultsFirstSubmitQcDate":"2023-11-13","resultsFirstPostDateStruct":{"date":"2023-12-05","type":"ACTUAL"},"dispFirstSubmitDate":"2022-03-25","dispFirstPostDateStruct":{"date":"2023-12-05","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-12-20","lastUpdatePostDateStruct":{"date":"2023-12-22","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Biogen","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with MDD.","detailedDescription":"This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen."},"conditionsModule":{"conditions":["Depressive Disorder, Major"],"keywords":["Depression","Depressive disorder","SAGE-217"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":543,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days.","interventionNames":["Drug: Placebo"]},{"label":"SAGE-217 50 mg","type":"EXPERIMENTAL","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator.","interventionNames":["Drug: SAGE-217"]}],"interventions":[{"type":"DRUG","name":"SAGE-217","description":"SAGE-217 oral capsules.","armGroupLabels":["SAGE-217 50 mg"]},{"type":"DRUG","name":"Placebo","description":"SAGE-217 matched-placebo oral capsules.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in the 17-item HAM-D Total Score at Day 15","description":"The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total HAM-D score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression. A negative change indicates improvement. A mixed Model for Repeated Measures (MMRM)was used for the analysis.","timeFrame":"Baseline, Day 15"}],"secondaryOutcomes":[{"measure":"Change From Baseline in the CGI-S Score at Day 15","description":"The CGI-S is a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A participant is assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7= among the most extremely ill participants. A negative change from baseline indicates improvement. MMRM was used for the analysis. A negative change from baseline indicates improvement. MMRM was used for the analysis.","timeFrame":"Baseline, Day 15"},{"measure":"Change From Baseline in the HAM-D Total Score at Days 3, 8 and 42","description":"The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total HAM-D score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression. A negative change from baseline indicates improvement. MMRM was used for the analysis.","timeFrame":"Baseline, Days 3, 8, and 42"},{"measure":"Percentage of Participants Achieving HAM-D Response","description":"The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total HAM-D score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression. HAM-D response is defined as having a greater than or equal to (≥) 50% reduction in HAM-D score from baseline. Generalized Estimating Equation (GEE) method was used for the analysis.","timeFrame":"Days 15 and 42"},{"measure":"Percentage of Participants Achieving HAM-D Remission","description":"The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total HAM-D score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression. HAM-D remission is defined as HAM-D total score less than or equal to (≤) 7. GEE model was used for the analysis.","timeFrame":"Days 15 and 42"},{"measure":"Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response at Day 15","description":"CGI-I response is defined as having a CGI-I score of \"very much improved\" (score of 1) or \"much improved\" (score of 2)\". The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. Response choices include 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. GEE model was used for the analysis.","timeFrame":"Day 15"},{"measure":"Change From Baseline in MADRS Total Score at Day 15","description":"The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS total score was calculated as the sum of the 10 individual item scores and each item yields a score of 0 to 6. The overall MADRS score ranges from 0 to 60 where higher MADRS scores indicate more severe depression. A negative change indicates improvement. MMRM was used analysis.","timeFrame":"Baseline, Day 15"},{"measure":"Change From Baseline in HAM-A Total Score at Day 15","description":"The 14-item HAM-A is comprised of a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The HAM-A total score was calculated as the sum of the 14 individual item scores. The scoring for HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe) to each item, with a total HAM-A score range of 0 to 56, where \\<17 indicates mild severity, 18 to 24 indicates mild to moderate severity, and 25 to 30 indicates moderate to severe severity. A negative change from baseline indicates improvement. MMRM was used for the analysis.","timeFrame":"Baseline, Day 15"},{"measure":"Time to First HAM-D Response","description":"17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. Total HAM-D score is sum of individual items, ranging from 0 to 52; where higher score indicates more depression. Time to first HAM-D response is defined as time from first administration of the study drug to first time when ≥50% reduction in HAM-D score from baseline is achieved.","timeFrame":"Up to Day 57"},{"measure":"Change From Baseline in Patient- Reported Outcome (PRO) Measures of Health-Related Quality of Life, as Assessed by the 36-item Short Form Version 2 (SF-36v2) Score at Days 8, 15, 28 and 42","description":"Participant's health was assessed using PRO health related quality of life (HRQOL) SF-36 V2. SF-36v2 covers 8 health dimensions, including 4 physical health status domains (physical functioning, role participation with physical health problems \\[role-physical\\], bodily pain, and general health) and 4 mental health status domains (vitality, social functioning, role participation with emotional health problems \\[role-emotional\\], and mental health). Physical Component Summary and the Mental Component Summary are derived from the 8 domains. Each domain is scored by summing the individual items, scores varying between 0 and 100. Both the domain scores and the component summary scores are norm-based. A higher score indicates a better state of health. Positive change indicates improvement. MMRM was used for the analysis.","timeFrame":"Baseline, Days 8, 15, 28 and 42"},{"measure":"Change From Baseline in PRO Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Total Score at Days 8, 15, 28 and 42","description":"The PHQ-9 is a participant-rated depressive symptom severity scale where scoring is based on responses to specific questions. The score was calculated as the sum of the 9 individual item scores. The PHQ-9 total score ranges from 0 to 27 categorized as follows: 1 to 4 = minimal depression, 5 to 9 = mild depression, 10 to 14 = moderate depression, 15 to 19 = moderately severe depression, and 20 to 27 = severe depression with a higher score indicating more depression. A negative change indicates improvements. MMRM was used for analysis.","timeFrame":"Baseline, Days 8, 15, 28 and 42"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Participant with diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version \\[SCID-5-CT\\], with symptoms that have been present for at least a 4-week period.\n2. Participant has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at screening and Day 1 (prior to dosing).\n3. Participants taking antidepressants must have been taking these medications at the same dose for at least 60 days prior to Day 1. Participants who have stopped taking antidepressants within 60 days must have stopped for longer than 5 half-lives of the antidepressant prior to Day 1. Participants receiving psychotherapy must have been receiving therapy on a regular schedule for at least 60 days prior to Day 1.\n4. Participant is willing to delay start of other antidepressant or antianxiety medications and any new pharmacotherapy regimens, including as-needed benzodiazepine anxiolytics and sleep aids, until after completion of the Day 42 visit.\n\nExclusion Criteria:\n\n1. Participant is currently at significant risk of suicide, as judged by the Investigator, or has attempted suicide associated with the current episode of MDD.\n2. Participant has onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period.\n3. Participant has a body mass index (BMI) ≤18 or ≥45 kg/m\\^2 at Screening, which is subject to a broader evaluation of medical comorbidities.\n4. Participant has treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment.\n5. Participant has a medical history of seizures, bipolar disorder, schizophrenia, and/or schizoaffective disorder.\n6. Participant has a history of mild, moderate, or severe substance use disorder (including benzodiazepines) diagnosed using DSM-5 criteria in the 12 months prior to screening.\n7. Participant is taking psychostimulants (eg, methylphenidate, amphetamine) or opioids, regularly or as-needed, at Day -28.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"64 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Sage Investigational Site","city":"Rogers","state":"Arkansas","zip":"72758","country":"United States","geoPoint":{"lat":36.33202,"lon":-94.11854}},{"facility":"Sage Investigational Site","city":"Bellflower","state":"California","zip":"90706","country":"United States","geoPoint":{"lat":33.88168,"lon":-118.11701}},{"facility":"Sage Investigational Site","city":"Garden Grove","state":"California","zip":"92845","country":"United States","geoPoint":{"lat":33.77391,"lon":-117.94145}},{"facility":"Sage Investigational Site","city":"Glendale","state":"California","zip":"91206","country":"United States","geoPoint":{"lat":34.14251,"lon":-118.25508}},{"facility":"Sage Investigational Site","city":"Lemon Grove","state":"California","zip":"91945","country":"United States","geoPoint":{"lat":32.74255,"lon":-117.03142}},{"facility":"Sage Investigational Site","city":"Orange","state":"California","zip":"92868","country":"United States","geoPoint":{"lat":33.78779,"lon":-117.85311}},{"facility":"Sage Investigational Site","city":"Pico Rivera","state":"California","zip":"90660","country":"United States","geoPoint":{"lat":33.98307,"lon":-118.09673}},{"facility":"Sage Investigational Site","city":"Redlands","state":"California","zip":"92374","country":"United States","geoPoint":{"lat":34.05557,"lon":-117.18254}},{"facility":"Sage Investigational Site","city":"San Diego","state":"California","zip":"92103","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Sage Investigational Site","city":"Sherman Oaks","state":"California","zip":"91403","country":"United States","geoPoint":{"lat":34.15112,"lon":-118.44925}},{"facility":"Sage Investigational Site","city":"Temecula","state":"California","zip":"92591","country":"United States","geoPoint":{"lat":33.49364,"lon":-117.14836}},{"facility":"Sage Investigational Site","city":"Coral Springs","state":"Florida","zip":"33067","country":"United States","geoPoint":{"lat":26.27119,"lon":-80.2706}},{"facility":"Sage Investigational Site","city":"Hollywood","state":"Florida","zip":"33024","country":"United States","geoPoint":{"lat":26.0112,"lon":-80.14949}},{"facility":"Sage Investigational Site","city":"Jacksonville","state":"Florida","zip":"32256","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Sage Investigational Site","city":"Lauderhill","state":"Florida","zip":"33319","country":"United States","geoPoint":{"lat":26.14036,"lon":-80.21338}},{"facility":"Sage Investigational Site","city":"Orange City","state":"Florida","zip":"32763","country":"United States","geoPoint":{"lat":28.94888,"lon":-81.29867}},{"facility":"Sage Investigational Site","city":"Orlando","state":"Florida","zip":"32801","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"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":"Alpharetta","state":"Georgia","zip":"30022","country":"United States","geoPoint":{"lat":34.07538,"lon":-84.29409}},{"facility":"Sage Investigational Site","city":"Atlanta","state":"Georgia","zip":"30328","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"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":"Skokie","state":"Illinois","zip":"60076","country":"United States","geoPoint":{"lat":42.03336,"lon":-87.73339}},{"facility":"Sage Investigational Site","city":"Flowood","state":"Mississippi","zip":"39232","country":"United States","geoPoint":{"lat":32.30959,"lon":-90.13898}},{"facility":"Sage Investigational Site","city":"O'Fallon","state":"Missouri","zip":"63368","country":"United States","geoPoint":{"lat":38.81061,"lon":-90.69985}},{"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":"Marlton","state":"New Jersey","zip":"08053","country":"United States","geoPoint":{"lat":39.89122,"lon":-74.92183}},{"facility":"Sage Investigational Site","city":"Charlotte","state":"North Carolina","zip":"28211","country":"United States","geoPoint":{"lat":35.22709,"lon":-80.84313}},{"facility":"Sage Investigational Site","city":"Cincinnati","state":"Ohio","zip":"45215","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"Sage Investigational Site","city":"Dayton","state":"Ohio","zip":"45417","country":"United States","geoPoint":{"lat":39.75895,"lon":-84.19161}},{"facility":"Sage Investigational Site","city":"North Canton","state":"Ohio","zip":"44720","country":"United States","geoPoint":{"lat":40.87589,"lon":-81.40234}},{"facility":"Sage Investigational Site","city":"Oklahoma City","state":"Oklahoma","zip":"73112","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"Sage Investigational Site","city":"Portland","state":"Oregon","zip":"97210","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"Sage Investigational Site","city":"Allentown","state":"Pennsylvania","zip":"18104","country":"United States","geoPoint":{"lat":40.60843,"lon":-75.49018}},{"facility":"Sage Investigational Site","city":"Charleston","state":"South Carolina","zip":"29407","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}},{"facility":"Sage Investigational Site","city":"Memphis","state":"Tennessee","zip":"38119","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"facility":"Sage Investigational Site","city":"DeSoto","state":"Texas","zip":"75115","country":"United States","geoPoint":{"lat":32.58986,"lon":-96.85695}},{"facility":"Sage Investigational Site","city":"Wichita Falls","state":"Texas","zip":"76309","country":"United States","geoPoint":{"lat":33.91371,"lon":-98.49339}},{"facility":"Sage Investigational Site","city":"Charlottesville","state":"Virginia","zip":"22903","country":"United States","geoPoint":{"lat":38.02931,"lon":-78.47668}}]},"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 543 participants were randomized, of which 543 were enrolled in this study and 537 received Investigational Product (IP). Part B was started after all participants in Part A (NCT03672175) completed Day 42 of the previous study.","recruitmentDetails":"Participants were enrolled in the study at 39 centers in the United States from 12 May 2020 to 21 April 2021.","groups":[{"id":"FG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days."},{"id":"FG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 milligrams (mg) received 40 mg for the remainder of the treatment period as per discretion of investigator."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"272"},{"groupId":"FG001","numSubjects":"271"}]},{"type":"Safety Set","comment":"Safety Set included all participants who were administered investigational product (IP).","achievements":[{"groupId":"FG000","numSubjects":"269"},{"groupId":"FG001","numSubjects":"268"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"235"},{"groupId":"FG001","numSubjects":"242"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"29"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Noncompliance","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Reason not Specified","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Randomized but not Treated","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Safety Set included all participants who were administered IP.","groups":[{"id":"BG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days."},{"id":"BG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"268"},{"groupId":"BG002","value":"537"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"268"},{"groupId":"BG002","value":"537"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"40.1","spread":"12.64"},{"groupId":"BG001","value":"39.4","spread":"12.30"},{"groupId":"BG002","value":"39.7","spread":"12.46"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"268"},{"groupId":"BG002","value":"537"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"166"},{"groupId":"BG001","value":"186"},{"groupId":"BG002","value":"352"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"103"},{"groupId":"BG001","value":"82"},{"groupId":"BG002","value":"185"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"268"},{"groupId":"BG002","value":"537"}]}],"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"54"},{"groupId":"BG001","value":"58"},{"groupId":"BG002","value":"112"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"215"},{"groupId":"BG001","value":"210"},{"groupId":"BG002","value":"425"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"268"},{"groupId":"BG002","value":"537"}]}],"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"17"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"46"},{"groupId":"BG001","value":"75"},{"groupId":"BG002","value":"121"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"206"},{"groupId":"BG001","value":"169"},{"groupId":"BG002","value":"375"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"12"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"6"}]}]}]},{"title":"17-item Hamilton Rating Scale for Depression (HAM-D) Total Score","description":"The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total HAM-D score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"score on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"268"},{"groupId":"BG002","value":"537"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"26.9","spread":"2.67"},{"groupId":"BG001","value":"26.8","spread":"2.60"},{"groupId":"BG002","value":"26.9","spread":"2.64"}]}]}]},{"title":"Clinical Global Impression - Severity (CGIS) Score","description":"The CGI-S is a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A participant is assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7= among the most extremely ill participants","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"score on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"268"},{"groupId":"BG002","value":"537"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4.8","spread":"0.52"},{"groupId":"BG001","value":"4.7","spread":"0.55"},{"groupId":"BG002","value":"4.7","spread":"0.54"}]}]}]},{"title":"Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score","description":"The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS total score was calculated as the sum of the 10 individual item scores and each item yields a score of 0 to 6. The total MADRS score ranges from 0 to 60, where higher scores indicate more severe depression.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"score on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"268"},{"groupId":"BG002","value":"537"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"35.0","spread":"4.73"},{"groupId":"BG001","value":"35.2","spread":"4.83"},{"groupId":"BG002","value":"35.1","spread":"4.78"}]}]}]},{"title":"Hamilton Anxiety Rating Scale (HAM-A) Total Score","description":"The 14-item HAM-A is comprised of a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The HAM-A total score will be calculated as the sum of the 14 individual item scores. The scoring for HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe) with a total HAM-A score range of 0 to 56, where less than (\\<)17 indicates mild severity, 18 to 24 indicates mild to moderate severity, and 25 to 30 indicates moderate to severe severity.","populationDescription":"\"Number analyzed\" = Number of participants evaluable for the specified baseline measure.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"score on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"268"},{"groupId":"BG001","value":"268"},{"groupId":"BG002","value":"536"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"20.7","spread":"5.51"},{"groupId":"BG001","value":"21.4","spread":"5.15"},{"groupId":"BG002","value":"21.0","spread":"5.34"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in the 17-item HAM-D Total Score at Day 15","description":"The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total HAM-D score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression. A negative change indicates improvement. A mixed Model for Repeated Measures (MMRM)was used for the analysis.","populationDescription":"The FAS included all randomized participants who were administered IP with valid baseline HAM-D total score and had at least 1 valid post-baseline HAM-D total score. Overall number of participants analyzed are the number of participants with data available for analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Day 15","groups":[{"id":"OG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days."},{"id":"OG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"248"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.3","spread":"0.50"},{"groupId":"OG001","value":"-14.1","spread":"0.51"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0141","statisticalMethod":"MMRM","paramType":"Least Squares (LS) Mean Difference","paramValue":"-1.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.1","ciUpperLimit":"-0.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.70","estimateComment":"Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure."}]},{"type":"SECONDARY","title":"Change From Baseline in the CGI-S Score at Day 15","description":"The CGI-S is a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A participant is assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7= among the most extremely ill participants. A negative change from baseline indicates improvement. MMRM was used for the analysis. A negative change from baseline indicates improvement. MMRM was used for the analysis.","populationDescription":"FAS included all randomized participants who were administered IP with valid baseline HAM-D total score and had at least 1 valid post-baseline HAM-D total score. Overall number of participants analyzed are the number of participants with data available for analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Day 15","groups":[{"id":"OG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days."},{"id":"OG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"266"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.6","spread":"0.08"},{"groupId":"OG001","value":"-1.8","spread":"0.08"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1193","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.4","ciUpperLimit":"0.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.11","estimateComment":"Model used was the MMRM with treatment (SAGE-217 or placebo), baseline CGI-S score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure."}]},{"type":"SECONDARY","title":"Change From Baseline in the HAM-D Total Score at Days 3, 8 and 42","description":"The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total HAM-D score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression. A negative change from baseline indicates improvement. MMRM was used for the analysis.","populationDescription":"FAS included all randomized participants who were administered IP with valid baseline HAM-D total score and had at least 1 valid post-baseline HAM-D total score. Number analyzed is the number of participants with data available for analysis at the given timepoints.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Days 3, 8, and 42","groups":[{"id":"OG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days."},{"id":"OG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"266"}]}],"classes":[{"title":"Change from Baseline at Day 3","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"263"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-6.8","spread":"0.38"},{"groupId":"OG001","value":"-9.8","spread":"0.38"}]}]},{"title":"Change from Baseline at Day 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"255"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-9.5","spread":"0.45"},{"groupId":"OG001","value":"-12.0","spread":"0.45"}]}]},{"title":"Change from Baseline at Day 42","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"240"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-12.6","spread":"0.55"},{"groupId":"OG001","value":"-13.5","spread":"0.55"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change from baseline at Day 3","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-3.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.0","ciUpperLimit":"-2.0","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.52","estimateComment":"Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure."},{"groupIds":["OG000","OG001"],"groupDescription":"Change from baseline at Day 8","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-2.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.8","ciUpperLimit":"-1.4","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.61","estimateComment":"Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure."},{"groupIds":["OG000","OG001"],"groupDescription":"Change from baseline at Day 42","nonInferiorityType":"SUPERIORITY","pValue":"0.2344","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.4","ciUpperLimit":"0.6","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.76","estimateComment":"Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure."}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving HAM-D Response","description":"The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total HAM-D score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression. HAM-D response is defined as having a greater than or equal to (≥) 50% reduction in HAM-D score from baseline. Generalized Estimating Equation (GEE) method was used for the analysis.","populationDescription":"FAS included all randomized participants who were administered IP with valid baseline HAM-D total score and had at least 1 valid post-baseline HAM-D total score. Number analyzed is the number of participants with data available for analysis at the given timepoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Days 15 and 42","groups":[{"id":"OG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days."},{"id":"OG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"266"}]}],"classes":[{"title":"Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"248"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"47.0"},{"groupId":"OG001","value":"56.0"}]}]},{"title":"Day 42","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"240"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"45.9"},{"groupId":"OG001","value":"52.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Day 15","nonInferiorityType":"SUPERIORITY","pValue":"0.0599","statisticalMethod":"Generalized Estimating Equation Model","paramType":"Odds Ratio (OR)","paramValue":"1.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.99","ciUpperLimit":"1.98","otherAnalysisDescription":"Model used is a GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D response for participants treated with SAGE-217 relative to that for participants treated with placebo."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 42","nonInferiorityType":"SUPERIORITY","pValue":"0.0889","statisticalMethod":"GEE Model","paramType":"Odds Ratio (OR)","paramValue":"1.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.95","ciUpperLimit":"1.94","otherAnalysisDescription":"Model used is a GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure.Odds ratio was the estimate of the odds of having HAM-D response for participants treated with SAGE-217 relative to that for participants treated with placebo."}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving HAM-D Remission","description":"The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total HAM-D score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression. HAM-D remission is defined as HAM-D total score less than or equal to (≤) 7. GEE model was used for the analysis.","populationDescription":"FAS included all randomized participants who were administered IP with valid baseline HAM-D total score and had at least 1 valid post-baseline HAM-D total score. Number analyzed is the number of participants with data available for analysis at the given timepoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Days 15 and 42","groups":[{"id":"OG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days."},{"id":"OG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"266"}]}],"classes":[{"title":"Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"248"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"27.1"},{"groupId":"OG001","value":"29.8"}]}]},{"title":"Day 42","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"240"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"29.6"},{"groupId":"OG001","value":"30.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Day 15","nonInferiorityType":"SUPERIORITY","pValue":"0.5495","statisticalMethod":"GEE Model","paramType":"Odds Ratio (OR)","paramValue":"1.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.76","ciUpperLimit":"1.66","otherAnalysisDescription":"Model used is GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline, assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D remission for participants treated with SAGE-217 relative to that for participants treated with placebo."},{"groupIds":["OG000","OG001"],"groupDescription":"Day 42","nonInferiorityType":"SUPERIORITY","pValue":"0.6790","statisticalMethod":"GEE Model","paramType":"Odds Ratio (OR)","paramValue":"1.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.74","ciUpperLimit":"1.60","otherAnalysisDescription":"Model used is GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline, assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D remission for participants treated with SAGE-217 relative to that for participants treated with placebo."}]},{"type":"SECONDARY","title":"Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response at Day 15","description":"CGI-I response is defined as having a CGI-I score of \"very much improved\" (score of 1) or \"much improved\" (score of 2)\". The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. Response choices include 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. GEE model was used for the analysis.","populationDescription":"FAS included all randomized participants who were administered IP with valid baseline HAM-D total score and had at least 1 valid post-baseline HAM-D total score. Overall number of participants is the participants with response.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Day 15","groups":[{"id":"OG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days."},{"id":"OG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"248"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51.0"},{"groupId":"OG001","value":"62.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Placebo, SAGE-217","nonInferiorityType":"SUPERIORITY","pValue":"0.0191","statisticalMethod":"GEE Model","paramType":"Odds Ratio (OR)","paramValue":"1.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.07","ciUpperLimit":"2.16","otherAnalysisDescription":"Model used was a GEE for binary response model, with factors for treatment, CGI-S baseline score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having CGI-I response for participants treated with SAGE-217 relative to that for participants treated with placebo."}]},{"type":"SECONDARY","title":"Change From Baseline in MADRS Total Score at Day 15","description":"The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS total score was calculated as the sum of the 10 individual item scores and each item yields a score of 0 to 6. The overall MADRS score ranges from 0 to 60 where higher MADRS scores indicate more severe depression. A negative change indicates improvement. MMRM was used analysis.","populationDescription":"FAS included all randomized participants who were administered IP with valid baseline HAM-D total score and had at least 1 valid post-baseline HAM-D total score. Overall number of participants analyzed is the number of participants with data available for analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Day 15","groups":[{"id":"OG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days."},{"id":"OG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"247"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.1","spread":"0.76"},{"groupId":"OG001","value":"-17.5","spread":"0.77"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Placebo, SAGE-217","nonInferiorityType":"SUPERIORITY","pValue":"0.0238","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-2.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.4","ciUpperLimit":"-0.3","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.05","estimateComment":"Model used was the MMRM with treatment (SAGE-217/placebo), baseline MADRS total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure"}]},{"type":"SECONDARY","title":"Change From Baseline in HAM-A Total Score at Day 15","description":"The 14-item HAM-A is comprised of a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The HAM-A total score was calculated as the sum of the 14 individual item scores. The scoring for HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe) to each item, with a total HAM-A score range of 0 to 56, where \\<17 indicates mild severity, 18 to 24 indicates mild to moderate severity, and 25 to 30 indicates moderate to severe severity. A negative change from baseline indicates improvement. MMRM was used for the analysis.","populationDescription":"FAS included all randomized participants who were administered IP with valid baseline HAM-D total score and had at least 1 valid post-baseline HAM-D total score. Overall number of participants analyzed is the number of participants with data available for analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Day 15","groups":[{"id":"OG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days."},{"id":"OG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"247"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.1","spread":"0.43"},{"groupId":"OG001","value":"-10.4","spread":"0.43"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Placebo, SAGE-217","nonInferiorityType":"SUPERIORITY","pValue":"0.0199","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-1.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.5","ciUpperLimit":"-0.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.58","estimateComment":"Model used was MMRM with treatment (SAGE-217/placebo), baseline HAM-A total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure."}]},{"type":"SECONDARY","title":"Time to First HAM-D Response","description":"17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. Total HAM-D score is sum of individual items, ranging from 0 to 52; where higher score indicates more depression. Time to first HAM-D response is defined as time from first administration of the study drug to first time when ≥50% reduction in HAM-D score from baseline is achieved.","populationDescription":"FAS included all randomized participants who were administered IP with valid baseline HAM-D total score and had at least 1 valid post-baseline HAM-D total score. Overall number of participants analyzed is the number of participants with response.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"days","timeFrame":"Up to Day 57","groups":[{"id":"OG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days."},{"id":"OG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"166"},{"groupId":"OG001","value":"197"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15","lowerLimit":"2","upperLimit":"57"},{"groupId":"OG001","value":"11","lowerLimit":"2","upperLimit":"54"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Patient- Reported Outcome (PRO) Measures of Health-Related Quality of Life, as Assessed by the 36-item Short Form Version 2 (SF-36v2) Score at Days 8, 15, 28 and 42","description":"Participant's health was assessed using PRO health related quality of life (HRQOL) SF-36 V2. SF-36v2 covers 8 health dimensions, including 4 physical health status domains (physical functioning, role participation with physical health problems \\[role-physical\\], bodily pain, and general health) and 4 mental health status domains (vitality, social functioning, role participation with emotional health problems \\[role-emotional\\], and mental health). Physical Component Summary and the Mental Component Summary are derived from the 8 domains. Each domain is scored by summing the individual items, scores varying between 0 and 100. Both the domain scores and the component summary scores are norm-based. A higher score indicates a better state of health. Positive change indicates improvement. MMRM was used for the analysis.","populationDescription":"FAS included all randomized participants who were administered IP with valid baseline HAM-D total score and had at least 1 valid post-baseline HAM-D total score. Number analyzed is the number of participants with data available for analysis at the given timepoints.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Days 8, 15, 28 and 42","groups":[{"id":"OG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days."},{"id":"OG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"266"}]}],"classes":[{"title":"Physical Functioning Domain Score: Change from Baseline at Day 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"261"},{"groupId":"OG001","value":"255"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.9","spread":"0.36"},{"groupId":"OG001","value":"2.4","spread":"0.37"}]}]},{"title":"Physical Functioning Domain Score: Change from Baseline at Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"247"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.3","spread":"0.38"},{"groupId":"OG001","value":"3.1","spread":"0.39"}]}]},{"title":"Physical Functioning Domain Score: Change from Baseline at Day 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Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"266"}]}],"classes":[{"title":"Change from Baseline at Day 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"261"},{"groupId":"OG001","value":"255"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-6.8","spread":"0.42"},{"groupId":"OG001","value":"-7.8","spread":"0.42"}]}]},{"title":"Change from Baseline at Day 15","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"247"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.3","spread":"0.45"},{"groupId":"OG001","value":"-9.4","spread":"0.46"}]}]},{"title":"Change from Baseline at Day 28","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"237"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-7.8","spread":"0.46"},{"groupId":"OG001","value":"-8.8","spread":"0.46"}]}]},{"title":"Change from Baseline at Day 42","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"240"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.5","spread":"0.48"},{"groupId":"OG001","value":"-9.0","spread":"0.48"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change from Baseline at Day 8","nonInferiorityType":"SUPERIORITY","pValue":"0.0828","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-1.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.1","ciUpperLimit":"0.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.57","estimateComment":"Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure."},{"groupIds":["OG000","OG001"],"groupDescription":"Change from Baseline at Day 15","nonInferiorityType":"SUPERIORITY","pValue":"0.0606","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-1.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.4","ciUpperLimit":"0.1","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.62","estimateComment":"Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure."},{"groupIds":["OG000","OG001"],"groupDescription":"Change from Baseline at Day 28","nonInferiorityType":"SUPERIORITY","pValue":"0.1079","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-1.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.3","ciUpperLimit":"0.2","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.63","estimateComment":"Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure."},{"groupIds":["OG000","OG001"],"groupDescription":"Change from Baseline at Day 42","nonInferiorityType":"SUPERIORITY","pValue":"0.3951","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.9","ciUpperLimit":"0.7","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.66","estimateComment":"Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure."}]}]},"adverseEventsModule":{"frequencyThreshold":"2","timeFrame":"From inform consent signing up to 28 days after the last dose (Up to 70 days)","description":"Safety set included all participants who were administered IP.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days.","deathsNumAffected":0,"deathsNumAtRisk":269,"seriousNumAffected":2,"seriousNumAtRisk":269,"otherNumAffected":59,"otherNumAtRisk":269},{"id":"EG001","title":"SAGE-217 50 mg","description":"Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. 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PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication."},"pointOfContact":{"title":"US Biogen Clinical Trial Center","organization":"Biogen","email":"clinicaltrials@biogen.com","phone":"866-633-4636"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2020-12-14","uploadDate":"2023-08-25T06:11","filename":"Prot_000.pdf","size":3409206},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2021-05-25","uploadDate":"2023-08-25T06:12","filename":"SAP_001.pdf","size":1076811}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2023-09-21","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"},{"id":"D003866","term":"Depressive Disorder"}],"ancestors":[{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"C000634505","term":"zuranolone"}]}},"hasResults":true}