{"protocolSection":{"identificationModule":{"nctId":"NCT02285504","orgStudyIdInfo":{"id":"547-PPD-201"},"organization":{"fullName":"Supernus Pharmaceuticals, Inc.","class":"INDUSTRY"},"briefTitle":"Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression","officialTitle":"An Open-Label Proof-of-Concept Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-547 Injection in the Treatment of Adult Female Patients With Severe Postpartum Depression"},"statusModule":{"statusVerifiedDate":"2021-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-01-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2015-06-05","type":"ACTUAL"},"completionDateStruct":{"date":"2015-06-05","type":"ACTUAL"},"studyFirstSubmitDate":"2014-10-22","studyFirstSubmitQcDate":"2014-11-04","studyFirstPostDateStruct":{"date":"2014-11-07","type":"ESTIMATED"},"resultsFirstSubmitDate":"2021-11-01","resultsFirstSubmitQcDate":"2021-11-01","resultsFirstPostDateStruct":{"date":"2021-12-02","type":"ACTUAL"},"dispFirstSubmitDate":"2017-04-25","dispFirstSubmitQcDate":"2017-04-25","dispFirstPostDateStruct":{"date":"2017-04-26","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-09-11","lastUpdatePostDateStruct":{"date":"2025-09-15","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Supernus Pharmaceuticals, Inc.","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression (PPD)."},"conditionsModule":{"conditions":["Postpartum Depression"],"keywords":["Postpartum depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":4,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"SAGE-547","type":"EXPERIMENTAL","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 micrograms per kilogram per hour \\[mcg/kg/hr\\] \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3).","interventionNames":["Drug: SAGE-547"]}],"interventions":[{"type":"DRUG","name":"SAGE-547","description":"Intravenous injection","armGroupLabels":["SAGE-547"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)","description":"AEs were any untoward medical occurrences in a participant who received study treatment without regard to possibility of causal relationship. TEAEs were defined as AEs with onset after the start of SAGE-547 infusion, or any worsening of a pre-existing medical condition or AEs with onset after the start of SAGE-547 infusion and until 7 days after the end of infusion (Day 11). TESAEs were defined as AEs with onset after the start of SAGE-547 infusion, or any worsening of a pre-existing medical condition or AEs with onset after the start of SAGE-547 infusion and until 30 days after the end of infusion (Day 34).","timeFrame":"TEAEs: Up to Day 11, TESAEs: Up to Day 34"},{"measure":"Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)","description":"Clinical laboratory evaluation included: Chemistry (ALT, AST, GGT) expressed in terms of units per liter (U/L). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)"},{"measure":"Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride","description":"Clinical laboratory evaluation included: Chemistry (carbon dioxide \\[CO2\\], sodium, potassium and chloride) expressed in terms of millimoles/liter (mmol/L). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)"},{"measure":"Change From Baseline in Clinical Laboratory Measures: Glucose, Total Bilirubin, Calcium, Blood Urea Nitrogen (BUN) and Creatinine","description":"Clinical laboratory evaluation included: Chemistry (glucose, total bilirubin, calcium, blood urea nitrogen \\[BUN\\] and creatinine) expressed in terms of milligrams/deciliter (mg/dL). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)"},{"measure":"Change From Baseline in Clinical Laboratory Measures: Albumin, Total Protein and Hemoglobin","description":"Clinical laboratory evaluation included: Chemistry (albumin, total protein), Hematology and Coagulation (hemoglobin) expressed in terms of g/dL. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)"},{"measure":"Change From Baseline in Clinical Laboratory Measure: Hematocrit","description":"Clinical laboratory evaluation included: Hematocrit expressed in terms of percentage. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)"},{"measure":"Change From Baseline in Clinical Laboratory Measures: Platelet Count, White Blood Cells (WBC), Absolute Lymphocytes, Absolute Neutrophils, Absolute Basophils, Absolute Eosinophils, Absolute Monocytes","description":"Clinical laboratory evaluation included: Platelet count, white blood cells (WBC), absolute lymphocytes, absolute neutrophils, absolute basophils, absolute eosinophils, absolute monocytes expressed in terms of 10\\^9 cells/L. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)"},{"measure":"Change From Baseline in Clinical Laboratory Measure: Red Blood Cells (RBC)","description":"Clinical laboratory evaluation included: RBC expressed in terms of 10\\^12 cells/L. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)"},{"measure":"Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Volume (MCV)","description":"Clinical laboratory evaluation included: MCV expressed in terms of femtoliters (fL). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)"},{"measure":"Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Hemoglobin (MCH)","description":"Clinical laboratory evaluation included: MCH expressed in terms of picogram (pg). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)"},{"measure":"Change From Baseline in Clinical Laboratory Measure: Prothrombin Time/International Normalized Ratio (PT/INR)","description":"Clinical laboratory evaluation included: PT/INR expressed in terms of seconds. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)"},{"measure":"Change From Baseline in Clinical Laboratory Measure: Potential of Hydrogen (pH)","description":"Clinical laboratory evaluation included: Urinalysis (pH). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)"},{"measure":"Change From Baseline in Clinical Laboratory Measure: Specific Gravity","description":"Clinical laboratory evaluation included: Urinalysis (specific gravity) expressed in terms of ratio. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)"},{"measure":"Change From Baseline in Vital Sign: Blood Pressure","description":"Vital sign parameters included supine systolic blood pressure (SBP), supine diastolic blood pressure (DBP), standing systolic blood pressure and standing diastolic blood pressure expressed in terms of millimeters of mercury (mmHg). The data was collected at time-points on Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs).","timeFrame":"Baseline, Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs)"},{"measure":"Change From Baseline in Vital Sign: Heart Rate","description":"Vital sign parameter included heart rate expressed in terms of beats per minute (bpm). The data was collected at time-points on Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs).","timeFrame":"Baseline, Day 1 (12 hrs) Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs)"},{"measure":"Change From Baseline in Vital Sign: Body Temperature","description":"Vital sign parameter included temperature expressed in terms of degree Celsius. The data was collected at time-points on Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs).","timeFrame":"Baseline, Day 1 (12 hrs) Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs)"},{"measure":"Change From Baseline in Vital Sign: Respiratory Rate","description":"Vital sign parameter included respiratory rate expressed in terms of breaths per minute. The data was collected at time-points on Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs).","timeFrame":"Baseline, Day 1 (12 hrs) Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs)"},{"measure":"Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, PR Interval, QTc Interval, and QRS Duration","description":"ECGs parameters included QT interval, PR interval, QTc interval, QRS duration expressed in terms of milliseconds (msec).","timeFrame":"Baseline, Day 4 (at 84 hrs)"},{"measure":"Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate","description":"ECGs parameter included heart rate expressed in terms of beats per minute (bpm).","timeFrame":"Baseline, Day 4 (at 84 hrs)"},{"measure":"Number of Participants With Physical Examination Findings","description":"Physical examinations included body weight, height, body mass index (BMI) and assessment of body systems (e.g., head, eyes, ears, nose, throat, lungs, abdomen, and extremities) as well as cognitive and mental health examinations (components of the neurological and psychiatric examinations, respectively).","timeFrame":"At Day 4"},{"measure":"Number of Participants With Concomitant Medication Usage","description":"Concomitant medications are other prescription medications, over the counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation.","timeFrame":"Baseline up to Day 11"},{"measure":"Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)","description":"C-SSRS scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicidal ideation and behavior, and a post-baseline evaluation that focuses on suicidality since the last study visit. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, (with score range from 1 to 5, higher score indicates more severity). The data was collected at time-points: Pre-infusion (Day 1 prior to dosing), Post-infusion (any time after the start of infusion on Day 1 up to 84 hrs).","timeFrame":"Pre-infusion (Day 1 prior to dosing), Post-infusion (any time after the start of infusion on Day 1 up to 84 hrs)"}],"secondaryOutcomes":[{"measure":"Maximum Plasma Concentration (Cmax) of SAGE-547","timeFrame":"Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose"},{"measure":"Time to Maximum Plasma Concentration (Tmax) of SAGE-547","description":"Tmax is defined as the time at which Cmax of SAGE-547 occurred.","timeFrame":"Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose"},{"measure":"Area Under the Concentration-Time Curve From Start of the Infusion Until the Time of the Last Sample (AUCall) of SAGE-547","description":"AUCall is defined as the area under the plasma SAGE-547 concentration time curves from the start of the infusion until the time the last sample was taken 72 hours later.","timeFrame":"Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose"},{"measure":"Area Under the Concentration-Time Curve From Time Zero to 60 Hours (AUC0-60) of SAGE-547","description":"AUC0-60 is defined as the area under the plasma SAGE-547 concentration time curve during the intravenous infusion.","timeFrame":"Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, and 60 hrs post-dose"},{"measure":"Area Under the Concentration-Time Curve in 24 Hours (AUC24) of SAGE-547","description":"AUC24 is defined as the area under the plasma SAGE-547 concentration-time curve in a 24-hour period during the maintenance dose.","timeFrame":"Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, and 24 hrs post-dose"},{"measure":"Average Drug Concentration in the Plasma at Steady State During a Dosing Interval (Cavg) of SAGE-547","description":"Cavg is defined as the plasma concentration of SAGE-547 at steady-state (average plasma concentration during the maintenance dose period; nominally 12 to 48 hrs).","timeFrame":"From 12 to 48 hrs (36 hr of maintenance dose period)"},{"measure":"Plasma Clearance (CL) of SAGE-547","description":"Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.","timeFrame":"Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose"},{"measure":"Change From Baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) Total Score","description":"The HAM-D-17 was used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D-17 is comprised of 17 individual items: 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, where 0 indicated none/absent and higher scores indicated greater depression. The Total Score can range from 0 (least depression) to 52 (greater depression), and higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.","timeFrame":"Baseline, Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), Day 3 (at 48 and 60 hrs), and Day 4 (at 84 hrs)"},{"measure":"Clinical Global Impression-Improvement (CGI-I) Score","description":"The CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). CGI-I assessment employs a 7-point Likert scale to measure the improvement in the participant's condition. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions.","timeFrame":"Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 84 hrs)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Adult females, 18-45 years old who experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery\n* Participant has ceased lactating, or if still lactating has already fully and permanently weaned their infant; if still actively breastfeeding, participant must agree to cease giving breast milk to their infant prior to study entry\n\nExclusion Criteria:\n\n* Recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, or eyes, ears, or nose and throat (EENT) disorders\n* Active psychosis\n* Medical history of seizures","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"45 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Stephen J Kanes, MD, PhD","affiliation":"Sage Therapeutics","role":"STUDY_CHAIR"}],"locations":[{"facility":"Sage Investigational Site","city":"Chapel Hill","state":"North Carolina","zip":"27514","country":"United States","geoPoint":{"lat":35.9132,"lon":-79.05584}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Sage Therapeutics","url":"http://www.sagerx.com/"}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"Data sharing will be consistent with the results submission policy of ClinicalTrials.gov."}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 6 participants were screened, 4 participants were treated and completed the study. This study consisted of up to a 3-day screening period, a 4-day (84-hour) active treatment period, a 7-day adverse event (AE) follow-up period, plus an additional 23 days of serious AE follow-up (with a telephone call at Day 11 and Day 34).","recruitmentDetails":"Participants were enrolled in the study at 1 center in the United States from 07 January 2015 to 05 June 2015.","groups":[{"id":"FG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 micrograms per kilogram per hour \\[mcg/kg/hr\\] \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"4"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection.","groups":[{"id":"BG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32.0","spread":"6.88"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)","description":"AEs were any untoward medical occurrences in a participant who received study treatment without regard to possibility of causal relationship. TEAEs were defined as AEs with onset after the start of SAGE-547 infusion, or any worsening of a pre-existing medical condition or AEs with onset after the start of SAGE-547 infusion and until 7 days after the end of infusion (Day 11). TESAEs were defined as AEs with onset after the start of SAGE-547 infusion, or any worsening of a pre-existing medical condition or AEs with onset after the start of SAGE-547 infusion and until 30 days after the end of infusion (Day 34).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"TEAEs: Up to Day 11, TESAEs: Up to Day 34","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]},{"title":"TESAEs","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Clinical Laboratory Measures: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT)","description":"Clinical laboratory evaluation included: Chemistry (ALT, AST, GGT) expressed in terms of units per liter (U/L). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"U/L","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change From Baseline at Day 2 (24 hrs): ALT","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.0","spread":"4.69"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs): ALT","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.7","spread":"7.02"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs): ALT","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.7","spread":"2.08"}]}]},{"title":"Change From Baseline at Day 2 (24 hrs): AST","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"6.19"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs): AST","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"6.24"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs): AST","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.7","spread":"5.69"}]}]},{"title":"Change From Baseline at Day 2 (24 hrs): GGT","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"2.08"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs): GGT","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.0","spread":"1.41"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs): GGT","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"5.5","spread":"9.19"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Clinical Laboratory Measures: Carbon Dioxide (CO2), Sodium, Potassium and Chloride","description":"Clinical laboratory evaluation included: Chemistry (carbon dioxide \\[CO2\\], sodium, potassium and chloride) expressed in terms of millimoles/liter (mmol/L). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection. 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Lymphocytes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.57","spread":"0.737"}]}]},{"title":"Change at Day 2 (24 hrs): Absolute Neutrophils","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.933","spread":"0.2082"}]}]},{"title":"Change at Day 3 (48 hrs): Absolute Neutrophils","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.250","spread":"0.2121"}]}]},{"title":"Change at Day 4 (84 hrs): Absolute Neutrophils","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.467","spread":"0.2082"}]}]},{"title":"Change at Day 2 (24 hrs): Absolute Basophils","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.00"}]}]},{"title":"Change at Day 3 (48 hrs): Absolute Basophils","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.00"}]}]},{"title":"Change at Day 4 (84 hrs): Absolute Basophils","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.00"}]}]},{"title":"Change at Day 2 (24 hrs): Absolute Eosinophils","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.03","spread":"0.058"}]}]},{"title":"Change at Day 3 (48 hrs): Absolute Eosinophils","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.05","spread":"0.071"}]}]},{"title":"Change at Day 4 (84 hrs): Absolute Eosinophils","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.100"}]}]},{"title":"Change at Day 2 (24 hrs): Absolute Monocytes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.10","spread":"0.100"}]}]},{"title":"Change at Day 3 (48 hrs): Absolute Monocytes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"0.071"}]}]},{"title":"Change at Day 4 (84 hrs): Absolute Monocytes","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.07","spread":"0.058"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Clinical Laboratory Measure: Red Blood Cells (RBC)","description":"Clinical laboratory evaluation included: RBC expressed in terms of 10\\^12 cells/L. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"10^12 cells/L","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change From Baseline at Day 2 (24 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.030","spread":"0.1924"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.090","spread":"0.2784"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.113","spread":"0.1656"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Volume (MCV)","description":"Clinical laboratory evaluation included: MCV expressed in terms of femtoliters (fL). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"fL","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change From Baseline at Day 2 (24 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.85","spread":"1.578"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.53","spread":"0.924"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.33","spread":"1.155"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Clinical Laboratory Measure: Mean Corpuscular Hemoglobin (MCH)","description":"Clinical laboratory evaluation included: MCH expressed in terms of picogram (pg). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change From Baseline at Day 2 (24 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"1.15"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"0.71"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"1.15"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Clinical Laboratory Measure: Prothrombin Time/International Normalized Ratio (PT/INR)","description":"Clinical laboratory evaluation included: PT/INR expressed in terms of seconds. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"seconds","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change From Baseline at Day 2 (24 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.30","spread":"0.700"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.05","spread":"0.636"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.37","spread":"0.902"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Clinical Laboratory Measure: Potential of Hydrogen (pH)","description":"Clinical laboratory evaluation included: Urinalysis (pH). The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pH","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change From Baseline at Day 2 (24 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.17","spread":"1.155"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.33","spread":"0.289"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","spread":"0.000"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Clinical Laboratory Measure: Specific Gravity","description":"Clinical laboratory evaluation included: Urinalysis (specific gravity) expressed in terms of ratio. The data was collected at time-points on Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ratio","timeFrame":"Baseline, Days 2 (at 24 hrs), 3 (at 48 hrs) and 4 (at 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change From Baseline at Day 2 (24 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.0080","spread":"0.00458"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.0017","spread":"0.00252"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.0015","spread":"0.00495"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Vital Sign: Blood Pressure","description":"Vital sign parameters included supine systolic blood pressure (SBP), supine diastolic blood pressure (DBP), standing systolic blood pressure and standing diastolic blood pressure expressed in terms of millimeters of mercury (mmHg). The data was collected at time-points on Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmHg","timeFrame":"Baseline, Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change From Baseline at Day 1 (12 hrs): Supine SBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.8","spread":"13.65"}]}]},{"title":"Change From Baseline at Day 2 (24 hrs): Supine SBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.3","spread":"11.95"}]}]},{"title":"Change From Baseline at Day 2 (36 hrs): Supine SBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"15.19"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs): Supine SBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-5.0","spread":"4.40"}]}]},{"title":"Change From Baseline at Day 3 (60 hrs): Supine 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DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"3.0","spread":"6.83"}]}]},{"title":"Change From Baseline at Day 2 (36 hrs): Supine DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.3","spread":"5.68"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs): Supine DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-5.0","spread":"5.42"}]}]},{"title":"Change From Baseline at Day 3 (60 hrs): Supine DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.0","spread":"6.22"}]}]},{"title":"Change From Baseline at Day 4 (72 hrs): Supine DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"9.75"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs): Supine DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.5","spread":"10.21"}]}]},{"title":"Change From Baseline at Day 1(12 hrs):Standing SBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.0","spread":"7.87"}]}]},{"title":"Change From Baseline at Day 2(24 hrs):Standing SBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"8.23"}]}]},{"title":"Change From Baseline at Day 2(36 hrs):Standing SBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.8","spread":"7.27"}]}]},{"title":"Change From Baseline at Day 3(48 hrs):Standing SBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"7.68"}]}]},{"title":"Change From Baseline at Day 3(60 hrs):Standing SBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"16.8","spread":"2.50"}]}]},{"title":"Change From Baseline at Day 4(72 hrs):Standing SBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.3","spread":"11.53"}]}]},{"title":"Change From Baseline at Day 4(84 hrs):Standing SBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.7","spread":"8.74"}]}]},{"title":"Change From Baseline at Day 1(12 hrs):Standing DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"8.52"}]}]},{"title":"Change From Baseline at Day 2(24 hrs):Standing DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"6.3","spread":"4.11"}]}]},{"title":"Change From Baseline at Day 2(36 hrs):Standing DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.5","spread":"9.11"}]}]},{"title":"Change From Baseline at Day 3(48 hrs):Standing DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"7.5","spread":"5.92"}]}]},{"title":"Change From Baseline at Day 3(60 hrs):Standing DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"13.8","spread":"8.81"}]}]},{"title":"Change From Baseline at Day 4(72 hrs):Standing DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"13.3","spread":"8.14"}]}]},{"title":"Change From Baseline at Day 4(84 hrs):Standing DBP","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"10.3","spread":"3.06"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Vital Sign: Heart Rate","description":"Vital sign parameter included heart rate expressed in terms of beats per minute (bpm). The data was collected at time-points on Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"bpm","timeFrame":"Baseline, Day 1 (12 hrs) Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change From Baseline at Day 1 (12 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.5","spread":"15.35"}]}]},{"title":"Change From Baseline at Day 2 (24 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"5.3","spread":"18.84"}]}]},{"title":"Change From Baseline at Day 2 (36 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.3","spread":"11.44"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.5","spread":"11.56"}]}]},{"title":"Change From Baseline at Day 3 (60 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.0","spread":"8.41"}]}]},{"title":"Change From Baseline at Day 4 (72 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-5.8","spread":"7.63"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.8","spread":"4.99"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Vital Sign: Body Temperature","description":"Vital sign parameter included temperature expressed in terms of degree Celsius. The data was collected at time-points on Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"degree Celsius","timeFrame":"Baseline, Day 1 (12 hrs) Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change From Baseline at Day 1 (12 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.20","spread":"0.32"}]}]},{"title":"Change From Baseline at Day 2 (24 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"0.15","spread":"0.23"}]}]},{"title":"Change From Baseline at Day 2 (36 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.15","spread":"0.33"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"0.25"}]}]},{"title":"Change From Baseline at Day 3 (60 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"0.03","spread":"0.31"}]}]},{"title":"Change From Baseline at Day 4 (72 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.30","spread":"0.37"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.45","spread":"0.46"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Vital Sign: Respiratory Rate","description":"Vital sign parameter included respiratory rate expressed in terms of breaths per minute. The data was collected at time-points on Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"breaths/min","timeFrame":"Baseline, Day 1 (12 hrs) Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 72 and 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change From Baseline at Day 1 (12 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"1.63"}]}]},{"title":"Change From Baseline at Day 2 (24 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"2.31"}]}]},{"title":"Change From Baseline at Day 2 (36 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"2.31"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"4.00"}]}]},{"title":"Change From Baseline at Day 3 (60 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.3","spread":"1.53"}]}]},{"title":"Change From Baseline at Day 4 (72 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"1.15"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs)","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"1.00"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, PR Interval, QTc Interval, and QRS Duration","description":"ECGs parameters included QT interval, PR interval, QTc interval, QRS duration expressed in terms of milliseconds (msec).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"msec","timeFrame":"Baseline, Day 4 (at 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change from Baseline at Day 4 (84 hrs):QT Interval","categories":[{"measurements":[{"groupId":"OG000","value":"-28.5","spread":"34.31"}]}]},{"title":"Change from Baseline at Day 4 (84 hrs):PR Interval","categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"9.87"}]}]},{"title":"Change from Baseline at Day 4(84 hrs):QTc Interval","categories":[{"measurements":[{"groupId":"OG000","value":"13.3","spread":"10.44"}]}]},{"title":"Change from Baseline at Day 4(84 hrs):QRS Duration","categories":[{"measurements":[{"groupId":"OG000","value":"-3.5","spread":"7.19"}]}]}]},{"type":"PRIMARY","title":"Change From Baseline in Electrocardiogram (ECG) Parameter: Heart Rate","description":"ECGs parameter included heart rate expressed in terms of beats per minute (bpm).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"bpm","timeFrame":"Baseline, Day 4 (at 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14.3","spread":"9.29"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Physical Examination Findings","description":"Physical examinations included body weight, height, body mass index (BMI) and assessment of body systems (e.g., head, eyes, ears, nose, throat, lungs, abdomen, and extremities) as well as cognitive and mental health examinations (components of the neurological and psychiatric examinations, respectively).","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"At Day 4","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Concomitant Medication Usage","description":"Concomitant medications are other prescription medications, over the counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation.","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline up to Day 11","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]}]},{"type":"PRIMARY","title":"Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)","description":"C-SSRS scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicidal ideation and behavior, and a post-baseline evaluation that focuses on suicidality since the last study visit. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, (with score range from 1 to 5, higher score indicates more severity). The data was collected at time-points: Pre-infusion (Day 1 prior to dosing), Post-infusion (any time after the start of infusion on Day 1 up to 84 hrs).","populationDescription":"Efficacy population included all participants who began infusion with SAGE-547 injection and who completed at least 12 hours of infusion and have efficacy evaluations through the 12-hour visit.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Pre-infusion (Day 1 prior to dosing), Post-infusion (any time after the start of infusion on Day 1 up to 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Pre-Infusion: Suicidal Ideation","categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]},{"title":"Post-Infusion: Suicidal Ideation","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Pre-Infusion: Suicidal Behavior","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Post-Infusion: Suicidal Behavior","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Maximum Plasma Concentration (Cmax) of SAGE-547","populationDescription":"Pharmacokinetic (PK) population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"nanograms per millilter (ng/mL)","timeFrame":"Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"97.2","spread":"77.3"}]}]}]},{"type":"SECONDARY","title":"Time to Maximum Plasma Concentration (Tmax) of SAGE-547","description":"Tmax is defined as the time at which Cmax of SAGE-547 occurred.","populationDescription":"PK population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"hours","timeFrame":"Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42","lowerLimit":"12","upperLimit":"48"}]}]}]},{"type":"SECONDARY","title":"Area Under the Concentration-Time Curve From Start of the Infusion Until the Time of the Last Sample (AUCall) of SAGE-547","description":"AUCall is defined as the area under the plasma SAGE-547 concentration time curves from the start of the infusion until the time the last sample was taken 72 hours later.","populationDescription":"PK population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"nanograms*hour per milliliter (ng*hr/mL)","timeFrame":"Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3380","spread":"1410"}]}]}]},{"type":"SECONDARY","title":"Area Under the Concentration-Time Curve From Time Zero to 60 Hours (AUC0-60) of SAGE-547","description":"AUC0-60 is defined as the area under the plasma SAGE-547 concentration time curve during the intravenous infusion.","populationDescription":"PK population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng*hr/mL","timeFrame":"Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, and 60 hrs post-dose","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3160","spread":"1360"}]}]}]},{"type":"SECONDARY","title":"Area Under the Concentration-Time Curve in 24 Hours (AUC24) of SAGE-547","description":"AUC24 is defined as the area under the plasma SAGE-547 concentration-time curve in a 24-hour period during the maintenance dose.","populationDescription":"PK population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available. Here, \"Overall Number of Participants Analyzed\" signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng*hr/mL","timeFrame":"Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, and 24 hrs post-dose","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1590","spread":"580"}]}]}]},{"type":"SECONDARY","title":"Average Drug Concentration in the Plasma at Steady State During a Dosing Interval (Cavg) of SAGE-547","description":"Cavg is defined as the plasma concentration of SAGE-547 at steady-state (average plasma concentration during the maintenance dose period; nominally 12 to 48 hrs).","populationDescription":"PK population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available. Here, \"Overall Number of Participants Analyzed\" signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mL","timeFrame":"From 12 to 48 hrs (36 hr of maintenance dose period)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"66.1","spread":"24.1"}]}]}]},{"type":"SECONDARY","title":"Plasma Clearance (CL) of SAGE-547","description":"Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.","populationDescription":"PK population included all who began infusion with SAGE-547 injection and for whom at least one evaluable PK sample was available.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Liters per hour per kilogram (L/hr/kg)","timeFrame":"Predose (0 hrs), and 0.5, 1, 2, 3, 4, 6, 12, 24, 36, 40, 44, 48, 60, and 72 hrs post-dose","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.08","spread":"0.22"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) Total Score","description":"The HAM-D-17 was used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D-17 is comprised of 17 individual items: 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, where 0 indicated none/absent and higher scores indicated greater depression. The Total Score can range from 0 (least depression) to 52 (greater depression), and higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.","populationDescription":"Safety population included all participants who began infusion with SAGE-547 injection.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), Day 3 (at 48 and 60 hrs), and Day 4 (at 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Change From Baseline at Day 1 (12 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-21.8","spread":"5.50"}]}]},{"title":"Change From Baseline at Day 2 (24 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-23.3","spread":"4.19"}]}]},{"title":"Change From Baseline at Day 2 (36 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-24.8","spread":"3.59"}]}]},{"title":"Change From Baseline at Day 3 (48 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-24.3","spread":"4.99"}]}]},{"title":"Change From Baseline at Day 3 (60 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-24.8","spread":"4.19"}]}]},{"title":"Change From Baseline at Day 4 (84 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"-21.3","spread":"6.85"}]}]}]},{"type":"SECONDARY","title":"Clinical Global Impression-Improvement (CGI-I) Score","description":"The CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). CGI-I assessment employs a 7-point Likert scale to measure the improvement in the participant's condition. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions.","populationDescription":"Efficacy population included all participants who began infusion with SAGE-547 injection and who completed at least 12 hours of infusion and had efficacy evaluations through the 12-hour visit.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Day 1 (12 hrs), Day 2 (at 24 and 36 hrs), on Day 3 (at 48 and 60 hrs), and Day 4 (at 84 hrs)","groups":[{"id":"OG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 mcg/kg/hr \\[4 hrs\\], 43 mcg/kg/hr \\[4 hrs\\] and 64.5 mcg/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 mcg/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 mcg/kg/hr \\[49 - 52 hrs\\], 43 mcg/kg/hr \\[53 - 56 hrs\\] and 21.5 mcg/kg/hr \\[57 - 60 hrs\\] on Day 3)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"4"}]}],"classes":[{"title":"Day 1 (12 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"1.8","spread":"0.50"}]}]},{"title":"Day 2 (24 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"0.50"}]}]},{"title":"Day 2 (36 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"0.00"}]}]},{"title":"Day 3 (48 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"0.50"}]}]},{"title":"Day 3 (60 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"1.3","spread":"0.50"}]}]},{"title":"Day 4 (84 hrs)","categories":[{"measurements":[{"groupId":"OG000","value":"1.5","spread":"0.58"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"AEs: Up to Day 11; SAEs: Up to Day 34","description":"Safety population included all participants who began infusion with SAGE-547 injection.","eventGroups":[{"id":"EG000","title":"SAGE-547","description":"Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 micrograms/kg/hr \\[4 hrs\\], 43 micrograms/kg/hr \\[4 hrs\\] and 64.5 micrograms/kg/hr \\[4 hrs\\] on Day 1, followed by 13 to 48 hrs \\[36 hrs\\] maintenance infusion of 86 micrograms/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 micrograms/kg/hr \\[49 - 52 hrs\\], 43 micrograms/kg/hr \\[53 - 56 hrs\\] and 21.5 micrograms/kg/hr \\[57 - 60 hrs\\] on Day 3).","deathsNumAffected":0,"deathsNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"otherNumAffected":4,"otherNumAtRisk":4}],"otherEvents":[{"term":"Infusion Site Discomfort","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4}]},{"term":"Infusion Site Erythema","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4}]},{"term":"Infusion Site Pain","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4}]},{"term":"Blood Thyroid Stimulating Hormone Increased","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (17.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4}]},{"term":"Sedation","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (17.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4}]},{"term":"Oropharyngeal Pain","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (17.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4}]},{"term":"Flushing","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (17.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution)."},"pointOfContact":{"title":"Medical Monitor","organization":"Sage Therapeutics","email":"info@sagerx.com","phone":"(617) 299-8380"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D019052","term":"Depression, Postpartum"}],"ancestors":[{"id":"D011644","term":"Puerperal Disorders"},{"id":"D011248","term":"Pregnancy Complications"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"C000625635","term":"brexanolone"}]}},"hasResults":true}