{"protocolSection":{"identificationModule":{"nctId":"NCT02614547","orgStudyIdInfo":{"id":"547-PPD-202 A"},"organization":{"fullName":"Supernus Pharmaceuticals, Inc.","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression","officialTitle":"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating The Efficacy, Safety, And Pharmacokinetics Of SAGE-547 Injection In The Treatment Of Adult Female Subjects With Severe Postpartum Depression"},"statusModule":{"statusVerifiedDate":"2022-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-12-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2016-06-22","type":"ACTUAL"},"completionDateStruct":{"date":"2016-06-22","type":"ACTUAL"},"studyFirstSubmitDate":"2015-11-02","studyFirstSubmitQcDate":"2015-11-23","studyFirstPostDateStruct":{"date":"2015-11-25","type":"ESTIMATED"},"resultsFirstSubmitDate":"2021-08-05","resultsFirstSubmitQcDate":"2021-09-10","resultsFirstPostDateStruct":{"date":"2021-09-13","type":"ACTUAL"},"dispFirstSubmitDate":"2017-08-04","dispFirstSubmitQcDate":"2017-08-04","dispFirstPostDateStruct":{"date":"2017-08-08","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 a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression."},"conditionsModule":{"conditions":["Severe Postpartum Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":21,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received infusion rates of placebo matched to SAGE-547.","interventionNames":["Drug: Placebo"]},{"label":"SAGE-547","type":"EXPERIMENTAL","description":"Participants received a 4-hour dose titration of 30 micrograms per kilogram per hour (micrograms/kg/hr) (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).","interventionNames":["Drug: SAGE-547"]}],"interventions":[{"type":"DRUG","name":"SAGE-547","description":"Administered as intravenous infusion.","armGroupLabels":["SAGE-547"]},{"type":"DRUG","name":"Placebo","description":"Administered as intravenous infusion.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline at End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total Score","description":"The HAM-D total score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, 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, 60 Hours"}],"secondaryOutcomes":[{"measure":"Percentage of Participants With HAM-D Response","description":"The HAM-D response was defined as having a 50 percent (%) or greater reduction from baseline in HAM-D total score. The HAM-D total score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, 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":"60 Hours, Days 7 and 30"},{"measure":"Percentage of Participants With HAM-D Remission","description":"The HAM-D remission was defined as having a HAM-D total score of less than or equal to (\\<=)7. The HAM-D total score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, 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":"60 Hours, Days 7, and 30"},{"measure":"Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score","description":"The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicate more severe depression. A negative change from baseline indicate less severe depression. A positive change from baseline indicates more severe depression.","timeFrame":"Baseline, 60 Hours, Days 7 and 30"},{"measure":"Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Response","description":"The CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. 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, and by definition, was evaluated against baseline conditions. CGI-I response was defined as having a CGI-I score of \"very much improved\" or \"much improved\".","timeFrame":"60 Hours, Days 7 and 30"},{"measure":"Change From Baseline in HAM-D Bech 6 Subscale","description":"The HAM-D Bech 6 subscale score was calculated as the sum of the following six items: depressed mood, feelings of guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores were transformed to a scale of 0 to 100, with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.","timeFrame":"Baseline, 60 Hours, Days 7 and 30"},{"measure":"Change From Baseline to 60 Hours in the HAM-D Individual Item Scores","description":"The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms 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. 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, 60 Hours"},{"measure":"Change From Baseline in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score","description":"The GAD-7 is a participant-rated, generalized anxiety symptom severity scale. Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = \"not at all sure,\" 1 = \"several days,\" 2 = \"over half the days,\" and 3 = \"nearly every day\" to the response categories. The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety. The GAD-7 total score was calculated as the sum of the seven individual item scores. A negative change from baseline indicates less anxiety. A positive change from baseline indicates more anxiety.","timeFrame":"Baseline, 60 Hours, Day 7 and 30"},{"measure":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.","timeFrame":"Up to 30 days"}]},"eligibilityModule":{"eligibilityCriteria":"Key Inclusion Criteria:\n\n* Participant either must have ceased lactating at Screening; or if still lactating at Screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at Screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug.\n* Participant had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).\n* Participant was less than or equal to (\\<=) six months postpartum.\n* Participant must be amenable to intravenous therapy.\n\nKey Exclusion Criteria:\n\n* Active psychosis.\n* Attempted suicide associated with index case of postpartum depression.\n* Medical history of seizures.\n* Medical history of bipolar disorder.\n\nNote: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion criteria may apply.","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":"Atlanta","state":"Georgia","zip":"30342","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Sage Investigational Site","city":"Worcester","state":"Massachusetts","zip":"01655","country":"United States","geoPoint":{"lat":42.26259,"lon":-71.80229}},{"facility":"Sage Investigational Site","city":"Chapel Hill","state":"North Carolina","zip":"27514","country":"United States","geoPoint":{"lat":35.9132,"lon":-79.05584}},{"facility":"Sage Investigational Site","city":"Philadelphia","state":"Pennsylvania","zip":"19104","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}}]},"referencesModule":{"references":[{"pmid":"33181049","type":"DERIVED","citation":"Gerbasi ME, Meltzer-Brody S, Acaster S, Fridman M, Bonthapally V, Hodgkins P, Kanes SJ, Eldar-Lissai A. Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making. J Womens Health (Larchmt). 2021 Mar;30(3):385-392. doi: 10.1089/jwh.2020.8483. Epub 2020 Nov 12."},{"pmid":"28619476","type":"DERIVED","citation":"Kanes S, Colquhoun H, Gunduz-Bruce H, Raines S, Arnold R, Schacterle A, Doherty J, Epperson CN, Deligiannidis KM, Riesenberg R, Hoffmann E, Rubinow D, Jonas J, Paul S, Meltzer-Brody S. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial. Lancet. 2017 Jul 29;390(10093):480-489. doi: 10.1016/S0140-6736(17)31264-3. Epub 2017 Jun 12."}],"seeAlsoLinks":[{"label":"Related Info","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 21 participants were randomized into the study to receive either placebo or SAGE-547.","recruitmentDetails":"Participants took part in the study at 4 centers in the United States from 15 December 2015 to 22 June 2016.","groups":[{"id":"FG000","title":"Placebo","description":"Participants received infusion rates of placebo matched to SAGE-547."},{"id":"FG001","title":"SAGE-547","description":"Participants received a 4-hour dose titration period of 30 micrograms per kilogram per hour (micrograms/kg/hr) (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized population included the subset of participants from all enrolled population who were randomized.","groups":[{"id":"BG000","title":"Placebo","description":"Participants received infusion rates of placebo matched to SAGE-547."},{"id":"BG001","title":"SAGE-547","description":"Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours)."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"21"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28.8","spread":"4.58"},{"groupId":"BG001","value":"27.4","spread":"5.34"},{"groupId":"BG002","value":"28.1","spread":"4.88"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"21"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","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"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"13"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline at End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total Score","description":"The HAM-D total score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, 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":"Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, 60 Hours","groups":[{"id":"OG000","title":"Placebo","description":"Participants received infusion rates of placebo matched to SAGE-547."},{"id":"OG001","title":"SAGE-547","description":"Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.75","spread":"2.800"},{"groupId":"OG001","value":"-20.97","spread":"2.938"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Mixed Effects Model for Repeated Measure (MMRM) used an unstructured covariance model time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.","nonInferiorityType":"SUPERIORITY","pValue":"0.008","statisticalMethod":"MMRM","paramType":"Least Squares Mean Difference","paramValue":"-12.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-20.77","ciUpperLimit":"-3.67","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"4.081"}]},{"type":"SECONDARY","title":"Percentage of Participants With HAM-D Response","description":"The HAM-D response was defined as having a 50 percent (%) or greater reduction from baseline in HAM-D total score. The HAM-D total score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, 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":"Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"60 Hours, Days 7 and 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received infusion rates of placebo matched to SAGE-547."},{"id":"OG001","title":"SAGE-547","description":"Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"title":"60 Hours","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"36.4"},{"groupId":"OG001","value":"70.0"}]}]},{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20.0"},{"groupId":"OG001","value":"80.0"}]}]},{"title":"Day 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"27.3"},{"groupId":"OG001","value":"70.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"60 Hours","nonInferiorityType":"SUPERIORITY","pValue":"0.198","statisticalMethod":"Fisher Exact","paramType":"Odds Ratio (OR)","paramValue":"4.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.49","ciUpperLimit":"37.67"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 7","nonInferiorityType":"SUPERIORITY","pValue":"0.023","statisticalMethod":"Fisher Exact","paramType":"Odds Ratio (OR)","paramValue":"16.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.31","ciUpperLimit":"239.57"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 30","nonInferiorityType":"SUPERIORITY","pValue":"0.086","statisticalMethod":"Fisher Exact","paramType":"Odds Ratio (OR)","paramValue":"6.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.70","ciUpperLimit":"62.08"}]},{"type":"SECONDARY","title":"Percentage of Participants With HAM-D Remission","description":"The HAM-D remission was defined as having a HAM-D total score of less than or equal to (\\<=)7. The HAM-D total score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, 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":"Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed'' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"60 Hours, Days 7, and 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received infusion rates of placebo matched to SAGE-547."},{"id":"OG001","title":"SAGE-547","description":"Participants received a 4-hour dose titration period of 30 (micrograms/kg/hr) (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"title":"60 Hours","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"9.1"},{"groupId":"OG001","value":"70.0"}]}]},{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"70.0"}]}]},{"title":"Day 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"18.2"},{"groupId":"OG001","value":"70.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"60 Hours","nonInferiorityType":"SUPERIORITY","pValue":"0.008","statisticalMethod":"Fisher Exact","paramType":"Odds Ratio (OR)","paramValue":"23.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.56","ciUpperLimit":"1152.71"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 7","nonInferiorityType":"SUPERIORITY","pValue":"0.003","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 30","nonInferiorityType":"SUPERIORITY","pValue":"0.030","statisticalMethod":"Fisher Exact","paramType":"Odds Ratio (OR)","paramValue":"10.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.01","ciUpperLimit":"140.57"}]},{"type":"SECONDARY","title":"Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score","description":"The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicate more severe depression. A negative change from baseline indicate less severe depression. A positive change from baseline indicates more severe depression.","populationDescription":"Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed'' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, 60 Hours, Days 7 and 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received infusion rates of placebo matched to SAGE-547."},{"id":"OG001","title":"SAGE-547","description":"Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"title":"Hour 60","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-12.10","spread":"3.817"},{"groupId":"OG001","value":"-27.96","spread":"4.001"}]}]},{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-11.60","spread":"3.766"},{"groupId":"OG001","value":"-27.56","spread":"3.929"}]}]},{"title":"Day 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-11.19","spread":"3.594"},{"groupId":"OG001","value":"-26.26","spread":"3.767"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"60 Hours: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment","nonInferiorityType":"SUPERIORITY","pValue":"0.010","statisticalMethod":"MMRM","paramType":"Least Squares Mean Difference","paramValue":"-15.86","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-27.50","ciUpperLimit":"-4.22","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.536"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 7: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment","nonInferiorityType":"SUPERIORITY","pValue":"0.009","statisticalMethod":"MMRM","paramType":"Least Square Mean Difference","paramValue":"-15.96","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-27.43","ciUpperLimit":"-4.50","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.448"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 30: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment","nonInferiorityType":"SUPERIORITY","pValue":"0.010","statisticalMethod":"MMRM","paramType":"Least Square Mean Difference","paramValue":"-15.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-26.05","ciUpperLimit":"-4.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"5.213"}]},{"type":"SECONDARY","title":"Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Response","description":"The CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. 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, and by definition, was evaluated against baseline conditions. CGI-I response was defined as having a CGI-I score of \"very much improved\" or \"much improved\".","populationDescription":"Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed'' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"60 Hours, Days 7 and 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received infusion rates of matching placebo identical to SAGE-547."},{"id":"OG001","title":"SAGE-547","description":"Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"title":"Hour 60","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"36.4"},{"groupId":"OG001","value":"80.0"}]}]},{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"20.0"},{"groupId":"OG001","value":"80.0"}]}]},{"title":"Day 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"27.3"},{"groupId":"OG001","value":"80.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"60 Hours","nonInferiorityType":"SUPERIORITY","pValue":"0.080","statisticalMethod":"Fisher Exact","paramType":"Odds Ratio (OR)","paramValue":"7.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.73","ciUpperLimit":"90.81"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 7","nonInferiorityType":"SUPERIORITY","pValue":"0.023","statisticalMethod":"Fisher Exact","paramType":"Odds Ratio (OR)","paramValue":"16.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.31","ciUpperLimit":"239.57"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 30","nonInferiorityType":"SUPERIORITY","pValue":"0.030","statisticalMethod":"Fisher Exact","paramType":"Odds Ratio (OR)","paramValue":"10.67","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.04","ciUpperLimit":"142.20"}]},{"type":"SECONDARY","title":"Change From Baseline in HAM-D Bech 6 Subscale","description":"The HAM-D Bech 6 subscale score was calculated as the sum of the following six items: depressed mood, feelings of guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores were transformed to a scale of 0 to 100, with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.","populationDescription":"Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, 60 Hours, Days 7 and 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received infusion rates of placebo matched to SAGE-547."},{"id":"OG001","title":"SAGE-547","description":"Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"title":"60 Hours","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.89","spread":"1.701"},{"groupId":"OG001","value":"-10.94","spread":"1.784"}]}]},{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.99","spread":"1.676"},{"groupId":"OG001","value":"-10.44","spread":"1.754"}]}]},{"title":"Day 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.34","spread":"1.772"},{"groupId":"OG001","value":"-10.14","spread":"1.858"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"60 Hours: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.","nonInferiorityType":"SUPERIORITY","pValue":"0.025","statisticalMethod":"MMRM","paramType":"Least Squares Mean Difference","paramValue":"-6.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.24","ciUpperLimit":"-0.86","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.466"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 7: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.","nonInferiorityType":"SUPERIORITY","pValue":"0.016","statisticalMethod":"MMRM","paramType":"Least Squares Mean Difference","paramValue":"-6.46","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.57","ciUpperLimit":"-1.34","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.427"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 30: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.","nonInferiorityType":"SUPERIORITY","pValue":"0.018","statisticalMethod":"MMRM","paramType":"Least Squares Mean Difference","paramValue":"-6.80","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-12.25","ciUpperLimit":"-1.35","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.568"}]},{"type":"SECONDARY","title":"Change From Baseline to 60 Hours in the HAM-D Individual Item Scores","description":"The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms 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. 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":"Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline, 60 Hours","groups":[{"id":"OG000","title":"Placebo","description":"Participants received infusion rates of placebo matched to SAGE-547."},{"id":"OG001","title":"SAGE-547","description":"Participants received a 4-hour dose titration period of 30 micrograms per kilogram per hour (micrograms/kg/hr) (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"title":"Depressed Mood, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"1.57"},{"groupId":"OG001","value":"-2.5","spread":"1.58"}]}]},{"title":"Feeling of Guilt ,Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.69"},{"groupId":"OG001","value":"-1.7","spread":"0.95"}]}]},{"title":"Suicide, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.67"},{"groupId":"OG001","value":"-1.1","spread":"0.88"}]}]},{"title":"Insomnia - Early, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.69"},{"groupId":"OG001","value":"-1.6","spread":"0.70"}]}]},{"title":"Insomnia -Middle, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.69"},{"groupId":"OG001","value":"-1.6","spread":"0.52"}]}]},{"title":"Insomnia - Late, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.50"},{"groupId":"OG001","value":"-1.1","spread":"0.74"}]}]},{"title":"Work and Activities, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-1.4","spread":"1.36"},{"groupId":"OG001","value":"-2.4","spread":"1.35"}]}]},{"title":"Retardation, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.5","spread":"0.69"},{"groupId":"OG001","value":"-0.8","spread":"0.79"}]}]},{"title":"Agitation, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"0.65"},{"groupId":"OG001","value":"-0.3","spread":"0.67"}]}]},{"title":"Anxiety-Psychic, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.9","spread":"1.30"},{"groupId":"OG001","value":"-1.9","spread":"1.29"}]}]},{"title":"Anxiety-Somatic, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"1.10"},{"groupId":"OG001","value":"-1.9","spread":"1.66"}]}]},{"title":"Gastrointestinal, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.81"},{"groupId":"OG001","value":"-0.7","spread":"0.95"}]}]},{"title":"Somatic General, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.67"},{"groupId":"OG001","value":"-1.5","spread":"0.85"}]}]},{"title":"Genital Symptoms, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.2","spread":"0.60"},{"groupId":"OG001","value":"-0.8","spread":"0.79"}]}]},{"title":"Hypochondriasis, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.3","spread":"1.19"},{"groupId":"OG001","value":"-0.5","spread":"0.71"}]}]},{"title":"Loss of Weight, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.67"},{"groupId":"OG001","value":"-0.2","spread":"0.67"}]}]},{"title":"Insight, Change From Baseline to 60 Hours","categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.00"},{"groupId":"OG001","value":"0.0","spread":"0.00"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score","description":"The GAD-7 is a participant-rated, generalized anxiety symptom severity scale. Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = \"not at all sure,\" 1 = \"several days,\" 2 = \"over half the days,\" and 3 = \"nearly every day\" to the response categories. The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety. The GAD-7 total score was calculated as the sum of the seven individual item scores. A negative change from baseline indicates less anxiety. A positive change from baseline indicates more anxiety.","populationDescription":"Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, 60 Hours, Day 7 and 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received infusion rates of matching placebo identical to SAGE-547."},{"id":"OG001","title":"SAGE-547","description":"Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"title":"60 Hours","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-9.08","spread":"1.673"},{"groupId":"OG001","value":"-7.21","spread":"1.757"}]}]},{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-7.96","spread":"1.986"},{"groupId":"OG001","value":"-9.44","spread":"1.986"}]}]},{"title":"Day 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-7.38","spread":"1.951"},{"groupId":"OG001","value":"-9.48","spread":"2.050"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"60 Hours","nonInferiorityType":"SUPERIORITY","pValue":"0.457","statisticalMethod":"ANCOVA","paramType":"Least Squares Mean Difference","paramValue":"1.87","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.30","ciUpperLimit":"7.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.461"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 7","nonInferiorityType":"SUPERIORITY","pValue":"0.613","statisticalMethod":"ANCOVA","paramType":"Least Square Mean","paramValue":"-1.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.50","ciUpperLimit":"4.55","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"-1.47"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 30","nonInferiorityType":"SUPERIORITY","pValue":"0.474","statisticalMethod":"ANCOVA","paramType":"Least Square Mean","paramValue":"-2.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.13","ciUpperLimit":"3.93","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.871"}]},{"type":"SECONDARY","title":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.","populationDescription":"Safety population included all randomized participants who started the study drug infusion.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Up to 30 days","groups":[{"id":"OG000","title":"Placebo","description":"Participants received infusion rates of placebo matched to SAGE-547."},{"id":"OG001","title":"SAGE-547","description":"Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 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Pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Dry Mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (18.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10}]},{"term":"Infusion Site Extravasation","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Infusion Site Pain","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Localised Odema","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Pyrexia","organSystem":"General disorders","sourceVocabulary":"MedDRA (18.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10}]},{"term":"Skin Abrasion","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (18.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Pain In Extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (18.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":10}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (18.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10}]},{"term":"Hot Flush","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (18.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":10}]}]},"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) 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