{"protocolSection":{"identificationModule":{"nctId":"NCT03665038","orgStudyIdInfo":{"id":"547-PPD-304"},"secondaryIdInfos":[{"id":"2017-004356-34","type":"EUDRACT_NUMBER"},{"id":"2017","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2017"}],"organization":{"fullName":"Supernus Pharmaceuticals, Inc.","class":"INDUSTRY"},"briefTitle":"A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)","officialTitle":"A Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression"},"statusModule":{"statusVerifiedDate":"2022-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-09-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-01-08","type":"ACTUAL"},"completionDateStruct":{"date":"2021-01-08","type":"ACTUAL"},"studyFirstSubmitDate":"2018-04-30","studyFirstSubmitQcDate":"2018-09-06","studyFirstPostDateStruct":{"date":"2018-09-11","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-07-15","resultsFirstSubmitQcDate":"2022-07-15","resultsFirstPostDateStruct":{"date":"2022-08-11","type":"ACTUAL"},"dispFirstSubmitDate":"2022-01-07","dispFirstSubmitQcDate":"2022-01-07","dispFirstPostDateStruct":{"date":"2022-01-11","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":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression (PPD)."},"conditionsModule":{"conditions":["Post Partum Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":28,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Brexanolone","type":"EXPERIMENTAL","description":"Participants will receive a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.","interventionNames":["Drug: Brexanolone"]}],"interventions":[{"type":"DRUG","name":"Brexanolone","description":"Administered as IV infusion.","armGroupLabels":["Brexanolone"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is 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":"From first dose of study drug up to end of follow-up period (up to Day 30)"}],"secondaryOutcomes":[{"measure":"Area Under the Concentration-Time Curve (AUC) From Time Zero to 60 Hours (AUC0-60)","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)"},{"measure":"AUC From Time Zero to Infinity (AUCinf)","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)"},{"measure":"Maximum (Peak) Plasma Concentration (Cmax)","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)"},{"measure":"Time at Maximum (Peak) Plasma Concentration (Tmax)","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)"},{"measure":"Steady-State Drug Concentration in the Plasma During Constant-Rate Infusion (Css)","description":"Given that brexanolone is infused to steady-state plasma concentrations, the model-predicted steady-state drug concentration in the plasma during constant-rate infusion value also represents the predicted maximum plasma concentration at the highest infused dose (90 ug/kg/h).","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)"},{"measure":"Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg)","description":"Cavg was evaluated as the time-weighted average plasma concentrations of brexanolone over the interval.","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)"},{"measure":"Half-Life of First Elimination Phase of Brexanolone (Thalf)","description":"Half-life is the time required for half of the drug to be eliminated from the serum.","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)"},{"measure":"Clearance of Brexanolone (CL/F)","description":"Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)"},{"measure":"Steady-State of Volume of Distribution (Vss)","description":"Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)"}]},"eligibilityModule":{"eligibilityCriteria":"Key Inclusion Criteria:\n\n1. Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Axis I Disorders (SCID-5).\n2. Participant is ≤6 months postpartum at screening.\n\nKey Exclusion Criteria:\n\n1. Active psychosis\n2. Attempted suicide during current episode of PPD\n3. Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.\n\nNote: Other protocol-defined inclusion/exclusion criteria may apply.","healthyVolunteers":false,"sex":"FEMALE","genderBased":true,"minimumAge":"15 Years","maximumAge":"17 Years","stdAges":["CHILD"]},"contactsLocationsModule":{"locations":[{"facility":"Sage Investigational Site","city":"Tempe","state":"Arizona","zip":"85226","country":"United States","geoPoint":{"lat":33.41477,"lon":-111.90931}},{"facility":"Sage Investigational Site","city":"North Little Rock","state":"Arkansas","zip":"72758","country":"United States","geoPoint":{"lat":34.76954,"lon":-92.26709}},{"facility":"Sage Investigational Site","city":"Miramar","state":"Florida","zip":"33029","country":"United States","geoPoint":{"lat":25.98731,"lon":-80.23227}},{"facility":"Sage Investigational Site","city":"Orlando","state":"Florida","zip":"32807","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Sage Investigational Site","city":"Pensacola","state":"Florida","zip":"32502","country":"United States","geoPoint":{"lat":30.42131,"lon":-87.21691}},{"facility":"Sage Investigational Site","city":"Pinellas Park","state":"Florida","zip":"33782","country":"United States","geoPoint":{"lat":27.8428,"lon":-82.69954}},{"facility":"Sage Investigational Site","city":"Pompano Beach","state":"Florida","zip":"33060","country":"United States","geoPoint":{"lat":26.23786,"lon":-80.12477}},{"facility":"Sage Investigational Site","city":"Atlanta","state":"Georgia","zip":"30331","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Sage Investigational Site","city":"Decatur","state":"Georgia","zip":"30030","country":"United States","geoPoint":{"lat":33.77483,"lon":-84.29631}},{"facility":"Sage Investigational Site","city":"Edgewood","state":"Kentucky","zip":"41017","country":"United States","geoPoint":{"lat":39.01867,"lon":-84.58189}},{"facility":"Sage Investigational Site","city":"Owensboro","state":"Kentucky","zip":"42303","country":"United States","geoPoint":{"lat":37.77422,"lon":-87.11333}},{"facility":"Sage Investigational Site","city":"Flowood","state":"Mississippi","zip":"39232","country":"United States","geoPoint":{"lat":32.30959,"lon":-90.13898}},{"facility":"Sage Investigational Site","city":"Jackson","state":"Mississippi","zip":"39216","country":"United States","geoPoint":{"lat":32.29876,"lon":-90.18481}},{"facility":"Sage Investigational Site","city":"Chapel Hill","state":"North Carolina","zip":"27599","country":"United States","geoPoint":{"lat":35.9132,"lon":-79.05584}},{"facility":"Sage Investigational Site","city":"Middleburg Heights","state":"Ohio","zip":"44130","country":"United States","geoPoint":{"lat":41.36144,"lon":-81.81291}},{"facility":"Sage Investigational Site","city":"Houston","state":"Texas","zip":"77058","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Sage Investigational Site","city":"League City","state":"Texas","zip":"77573","country":"United States","geoPoint":{"lat":29.50745,"lon":-95.09493}}]},"referencesModule":{"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":"As per Protocol Versions 1 through 3, the study was initiated as a double-blind, placebo-controlled study, in which participants received brexanolone or brexanolone-matching placebo in a blinded manner. As per Protocol Version 4, the study was transitioned to an open-label study, where all participants received brexanolone.","recruitmentDetails":"Participants took part in the study at 8 investigating sites in the United States, from 07 September 2018 to 08 January 2021.","groups":[{"id":"FG000","title":"Double-Blind Phase: Placebo","description":"Participants received a 60-hour single continuous intravenous (IV) infusion of brexanolone-matching placebo, at 30 micrograms per kilogram per hour (mcg/kg/hour) (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study."},{"id":"FG001","title":"Double-Blind Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study."},{"id":"FG002","title":"Open-Label Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"12"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"11"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The safety set included all participants administered study drug.","groups":[{"id":"BG000","title":"Double-Blind Phase: Placebo","description":"Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study."},{"id":"BG001","title":"Double-Blind Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study."},{"id":"BG002","title":"Open-Label Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"28"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16.6","spread":"0.52"},{"groupId":"BG001","value":"16.4","spread":"0.52"},{"groupId":"BG002","value":"16.3","spread":"0.78"},{"groupId":"BG003","value":"16.4","spread":"0.63"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"28"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"26"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","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":"1"},{"groupId":"BG003","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"22"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"5"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs)","description":"An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is 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":"The safety set included all participants administered study drug.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From first dose of study drug up to end of follow-up period (up to Day 30)","groups":[{"id":"OG000","title":"Double-Blind Phase: Placebo","description":"Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study."},{"id":"OG001","title":"Double-Blind Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study."},{"id":"OG002","title":"Open-Label Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"5"}]}]}]},{"type":"SECONDARY","title":"Area Under the Concentration-Time Curve (AUC) From Time Zero to 60 Hours (AUC0-60)","populationDescription":"The pharmacokinetic (PK) set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hours*nanograms per milliliter(hr*ng/mL)","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)","groups":[{"id":"OG000","title":"Double-Blind Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study."},{"id":"OG001","title":"Open-Label Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3694.9","spread":"397.90"},{"groupId":"OG001","value":"3516.0","spread":"562.85"}]}]}]},{"type":"SECONDARY","title":"AUC From Time Zero to Infinity (AUCinf)","populationDescription":"The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hr*ng/mL","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)","groups":[{"id":"OG000","title":"Double-Blind Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study."},{"id":"OG001","title":"Open-Label Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4125.9","spread":"481.84"},{"groupId":"OG001","value":"3982.2","spread":"709.70"}]}]}]},{"type":"SECONDARY","title":"Maximum (Peak) Plasma Concentration (Cmax)","populationDescription":"The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"nanograms per milliliter (ng/mL)","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)","groups":[{"id":"OG000","title":"Double-Blind Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study."},{"id":"OG001","title":"Open-Label Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"85.31","spread":"9.571"},{"groupId":"OG001","value":"81.66","spread":"13.528"}]}]}]},{"type":"SECONDARY","title":"Time at Maximum (Peak) Plasma Concentration (Tmax)","populationDescription":"The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"hour (hr)","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)","groups":[{"id":"OG000","title":"Double-Blind Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study."},{"id":"OG001","title":"Open-Label Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52.20","lowerLimit":"52.0","upperLimit":"52.4"},{"groupId":"OG001","value":"52.30","lowerLimit":"52.1","upperLimit":"54.9"}]}]}]},{"type":"SECONDARY","title":"Steady-State Drug Concentration in the Plasma During Constant-Rate Infusion (Css)","description":"Given that brexanolone is infused to steady-state plasma concentrations, the model-predicted steady-state drug concentration in the plasma during constant-rate infusion value also represents the predicted maximum plasma concentration at the highest infused dose (90 ug/kg/h).","populationDescription":"The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"ng/mL","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)","groups":[{"id":"OG000","title":"Double-Blind Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study."},{"id":"OG001","title":"Open-Label Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"79.4"},{"groupId":"OG001","value":"79.4"}]}]}]},{"type":"SECONDARY","title":"Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg)","description":"Cavg was evaluated as the time-weighted average plasma concentrations of brexanolone over the interval.","populationDescription":"The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mL","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of 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study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61.59","spread":"6.639"},{"groupId":"OG001","value":"58.60","spread":"9.386"}]}]}]},{"type":"SECONDARY","title":"Half-Life of First Elimination Phase of Brexanolone (Thalf)","description":"Half-life is the time required for half of the drug to be eliminated from the serum.","populationDescription":"The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hour","timeFrame":"Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)","groups":[{"id":"OG000","title":"Double-Blind Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study."},{"id":"OG001","title":"Open-Label Phase: Brexanolone","description":"Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.24","spread":"0.466"},{"groupId":"OG001","value":"12.55","spread":"1.096"}]}]}]},{"type":"SECONDARY","title":"Clearance of 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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":"medinfo@sagerx.com","phone":"(617) 299-8380"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2019-12-20","uploadDate":"2022-07-15T09:49","filename":"Prot_000.pdf","size":2872208},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis 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