{"protocolSection":{"identificationModule":{"nctId":"NCT02942017","orgStudyIdInfo":{"id":"547-PPD-202 C"},"organization":{"fullName":"Supernus Pharmaceuticals, Inc.","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)","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 and Adult Female Subjects With Moderate Postpartum Depression"},"statusModule":{"statusVerifiedDate":"2022-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-07"},"primaryCompletionDateStruct":{"date":"2017-09-17","type":"ACTUAL"},"completionDateStruct":{"date":"2017-10-11","type":"ACTUAL"},"studyFirstSubmitDate":"2016-10-20","studyFirstSubmitQcDate":"2016-10-20","studyFirstPostDateStruct":{"date":"2016-10-21","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-04-11","resultsFirstSubmitQcDate":"2019-05-22","resultsFirstPostDateStruct":{"date":"2019-06-13","type":"ACTUAL"},"dispFirstSubmitDate":"2018-09-06","dispFirstSubmitQcDate":"2018-09-06","dispFirstPostDateStruct":{"date":"2018-09-10","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,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score."},"conditionsModule":{"conditions":["Postpartum Depression"],"keywords":["Moderate Postpartum Depression","SAGE-547"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":108,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received an infusion rate equivalent to the 90 micrograms per kilogram per hour (μg/kg/h) group.","interventionNames":["Drug: Placebo"]},{"label":"SAGE-547 90 μg/kg/h","type":"EXPERIMENTAL","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).","interventionNames":["Drug: SAGE-547 90 μg/kg/h"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"Intravenous infusion of matching placebo for SAGE-547.","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"SAGE-547 90 μg/kg/h","description":"Intravenous infusion of SAGE-547","armGroupLabels":["SAGE-547 90 μg/kg/h"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline at 60 Hours in 17-Item 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. 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, Hour 60"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HAM-D Total Score at Day 30","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. 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 30"},{"measure":"Change From Baseline in 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. 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, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14 and 21"},{"measure":"Percentage of Participants With HAM-D Response","description":"The HAM-D response is defined as having a 50% 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. 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":"Hour 60, Days 7 and 30"},{"measure":"Percentage of Participants With HAM-D Remission","description":"HAM-D remission is defined as having a HAM-D total score of ≤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. 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":"Hour 60, Days 7 and 30"},{"measure":"Change From Baseline in HAM-D Bech 6 Subscale","description":"The HAM-D Bech 6 subscale score is calculated as the sum of the following six items: Item # 1 (depressed mood), Item # 2 (feelings of guilt), Item # 7 (work and activities), Item # 8 (retardation), Item # 10 (anxiety psychic), and Item # 13 (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 100-point scale 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, Hour 60, Days 7 and 30"},{"measure":"Change From Baseline in 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, Hours 2, 4, 8, 12, 24, 36, 48, 60, 72, and Days 7, 14, 21, and 30"},{"measure":"Change From Baseline at Key Time Points in Montgomery-Åsberg 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 indicates more severe depression. A negative change from baseline indicates less severe depression. A positive change from baseline indicates more severe depression.","timeFrame":"Baseline, Hour 60, Days 7 and 30"},{"measure":"Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response","description":"The CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). 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. By definition, all CGI-I assessments were evaluated against baseline conditions.","timeFrame":"Hour 60, Days 7 and 30"},{"measure":"Change From Baseline in the 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, Hour 60, Days 7, 14, 21 and 30"},{"measure":"Percentage of Participants With Treatment Emergent Adverse Event (TEAE)","description":"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (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 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":"Up to approximately 37 days"},{"measure":"Time to Change in Antidepressant Medication","description":"The time to first start or increase in the dose and time to first stop or decrease in the dose of any antidepressant medication.","timeFrame":"Up to approximately 37 days"}]},"eligibilityModule":{"eligibilityCriteria":"Key Inclusion Criteria:\n\n* Participant either must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s).\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 had a HAM-D total score of ≥20 and ≤25 at screening and Day 1 (prior to dosing).\n* Participant was ≤ six months postpartum.\n* Participant was 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 bipolar disorder.\n\nNote: Other protocol-defined inclusion/exclusion criteria applied.","healthyVolunteers":false,"sex":"FEMALE","genderBased":true,"genderDescription":"Female participants between 18 and 45 years of age with PPD, defined as those who had a major depressive episode that began no earlier than the third trimester and no later than the first four weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM), 4th Edition Axis I Disorders (SCID-I), a HAM-D total score of ≥20 and ≤25 at screening and Day 1 (prior to dosing), and who were ≤6 months postpartum at screening were eligible for enrollment.","minimumAge":"18 Years","maximumAge":"45 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Helen Colquhoun, MD","affiliation":"Sage Therapeutics","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Sage Investigational Site","city":"Chandler","state":"Arizona","zip":"85226","country":"United States","geoPoint":{"lat":33.30616,"lon":-111.84125}},{"facility":"Sage Investigational Site","city":"Rogers","state":"Arkansas","zip":"72758","country":"United States","geoPoint":{"lat":36.33202,"lon":-94.11854}},{"facility":"Sage Investigational Site","city":"Lemon Grove","state":"California","zip":"91945","country":"United States","geoPoint":{"lat":32.74255,"lon":-117.03142}},{"facility":"Sage Investigational Site","city":"Orange","state":"California","zip":"92868","country":"United States","geoPoint":{"lat":33.78779,"lon":-117.85311}},{"facility":"Sage Investigational Site","city":"Ventura","state":"California","zip":"93003","country":"United 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States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Sage Investigational Site","city":"Richardson","state":"Texas","zip":"75080","country":"United States","geoPoint":{"lat":32.94818,"lon":-96.72972}},{"facility":"Sage Investigational Site","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Sage Investigational Site","city":"Orem","state":"Utah","zip":"84058","country":"United States","geoPoint":{"lat":40.2969,"lon":-111.69465}}]},"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":"30177236","type":"DERIVED","citation":"Meltzer-Brody S, Colquhoun H, Riesenberg R, Epperson CN, Deligiannidis KM, Rubinow DR, Li H, Sankoh AJ, Clemson C, Schacterle A, Jonas J, Kanes S. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet. 2018 Sep 22;392(10152):1058-1070. doi: 10.1016/S0140-6736(18)31551-4. Epub 2018 Aug 31."}],"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 108 participants were randomized into the study to receive either placebo or SAGE-547, 104 of whom received the study drug.","recruitmentDetails":"Participants took part in the study at 32 centers in United States from 25 July 2016 to 11 October 2017.","groups":[{"id":"FG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 micrograms per kilogram per hour (μg/kg/h) group."},{"id":"FG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"54"},{"groupId":"FG001","numSubjects":"54"}]},{"type":"Treated","achievements":[{"groupId":"FG000","numSubjects":"53"},{"groupId":"FG001","numSubjects":"51"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"48"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"6"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Randomized but not dosed","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Participants who received the study drug.","groups":[{"id":"BG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group."},{"id":"BG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"53"},{"groupId":"BG001","value":"51"},{"groupId":"BG002","value":"104"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"27.3","spread":"5.90"},{"groupId":"BG001","value":"28.2","spread":"6.09"},{"groupId":"BG002","value":"27.8","spread":"5.98"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"53"},{"groupId":"BG001","value":"51"},{"groupId":"BG002","value":"104"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"41"}]}]},{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"62"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Hispanic or Latina","categories":[{"measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"24"}]}]},{"title":"Not Hispanic or Latina","categories":[{"measurements":[{"groupId":"BG000","value":"39"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"80"}]}]}]},{"title":"Hamilton Rating Scale for Depression (HAMD) 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.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"score on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22.7","spread":"1.59"},{"groupId":"BG001","value":"22.6","spread":"1.56"},{"groupId":"BG002","value":"22.7","spread":"1.57"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline at 60 Hours in 17-Item 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. 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":"All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Hour 60","groups":[{"id":"OG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group."},{"id":"OG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.12","spread":"0.773"},{"groupId":"OG001","value":"-14.62","spread":"0.782"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0160","statisticalMethod":"MMRM","paramType":"Least Square (LS) Mean Difference","paramValue":"-2.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.52","ciUpperLimit":"-0.48","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.019"}]},{"type":"SECONDARY","title":"Change From Baseline in HAM-D Total Score at Day 30","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. 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":"All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Day 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group."},{"id":"OG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.23","spread":"0.934"},{"groupId":"OG001","value":"-14.69","spread":"0.955"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6710","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.54","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.98","ciUpperLimit":"3.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.271"}]},{"type":"SECONDARY","title":"Change From Baseline in 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. 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":"All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14 and 21","groups":[{"id":"OG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group."},{"id":"OG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Change at Hour 2","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.00","spread":"0.598"},{"groupId":"OG001","value":"-4.60","spread":"0.595"}]}]},{"title":"Change at Hour 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-6.55","spread":"0.701"},{"groupId":"OG001","value":"-7.32","spread":"0.702"}]}]},{"title":"Change at Hour 8","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-7.44","spread":"0.738"},{"groupId":"OG001","value":"-8.38","spread":"0.740"}]}]},{"title":"Change at Hour 12","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"50"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-7.96","spread":"0.758"},{"groupId":"OG001","value":"-9.10","spread":"0.762"}]}]},{"title":"Change at Hour 24","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"50"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-9.81","spread":"0.820"},{"groupId":"OG001","value":"-11.42","spread":"0.827"}]}]},{"title":"Change at Hour 36","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"49"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-10.45","spread":"0.833"},{"groupId":"OG001","value":"-12.31","spread":"0.843"}]}]},{"title":"Change at Hour 48","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"49"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-10.59","spread":"0.860"},{"groupId":"OG001","value":"-13.00","spread":"0.873"}]}]},{"title":"Change at Hour 72","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"49"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-11.83","spread":"0.829"},{"groupId":"OG001","value":"-15.31","spread":"0.841"}]}]},{"title":"Change at Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"50"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-10.74","spread":"1.042"},{"groupId":"OG001","value":"-13.98","spread":"1.061"}]}]},{"title":"Change at Day 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"31"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-11.40","spread":"0.989"},{"groupId":"OG001","value":"-13.43","spread":"1.013"}]}]},{"title":"Change at Day 21","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"32"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-13.26","spread":"1.022"},{"groupId":"OG001","value":"-13.59","spread":"1.041"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4216","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.60","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.06","ciUpperLimit":"0.87","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.738"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3947","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.57","ciUpperLimit":"1.02","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.905"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3280","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.95","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.86","ciUpperLimit":"0.96","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.962"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2522","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-1.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.12","ciUpperLimit":"0.83","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.994"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1431","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-1.61","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.78","ciUpperLimit":"0.55","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.091"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0991","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-1.85","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.06","ciUpperLimit":"0.36","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.113"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0389","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-2.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.71","ciUpperLimit":"-0.13","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.155"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0022","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-3.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.67","ciUpperLimit":"-1.28","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.108"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0255","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-3.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.08","ciUpperLimit":"-0.40","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.429"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1375","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-2.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.73","ciUpperLimit":"0.66","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.356"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8170","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.11","ciUpperLimit":"2.46","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.400"}]},{"type":"SECONDARY","title":"Percentage of Participants With HAM-D Response","description":"The HAM-D response is defined as having a 50% 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. 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":"All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Hour 60, Days 7 and 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group."},{"id":"OG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Hour 60","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"49"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"59.6"},{"groupId":"OG001","value":"75.5"}]}]},{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"50"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"50.9"},{"groupId":"OG001","value":"66.0"}]}]},{"title":"Day 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"78.8"},{"groupId":"OG001","value":"70.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.","nonInferiorityType":"SUPERIORITY","pValue":"0.0168","statisticalMethod":"GEE method","paramType":"Odds Ratio (OR)","paramValue":"2.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.2","ciUpperLimit":"6.7"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.","nonInferiorityType":"SUPERIORITY","pValue":"0.0482","statisticalMethod":"GEE method","paramType":"Odds Ratio (OR)","paramValue":"2.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.0","ciUpperLimit":"6.6"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.","nonInferiorityType":"SUPERIORITY","pValue":"0.5857","statisticalMethod":"GEE method","paramType":"Odds Ratio (OR)","paramValue":"0.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.3","ciUpperLimit":"2.0"}]},{"type":"SECONDARY","title":"Percentage of Participants With HAM-D Remission","description":"HAM-D remission is defined as having a HAM-D total score of ≤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. 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":"All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Hour 60, Days 7 and 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group."},{"id":"OG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Hour 60","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"49"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"38.5"},{"groupId":"OG001","value":"61.2"}]}]},{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"50"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"32.1"},{"groupId":"OG001","value":"56.0"}]}]},{"title":"Day 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"61.5"},{"groupId":"OG001","value":"47.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Hour 60: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.","nonInferiorityType":"SUPERIORITY","pValue":"0.0033","pValueComment":"Hour 60:","statisticalMethod":"GEE method","paramType":"Odds Ratio (OR)","paramValue":"3.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.5","ciUpperLimit":"7.9"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 7: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.","nonInferiorityType":"SUPERIORITY","pValue":"0.0046","statisticalMethod":"GEE method","paramType":"Odds Ratio (OR)","paramValue":"3.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.5","ciUpperLimit":"9.3"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 30: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.","nonInferiorityType":"SUPERIORITY","pValue":"0.3085","statisticalMethod":"GEE method","paramType":"Odds Ratio (OR)","paramValue":"0.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.3","ciUpperLimit":"1.5"}]},{"type":"SECONDARY","title":"Change From Baseline in HAM-D Bech 6 Subscale","description":"The HAM-D Bech 6 subscale score is calculated as the sum of the following six items: Item # 1 (depressed mood), Item # 2 (feelings of guilt), Item # 7 (work and activities), Item # 8 (retardation), Item # 10 (anxiety psychic), and Item # 13 (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 100-point scale 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":"All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Hour 60, Days 7 and 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group."},{"id":"OG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Change at Hour 60","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"49"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-29.23","spread":"2.248"},{"groupId":"OG001","value":"-37.59","spread":"2.276"}]}]},{"title":"Change at Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"50"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-25.05","spread":"2.624"},{"groupId":"OG001","value":"-34.80","spread":"2.668"}]}]},{"title":"Change at Day 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-36.24","spread":"2.345"},{"groupId":"OG001","value":"-34.86","spread":"2.390"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0063","statisticalMethod":"MMRM","paramType":"LS mean difference","paramValue":"-8.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-14.29","ciUpperLimit":"-2.42","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.989"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0074","statisticalMethod":"MMRM","paramType":"LS mean difference","paramValue":"-9.75","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-16.83","ciUpperLimit":"-2.68","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.566"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. 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All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0844","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.71","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.191"},{"groupIds":["OG000","OG001"],"groupDescription":"Depressed Mood, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1325","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.68","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.193"},{"groupIds":["OG000","OG001"],"groupDescription":"Depressed Mood, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0332","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.41","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.79","ciUpperLimit":"-0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.192"},{"groupIds":["OG000","OG001"],"groupDescription":"Depressed Mood, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1273","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.67","ciUpperLimit":"0.08","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.189"},{"groupIds":["OG000","OG001"],"groupDescription":"Depressed Mood, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1059","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.66","ciUpperLimit":"0.06","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.182"},{"groupIds":["OG000","OG001"],"groupDescription":"Depressed Mood, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0683","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.82","ciUpperLimit":"0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.215"},{"groupIds":["OG000","OG001"],"groupDescription":"Depressed Mood, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4458","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.64","ciUpperLimit":"0.28","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.232"},{"groupIds":["OG000","OG001"],"groupDescription":"Depressed Mood, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2905","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.21","ciUpperLimit":"0.70","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.228"},{"groupIds":["OG000","OG001"],"groupDescription":"Depressed Mood, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3096","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.18","ciUpperLimit":"0.55","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.182"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1925","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.55","ciUpperLimit":"0.11","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.165"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0101","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.77","ciUpperLimit":"-0.11","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.168"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1546","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.56","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.163"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0901","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.62","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.168"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0717","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.62","ciUpperLimit":"0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.162"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0468","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.34","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.68","ciUpperLimit":"0.00","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.169"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2222","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.56","ciUpperLimit":"0.13","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.173"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0682","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.60","ciUpperLimit":"0.02","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.156"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0147","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.72","ciUpperLimit":"-0.08","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.160"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Day 7:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0837","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.68","ciUpperLimit":"0.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.182"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5828","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.46","ciUpperLimit":"0.26","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.179"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5674","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.43","ciUpperLimit":"0.24","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.168"},{"groupIds":["OG000","OG001"],"groupDescription":"Feeling of Guilt, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4613","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.18","ciUpperLimit":"0.40","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.145"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Hour 2:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3240","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.24","ciUpperLimit":"0.08","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.082"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3023","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.24","ciUpperLimit":"0.08","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.082"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4127","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.23","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.082"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2819","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.25","ciUpperLimit":"0.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.082"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3884","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.23","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.082"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2750","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.25","ciUpperLimit":"0.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.082"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1811","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.27","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.082"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3854","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.23","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.082"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3822","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.23","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.082"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9255","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.17","ciUpperLimit":"0.15","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.082"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6714","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.14","ciUpperLimit":"0.22","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.091"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9838","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.18","ciUpperLimit":"0.18","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.091"},{"groupIds":["OG000","OG001"],"groupDescription":"Suicide, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8884","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.17","ciUpperLimit":"0.15","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.083"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6996","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.23","ciUpperLimit":"0.16","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.097"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4426","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.15","ciUpperLimit":"0.33","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.121"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8743","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.20","ciUpperLimit":"0.24","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.110"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3498","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.12","ciUpperLimit":"0.35","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.118"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0839","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.56","ciUpperLimit":"0.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.151"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2595","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.49","ciUpperLimit":"0.13","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.157"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0560","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.66","ciUpperLimit":"0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.168"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6187","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.45","ciUpperLimit":"0.27","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.180"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Hour 72 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0187","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.39","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.72","ciUpperLimit":"-0.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.163"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1531","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.62","ciUpperLimit":"0.10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.180"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3341","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.58","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.197"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8969","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.40","ciUpperLimit":"0.46","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.216"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Early, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5862","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.25","ciUpperLimit":"0.44","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.174"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3776","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"0.34","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.117"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9029","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.26","ciUpperLimit":"0.23","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.121"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6173","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.18","ciUpperLimit":"0.30","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.121"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2433","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.10","ciUpperLimit":"0.39","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.124"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Hour 24 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0234","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.59","ciUpperLimit":"-0.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.139"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0540","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.55","ciUpperLimit":"0.00","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.139"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0406","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.58","ciUpperLimit":"-0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.144"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0295","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.56","ciUpperLimit":"-0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.132"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0925","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.50","ciUpperLimit":"0.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.135"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1631","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.52","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.152"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2213","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.60","ciUpperLimit":"0.14","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.185"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9175","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.36","ciUpperLimit":"0.39","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.189"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Middle, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6763","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.40","ciUpperLimit":"0.26","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.165"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3805","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"0.35","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.121"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6073","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.19","ciUpperLimit":"0.32","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.127"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.7848","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.27","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.119"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9038","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.25","ciUpperLimit":"0.23","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.121"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6869","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.134","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.32","ciUpperLimit":"0.21","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.134"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9272","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.26","ciUpperLimit":"0.29","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.139"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6931","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.31","ciUpperLimit":"0.21","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.131"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8262","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.29","ciUpperLimit":"0.23","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.132"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0749","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.54","ciUpperLimit":"0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.141"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1923","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.45","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.135"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0326","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.38","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.73","ciUpperLimit":"-0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.176"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4440","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.47","ciUpperLimit":"0.21","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.171"},{"groupIds":["OG000","OG001"],"groupDescription":"Insomnia-Late, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.7057","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.32","ciUpperLimit":"0.22","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.134"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2865","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.42","ciUpperLimit":"0.13","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.137"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9475","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.33","ciUpperLimit":"0.35","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.170"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1880","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.61","ciUpperLimit":"0.12","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.185"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5950","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.51","ciUpperLimit":"0.29","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.203"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Hour 24 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9636","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.39","ciUpperLimit":"0.41","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.200"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5836","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.50","ciUpperLimit":"0.28","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.196"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1568","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.63","ciUpperLimit":"0.10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.184"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0155","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"LS Mean Difference","paramValue":"-0.44","ciPctValue":"5","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.79","ciUpperLimit":"-0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.177"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0504","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.38","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.76","ciUpperLimit":"0.00","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.192"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1865","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.70","ciUpperLimit":"0.14","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.212"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0518","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.43","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.87","ciUpperLimit":"0.00","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.220"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8330","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.42","ciUpperLimit":"0.53","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.239"},{"groupIds":["OG000","OG001"],"groupDescription":"Work and Activities, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8440","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.34","ciUpperLimit":"0.42","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.191"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4602","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.15","ciUpperLimit":"0.33","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.121"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0891","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.20","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.03","ciUpperLimit":"0.43","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.117"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3088","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.11","ciUpperLimit":"0.35","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.117"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8560","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.24","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.112"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9702","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.24","ciUpperLimit":"0.25","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.125"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8001","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.25","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.114"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects","nonInferiorityType":"SUPERIORITY","pValue":"0.3223","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.11","ciUpperLimit":"0.32","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.109"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects","nonInferiorityType":"SUPERIORITY","pValue":"0.3385","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.26","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.089"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects","nonInferiorityType":"SUPERIORITY","pValue":"0.7003","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.16","ciUpperLimit":"0.24","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.100"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects","nonInferiorityType":"SUPERIORITY","pValue":"0.0311","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.41","ciUpperLimit":"-0.02","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.099"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects","nonInferiorityType":"SUPERIORITY","pValue":"0.1976","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.26","ciUpperLimit":"0.06","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.079"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects","nonInferiorityType":"SUPERIORITY","pValue":"0.5489","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.24","ciUpperLimit":"0.13","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.092"},{"groupIds":["OG000","OG001"],"groupDescription":"Retardation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects","nonInferiorityType":"SUPERIORITY","pValue":"0.7992","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.17","ciUpperLimit":"0.13","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.075"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0573","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.20","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.40","ciUpperLimit":"0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.103"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0431","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.44","ciUpperLimit":"-0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.110"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0060","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.52","ciUpperLimit":"-0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.108"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0215","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.55","ciUpperLimit":"-0.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.127"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0422","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.44","ciUpperLimit":"-0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.109"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0433","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.51","ciUpperLimit":"-0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.126"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0051","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.34","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.57","ciUpperLimit":"-0.10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.118"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0973","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.48","ciUpperLimit":"0.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.133"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0036","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.38","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.63","ciUpperLimit":"-0.13","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.126"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0498","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.52","ciUpperLimit":"0.00","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.131"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5111","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.39","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.147"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5839","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.39","ciUpperLimit":"0.22","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.155"},{"groupIds":["OG000","OG001"],"groupDescription":"Agitation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1905","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.33","ciUpperLimit":"0.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.100"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1767","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.54","ciUpperLimit":"0.10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.162"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5182","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.47","ciUpperLimit":"0.24","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.180"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3930","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.53","ciUpperLimit":"0.21","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.185"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5212","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.50","ciUpperLimit":"0.25","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.189"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4741","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.50","ciUpperLimit":"0.23","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.184"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4482","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.51","ciUpperLimit":"0.23","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.186"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0963","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.31","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.69","ciUpperLimit":"0.06","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.187"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0030","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.86","ciUpperLimit":"-0.18","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.171"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1116","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.63","ciUpperLimit":"0.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.177"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0040","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.86","ciUpperLimit":"-0.17","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.173"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Day 14 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8253","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.54","ciUpperLimit":"0.43","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.244"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Day 21 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5795","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.30","ciUpperLimit":"0.53","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.209"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Psychic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4032","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.21","ciUpperLimit":"0.51","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.182"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6117","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.33","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.133"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4716","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.35","ciUpperLimit":"0.16","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.130"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6041","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.34","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.136"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0424","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.53","ciUpperLimit":"-0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.132"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.7622","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.32","ciUpperLimit":"0.23","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.138"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2689","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.40","ciUpperLimit":"0.11","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.130"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2110","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.44","ciUpperLimit":"0.10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.134"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5873","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.34","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.135"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0450","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.46","ciUpperLimit":"-0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.114"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0847","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.57","ciUpperLimit":"0.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.152"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2522","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.16","ciUpperLimit":"0.60","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.189"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5026","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.43","ciUpperLimit":"0.21","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.160"},{"groupIds":["OG000","OG001"],"groupDescription":"Anxiety Somatic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5911","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.38","ciUpperLimit":"0.22","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.149"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5800","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.18","ciUpperLimit":"0.31","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.122"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6754","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.31","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.129"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1006","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.04","ciUpperLimit":"0.42","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.116"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3588","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"0.35","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.120"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5807","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.28","ciUpperLimit":"0.16","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.109"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4241","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"0.31","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.112"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.7984","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.26","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.115"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8732","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.22","ciUpperLimit":"0.26","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.122"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8621","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.19","ciUpperLimit":"0.23","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.107"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1087","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.20","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.45","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.126"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2153","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.41","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.125"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1422","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.51","ciUpperLimit":"0.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.145"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms Gastrointestinal, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.7211","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.19","ciUpperLimit":"0.27","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.114"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms General, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8224","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.18","ciUpperLimit":"0.23","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.103"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms General, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6362","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.31","ciUpperLimit":"0.19","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.126"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms General, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6094","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.31","ciUpperLimit":"0.18","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.123"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms General, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0457","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.49","ciUpperLimit":"0.00","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.123"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms General, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5691","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.36","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.140"},{"groupIds":["OG000"],"groupDescription":"Somatic Symptoms General, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2942","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.40","ciUpperLimit":"0.12","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.130"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms General, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5389","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.35","ciUpperLimit":"0.19","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.136"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms General, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4061","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.40","ciUpperLimit":"0.16","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.141"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms General, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0990","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.56","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.153"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms General, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0108","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.63","ciUpperLimit":"-0.08","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.138"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms General, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0889","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.59","ciUpperLimit":"0.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.160"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms General, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3721","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.18","ciUpperLimit":"0.49","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.169"},{"groupIds":["OG000","OG001"],"groupDescription":"Somatic Symptoms General, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5513","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.36","ciUpperLimit":"0.20","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.141"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0748","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.01","ciUpperLimit":"0.26","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.067"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3545","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.09","ciUpperLimit":"0.25","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.087"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6531","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.14","ciUpperLimit":"0.23","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.094"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.7520","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.26","ciUpperLimit":"0.19","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.115"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8861","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.26","ciUpperLimit":"0.23","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.123"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3280","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.38","ciUpperLimit":"0.13","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.127"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1123","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.46","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.128"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2541","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.36","ciUpperLimit":"0.10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.116"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0110","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.37","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.66","ciUpperLimit":"-0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.143"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.7720","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.36","ciUpperLimit":"0.27","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.158"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6311","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.52","ciUpperLimit":"0.32","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.210"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6877","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.50","ciUpperLimit":"0.33","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.207"},{"groupIds":["OG000","OG001"],"groupDescription":"Genital Symptoms, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2465","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.15","ciUpperLimit":"0.58","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.186"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1279","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.36","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.101"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3946","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.26","ciUpperLimit":"0.10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.093"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6694","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.23","ciUpperLimit":"0.15","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.095"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1113","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.36","ciUpperLimit":"0.04","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.100"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5811","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"0.23","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.089"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6794","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.25","ciUpperLimit":"0.17","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.106"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6031","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.14","ciUpperLimit":"0.25","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.099"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6673","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.24","ciUpperLimit":"0.15","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.099"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6472","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.25","ciUpperLimit":"0.16","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.102"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8654","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.26","ciUpperLimit":"0.22","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.119"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2101","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.48","ciUpperLimit":"0.11","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.140"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.7128","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.30","ciUpperLimit":"0.21","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.126"},{"groupIds":["OG000","OG001"],"groupDescription":"Hypochondriasis, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3297","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.27","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.090"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of weight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4493","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.08","ciUpperLimit":"0.19","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.069"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of weight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0717","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.01","ciUpperLimit":"0.31","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.081"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of Weight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1054","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.02","ciUpperLimit":"0.24","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.066"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of Weight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0408","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.01","ciUpperLimit":"0.36","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.088"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of Weight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0233","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.20","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.03","ciUpperLimit":"0.38","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.088"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of Weight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3610","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.09","ciUpperLimit":"0.26","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.088"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of Weight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2358","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.08","ciUpperLimit":"0.32","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.100"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of Weight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9492","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.16","ciUpperLimit":"0.17","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.085"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of Weight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4352","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.28","ciUpperLimit":"0.12","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.102"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of Weight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1176","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.20","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.05","ciUpperLimit":"0.44","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.125"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of Weight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.7812","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.30","ciUpperLimit":"0.40","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.174"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of Weight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.5085","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.48","ciUpperLimit":"0.24","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.182"},{"groupIds":["OG000","OG001"],"groupDescription":"Loss of Weight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8274","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.28","ciUpperLimit":"0.34","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.156"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3675","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.045"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1818","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.15","ciUpperLimit":"0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.045"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0826","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.17","ciUpperLimit":"0.01","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.045"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6436","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.11","ciUpperLimit":"0.07","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.045"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1827","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.15","ciUpperLimit":"0.03","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.045"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9859","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.09","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.045"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6672","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.07","ciUpperLimit":"0.11","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.045"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2031","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.03","ciUpperLimit":"0.15","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.046"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6664","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.07","ciUpperLimit":"0.11","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.045"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.3417","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"0.05","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.045"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.6622","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.12","ciUpperLimit":"0.08","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.051"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9087","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.11","ciUpperLimit":"0.09","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.051"},{"groupIds":["OG000","OG001"],"groupDescription":"Insight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.8263","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.08","ciUpperLimit":"0.10","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.046"}]},{"type":"SECONDARY","title":"Change From Baseline at Key Time Points in Montgomery-Åsberg 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 indicates more severe depression. A negative change from baseline indicates less severe depression. A positive change from baseline indicates more severe depression.","populationDescription":"All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Hour 60, Days 7 and 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group."},{"id":"OG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Hour 60","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"49"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-15.66","spread":"1.329"},{"groupId":"OG001","value":"-20.52","spread":"1.333"}]}]},{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"49"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-15.35","spread":"1.658"},{"groupId":"OG001","value":"-18.91","spread":"1.676"}]}]},{"title":"Day 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-20.52","spread":"1.489"},{"groupId":"OG001","value":"-20.48","spread":"1.504"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.0033","statisticalMethod":"MMRM","paramType":"LS mean difference","paramValue":"-4.86","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.06","ciUpperLimit":"-1.66","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.612"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1017","statisticalMethod":"MMRM","paramType":"LS mean difference","paramValue":"-3.56","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.84","ciUpperLimit":"0.72","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.154"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.9845","statisticalMethod":"MMRM","paramType":"LS mean difference","paramValue":"0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.72","ciUpperLimit":"3.79","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.884"}]},{"type":"SECONDARY","title":"Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response","description":"The CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). 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. By definition, all CGI-I assessments were evaluated against baseline conditions.","populationDescription":"All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Hour 60, Days 7 and 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group."},{"id":"OG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Hour 60","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"49"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"55.8"},{"groupId":"OG001","value":"79.6"}]}]},{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"50"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"54.7"},{"groupId":"OG001","value":"70.0"}]}]},{"title":"Day 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"78.8"},{"groupId":"OG001","value":"81.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.","nonInferiorityType":"SUPERIORITY","pValue":"0.0005","statisticalMethod":"GEE method","paramType":"Odds Ratio (OR)","paramValue":"5.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.0","ciUpperLimit":"12.5"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.","nonInferiorityType":"SUPERIORITY","pValue":"0.0478","statisticalMethod":"GEE method","paramType":"Odds Ratio (OR)","paramValue":"2.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.0","ciUpperLimit":"8.4"},{"groupIds":["OG000","OG001"],"groupDescription":"Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.","nonInferiorityType":"SUPERIORITY","pValue":"0.4399","statisticalMethod":"GEE method","paramType":"Odds Ratio (OR)","paramValue":"1.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.5","ciUpperLimit":"4.6"}]},{"type":"SECONDARY","title":"Change From Baseline in the 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":"All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline, Hour 60, Days 7, 14, 21 and 30","groups":[{"id":"OG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group."},{"id":"OG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Hour 60","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"46"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-6.41","spread":"0.814"},{"groupId":"OG001","value":"-7.58","spread":"0.850"}]}]},{"title":"Day 7","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-7.67","spread":"0.858"},{"groupId":"OG001","value":"-8.43","spread":"0.879"}]}]},{"title":"Day 14","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"29"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-7.90","spread":"0.937"},{"groupId":"OG001","value":"-9.76","spread":"0.961"}]}]},{"title":"Day 21","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"30"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-8.92","spread":"1.053"},{"groupId":"OG001","value":"-10.88","spread":"1.081"}]}]},{"title":"Day 30","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"46"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-9.89","spread":"0.884"},{"groupId":"OG001","value":"-10.20","spread":"0.913"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.2636","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-1.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.24","ciUpperLimit":"0.90","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.041"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.4897","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.76","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.96","ciUpperLimit":"1.43","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.103"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1341","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-1.86","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.30","ciUpperLimit":"0.59","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.227"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.1691","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-1.95","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.76","ciUpperLimit":"0.85","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.408"},{"groupIds":["OG000","OG001"],"groupDescription":"Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.","nonInferiorityType":"SUPERIORITY","pValue":"0.7852","statisticalMethod":"MMRM","paramType":"LS Mean Difference","paramValue":"-0.31","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.60","ciUpperLimit":"1.97","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.149"}]},{"type":"SECONDARY","title":"Percentage of Participants With Treatment Emergent Adverse Event (TEAE)","description":"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (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 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 randomized participants who started the study drug infusion.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Up to approximately 37 days","groups":[{"id":"OG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group."},{"id":"OG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"45.3"},{"groupId":"OG001","value":"49.0"}]}]}]},{"type":"SECONDARY","title":"Time to Change in Antidepressant Medication","description":"The time to first start or increase in the dose and time to first stop or decrease in the dose of any antidepressant medication.","populationDescription":"All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"days","timeFrame":"Up to approximately 37 days","groups":[{"id":"OG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group."},{"id":"OG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Time to first start/increase in dose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"8","lowerLimit":"4","upperLimit":"13"},{"groupId":"OG001","value":"10","lowerLimit":"7","upperLimit":"17"}]}]},{"title":"Time to first stop/decrease in dose","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"18","lowerLimit":"18","upperLimit":"18"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Up to approximately 37 days","description":"The Safety Set included all randomized participants who started the study drug infusion.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Participants received an infusion rate equivalent to the 90 μg/kg/h group.","deathsNumAffected":0,"deathsNumAtRisk":53,"seriousNumAffected":0,"seriousNumAtRisk":53,"otherNumAffected":13,"otherNumAtRisk":53},{"id":"EG001","title":"SAGE-547 90 μg/kg/h","description":"Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).","deathsNumAffected":0,"deathsNumAtRisk":51,"seriousNumAffected":1,"seriousNumAtRisk":51,"otherNumAffected":21,"otherNumAtRisk":51}],"seriousEvents":[{"term":"Altered state of consciousness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":53},{"groupId":"EG001","numAffected":1,"numAtRisk":51}]},{"term":"Syncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":53},{"groupId":"EG001","numAffected":1,"numAtRisk":51}]}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":53},{"groupId":"EG001","numAffected":5,"numAtRisk":51}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":53},{"groupId":"EG001","numAffected":3,"numAtRisk":51}]},{"term":"Infusion site pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":53},{"groupId":"EG001","numAffected":5,"numAtRisk":51}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":53},{"groupId":"EG001","numAffected":5,"numAtRisk":51}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":53},{"groupId":"EG001","numAffected":9,"numAtRisk":51}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":53},{"groupId":"EG001","numAffected":4,"numAtRisk":51}]}]},"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"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2017-03-16","uploadDate":"2019-04-11T11:03","filename":"Prot_000.pdf","size":19243600},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2017-10-27","uploadDate":"2019-04-11T11:04","filename":"SAP_001.pdf","size":1134424}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","removedCountries":["New Zealand"]},"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}