[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650341":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":40,"locations":35,"responsibleParty":46,"collaborators":35,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":35,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":35,"overallStatus":68,"whyStopped":35,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":35},{"fullName":5,"class":6},"Intra-Cellular Therapies, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Lumateperone: Dose 1","EXPERIMENTAL","Eligible participants will receive dose 1 of lumateperone once daily starting on Day 1 of Double-blind (DB) treatment period for up to 6 weeks. At Visit Week 6, participants who completed DB Treatment Period, may have the option to roll over into an open-label (OL) treatment period to receive dose 1 or dose 2 of lumateperone for up to 24 weeks.",[13],"Drug: Lumateperone",{"label":15,"type":10,"description":16,"interventionNames":17},"Lumateperone: Dose 2","Eligible participants will receive dose 2 of lumateperone once daily starting on Day 1 of DB treatment period for up to 6 weeks. At Visit Week 6, participants who completed DB Treatment Period, may have the option to roll over into an OL treatment period to receive dose 1 or dose 2 of lumateperone for up to 24 weeks.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR","Eligible participants will receive placebo once daily starting on Day 1 of DB treatment period for up to 6 weeks. At Visit Week 6, participants who complete the DB treatment period, may have the option to participate in OL treatment period to receive dose 1 or dose 2 of lumateperone for up to 24 weeks.",[13,23],"Drug: Placebo",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Lumateperone","Participants will receive lumateperone orally.",[9,15,19],[31],"Caplyta",{"type":26,"name":19,"description":33,"armGroupLabels":34,"otherNames":35},"Participants will receive placebo orally.",[19],null,[37],{"name":38,"affiliation":5,"role":39},"Intra-Cellular Therapies, Inc. Clinical Trial","STUDY_DIRECTOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":35,"email":45},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",{"type":47,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100650341","phase-3-a-study-of-lumateperone-versus-placebo-in-participants-with-major-depressive-disorder-100650341",false,"NCT07747389","A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Fixed Doses of Lumateperone Administered as Monotherapy in Participants With Major Depressive Disorder and an Open-label Long-term Extension Treatment With Lumateperone","CANDLE","Inclusion criteria:\n\n* Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and where applicable at DB period baseline\n* Medically stable based on clinical laboratory tests performed at screening and where applicable at DB period baseline\n* Meets the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnostic criteria for recurrent or single episode MDD, without psychotic features, based upon clinical assessment and confirmed by Structured Clinical Interview for DSM-5 Axis I Disorders - Clinical Trials Version (SCID-CT)\n* Has moderate-to-severe depression as measured by a rater-administered MADRS total greater than or equal to (\\>=) 26 score and corresponding to a CGI-S score of \\>=4 at screening and DB baseline\n* Has a Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score of \\>=15 at screening and DB baseline\n\nExclusion criteria:\n\n* The participant experiences a \\>=25 percent (%) decrease in the MADRS total score between screening and DB baseline\n* The participant experiences a \\>=25% decrease in the QIDS-SR-16 total score between screening and DB baseline\n* Has homicidal ideation\u002Fintent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening period, per the investigator's clinical judgment or based on the Columbia-Suicide Severity Rating Scale (C-SSRS), corresponding to a response of \"Yes\" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or a history of suicidal behavior within the past 6 months prior to the start of the screening period\n* Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening\n* Has a history or evidence of clinically meaningful noncompliance with antidepressant therapy (ADT)s","ALL","18 Years","74 Years",{"count":60,"type":61},585,"ESTIMATED","INTERVENTIONAL",[64],"PHASE3","The purpose of the study is to assess how well each dose of lumateperone (Dose 1 and 2) works when given alone as compared to placebo in participants with major depressive disorder (MDD; a medical condition characterized by a persistent feeling of deep sadness, hopelessness, and a loss of interest in activities for a prolonged period of time and interfere with ability to function).",[67],"Depressive Disorder, Major","NOT_YET_RECRUITING","2026-07-30",{"date":71,"type":72},"2026-08-05","ACTUAL",{"date":74,"type":61},"2026-10-20",{"date":76,"type":61},"2029-09-20",{"name":5,"class":6}]