[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638441":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":71,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":28,"enrollmentInfo":88,"targetDuration":28,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":104,"whyStopped":28,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lumateperone","EXPERIMENTAL","The starting dose of lumateperone or placebo will typically be 21 mg\u002Fday for the first week. Those participants who are taking moderate or strong CYP3A4 inhibitors will start at 10.5 mg\u002F day. The dose will be increased for most participants to 42 mg\u002F day at Week 2 and maintained until Week 10. Participants with moderate or severe hepatic impairment (Child-Pugh class B or C) will be maintained at 21 mg\u002Fday. Participants who are taking strong CYP3A4 inhibitors will be maintained at 10.5 mg\u002F day. Participants who are taking moderate CYP3A4 inhibitors will increase as tolerated to 21 mg\u002F day.",[13],"Drug: Lumateperone",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Participants will be randomized to take either lumateperone or placebo along with their existing antidepressant for 10 weeks. Dose will range from 10.5mg-42mg over the course of the study.",[9],[25],"Caplyta",{"type":21,"name":15,"description":22,"armGroupLabels":27,"otherNames":28},[15],null,[30],{"name":31,"affiliation":5,"role":32},"Eric J Lenze, MD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Anna Kinghorn, MS","CONTACT","314-362-8761","akinghorn@wustl.edu",{"name":40,"role":36,"phone":41,"phoneExt":28,"email":42},"Julie Schweiger","314-362-3153","schweigj@wustl.edu",[44,60],{"facility":45,"status":28,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University of Arizona","Tucson","Arizona","85713","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-110.92648,32.22174,{"lat":55,"lon":54},[58],{"name":59,"role":32,"phone":28,"phoneExt":28,"email":28},"Jordan Karp, MD",{"facility":5,"status":28,"city":61,"state":62,"zip":63,"country":49,"countryCode":50,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"St Louis","Missouri","63110",{"type":52,"coordinates":65},[66,67],-90.19789,38.62727,{"lat":67,"lon":66},[70],{"name":31,"role":32,"phone":28,"phoneExt":28,"email":28},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Eric Lenze","Wallace and Lucille K Renard Prof of Psychiatry",[76],{"name":77,"class":78},"Intra-Cellular Therapies, Inc.","INDUSTRY","100638441","phase-3-lumateperone-for-late-life-depression-100638441",false,"NCT07623135","Lumateperone for Late-Life Depression","IRL Grey-C","Inclusion Criteria:\n\n* Age \\>=60\n* Current unipolar non-psychotic major depression determined by SCID-5\n* MADRS score \\>=20 at screening and \\>=18 at baseline\n* Treatment-resistance defined as documented history of non-response to at least two oral medications of adequate dose and duration in this episode or previous episode, OR clinician determination that treatment augmentation is appropriate\n* Currently taking oral antidepressant prescribed at least minimum therapeutic dose and for at least six weeks duration\n* MMSE score of \\>\u002F=24\n\nExclusion Criteria:\n\n* Dementia\n* High risk for suicide, defined as a 4 or 5 on C-SSRS (indicating active suicidal ideation with current or recent intent or plan), and unable to be managed safely in the clinical trial. Urgent psychiatric referral will be made in these cases.\n* High risk alcohol use: defined as a score of 6 or more on the AUDIT-C\n* Medically inappropriate for participation as determined by PIs.","ALL","60 Years",{"count":89,"type":90},100,"ESTIMATED","INTERVENTIONAL",[93],"PHASE3","The purpose of this research study is to examine how well a medication called lumateperone (Caplyta) works to relieve depression in older adults with treatment-resistant depression. Lumateperone (Caplyta) is approved by the U.S. Food and Drug Administration to treat Major Depressive Disorder in adults who are also taking another antidepressant medication. This study will compare lumateperone (Caplyta) to placebo (a sugar pill without medication).",[96,97,98],"Treatment Resistant Depression (TRD)","Late Life Depression (LLD)","Depression \u002F Major Depressive Disorder",[100,101,102,103],"Late life depression treatment","Treatment resistant depression in older adults","major depression","lumateperone","NOT_YET_RECRUITING","2026-05-28",{"date":107,"type":108},"2026-06-03","ACTUAL",{"date":110,"type":90},"2026-06",{"date":112,"type":90},"2028-06",{"name":73,"class":6},2]