[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610428":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":34,"centralContacts":44,"locations":50,"responsibleParty":300,"collaborators":34,"id":302,"slug":303,"hasResults":304,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":304,"sex":310,"minAge":311,"maxAge":312,"enrollmentInfo":313,"targetDuration":34,"studyType":316,"phases":317,"briefSummary":319,"conditions":320,"keywords":34,"overallStatus":53,"whyStopped":34,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intranasal Esketamine + Oral Placebo","EXPERIMENTAL","Participants will receive intranasal esketamine 84 milligrams (mg) along with oral placebo solution twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a decrease to intranasal esketamine 56 mg (in a blinded fashion per investigator's judgment) is permitted. Thereafter, dose may be flexed between 56 mg and 84 mg during the treatment period.",[13,14],"Drug: Esketamine","Other: Oral Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Intranasal Placebo + Oral Midazolam","PLACEBO_COMPARATOR","Participants will receive oral midazolam (0.0625 milligrams per kilograms \\[mg\u002Fkg\\]) and intranasal placebo twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a sham decrease to esketamine 56 mg dose (in a blinded fashion per investigator's judgment) is permitted. Thereafter, sham dose may be flexed between 56 mg and 84 mg during the treatment period.",[20,21],"Drug: Midazolam","Other: Intranasal Placebo",[23,30,35,40],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Esketamine","Esketamine will be administered as intranasal solution.",[9],[29],"JNJ-54135419",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Midazolam","Midazolam will be administered as oral solution.",[16],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"OTHER","Oral Placebo","Placebo will be administered as oral solution.",[9],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":34},"Intranasal Placebo","Intranasal placebo will be administered as nasal solution.",[16],[45],{"name":46,"role":47,"phone":48,"phoneExt":34,"email":49},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[51,65,75,85,95,106,115,124,133,139,150,159,168,179,188,197,206,215,226,235,244,253,262,273,282,288,294],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":34},"University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-86.80249,33.52066,{"lat":63,"lon":62},{"facility":66,"status":53,"city":67,"state":68,"zip":69,"country":57,"countryCode":58,"cosmosGeoPoint":70,"geoPoint":74,"contacts":34},"Peachford Hospital-Atlanta Behavioral Research","Atlanta","Georgia","30338",{"type":60,"coordinates":71},[72,73],-84.38798,33.749,{"lat":73,"lon":72},{"facility":76,"status":53,"city":77,"state":78,"zip":79,"country":57,"countryCode":58,"cosmosGeoPoint":80,"geoPoint":84,"contacts":34},"University of Cincinnati","Cincinnati","Ohio","45219",{"type":60,"coordinates":81},[82,83],-84.51439,39.12711,{"lat":83,"lon":82},{"facility":86,"status":53,"city":87,"state":88,"zip":89,"country":57,"countryCode":58,"cosmosGeoPoint":90,"geoPoint":94,"contacts":34},"Bradley Hospital","East Providence","Rhode Island","02915",{"type":60,"coordinates":91},[92,93],-71.37005,41.81371,{"lat":93,"lon":92},{"facility":96,"status":53,"city":97,"state":34,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":34},"Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose","Criciúma","88811 000","Brazil","BR",{"type":60,"coordinates":102},[103,104],-49.36972,-28.6775,{"lat":104,"lon":103},{"facility":107,"status":53,"city":108,"state":34,"zip":109,"country":99,"countryCode":100,"cosmosGeoPoint":110,"geoPoint":114,"contacts":34},"Instituto Apice","Salvador","40170 108",{"type":60,"coordinates":111},[112,113],-38.49096,-12.97563,{"lat":113,"lon":112},{"facility":116,"status":53,"city":117,"state":34,"zip":118,"country":99,"countryCode":100,"cosmosGeoPoint":119,"geoPoint":123,"contacts":34},"Centro Integrado Facili","São Bernardo do Campo","09726 150",{"type":60,"coordinates":120},[121,122],-46.565,-23.69389,{"lat":122,"lon":121},{"facility":125,"status":53,"city":126,"state":34,"zip":127,"country":99,"countryCode":100,"cosmosGeoPoint":128,"geoPoint":132,"contacts":34},"Instituto de Pesquisa Pensi Sandra Mutarelli Setubal","São Paulo","01 227 200",{"type":60,"coordinates":129},[130,131],-46.63611,-23.5475,{"lat":131,"lon":130},{"facility":134,"status":53,"city":126,"state":34,"zip":135,"country":99,"countryCode":100,"cosmosGeoPoint":136,"geoPoint":138,"contacts":34},"Fundacao Faculdade de Medicina Hospital da Clinicas da Faculdade de Medicina de Sao Paulo","05403 010",{"type":60,"coordinates":137},[130,131],{"lat":131,"lon":130},{"facility":140,"status":53,"city":141,"state":34,"zip":142,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":149,"contacts":34},"Debreceni Egyetem Klinikai Kozpont","Debrecen","4031","Hungary","HU",{"type":60,"coordinates":146},[147,148],21.62444,47.53167,{"lat":148,"lon":147},{"facility":151,"status":53,"city":152,"state":34,"zip":153,"country":143,"countryCode":144,"cosmosGeoPoint":154,"geoPoint":158,"contacts":34},"Petz Aladar Megyei Oktato Korhaz","Győr","9023",{"type":60,"coordinates":155},[156,157],17.63512,47.68333,{"lat":157,"lon":156},{"facility":160,"status":53,"city":161,"state":34,"zip":162,"country":143,"countryCode":144,"cosmosGeoPoint":163,"geoPoint":167,"contacts":34},"Szegedi Tudomanyegyetem","Szeged","6720",{"type":60,"coordinates":164},[165,166],20.14824,46.253,{"lat":166,"lon":165},{"facility":169,"status":53,"city":170,"state":34,"zip":171,"country":172,"countryCode":173,"cosmosGeoPoint":174,"geoPoint":178,"contacts":34},"Presidio Ospedaliero Santa Marta e Santa Venera","Acireale","95024","Italy","IT",{"type":60,"coordinates":175},[176,177],15.16577,37.60886,{"lat":177,"lon":176},{"facility":180,"status":53,"city":181,"state":34,"zip":182,"country":172,"countryCode":173,"cosmosGeoPoint":183,"geoPoint":187,"contacts":34},"AOU Meyer","Florence","50134",{"type":60,"coordinates":184},[185,186],11.24626,43.77925,{"lat":186,"lon":185},{"facility":189,"status":53,"city":190,"state":34,"zip":191,"country":172,"countryCode":173,"cosmosGeoPoint":192,"geoPoint":196,"contacts":34},"Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia","Foggia","71122",{"type":60,"coordinates":193},[194,195],15.55188,41.45845,{"lat":195,"lon":194},{"facility":198,"status":53,"city":199,"state":34,"zip":200,"country":172,"countryCode":173,"cosmosGeoPoint":201,"geoPoint":205,"contacts":34},"Azienda Ospedaliera Universitaria Federico II","Naples","80131",{"type":60,"coordinates":202},[203,204],14.26811,40.85216,{"lat":204,"lon":203},{"facility":207,"status":53,"city":208,"state":34,"zip":209,"country":172,"countryCode":173,"cosmosGeoPoint":210,"geoPoint":214,"contacts":34},"Azienda Ospedaliero Universitaria di Sassari","Sassari","07100",{"type":60,"coordinates":211},[212,213],8.55552,40.72586,{"lat":213,"lon":212},{"facility":216,"status":53,"city":217,"state":34,"zip":218,"country":219,"countryCode":220,"cosmosGeoPoint":221,"geoPoint":225,"contacts":34},"Hosp. Clinic de Barcelona","Barcelona","08036","Spain","ES",{"type":60,"coordinates":222},[223,224],2.15899,41.38879,{"lat":224,"lon":223},{"facility":227,"status":53,"city":228,"state":34,"zip":229,"country":219,"countryCode":220,"cosmosGeoPoint":230,"geoPoint":234,"contacts":34},"Fundacio Althaia Xarxa Assistencial Universitaria de Manresa","Manresa","08243",{"type":60,"coordinates":231},[232,233],1.82399,41.72815,{"lat":233,"lon":232},{"facility":236,"status":53,"city":237,"state":34,"zip":238,"country":219,"countryCode":220,"cosmosGeoPoint":239,"geoPoint":243,"contacts":34},"Hosp. Univ. Central de Asturias","Oviedo","33011",{"type":60,"coordinates":240},[241,242],-5.84476,43.36029,{"lat":242,"lon":241},{"facility":245,"status":53,"city":246,"state":34,"zip":247,"country":219,"countryCode":220,"cosmosGeoPoint":248,"geoPoint":252,"contacts":34},"Clinica Univ. de Navarra","Pamplona","31008",{"type":60,"coordinates":249},[250,251],-1.64323,42.81687,{"lat":251,"lon":250},{"facility":254,"status":53,"city":255,"state":34,"zip":256,"country":219,"countryCode":220,"cosmosGeoPoint":257,"geoPoint":261,"contacts":34},"Hosp.Univ.Parc Tauli","Sabadell","08208",{"type":60,"coordinates":258},[259,260],2.10942,41.54329,{"lat":260,"lon":259},{"facility":263,"status":53,"city":264,"state":34,"zip":265,"country":266,"countryCode":267,"cosmosGeoPoint":268,"geoPoint":272,"contacts":34},"Mackay Memorial Hospital Tamsui Branch","New Taipei City","251","Taiwan","TW",{"type":60,"coordinates":269},[270,271],121.45703,25.06199,{"lat":271,"lon":270},{"facility":274,"status":53,"city":275,"state":34,"zip":276,"country":266,"countryCode":267,"cosmosGeoPoint":277,"geoPoint":281,"contacts":34},"National Taiwan University Hospital","Taipei","100",{"type":60,"coordinates":278},[279,280],121.52639,25.05306,{"lat":280,"lon":279},{"facility":283,"status":53,"city":275,"state":34,"zip":284,"country":266,"countryCode":267,"cosmosGeoPoint":285,"geoPoint":287,"contacts":34},"Taipei Medical University Hospital","110",{"type":60,"coordinates":286},[279,280],{"lat":280,"lon":279},{"facility":289,"status":53,"city":275,"state":34,"zip":290,"country":266,"countryCode":267,"cosmosGeoPoint":291,"geoPoint":293,"contacts":34},"Taipei Veterans General Hospital","112",{"type":60,"coordinates":292},[279,280],{"lat":280,"lon":279},{"facility":295,"status":53,"city":275,"state":34,"zip":296,"country":266,"countryCode":267,"cosmosGeoPoint":297,"geoPoint":299,"contacts":34},"Tri-Service General Hospital","114",{"type":60,"coordinates":298},[279,280],{"lat":280,"lon":279},{"type":301,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100610428","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-esketamine-for-reduction-of-symptoms-of-major-depressive-disorder-100610428",false,"NCT07227454","A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder","A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants With Acute Suicidal Ideation or Behavior","AVENUE","Inclusion Criteria:\n\n* Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD) based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview for children and adolescents (MINI-KID)\n* Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of \"Markedly\" or greater (that is, greater than or equal to \\[\\>=\\] 4) at both screening and baseline (predose) visits\n* Must have a children's depression rating scale - revised (CDRS-R) total score \\>= 58 at baseline (predose)\n* In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality\n* Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening\n\nExclusion Criteria:\n\n* Participant has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder\n* Participant currently meets DSM-5 criteria for borderline personality disorder\n* Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis\n* Participant has a history of seizure disorder\n* Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients","ALL","12 Years","17 Years",{"count":314,"type":315},258,"ESTIMATED","INTERVENTIONAL",[318],"PHASE3","The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.",[321],"Depressive Disorder, Major","2026-06-04",{"date":324,"type":325},"2026-06-05","ACTUAL",{"date":327,"type":325},"2026-01-08",{"date":329,"type":315},"2031-09-15",{"name":5,"class":6},27]