[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610294":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":43,"collaborators":20,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":20,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":20,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":20,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SEP-363856 75 or 100 mg\u002Fday (dose selected per protocol)","EXPERIMENTAL","SEP-363856 will be administered at 50 mg\u002Fday from Day 1 to Day 3, and 75 mg\u002Fday from Day 4 to Day 7. From Day 8 onward, the dose will, in principle, be 100 mg\u002Fday unless there are tolerability concerns; however, in accordance with protocol, the investigator or sub-investigator may select either 75 mg\u002Fday or 100 mg\u002Fday.",[13],"Drug: SEP-363856",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","SEP-363856","Tablet, once daily, for 52 weeks",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Nobuhito Sanada","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":20},"Drug Information Center","CONTACT","+81-3-6361-7314",[31],{"facility":32,"status":33,"city":34,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":20},"Jimbo Kokorono Clinic","RECRUITING","Fukuoka","Japan","JP",{"type":38,"coordinates":39},"Point",[40,41],130.41667,33.6,{"lat":41,"lon":40},{"type":44,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100610294","phase-3-a-long-term-administration-trial-of-sep-363856-in-patients-with-schizophrenia-100610294",false,"NCT07225712","A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia","A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Tolerability, Safety, and Efficacy of Long-term Administration of SEP-363856 in Patients With Schizophrenia","Inclusion Criteria:\n\n* Japanese male or female participants 18 years of age or older at the time of informed consent\n* Diagnosed with schizophrenia according to the DSM-5®\n* Judged by the investigator to be clinically stable for at least 8 weeks prior to screening\n* PANSS total score of 80 or less and CGI-S score 4 or less at both screening and baseline\n* No changes in antipsychotic medication for at least 6 weeks before screening (excluding minor dose adjustments for tolerability)\n\nExclusion Criteria:\n\n* History of psychiatric hospitalization within 8 weeks prior to screening\n* Treatment-resistant to antipsychotic therapy (ie, within 1 year to screening, despite administration of two or more marketed antipsychotics at appropriate doses for at least 4 weeks \\[28 consecutive days\\] in accordance with the package insert, psychiatric symptoms did not improve)\n* History of treatment with clozapine\n* Unwillingness, before or during the trial period, to comply with the requirements for prior and concomitant medications\u002Ftherapies as specified in the protocol or use of prohibited medications at screening or baseline as specified in the protocol.","ALL","18 Years",{"count":55,"type":56},100,"ESTIMATED","INTERVENTIONAL",[59],"PHASE3","To evaluate the safety of SEP-363856 (75 mg\u002Fday or 100 mg\u002Fday) administered for 52 weeks in adult participants with schizophrenia",[62],"Schizophrenia","2026-01-13",{"date":65,"type":66},"2026-01-14","ACTUAL",{"date":68,"type":66},"2025-12-22",{"date":70,"type":56},"2028-03",{"name":5,"class":6},1]