[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623456":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":34,"responsibleParty":51,"collaborators":25,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":25,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":25,"overallStatus":72,"whyStopped":25,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Luye Pharma Group Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LY03020","EXPERIMENTAL","Subjects will take LY03020 from Day 1 to Day 48",[13],"Drug: LY03020",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Subjects will take Placebo from Day 1 to Day 48",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","administered orally",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Yufeng Wang","CONTACT","18665029373","wangyufeng@luye.com",[35],{"facility":36,"status":25,"city":37,"state":25,"zip":25,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Beijing AnDing Hospital Capital Medical University","Beijing","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},[47],{"name":48,"role":31,"phone":49,"phoneExt":25,"email":50},"Yang Li","15810468016","liyang2007428@hotmail.com",{"type":52,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100623456","phase-2-a-phase-2-study-to-evaluate-the-efficacy-and-safety-of-ly03020-in-acutely-psychotic-participants-with-schizophrenia-100623456",false,"NCT07396870","A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia","A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dosed Phase II Clinical Study to Evaluate the Efficacy and Safety of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Acutely Psychotic Adult Subjects With Schizophrenia","Inclusion Criteria:\n\n* Subjects and their guardians sign informed consent voluntarily.\n* Male or female subject aged 18 to 65 years (inclusive).\n* Subject meets DSM-5 criteria for schizophrenia and confirmed using the Mandarin for China Translation Version 7.0.2).\n* According to the investigator's assessment, subject has an acute exacerbation or relapse of schizophrenia requiring hospitalization (no longer than 2 months). Continuing hospitalization does not exceed 2 weeks for patients with acute psychotic exacerbation or relapse that require the hospitalization prior to screening.\n* Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 (moderate) on 2 or more of the following PANSS items: delusions(P1), conceptual disorganization(P2), hallucinations(P3), and suspicion, victimization (P6) at screening and baseline.\n* Subject must have a CGI-S score ≥ 4 at screening and baseline.\n\nExclusion Criteria:\n\n* \\- Subject who has a history or presence of symptoms consistent with a major psychiatric disorder other than schizophrenia as defined by DSM-5;\n* According to the investigator's assessment, subject has a treatment-resistant schizophrenia;\n* Subject who has a history or presence of symptoms consistent with neuroleptic malignant syndrome (NMS);\n* Subject has received electroconvulsive therapy treatment within 3 months prior to screening or is expected to require ECT during the study;\n* History of suicide attempts (including actual attempts, interrupted attempts, or failed attempts) within 1 year prior to screening or suicidal ideation within 6 months prior to screening, defined as affirmative responses (\"yes\") to question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening\u002Fbaseline;\n* History or presence of the following treatments:\n\nWithin 1 week prior to randomization or within 5 half lives (whichever is longer), subject has been treated with short acting antipsychotic drugs or other psychoactive drugs (such as antidepressants, mood stabilizers, and antiepileptic drugs), except for anti-anxiety drugs or sedative hypnotic drugs that can be used according to the protocol; Within two treatment cycles prior to randomization, subject has used long-acting antipsychotic drugs; Within 4 weeks prior to randomization, subject has used monoamine oxidase inhibitors (MAOIs); Previously used sufficient amounts and periods of clozapine for the treatment of schizophrenia;\n\n* Congenital long QT syndrome; uncontrolled or severe cardiovascular disease, including NYHA class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to screening, or presence of treatment-requiring severe arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) at screening; resting heart rate \\\u003C50 beats per minute (bpm) and the abnormality has clinical significance according to the researchers' assessment at screening\u002Fbaseline; or QTc \\>450 ms (male) \u002F QTc \\>460 ms (female) based on Fridericia's formula-corrected measurements and the abnormality has clinical significance according to the researchers' assessment at screening\u002Fbaseline;\n* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma;.\n* Subjects with a history of orthostatic hypotension or syncope.","ALL","18 Years","65 Years",{"count":64,"type":65},160,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, fixed-dosed phase II clinical study to evaluate the efficacy and safety of LY03020 in chinese acutely psychotic adult subjects with schizophrenia.",[71],"Schizophrenia","NOT_YET_RECRUITING","2026-02-02",{"date":75,"type":76},"2026-02-09","ACTUAL",{"date":78,"type":65},"2026-03-31",{"date":80,"type":65},"2027-12-31",{"name":5,"class":6},1]