[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623456":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":28,"studyPopulation":28,"armGroups":40,"interventions":53,"overallOfficials":28,"centralContacts":60,"locations":66,"responsibleParty":83,"collaborators":28,"id":85,"slug":28,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":28,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":28,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":28,"overallStatus":103,"whyStopped":28,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Luye Pharma Group Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score","The total score is 30-210, higher score is indicative of greater symptomatology.","baseline to week 6 of maintenance treatment",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Change from Baseline in PANSS Positive subscale score","The PANSS Positive subscale score is 7-49, higher score is indicative of greater symptomatology.",{"measure":18,"description":19,"timeFrame":12},"Change from Baseline in PANSS Negative subscale score","The PANSS Negative subscale score is 7-49, higher score is indicative of greater symptomatology.",{"measure":21,"description":22,"timeFrame":12},"Change from Baseline in PANSS General Psychopathology subscale score","The PANSS General Psychopathology subscale score is 16-112, higher score is indicative of greater symptomatology.",{"measure":24,"description":25,"timeFrame":12},"Change from Baseline in Clinical Global Impression-Severity (CGI-S) score","CGI-S is 0-7 with higher score is indicative of greater symptomatology",{"measure":27,"description":28,"timeFrame":12},"The Incidence of Overall AEs",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":35},"QUADRUPLE",[36,37,38,39],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"LY03020","EXPERIMENTAL","Subjects will take LY03020 from Day 1 to Day 48",[46],"Drug: LY03020",{"label":48,"type":49,"description":50,"interventionNames":51},"Placebo","PLACEBO_COMPARATOR","Subjects will take Placebo from Day 1 to Day 48",[52],"Drug: Placebo",[54,58],{"type":55,"name":42,"description":56,"armGroupLabels":57,"otherNames":28},"DRUG","administered orally",[42],{"type":55,"name":48,"description":56,"armGroupLabels":59,"otherNames":28},[48],[61],{"name":62,"role":63,"phone":64,"phoneExt":28,"email":65},"Yufeng Wang","CONTACT","18665029373","wangyufeng@luye.com",[67],{"facility":68,"status":28,"city":69,"state":28,"zip":28,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Beijing AnDing Hospital Capital Medical University","Beijing","China","CN",{"type":73,"coordinates":74},"Point",[75,76],116.39723,39.9075,{"lat":76,"lon":75},[79],{"name":80,"role":63,"phone":81,"phoneExt":28,"email":82},"Yang Li","15810468016","liyang2007428@hotmail.com",{"type":84,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","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":95,"type":96},160,"ESTIMATED","INTERVENTIONAL",[99],"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.",[102],"Schizophrenia","NOT_YET_RECRUITING","2026-02-02",{"date":106,"type":107},"2026-02-09","ACTUAL",{"date":109,"type":96},"2026-03-31",{"date":111,"type":96},"2027-12-31",{"name":5,"class":6},1]