Testing LY03020 for Adults With Schizophrenia During Acute Psychosis
Tests LY03020 against a placebo in adults with acute schizophrenia symptoms.
Plain-language title generated from the registry record
Registry title: A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07396870, who can take part
Where in China
- Beijing Anding Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Luye Pharma Group Ltd.
- Trial code
- NCT07396870
- Record updated
- 9 February 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Subjects and their guardians sign informed consent voluntarily; Male or female subject aged 18 to 65 years (inclusive); Subject meets DSM-5 criteria for schizophrenia and confirmed using the Mandarin for China Translation Version 7.0.2); 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; 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; Subject must have a CGI-S score ≥ 4 at screening and baseline.
Exclusion: Subject has received electroconvulsive therapy treatment within 3 months prior to screening or is expected to require ECT during the study; 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/baseline; History or presence of the following treatments:; Within 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; - Subject who has a history or presence of symptoms consistent with a major psychiatric disorder other than schizophrenia as defined by DSM-5; Subject who has a history or presence of symptoms consistent with neuroleptic malignant syndrome (NMS); Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma; Subjects with a history of orthostatic hypotension or syncope; 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 <50 beats per minute (bpm) and the abnormality has clinical significance according to the researchers' assessment at screening/baseline; or QTc >450 ms (male) / QTc >460 ms (female) based on Fridericia's formula-corrected measurements and the abnormality has clinical significance according to the researchers' assessment at screening/baseline; According to the investigator's assessment, subject has a treatment-resistant schizophrenia.