Clinical Trials in China / NCT07396870
Starting soon
Phase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia
NCT07396870 · tracked via the Priya Life Science China tracker
Condition(s) studied
Schizophrenia
Investigational drug(s) / intervention(s)
LY03020 →Placebo
LY03020: administered orally
Placebo: administered orally
Study summary
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.
Eligibility
Inclusion Criteria:
* 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 Criteria:
* \- Subject who has a history or presence of symptoms consistent with a major psychiatric disorder other than schizophrenia as defined by DSM-5;
* According to the investigator's assessment, subject has a treatment-resistant schizophrenia;
* Subject who has a history or presence of symptoms consistent with neuroleptic malignant syndrome (NMS);
* 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;
* 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;
* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma;.
* Subjects with a history of orthostatic hypotension or syncope.
Primary outcome measure(s)
- Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score — baseline to week 6 of maintenance treatment
The total score is 30-210, higher score is indicative of greater symptomatology.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing AnDing Hospital Capital Medical University | Beijing | China |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07396870 on ClinicalTrials.gov ↗ ← All trials in China