Schizophrenia
Conditions
Brief 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.
Interventions
DRUGLY03020
administered orally
DRUGPlacebo
administered orally
Sponsors
Luye Pharma Group Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in PANSS Positive subscale score | baseline to week 6 of maintenance treatment | The PANSS Positive subscale score is 7-49, higher score is indicative of greater symptomatology. |
| Change from Baseline in PANSS Negative subscale score | baseline to week 6 of maintenance treatment | The PANSS Negative subscale score is 7-49, higher score is indicative of greater symptomatology. |
| Change from Baseline in PANSS General Psychopathology subscale score | baseline to week 6 of maintenance treatment | The PANSS General Psychopathology subscale score is 16-112, higher score is indicative of greater symptomatology. |
| Change from Baseline in Clinical Global Impression-Severity (CGI-S) score | baseline to week 6 of maintenance treatment | CGI-S is 0-7 with higher score is indicative of greater symptomatology |
| The Incidence of Overall AEs | baseline to week 6 of maintenance treatment | — |
Countries
China
Contacts
CONTACTYufeng Wang
Outcome results
None listed