NCT07396870尚未招募2 期
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
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •- 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.
研究组 & 干预措施
LY03020
Experimental
Subjects will take LY03020 from Day 1 to Day 48
干预措施: LY03020 (Drug)
Placebo
Placebo Comparator
Subjects will take Placebo from Day 1 to Day 48
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score
时间窗: baseline to week 6 of maintenance treatment
The total score is 30-210, higher score is indicative of greater symptomatology.
次要结局
- Change from Baseline in PANSS Positive subscale score(baseline to week 6 of maintenance treatment)
- Change from Baseline in PANSS Negative subscale score(baseline to week 6 of maintenance treatment)
- Change from Baseline in PANSS General Psychopathology subscale score(baseline to week 6 of maintenance treatment)
- Change from Baseline in Clinical Global Impression-Severity (CGI-S) score(baseline to week 6 of maintenance treatment)
- The Incidence of Overall AEs(baseline to week 6 of maintenance treatment)
研究者
研究点 (1)
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