A Randomized, Double-Blind, Active-Controlled and Placebo-Controlled Phase 2b Clinical Study to Evaluate the Efficacy and Safety of HS-10380 in Chinese Adult Patients With Acute Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 363
- 试验地点
- 1
- 主要终点
- Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42)
研究概览
简要总结
This is a Phase 2b, randomized, double-blind, parallel-group, active-controlled and placebo-controlled, multicenter inpatient study to examine the efficacy and safety of HS-10380 in adult Participants who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of HS-10380 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate the response rate, improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics.
详细描述
This trial is a Phase 2b, randomized, double-blind, parallel-group, active-controlled and placebo-controlled, multicenter inpatient study, aims to further evaluate the efficacy and safety of HS-10380 in participants with acute schizophrenia, who were randomized (2:2:2:1:2) to receive HS-10380 ( Low Dose), HS-10380 (Medium dose), HS-10380 ( High Dose), Aripiprazole, or placebo, with the primary endpoint as the changes from baseline in PANSS total score on D42.
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
- •Participant is aged 18-65 years, inclusive, at screening.
- •Body mass index must be ≥18.0 and ≤40.0 kg/m² at screening.
- •Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria.
- •Participant is experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months before screening.
- •Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening or baseline Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening: Item 1 (P1; delusions)\Item 2 (P2; conceptual disorganization)\Item 3 (P3; hallucinatory behavior)\Item 6 (P6; suspiciousness/persecution).
排除标准
- •Judged by the investigator as having treatment-resistant schizophrenia.
- •Patients with risk of violent or destructive behavior, or suicidal risk.
- •History or presence of clinically significant neuropsychiatric, cardiovascular, urinary, digestive, respiratory, musculoskeletal, metabolic/endocrine, hematological, immune, dermatological, and oncological systems disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
- •Received electroconvulsive therapy within 3 months prior to screening, or received systemic transcranial magnetic stimulation (TMS) therapy within 1 month prior to screening.
- •Used clozapine or long-acting antipsychotic medications within 6 months prior to screening, or within 5 half-lives of long-acting antipsychotic medications at screening, whichever is longer.
- •Previous inadequate response to adequate dose and duration of aripiprazole treatment (≥20 mg/day for at least 6 weeks).
- •History of epilepsy (except febrile convulsions) or neuroleptic malignant syndrome.
- •Any surgical condition or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a risk to trial participants, such as history of gastrointestinal surgery (gastrectomy, gastroenterostomy, bowel resection, etc.), urinary tract obstruction, or dysuria.
- •History of severe allergic reactions.
- •Female patients who are pregnant, in puerperium, or lactating at screening or baseline.
- •History of drug abuse within 1 year prior to screening.
- •History of alcohol abuse within 6 months prior to screening.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
HS-10380 Low Dose
干预措施: HS-10380 Low Dose (Drug)
HS-10380 Medium dose
干预措施: HS-10380 Medium dose (Drug)
HS-10380 High Dose
干预措施: HS-10380 High Dose (Drug)
Aripiprazole
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42)
时间窗: Baseline and Week 6
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
次要结局
- Percentage of Positive and Negative Syndrome Scale (PANSS) Responders (>=40% Change in PANSS Total Score) at Day 42(Baseline and Week 6)
- Change in Marder 5-factor score of the PANSS scale at Day 42 compared with baseline(Baseline and Week 6)
- Change in Calgary Depression Scale for Schizophrenia (CDSS) score at Day 42 compared with baseline(Baseline and Week 6)
- Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 42(Baseline and Week 6)
- Clinical Global Impression-Improvement (CGI-I) Score at Day 42(Week 1 and Week 6)