A Randomized Controlled Multi-center Clinical Study Focusing on Validating and Optimizing Model of Antipsychotics Selection in China
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Change of PSP from Baseline
研究概览
简要总结
This multi-centre study will evaluate the clinical efficacy of 3 atypical antipsychotics treatment in Chinese Patients with Schizophrenia by comparing model-decision with real-world psychiatrist-decision. The three atypical antipsychotics are olanzapine (5-20 milligram per day), risperidone (2-6 milligram per day) and aripiprazole (5-30 milligram per day). The main purpose of this study is to explore the potential difference between modal-aided-decision with clinician-decision in order to validate and optimize the selection model that has been established in advance.
The efficacy evaluations include symptoms, social function, recurrence rate and hospitalization. Visits occurs at 0, 4, 8, 13, 26, 52 weeks.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An in-patient or out-patient (male or female) and aged ≥18 years
- •A diagnosis of schizophrenia, DSM-5 (Diagnostic and Statistical Manual Diploma in Social Medicine-5)
- •Subjects must have the ability to effectively communicate with investigator, complete study related documents, comprehend the key components of the consent form and must provide written informed consent to participate in the study prior to any study specific assessments or procedures.
- •Patients are taking or will take atypical antipsychotics which include olanzapine, risperidone, aripiprazole.
- •Baseline PANSS Total Score ≥70
排除标准
- •Participation in other clinical studies.
- •Known intolerance or lack of efficacy to olanzapine, risperidone or aripiprazole.
- •Use of clozapine within 28 days prior to randomization.
- •Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.
研究组 & 干预措施
non-model
real-world psychiatrist decision
干预措施: non-model (Other)
model
model aided decision
干预措施: model (Other)
结局指标
主要结局
Change of PSP from Baseline
时间窗: 52 weeks
PSP assessment at 52 weeks
次要结局
- Change of PRL from Baseline(52 weeks)
- Number of Participants with abnormal ECG(52 weeks)
- Number of Participants with EPS(52 weeks)
- Change of liver function from Baseline(52 weeks)
- Change of CGI from Baseline(52 weeks)
- Change of CDSS from Baseline(52 weeks)
- Number of Participants with abnormal sexual function(52 weeks)
- Change of PANSS from Baseline(52 weeks)