An Observational Study on Atypical Antipsychotics Long-term Treatment Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Number of Participants with abnormal ECG
研究概览
简要总结
This multi-centre study will evaluate the safety and related factors study of atypical antipsychotics long-term treatment in Chinese Patients with Schizophrenia. The atypical antipsychotics include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine. This is an open, cohort, multi-center observational clinical study. The main purpose is to evaluate the safety. And the second purpose is to evaluate the efficacy of atypical antipsychotics. The efficacy evaluations include symptoms, social function, recurrence rate and hospitalization. This study belongs to IV period post-marketing drugs research. Planned sample size is 3000 cases.
Visits occurs at 0,4,8,13,26,52,78,104,130 and 156 weeks. The main indexes include physical examination, vital signs, abdominal circumference , laboratory tests (blood cell analysis/ blood biochemical tests / prolactin (PRL) / thyroxine, etc.), adverse events, 12-lead electrocardiogram( ECG), extrapyramidal syndrome(EPS )assessment, sexual function evaluation, medication and other subjective feelings. The second indexes include scales of Positive and Negative Syndrome Scale(PANSS)，Clinical Global Impression-severity of Illness Scale(CGI-S), Calgary Depression Scale for Schizophrenia(CDSS),Personal and Social Performance Scale(PSP), the MOS 36 一 item Short Form Health Survey(SF-36), relapse rate, drug consolidation, medical-related expenses, income, drug plasma concentration and genetic information.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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-IV(Diagnostic and Statistical Manual Diploma in Social Medicine-IV)
- •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 quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine
排除标准
- •Participation in other clinical studies.
- •Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.
结局指标
主要结局
Number of Participants with abnormal ECG
时间窗: at 156 weeks
ECG examination at 156 weeks
Change from Baseline liver function
时间窗: at 156 weeks
Measure blood biochemical tests at 156 weeks
Change from Baseline thyroxine
时间窗: at 156 weeks
thyroxine laboratory tests at 156 weeks
Change from Baseline Systolic Blood Pressure
时间窗: at 156 weeks
Measure blood pressure at 156 weeks
Change from Baseline PRL
时间窗: at 156 weeks
Measure PRL level at 156 weeks
Number of Participants with EPS
时间窗: at 156 weeks
EPS assessment at 156 weeks
Number of participants with abnormal sexual function
时间窗: at 156 weeks
sexual function evaluation medication at 156 weeks
次要结局
- Change from Baseline deduction of CGI-S(at 156 weeks)
- Change from Baseline deduction of PANSS(at 156 weeks)
- Change from Baseline deduction of PSP(at 156 weeks)
- Change from Baseline deduction of CDSS(at 156 weeks)