Effectiveness of 6 Antipsychotic Drugs in the Treatment of Acute Exacerbations of Chronic Inpatients With Schizophrenia: a Randomized Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
The purpose of this study is to compare the efficacy and side effects of 6 commonly used antipsychotic drugs in the treatment of schizophrenia in a Chinese population.
详细描述
The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared with that of older agents has been incompletely addressed, though newer agents are currently used far more commonly. The investigators compared a first-generation antipsychotic, perphenazine or haloperidol, with several newer drugs in a double-blind study.
METHODS: A total of 550 patients with schizophrenia were recruited at 4 Chinese sites and randomly assigned to receive perphenazine (16 to 64 mg per day) or haloperidol(6 t0 20mg per day), olanzapine (5 to 20 mg per day), quetiapine (400 to 750 mg per day), aripiprazole (10 to 30 mg per day) or risperidone (2 to 6.0 mg per day) for up to 8 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' diagnoses is based on the results of the Structured Clinical Interview for DSM (SCID) using the criteria of the fourth edition of the Diagnostic and Statistical Manual (DSM-IV), physical exams and routine chemistry, and hematology laboratory tests. Attending-level psychiatrists will use a Chinese translation of the SCID to interview patients and their family members, who are given freedom to ask additional questions if respondents do not understand the standard probes.
- •Patients must meet the following criteria: (1) diagnosis of schizophrenia; (2) duration of illness more than 2 years; (3) between 25 and 60 years of age; and (5) have NOT received antipsychotic medication for at least 1 month;(6) acute exacerbations of chronic inpatients.
- •A complete medical history, electroencephalograms and electrocardiogram are obtained, and a physical examination and laboratory tests are performed at study entrance. None of the study participants have abnormal findings on these tests.
排除标准
- 未提供
研究组 & 干预措施
Typical antipsychotic
Haloperidol (6~20mg/day) and perphenazine (16~64mg/day) for 8 weeks.
干预措施: Typical antipsychotic (Drug)
Risperidone
Risperidone, 2~6mg/day, twice day, 8 weeks
干预措施: Risperidone (Drug)
Olanzapine
5~20mg/day
干预措施: Olanzapine (Drug)
Quetiapine
400~750mg/day
干预措施: Quetiapine (Drug)
Aripiprazole
Aripiprazole, 10~30mg/day, twice per day, 8 weeks
干预措施: Aripiprazole (Device)
Ziprasidone
Ziprasidone, 80~160mg/day, twice per day, 8 weeks
干预措施: Ziprasidone (Drug)
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
时间窗: Baseline, 8 weeks
次要结局
- Clinical Global Impression (CGI)(Baseline, 8 weeks)
研究者
Xiang Yang Zhang
Director, the Research Center
Beijing HuiLongGuan Hospital