NCT00645372已完成3 期
A Six Week, Multicenter, Double Blind, Double-Dummy, Parallel, Comparative Study To Compare The Efficacy, Safety And Tolerability Of Ziprasidone With Risperidone In The Treatment Of Chinese Subjects With Acute Exacerbation Of Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2004年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 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
The purpose of this study is to compare the efficacy and safety of ziprasidone and risperidone for the treatment of schizophrenia in Chinese patients
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
- Double (Participant, Investigator)
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
- •Hospitalized patients with schizophrenia
- •Miminum PANSS score of 60 when randomized
排除标准
- •Planned, regular use of antipsyhotics within 1 week of randomization
- •Previous treatment with risperidone that resulted in intolerance or lack of response to risperidone
研究组 & 干预措施
A
Active Comparator
干预措施: Risperidone (Drug)
B
Experimental
干预措施: Ziprasidone (Drug)
结局指标
主要结局
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
时间窗: Week 6
次要结局
- Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score(Weeks 1, 2, 4, and 6)
- Adverse events, laboratory test changes, movement disorder scale scores(Weeks 1, 2, 4, and 6)
- Clinical Global Impression-Severity (CGI-S) score(Baseline and Weeks 1, 2, 4, and 6)
- Clinical Global Impression-Improement (CGI-I) score(Weeks 1, 2, 4, and 6)
- Change from baseline in PANSS negative subscale score(Weeks 1, 2, 4, and 6)
- Change from baseline in PANSS general psychopathology subscale score(Weeks 1, 2, 4, and 6)
- Change from baseline in PANSS positive subscale score(Weeks 1, 2, 4, and 6)
- PANSS responder rate(Weeks 1, 2, 4 and 6)
研究者
研究点 (1)
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