NCT00645515终止3 期
Ziprasidone Versus Risperidone In The Treatment Of Chronic Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study
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 240 人开始时间: 2003年6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
- 终止
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
研究概览
简要总结
The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia
- •CGI-S score of 4 or less at baseline
排除标准
- •Concurrent antipsychotic treatment
- •Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
- •Acute exacerbation of schizophrenia within 3 months of baseline
研究组 & 干预措施
Arm A
Experimental
干预措施: Ziprasidone (Drug)
Arm B
Active Comparator
干预措施: Risperidone (Drug)
结局指标
主要结局
Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
时间窗: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
次要结局
- Laboratory tests and electrocardiogram at Week 24(Screening and Week 24)
- Change from baseline in cognitive function assessment at Weeks 4 and 24(Day 1 and Weeks 4 and 24)
- Change from baseline in Patient Preference Scale (PPS) at Weeks 4, 10, 12, 16, and 24(Day 1 and Weeks 4, 10, 12, 16, and 24)
- Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24(Day 1 and Weeks 1, 4, 12, 16, and 24)
- Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24(Day 1 and Weeks 1, 4, 12, 16, and 24)
- Clinical Global Impressions-Improvement (CGI-I) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24(Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24)
- Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores at Weeks 3, 4, 6, 10, 12, 16, and 24(Day 1 and Weeks 3, 4, 6, 10, 12, 16, and 24)
- Adverse events on Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24(Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24)
- Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24(Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24)
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores and negative subscale scores at Weeks 4, 10, 12, 16, and 24(Day 1 and Weeks 4, 10, 12, 16, and 24)
- Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movements Scale (AIMS) scores at Weeks 4, 10, 12, 16, and 24(Day 1 and Weeks 4, 10, 12, 16, and 24)
研究者
研究点 (1)
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