NCT00723606已完成3 期
A Randomized, Open Label, Rater Blind, Flexible Dose Multi-Center Study Comparing The Efficacy And Safety Of Intramuscular Ziprasidone With Haloperidol For Three Days In Patients With Agitation 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 376 人开始时间: 2008年9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
- 376
- 试验地点
- 1
- 主要终点
- Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours
研究概览
简要总结
This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia
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
- None
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
- •Male or female Chinese subjects aged 18-65 years (including 65) at screening.
- •Subjects meeting the ICD-10 (Classification of Mental and Behavioral Disorders) criteria for schizophrenia (F20.X).
- •Subjects who are in acute phase of schizophrenia and are appropriate to receive intramuscular medication for at least 3 days
排除标准
- •History of clinically significant physical illness especially myocardial infarction, non compensatory heart failure etc.
- •Subjects receiving an investigational agent in the previous 3 months prior to screening.
- •Use of antipsychotic agents within 12 hours or parenteral benzodiazepines within 4 hours prior to randomization and during the study.
研究组 & 干预措施
Intramuscular ziprasidone
Experimental
干预措施: Intramuscular ziprasidone mesylate (Drug)
Intramuscular haloperidol
Active Comparator
干预措施: Intramuscular haloperidol (Drug)
结局指标
主要结局
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours
时间窗: Baseline, 72 hours
BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. Change: score at final visit minus score at baseline.
次要结局
- BPRS Agitation Subscale Response at 72 Hours(72 hours)
- Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours(Baseline, 72 hours)
- Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours(Baseline, 72 hours)
- Change From Baseline in BPRS Agitation Subscale Score at 72 Hours(Baseline, 72 hours)
- Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours(72 hours)
研究者
研究点 (1)
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