NCT00250575已完成3 期
A 24-week, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Values of hematological tests during the 24 week treatment
研究概览
简要总结
Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.
This study is not recruiting in the United States.
详细描述
Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as schizophrenia
- •Not responded to at least two atypical antipshychotics launched in Japan
- •Inpatient
排除标准
- •Low white blood cell count
- •Significant heart diseases
- •Diabetes mellitus
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
干预措施: Clozapine (Drug)
结局指标
主要结局
Values of hematological tests during the 24 week treatment
Incidence of hematological adverse events during the 24 week treatment
Compliance to Clozapine Patient Monitoring System during the 24 week treatment
次要结局
- Changes in the symptoms of psychosis every 4 weeks up to week 24
- Global change in severity of psychosis at baseline and week 12
- Global impression of change in the condition of patients at week 12 and 24
研究者
研究点 (2)
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