NCT00154258已完成2 期
An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-resistant Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 19
- 主要终点
- Echo cardiogram at every 24 weeks
研究概览
简要总结
Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long term treatment of clozapine in patients with treatment-resistant schizophrenia.
详细描述
Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long term treatment 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
- •Attended the previous Phase IIb (core) study
- •Improved during the core study
- •No safety issues during the core study
排除标准
- •Discontinued the core study
- •Pregnant or nursing (lactating) women
- •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
Echo cardiogram at every 24 weeks
时间窗: Baseline to 52 weeks
Vital signs at every 4 weeks
时间窗: Baseline to 52 weeks
Adverse events during the long term treatment (until NDA approval)
时间窗: Baseline to 52 weeks
Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)
时间窗: Baseline to 52 weeks
ECG at every 12 weeks
时间窗: Baseline to 52 weeks
次要结局
- Changes in the symptoms of psychosis at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks(Baseline to 52 weeks)
- Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks(Baseline to 52 weeks)
研究者
相似试验
已完成
3 期
A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant SchizophreniaSchizophreniaNCT00250575Novartis43
Unknown
4 期
Clozapine Versus Other Atypical Antipsychotics for Bipolar DisorderBipolar DisorderNCT02562287Hospital de Clinicas de Porto Alegre54
已完成
2 期
Clozapine for Treatment-Resistant ManiaBipolar DisorderNCT00029458National Institute of Mental Health (NIMH)42
已完成
4 期
Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I DisorderBipolar DisorderNCT00139594Novartis181
已完成
不适用
Biomarker and Safety Study of Clozapine in Patients With Benign Ethnic Neutropenia (BEN)SchizophreniaNCT02404155University of Maryland, Baltimore274