NCT00224315已完成4 期
Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial
Central Institute of Mental Health, Mannheim2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2003年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- PANSS, SANS, HAMD, GAF, CGI, QTc
研究概览
简要总结
We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.
详细描述
Partial response of schizophrenic psychoses to a monotherapy with clozapine is a frequent problem of clinical psychiatry. Current problems are treatment resistant positive and/or negative symptoms, as well as side effects. Therefore, different strategies of augmentations have been applied. Based on successful experiences in case reports and results of other work groups, we aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment resistant schizophrenic or schizoaffective disorder under therapy with clozapine,
- •Age between 18 and 70,
- •Informed consent
排除标准
- •No informed consent,
- •Intolerance with respect to ziprasidone or risperidone,
- •Contraindications with respect to these substances,
- •Gravidity or missing anticonceptive safety
- •Substance dependance (excluded nicotin)
结局指标
主要结局
PANSS, SANS, HAMD, GAF, CGI, QTc
次要结局
- Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate
研究者
研究点 (2)
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