NCT00245674已完成4 期
Solian Solution to Treat Schizophrenic Patients During an Acute Episode
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- *analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.
研究概览
简要总结
During this study the efficacy and safety profile will be evaluated of the use of amisulpride in the form of a solution in schizophrenic patients with an acute episode.
The main purpose of the study is to observe the anti-psychotic effect of amisulpride as a solution during the first days of an acute episode of schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •schizophrenic in-patients with an acute episode
- •aged between 18 and 65 years
- •written informed consent
排除标准
- •pregnancy and breast-feeding
- •breast cancer, prolactinoma, pheochromocytoma
- •hypersensitivity to amisulpride or one of the other excipients
- •contra-indications when using amisulpride as per the SmPC
结局指标
主要结局
*analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.
次要结局
- *analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.
研究者
研究点 (1)
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