NCT00331981已完成4 期
Study of the Efficacy and Safety After Long-Term Treatment With Amisulpride in Schizophrenic Patients
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
- 138
- 试验地点
- 2
- 主要终点
- PANSS scores
研究概览
简要总结
Primary purpose:
- To find out how effective is long term treatment with amisulpride on the positive and negative symptoms in schizophrenic patients
- To find out how safe is long term treatment with amisulpride in schizophrenic patients
Secondary purpose:
- To find out how effective is long term treatment with amisulpride on the quality of life in schizophrenic patients
- To find out how effective is long term treatment with amisulpride on the cognitive function in schizophrenic patients
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as schizophrenia or schizophrenic disorder according to DSM-IV
- •Patients who need new anti-psychotic drugs or need to change the medication due to aggravations of symptoms or recurrence
排除标准
- •Patients with positive symptoms in whom the disorder does not correspond to schizophrenic criteria. (e.g, schizoaffective disorder)
- •Patients hypersensitive to the active ingredient or to other ingredients of the study drug
- •Prolactin-dependant tumors, pituitary gland prolactinomas and breast cancer
- •Pheochromocytoma or Parkinson's disease
- •Pregnancy or breast feeding
- •Current or recently withdrawn from drug abuse or alcoholism
- •Chronic renal failure and other internal or surgical disease which physician decides will be worsened by trial medication or that will affect the metabolism or effects of the trial medication
- •Patients with previous histories and clinical improvement was not seen in spite of treatment with 2 anti-psychotics for over 8 weeks
- •Slow heart rate of <55bpm, low blood potassium level, congenital prolongation of the QT interval
- •Current treatment with a drug likely to cause markedly slow heart rate(<55bpm), low blood potassium level, slowing of intercardiac condition or prolongation of the QT interval
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
PANSS scores
时间窗: at every visit
次要结局
未报告次要终点
研究者
研究点 (2)
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