NCT00436371已完成4 期
The Use of Amisulpride in Schizophrenic Acute Phase Patients.
适应症
干预措施
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
- 50
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
To collect the safety and response of using Amisulpride in acute 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed as Diagnostic and Statistical Manual of Mental Disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode
排除标准
- •Patients previously treated with amisulpride
- •Patients have comorbidity which may interfere with the treatment or follow-up
- •Patients currently taking depot antipsychotics (at least 30 days washout period is needed)
- •Patients currently/ or recently (< 3 months) withdrawn from drug or alcohol abuse
- •Pregnant or lactation
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
Amisulpride 400-800mg per day on a twice-a-day regimen
干预措施: Amisulpride (Drug)
结局指标
主要结局
Adverse events
时间窗: all across the study
次要结局
- Clinical Global Impressions(All accross the study)
- Patient compliance(all across the study)
- Percentage of patient completing treatment(all across the study)
- Changes in body weight(At baseline and day 84)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
SOLIACS: Solian Solution in the Acute SettingSchizophreniaNCT00245674Sanofi300
已完成
4 期
Effectiveness and Safety of Amisulpride in Chinese Patients With SchizophreniaSchizophreniaNCT01795183Sanofi316
已完成
4 期
Amisulpride Augmentation in Clozapine-unresponsive SchizophreniaSchizophreniaNCT01246232Imperial College London69
撤回
不适用
Clozapine Versus Amisulpride in Treatment-resistant Schizophrenia PatientsTreatment Resistant DisordersSchizophreniaNCT01448499Geha Mental Health Center
已完成
不适用
Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar DisorderSchizophreniaBipolar DisorderNCT00216723Korea Otsuka Pharmaceutical Co., Ltd.3,000