NCT01160679已完成不适用
Effectiveness of Atypical Antipsychotics on Anhedonic Features in Patients With Schizophrenia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- The change of total score of SHAPS
研究概览
简要总结
This prospective, multi-center, 12 weeks naturalistic NIS trial will be conducted in 25 hospitals in naturalistic treatment setting. There will be no experimental component associated with this study and all observational activities have to be part of routine care visit: baseline (week 0), week 4 and week 12.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented clinical diagnosis of schizophrenia meeting the Diagnostic and Statistical Manual of Mental Disorders,(DSM-IV-TR) criteria
- •Patients who already take one atypical at inclusion it is started at least 1 week and up to 4 weeks before the inclusion
排除标准
- •Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I
- •Patients with antipsychotic combinations (more than two agents)
- •Patients who are already on any mood stabilizers and antidepressant
- •Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrollment
- •Patients who have been treated with antipsychotics in depot formulations for the last two months
- •Previous enrollment or randomisation of treatment in the present NIS
- •Patients who had participated in other clinical trials within 4 weeks prior to enrollment period
- •Pregnant women or women who are breast-feeding
结局指标
主要结局
The change of total score of SHAPS
时间窗: At 12 weeks
次要结局
- Proportion of patients having a score of 1 or 2 in CGI-I score(At 12 weeks)
- Proportion of significantly improved patients in SHAPS total score (more than 30%)(At 12 weeks)
- Changes of Clinical Global Impression (CGI)-Severity score(At 12 weeks)
- The mean change MADRS total score(At 12 weeks)
研究者
研究点 (1)
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