NCT00981123已完成不适用
Non-interventional Study to Observe Efficacy and Usage of Quetiapine in Acute Episodes of Schizophrenia and as Maintenance Therapy Following Standard Clinical Practice in Croatia
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
- 500
- 试验地点
- 1
- 主要终点
- To assess severity of illness and global improvement in patients after 6 months of quetiapine therapy using Clinical Global Impression (CGI) scale
研究概览
简要总结
Observational, non-comparative, epidemiological study to collect and analyse real life data on schizophrenic patients receiving quetiapine according to the standard medical practice in Croatia. The main objectives are to assess after 6 months of quetiapine therapy severity of illness and global improvement in patients using Clinical Global Impression (CGI) scale.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of schizophrenia
- •Patients who are already treated with quetiapine for at least 12 weeks (outpatients or hospitalised patients)
- •Patients capable of signing ICF
排除标准
- •Patients with hypersensitivity to active substance or any of the excipients of this product
- •Patients with contraindication for quetiapine therapy according to the approved SmPC
结局指标
主要结局
To assess severity of illness and global improvement in patients after 6 months of quetiapine therapy using Clinical Global Impression (CGI) scale
时间窗: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)
次要结局
- To measure therapeutic response in schizophrenic patients using BPRS scale(BPRS - 2 measures (after 3 and after 6 months of quetiapine therapy))
- To evaluate compliance with the prescribed antipsychotic treatment(CGI - 2 measures (after 3 and after 6 months of quetiapine therapy))
- To evaluate prescribing practices for quetiapine in the treatment of schizophrenia in Croatia(3 measures (at the time of quetiapine therapy introduction, after 3 and 6 m of quetiapine therapy))
- To evaluate type and frequency of concomitant therapy(At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in concomitant therapy)
- To evaluate average number of hospitalisations(At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in numbers of hospitalisations)
- To evaluate frequency of mental illnesses in patient's family(at visit 1 (day 0))
研究者
研究点 (1)
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