NCT00921362已完成不适用
Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme
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
- 1,387
- 主要终点
- Brief Psychiatric Rating Scale - BPRS
研究概览
简要总结
Patients eligible for entry into the study have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature.The primary purpose of the study is to observe symptoms changes over 6 months in schizophrenia in patients treated with Seroquel; additionally disease severity and treatment compliance are followed
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To assess at baseline and after treatment administration the severity of the illness in patients with schizophrenia, using the scores obtained after the application of the CGI scale
- •To assess the changes in symptoms of patients treated with Seroquel for 24 weeks, using BPRS (Brief Psychiatry Rating Scale) as measuring tool
排除标准
- •All the patients who have a known hypersensitivity to Seroquel /quetiapine or any of its excipients will not be included in this study.
结局指标
主要结局
Brief Psychiatric Rating Scale - BPRS
时间窗: Monthly at every clinic visit- 7 times
次要结局
- Clinical Global Impression Severity of Illness(Monthly/ at every clinic visit-7 times)
- CGI-S Clinical Global Impression Improvement CGI -I(Monthly/ at every clinic visit except first visit- 6 times)
研究者
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