NCT00750087已完成不适用
Non-interventional Study to Observe Treatment Efficacy in Maintaining Symptoms Control in Patients With Schizophrenia, Treated With Seroquel XR
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
- 578
- 试验地点
- 1
- 主要终点
- Brief Psychiatric Rating Scale - BPRS
研究概览
简要总结
the primary purpose of the study is to observe symptoms control in schizophrenia for 6 months in patients treated with Seroquel XR.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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
- •Patients will have a diagnosis of schizophrenia , as defined by DSM-IV-TR and their symptoms are controlled with Seroquel XR therapy started approximately 1 month before
- •All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.
排除标准
- •All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study.
- •As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.
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 - CGI -S(monthly/ at every clinic visit- 7 times)
- Clinical Global Impression Improvement CGI -I(monthly/ at every clinic visit except first visit- 6 times)
- Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF)(twice/first and last clinic visit)
研究者
研究点 (1)
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