A Non-interventional Study Evaluating the Clinical Benefit and Effectiveness of Quetiapine Fumarate Extended-Release Tablets (SEROQUEL XRâ) in Subjects With Schizophrenia-An Observational, Multicentric Prospective Study

AstraZeneca1 个研究点分布在 1 个国家目标入组 1,494 人开始时间: 2009年7月最近更新: 2010年3月12日

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: 1,494
试验地点: 1
主要终点: Change from baseline of the Clinical Global Impression score - Clinical Benefit Scale (CGI-CB) after 2 months of treatment with Seroquel XR

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of this NIS is to assess the clinical benefit subjects derive from taking seroquel XR, using the CGI-CB. The secondary objective is to assess the effectiveness,safety and tolerability of seroquel XR tablets.

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 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosed as Schizophrenia according to DSM-IV-TR criteria
•Patients who are taking Seroquel XR no longer than 1 month
•Patients who get antipsychotics monotherapy at least 1 week before enroll in this study

排除标准

•First episode, drug naive schizophrenic subjects.
•Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I diagnosis,concomitant organic mental disorder or mental retardation that in the opinion of the Principal Investigator may interfere with study conduct or interpretation.
•Known lack of response to clozapine or treatment with clozapine within 4 weeks prior to enrollment.

结局指标

主要结局

Change from baseline of the Clinical Global Impression score - Clinical Benefit Scale (CGI-CB) after 2 months of treatment with Seroquel XR

时间窗: 8 weeks

次要结局

CGI-I score's change from 7th day to 8weeks(8 weeks)
Patients' ratio who've been improved CGI-S score more than 4, from baseline to 8weeks(8 weeks)

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (1)

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