Non-interventional Clinical Study to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia, Treated With Atypical Antipsychotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- To compare improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the Seroquel SR-treated group.
研究概览
简要总结
The purpose of the study is to monitor the general functional changes among patients with schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6 months.The primary study objective is to compare general functioning of patients with schizophrenia treated with Seroquel SR between baseline and the last study visit. The secondary study objectives are to compare general functioning of patients with schizophrenia treated with other atypical antipsychotic medicinal products administered once daily between baseline and the last study visit, monitoring of other indicators of clinical improvement, evaluation of patient compliance and assessment of occurrence of adverse effects
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients have a diagnosis of schizophrenia, as defined by DSM-IV-TR
- •patients' symptoms are controlled with Seroquel SR started up to 1 month before the inclusion
- •or patients' symptoms are controlled with other atypical antipsychotic in once daily formulation started up to 1 month before the inclusion
排除标准
- •patients who are treated with Seroquel SR or other antipsychotic more than 1 month
- •patients with prescribed antipsychotic combinations
- •pregnant women or women who are breast-feeding
- •patients who have been treated with antipsychotics in depot formulations for the last two months
结局指标
主要结局
To compare improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the Seroquel SR-treated group.
时间窗: three times: 0, 12 and 24 weeks after inclusion
次要结局
- To assess improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the group of patients treated with other atypical antipsychotics(three times: 0, 12 and 24 weeks after inclusion)