NCT00534222已完成不适用
Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect
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
- 387
- 试验地点
- 1
研究概览
简要总结
With this observational study we want to examine if the intensity of agitation, the intensity of psychotic symptoms and the presence of sleeping disorder predict the success of the treatment with a atypical antipsychotic after 12 weeks of treatment with patients with a psychotic and/or manic episode. In this study it will be examined what the percentage of patients with a 2-point improvement at the CGI-scale is. Of these group, the responders, retrospective the profile of the responders will be analysed (key-factors and confounders).
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
- 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 a manic episode or patients diagnosed with schizophrenia (psychotic episode)
- •Patients who start a treatment with an atypical antipsychotic : quetiapine, olanzapine or risperidone
- •Patients who are prepared to consent to make the coded data available to AstraZeneca
- •Patients with a CGI ≥ 4
排除标准
- •Patients with a serious underlying disease (including renal or hepatic insufficiency, cancer, cardiovascular diseases and suchlike).
- •Contra-indications for quetiapine, olanzapine or risperidone according to the SmPC for these products
- •Patients unable to give informed consent according to the attending physician
研究者
研究点 (1)
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