NCT00689325已完成不适用
A Non-interventional Study Evaluating Well-being/Quality of Life in Schizophrenic Patients Treated With Seroquel XR® (Quetiapine) and Other Atypical Antipsychotics.A 9-month, Observational, Multicentric Prospective Study.
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
- 158
- 试验地点
- 1
- 主要终点
- Subjective Wellbeing under Neuroleptics' SWN-K-score; Change from baseline of QoL assessed by the SWN-K after 9 months of treatment with atypical antipsychotics.
研究概览
简要总结
To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with atypical antipsychotics.
研究设计
- 研究类型
- Observational
- 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
- •Diagnosis of schizophrenia
- •Treatment with one atypical antipsychotic* (for a first/new episode or a switch of therapy) for at least 2 weeks and maximum 8 weeks prior to the first study visit.
- •Patient takes an AAP according to local SPC and current medical practice
- •The patient must be able to understand and comply with the study requirements as judged by the investigator, e.g. patient must be able to read and write
排除标准
- •Treatment with an additional AAP or AP to the initial prescribed AAP within the 2-8 weeks before the patient is included in the study
- •Since the use of clozapine is limited, due to, among other things, the risk for agranulocytosis, patients on treatment with this '2nd line'AAP are excluded.
- •Previous enrolment or treatment in the present NIS
- •Known allergy to the prescribed AAP or any of its substances
结局指标
主要结局
Subjective Wellbeing under Neuroleptics' SWN-K-score; Change from baseline of QoL assessed by the SWN-K after 9 months of treatment with atypical antipsychotics.
时间窗: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
次要结局
- Positive And Negative Syndrome Scale-PANSS-8score(At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation)
- Global Assessment of Functioning 'GAF' scale(At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation)
- Disease insight; G-12 item of PANSS(At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation)
研究者
研究点 (1)
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