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临床试验/NCT00934726
NCT00934726已完成不适用

Patient Satisfaction and Quality of Life Under Treatment With Seroquel XR

AstraZeneca0 个研究点目标入组 150 人开始时间: 2009年7月最近更新:
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
150
主要终点
Subject wellbeing under Neuroleptics scale (Quality of Life)

研究概览

简要总结

Since subjective well-being and quality of life (QoL) are increasingly being recognized as important treatment outcomes in patients with schizophrenia (Hofer et al., 2004; Becker et al., 2005), the aim of this study is to investigate the effect of treatment with quetiapine XR on these parameters in the acute hospital and the subsequent ambulant care setting. The study is planned to be conducted in 15 centers all over Austria and, overall, about 150 inpatients with a ICD-10 diagnosis of acute schizophrenia are planning to be enrolled. The duration of the whole trial will be approximately 4 months, whereas 2 visits during hospitalization and two further visits after discharge will be scheduled. At each visit, adverse events and safety parameters, patient satisfaction and effectiveness of the current treatment, as well as concomitant medication and dosing schedules will be assessed and documented.In addition to that, the patients' overall satisfaction with antipsychotic therapy and their current quality of life will be determined using a QoL questionnaire, focussing on the subjective experience with quetiapine XR.

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

入选标准

  • Adult schizophrenia patients
  • Inclusion according to Summary of product characteristics

排除标准

  • Diagnosis other than schizophrenia
  • Patients for which Seroquel XR is not registered (pregnant women, children and adolescents...)

结局指标

主要结局

Subject wellbeing under Neuroleptics scale (Quality of Life)

时间窗: 4 months

次要结局

  • BPRS (Brief Psychiatric Rating Scale)(4 months)
  • CGI (Clinical Global Impression)(4 months)
  • All adverse events occurring during the study will be documented(4 months)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

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