NCT00617214终止不适用
Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Non-interventional Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Subjective Well-Being measured via SWN patient questionnaire
研究概览
简要总结
Purpose of this non-interventional study (NIS) is to assess the effect of the participation in an integrated care program on treatment outcomes in patients treated with Seroquel for schizophrenia.
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
- •Outpatients suffering from schizophrenia, schizoaffective disorder, schizophreni-form disorder, delusional disorder or psychotic disorder not otherwise specified
- •Age 18 - 65 years
- •Current stable treatment with Seroquel according to SmPC since at least 2 months
- •Given consent to take part in an integrated care program prior to study startWritten informed consent to take part in this NIS
排除标准
- •Presence of any contraindication as described in the SmPC
- •Cancellation of participation in the integrated care program
结局指标
主要结局
Subjective Well-Being measured via SWN patient questionnaire
时间窗: 6 month period of observation,4 assessments
次要结局
- Quality of Life and patient's satisfaction measured by Q-LES-Q-18 and CSQ-8(6 month period of observation, 1 assessment at end of NIS)
- Symptomatic and functional outcome measured by CGI-S, PANSS-8, GAF, EQ-5D and VOI(6 month period of observation, 4 assesments)
- Compliance and health economic aspects measured by MARS, days of hospitalization, productivity loss(6 month period of observation, 4 assesments)
研究者
研究点 (1)
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