Prospective Observational Study About Progress of Subjective Well-being Sensation in Schizophrenic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Total score in Subjective Well-being under Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment after 6 months vs baseline
研究概览
简要总结
Observational, non-interventional, longitudinal, prospective,multicenter, open label (No treatment is involved). 4 assessment will be carried out , in months 0, 1, 3 and 6. The primary objective is to asses evolution of subjective well-being and depressive symptoms in schizophrenic patients for six months after an acute episode treated in outpatient psychiatric units. The primary endpoint is: Total score in Subjective Well-being under Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment after 6 months vs baseline. Secondary objectives include: To evaluate the relationship between subjective well-being and psychopathology, subjective clinical global impression, adverse events and compliance of treatment. Also to compare the clinical global impression of psychiatrist and patient. In addiction to know the clinical, social and demographic factors involve in the subjective well-being and patient clinical global impression.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written inform consent
- •Diagnosed of Schizophrenia of Schizoaffective Disorder based on DSM-IV-TR
- •With an acute episode or worsening of clinical status. Defined as change in clinical status that need a significant change in therapeutic plan.
- •Able to understand and comply with requirements of the study
排除标准
- •Mental retardation
- •Unstable somatic disease, that is not receiving adequate treatment, based on investigator opinion.
- •To have been recruited in a clinical trial in the last 4 weeks
- •To have planned the inclusion in a clinical trial during the follow-up of this study
结局指标
主要结局
Total score in Subjective Well-being under Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment after 6 months vs baseline
时间窗: Months: 0, 1, 3 and 6
次要结局
- Patient Clinical Impression(Months: 0, 1, 3 and 6)
- Clinical evaluation and social performance(Months: 0, 1, 3 and 6)
- Adverse events reported by patients(Months: 0, 1, 3 and 6)