A Naturalistic Observational Study to Evaluate Efficacy of 2nd-generation Antipsychotics and Remission Status for Patients With Schizophrenia / Schizoaffective Disorder
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 490
- 试验地点
- 1
- 主要终点
- CGI-Severity of illness (CGI-SI)
概览
简要总结
The objective of this study is to evaluate under routine clinical setting the efficacy and remission status from treatment of 2nd-generation antipsychotic in patients who is upon acute episode or not achieving remission under regular treatment from schizophrenia/schizoaffective disorder. This study will collect in real-life practice the severity of schizophrenia by Clinical Global Impression (CGI), also evaluate the criteria of schizophrenia remission applying 8 items of Positive and Negative Syndrome Scale (PANSS) from Andresen working group, the Montgomery and Asberg Depression Rating Scale (MADRS), and the Global Assessment of Functioning Scale (GAF). Side effect of movement disorder will be evaluated by Drug Induced Extrapyramidal Symptoms Scale (DIEPSS). Tolerability for treatment will be monitored by documenting spontaneous reports on adverse events as well as change in body weight.
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
- •Patients with acute episode (first or relapse), or upon revisit and identified not achieving remission of schizophrenia or schizoaffective disorder (according to remission criteria of schizophrenia)
- •Male or female aged between 18 and 65 years
- •Patients recruited from both in-patient and out-patient clinics
- •Patients who are cooperative, by judgment from investigators, and the use of oral antipsychotic considered adequate
排除标准
- •Pregnancy or lactation
- •Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- •Known intolerance, lack of response, or contraindication to prescribed atypical antipsychotic, as judged by the investigator
- •Administration of a depot antipsychotic injection within one dosing interval (for the depot) before enrolment and patients prescribed with clozapine within 3 months prior to enrolment
结局指标
主要结局
CGI-Severity of illness (CGI-SI)
时间窗: Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4)
次要结局
- CGI-Degree of change (CGI-DC)(Visit 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4))
- MADRS, GAF, DIEPSS(Visit 1(Day 0), 2(Day 3), 3(Week 1), 4(Week 2), 5(Week 4))
- Remission status(Visit 1(Day 0), 5(Week 4))