Atypical Antipsychotics in the Treatment of Affective Symptoms of Schizophrenia in Hungary.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,153
- 试验地点
- 1
- 主要终点
- Change from baseline on clinical global impression scale up to 6 months of schizophrenic outpatients with affective symptoms.
研究概览
简要总结
This is a noninterventional observational study lead amongst psychiatrists, to assess the the overall status of schizophrenic outpatients with affective symptoms treated with atypical antipsychotics.
详细描述
Atypical antipsychotics in the treatment of affective symptoms of schizophrenia in Hungary
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
- 否
入选标准
- •Schizophrenic outpatients diagnosis based on DSM -IV above 18 years of age with affective symptoms.
- •Atypical antipsychotic treatment at least for a month before study inclusion.
排除标准
- •Pregnancy.
- •Hepatic disease.
- •Diabetes mellitus.
- •Severe cerebro- or cardiovascular disease.
结局指标
主要结局
Change from baseline on clinical global impression scale up to 6 months of schizophrenic outpatients with affective symptoms.
时间窗: 3 and 6 months
The Clinical Global Impression Scale (CGI) is a brief clinician-rated instrument. The CGI severity of illness measure (CGI-S) is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The CGI global improvement measure (CGI-I) is rated from 1 (very much improved) to 7 (very much worse). "0" stands for "not assessed". Means and standard deviations (SD) for CGI-S(baseline), CGI-S (1.visit) CGI-S (2.visit) and for CGI-I will be calculated.
次要结局
- Description of the relation between and the change of affective symptoms and overall clinical status.(3 and 6 months)
- Assessment of the efficacy of different atypical antipsychotics in the treatment of schizophrenia with affective symptoms measured by the difference in Raskin Scale.(From baseline up to 6 months)
- Assessment of the efficacy of different atypical antipsychotics in the treatment of schizophrenia with affective symptoms measured by the difference in CGI-S (CGI severity of illness measure) and CGI-I (CGI global improvement measure).(From baseline up to 6 months)