NCT00999895已完成不适用
A Non-interventional, Prospective, Open-label Study for the Evaluation of the Selection and Outcome of the Antipsychotic Treatment Switch in Outpatients With Schizophrenia - ETOS Study
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
- 574
- 试验地点
- 1
- 主要终点
- CGI-CB scale score of subjects achieving a score of < 4.
研究概览
简要总结
The purpose of the study is to evaluate the outcome of treatment switch defined as an improvement in CGI-CB scale (Clinical Global Impression - Clinical Benefit).
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
- •Diagnosis of schizophrenia (as per DSM-IV), at least 6 months prior to enrolment in the study
- •Subjects who have initiated a new antipsychotic treatment within the preceding 2 weeks
- •Subjects whose prior and current antipsychotic treatment consists of any typical or atypical antipsychotic monotherapy
排除标准
- •Subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from schizophrenia), as per DSM-IV Axis Ι, concomitant organic mental disorder or mental retardation
- •Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria and not in full remission
- •Female subjects who are pregnant or lactating
结局指标
主要结局
CGI-CB scale score of subjects achieving a score of < 4.
时间窗: At Week 18 - once
次要结局
- Change in PANSS scale(Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks)
- Change in BARS scale(Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks)
- Changes in CGI-S and CGI-I scales(Baseline (Day 0) to the end of study treatment (week 6, week 12, week 18) or the premature study withdrawal of the subject - up to 4 times in 18 weeks)
研究者
研究点 (1)
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