MAintain the Efficacy and Safety in Treatment of Schizophrenia After Switching to Long-acTing Injectable aRipiprazole From Oral Atypical Antipsychotics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 27
- 主要终点
- PANSS total score
研究概览
简要总结
Interventional, multicenter, open-label, 20 weeks study
- To identify efficacy and safety in switching from oral aripiprazole to Abilify Maintena.
- To identify efficacy and safety in switching from oral atypical antipsychotics other than aripiprazole to Abilify Maintena
详细描述
We would like to evaluate the efficacy and safety when switching to Abilify Maintena according to the approved indication of Abilify Maintena, for subjects who are taking oral antipsychotic drugs. It is expected that this will serve as a basis for suggesting a successful switching guideline from oral antipsychotics to Abilify Maintena, which can be applicable in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
Schizophrenia patients who are taking oral aripiprazole will be switched to Abilify maintena
干预措施: Abilify maintena (Drug)
Group 2
Schizophrenia patients who are taking other oral atypical antipsychotics will be switched to Abilify maintena
干预措施: Abilify maintena (Drug)
结局指标
主要结局
PANSS total score
时间窗: 16 weeks
Change in PANSS total score from baseline to Week 16
次要结局
- CGI-S(16 weeks)
- CGI-I(16 weeks)
- PANSS positive and negative subscale score(16 weeks)
- IAQ score(16 weeks)