NCT00347425已完成3 期
A Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 122
- 主要终点
- Successful switch defined as those who complete the 4 weeks core study with no worsening of 2 successive post baseline assessments on the CGIS, exacerbation of EPS, or cardiovascular risk factors (body weight and fasting triglycerides) from baseline.
研究概览
简要总结
The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated
排除标准
- •Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria
研究组 & 干预措施
A
Other
干预措施: Aripiprazole (Drug)
A
Other
干预措施: Olanzapine (Drug)
A
Other
干预措施: Risperidone (Drug)
A
Other
干预措施: Quetiapine (Drug)
A
Other
干预措施: Ziprasidone (Drug)
B
Other
干预措施: Aripiprazole (Drug)
B
Other
干预措施: Olanzapine (Drug)
B
Other
干预措施: Risperidone (Drug)
B
Other
干预措施: Quetiapine (Drug)
B
Other
干预措施: Ziprasidone (Drug)
结局指标
主要结局
Successful switch defined as those who complete the 4 weeks core study with no worsening of 2 successive post baseline assessments on the CGIS, exacerbation of EPS, or cardiovascular risk factors (body weight and fasting triglycerides) from baseline.
时间窗: 4 weeks
次要结局
- Adverse events(26 weeks)
研究者
研究点 (122)
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