NCT04127058已完成1 期
A Safety/Tolerance Study to Evaluate a New Titration Scheme in Patients With Bipolar I Disorder or Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The frequency of treatment-emergent adverse events as measured by the number of events
研究概览
简要总结
This is a single-center open-label study to be conducted in the United States in subjects with bipolar I disorder or schizophrenia.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 to 65 years of age (inclusive)
- •Diagnosed with either schizophrenia or bipolar I disorder, manic or mixed type as per DSM-V criteria
- •Symptomatically stable within the past two months
排除标准
- •Exposure to any investigational medication, including placebo, in the past 60 days
- •Non-response to clozapine
研究组 & 干预措施
CYP2D6 non-poor metabolizers
Other
titrated up to 24 mg daily (12 mg b.i.d.)
干预措施: Iloperidone (Drug)
CYP2D6 poor metabolizers
Other
titrated up to 12 mg daily (6 mg b.i.d.)
干预措施: Iloperidone (Drug)
结局指标
主要结局
The frequency of treatment-emergent adverse events as measured by the number of events
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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