NCT01638689已完成1 期
A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in binding potential of 11C-AZ10419369 between baseline and post-dose condition
研究概览
简要总结
Healthy males were examined with positron emission tomography (PET) and the radioligand 11C-AZ10419369, before and after administration of a single dose escitalopram. A change in the binding potential of 11C-AZ10419369 between the baseline and the post-dose condition was hypothesized to reflect a change in serotonin concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Male gender
- •Age 20 to 30 years
- •Healthy according to physical examination, ECG, MRI and blood chemistry
排除标准
- •Past or present psychiatric disease
- •Past or present brain disorder or injury, including loss of consciousness for more than five minutes
- •Past or present drug or alcohol abuse
- •Past or present use of antidepressant or antipsychotic medications
- •Regular use of medications (including herbals), that could interfere with the pharmacodynamics or pharmacokinetics of escitalopram
- •Significant abnormality on ECG
- •Structural abnormality in the brain confirmed by MR examination
- •Claustrophobia
- •Any metal devises or implants in the body
- •Intolerance to escitalopram or any of the components of the formula
- •Predisposition to motion sickness
- •Inability to understand and comply with the study requirements
- •Any medical condition that, in the opinion of the investigator, make the subject unsuitable for the study or put the subject at additional risk
结局指标
主要结局
Change in binding potential of 11C-AZ10419369 between baseline and post-dose condition
时间窗: One day (PET measurement before and after escitalopram administration on the same day)
次要结局
未报告次要终点
研究者
Magdalena Nord
MD
Karolinska Institutet
研究点 (2)
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