Effects of Oxytocin on Cognitive Control in Adults With Attention Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Stop-signal task
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled crossover study of single-dose intranasal oxytocin (24 IU) in 18-55 year-old men with attention deficit/hyperactivity disorder (ADHD). Following a screening visit to determine eligibility, participants will return for two main study visits. During the main study visits, study participants will receive either oxytocin (Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland) or placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy), followed by assessments of cognitive control over attention and behavior. Twenty-four participants will be randomized 1:1 to one of two drug orders, i.e., oxytocin - placebo or placebo - oxytocin. In an additional neuroimaging substudy, a subset of participants will undergo task-based and resting-state functional magnetic resonance imaging (fMRI) following oxytocin/placebo administration to investigate the effects of oxytocin on fMRI activation and functional connectivity within the cognitive control network.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 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
Drug order: Oxytocin - placebo
干预措施: Oxytocin nasal spray (Drug)
Drug order: Oxytocin - placebo
干预措施: Placebo nasal spray (Drug)
Drug order: Placebo - oxytocin
干预措施: Oxytocin nasal spray (Drug)
Drug order: Placebo - oxytocin
干预措施: Placebo nasal spray (Drug)
结局指标
主要结局
Stop-signal task
时间窗: First and second main study visits (1-4 weeks apart)
Mean difference in performance on the stop-signal task between the oxytocin and placebo visits (e.g., stop-signal reaction time)
次要结局
- AX-CPT(First and second main study visits (1-4 weeks apart))
- Category switch task(First and second main study visits (1-4 weeks apart))
- Global/local task(First and second main study visits (1-4 weeks apart))
- Simon task(First and second main study visits (1-4 weeks apart))
研究者
Elizabeth Austen Lawson
Assistant Professor of Medicine, Harvard Medical School
Massachusetts General Hospital