Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- BOLD signal during response inhibition
研究概览
简要总结
The investigators' goal is to develop neuroimaging biomarkers to predict response to treatment with methylphenidate, which then can be used in the development of novel pharmacological treatments for attention-deficit/hyperactivity disorder (ADHD). The overall objective of this study is to measure the changes in task-related neural activity related to symptoms of ADHD (measured by functional MRI) and brain glutamate levels (measured by magnetic resonance spectroscopy, MRS) after treatment with methylphenidate (MPH). This will be a double-blind crossover of methylphenidate and placebo in adults with ADHD. Participants will complete neuropsychological testing along with fMRI and MRS scans after a single dose of each treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •right handed
排除标准
- •pregnant or breast feeding
- •past or current neurological disorder
- •non-ADHD cause of cognitive impairment
- •uncontrolled medical disorder
- •head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma
- •having an adverse reaction to methylphenidate, or other stimulant medication
- •having a contraindication to MRI
- •current smoking
研究组 & 干预措施
Methylphenidate first
Single oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week.
干预措施: Methylphenidate (Drug)
Methylphenidate first
Single oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week.
干预措施: Placebo (Drug)
Placebo first
Matching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week.
干预措施: Methylphenidate (Drug)
Placebo first
Matching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week.
干预措施: Placebo (Drug)
结局指标
主要结局
BOLD signal during response inhibition
时间窗: Approximately 90 minutes after dose
BOLD signal (brain activity during fMRI, arbitrary units) in the anterior cingulate cortex during response inhibition.
Glutamate level in the anterior cingulate cortex
时间窗: Approximately 2 hours after dose
Glutamate level (measured by MRS, institutional units) in the anterior cingulate cortex.
次要结局
未报告次要终点