Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD Treated With Methylphenidate or Atomoxetine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 主要终点
- resting state functional magnetic resonance imaging (rs-fMRI)
研究概览
简要总结
Attention-deficit/hyperactivity disorder(ADHD) is highly prevalent among children and adolescents and often associated with poor long-term outcomes in adulthood. it is thus a serious public health problem. Methylphenidate(MPH) and Atomoxetine(ATX) are most frequently used for treating ADHD in many countries but the individual treatment response varies. Some patients present good response to either MPH or ATX with minimal or no symptoms left and optimal functioning(remission) after treatment, while others are poor responders to one of the two or even both. The underlying mechanism for the heterogenous responsiveness remains unknown. Thus we proposed to use multimodule magnetic resonance imaging(MRI) technology to explore the neural mechanisms of remission in children with ADHD treated with MPH or ATX.
详细描述
the main aim of the current study is to explore the mechanism of remission in children with ADHD treated by MPH or ATX. Baseline information including demographic information, clinical features including ADHD symptoms, cognitive assessments such as executive function, MRI scans including resting state functional MRI, structural MRI, and DTI would be acquired in each participant. after 8-12 weeks of treating with MPH or ATX, patients would be classified into subgroups of remitted and unremitted groups. all baseline tests would be acquired again at the end of the study. comparisons would be done to explore the remission mechanism induced by MPH or ATX
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical diagnosis of ADHD, based on K-SADS-PL medication naive aged 6-16
排除标准
- •history of severe head injury (with coma) other severe physical problem or disease in nervous system intelligence quotient (IQ) < 80
研究组 & 干预措施
non responder to ATX
patients don't show remission after 8-12 weeks of treatment with ATX
干预措施: ATX (Drug)
MPH induced Remission
patients show remission after 8-12 weeks of treatment with MPH
干预措施: MPH (Drug)
non responder to MPH
patients don't show remission after 8-12 weeks of treatment with MPH
干预措施: MPH (Drug)
ATX induced remission
patients show remission after 8-12 weeks of treatment with ATX
干预措施: ATX (Drug)
结局指标
主要结局
resting state functional magnetic resonance imaging (rs-fMRI)
时间窗: 8 to 12 weeks
participants undergo resting state functional MRI (rs-fMRI) scan both in baseline and follow-up, and the duration for each rs-fMRI is 8 minutes.
side effect assessment
时间窗: 8 to 12 weeks
with clinical global impression scale
Clinical Global Impressions-Improvement scale (CGI-I)
时间窗: 8 to 12 weeks
to define remission, participants will assessed by CGI-I in follow-up, and Clinical Global Impressions-Severity scale (CGI-S) in baseline.
Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ)
时间窗: 8 to 12 weeks
to define remission, using Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ), both in baseline and follow-up
次要结局
- Structural magnetic resonance imaging (sMRI)(8 to 12 week)
- WEISS Functional Impairment Rating Scale-parent report (WFIRS-P)(8 to 12 weeks)
- Diffusion Tensor Imaging (DTI)(8 to 12 weeks)
- The Cambridge Neuropsychological Tests Automated Battery（CANTAB）(8 to 12 weeks)
- Behavior Rating Inventory of Executive Function (BRIEF)(8 to 12 weeks)
研究者
Qingjiu Cao
Assoc Prof. Dr.
Peking University Sixth Hospital