Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD
- Conditions
- ADHD
- Interventions
- Drug: ATX
- Registration Number
- NCT05229627
- Lead Sponsor
- Peking University Sixth Hospital
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
- clinical diagnosis of ADHD, based on K-SADS-PL medication naive aged 6-16
- history of severe head injury (with coma) other severe physical problem or disease in nervous system intelligence quotient (IQ) < 80
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ATX induced remission ATX patients show remission after 8-12 weeks of treatment with ATX non responder to ATX ATX patients don't show remission after 8-12 weeks of treatment with ATX MPH induced Remission MPH patients show remission after 8-12 weeks of treatment with MPH non responder to MPH MPH patients don't show remission after 8-12 weeks of treatment with MPH
- Primary Outcome Measures
Name Time Method side effect assessment 8 to 12 weeks with clinical global impression scale
resting state functional magnetic resonance imaging (rs-fMRI) 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.
Clinical Global Impressions-Improvement scale (CGI-I) 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) 8 to 12 weeks to define remission, using Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ), both in baseline and follow-up
- Secondary Outcome Measures
Name Time Method Structural magnetic resonance imaging (sMRI) 8 to 12 week participants undergo structural magnetic resonance imaging (sMRI) scan both in baseline and follow-up, and the duration for each sMRI is 5 minutes.
WEISS Functional Impairment Rating Scale-parent report (WFIRS-P) 8 to 12 weeks to assess the improvement of social function impairment in ADHD, participants will finish the WFIRS-P both in baseline and follow-up
Diffusion Tensor Imaging (DTI) 8 to 12 weeks participants undergo DTI scan both in baseline and follow-up, and the duration for each sMRI is 10 minutes.
The Cambridge Neuropsychological Tests Automated Battery（CANTAB） 8 to 12 weeks to assess the improvement of neuropsychological executive function in ADHD, participants will finish the executive functional test measured by CANTAB both in baseline and follow-up
Behavior Rating Inventory of Executive Function (BRIEF) 8 to 12 weeks to assess the improvement of ecological executive function in ADHD, participants will finish the BRIEF both in baseline and follow-up