Clinical trial NCT05229627: Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD
Official title: Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD Treated With Methylphenidate or Atomoxetine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ADHD
Keywords: multimodule MRI, remission, MPH, ATX, ADHD
Lead sponsor: Peking University Sixth Hospital
Sponsor class: OTHER
Collaborators: name: Hangzhou Normal University
First posted: 2022-02-08
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the ADHD group would be recruited by the clinic for child psychiatry in Peking University sixth hospital; while the healthy control would be recruited in community setting

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

Eligibility criteria: Inclusion Criteria:

- clinical diagnosis of ADHD, based on K-SADS-PL medication naive aged 6-16

Exclusion Criteria:

- history of severe head injury (with coma) other severe physical problem or disease in nervous system intelligence quotient (IQ) \< 80

Primary outcomes:
measure: Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ)
timeFrame: 8 to 12 weeks
measure: Clinical Global Impressions-Improvement scale (CGI-I)
timeFrame: 8 to 12 weeks
measure: resting state functional magnetic resonance imaging (rs-fMRI)
timeFrame: 8 to 12 weeks
measure: side effect assessment
timeFrame: 8 to 12 weeks
Secondary outcomes:
measure: Structural magnetic resonance imaging (sMRI)
timeFrame: 8 to 12 week
measure: Diffusion Tensor Imaging (DTI)
timeFrame: 8 to 12 weeks
measure: WEISS Functional Impairment Rating Scale-parent report (WFIRS-P)
timeFrame: 8 to 12 weeks
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: 8 to 12 weeks
measure: The Cambridge Neuropsychological Tests Automated Battery（CANTAB）
timeFrame: 8 to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Sixth Hospital
name: Qingjiu Cao, PhD
role: PRINCIPAL_INVESTIGATOR
References: