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Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD

Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD Treated With Methylphenidate or Atomoxetine

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05229627
Enrollment
250
Registered
2022-02-08
Start date
2016-01-31
Completion date
2023-12-31
Last updated
2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

multimodule MRI, remission, MPH, ATX, ADHD

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

Interventions

DRUGMPH

the drug would be prescribed to patients without any contraindication

DRUGATX

the drug would be prescribed to patients without any contraindication

Sponsors

Hangzhou Normal University
CollaboratorOTHER
Peking University Sixth Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ)8 to 12 weeksto define remission, using Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ), both in baseline and follow-up
Clinical Global Impressions-Improvement scale (CGI-I)8 to 12 weeksto define remission, participants will assessed by CGI-I in follow-up, and Clinical Global Impressions-Severity scale (CGI-S) in baseline.
resting state functional magnetic resonance imaging (rs-fMRI)8 to 12 weeksparticipants 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 assessment8 to 12 weekswith clinical global impression scale

Secondary

MeasureTime frameDescription
Structural magnetic resonance imaging (sMRI)8 to 12 weekparticipants undergo structural magnetic resonance imaging (sMRI) scan both in baseline and follow-up, and the duration for each sMRI is 5 minutes.
The Cambridge Neuropsychological Tests Automated Battery(CANTAB)8 to 12 weeksto 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
Diffusion Tensor Imaging (DTI)8 to 12 weeksparticipants undergo DTI scan both in baseline and follow-up, and the duration for each sMRI is 10 minutes.
WEISS Functional Impairment Rating Scale-parent report (WFIRS-P)8 to 12 weeksto assess the improvement of social function impairment in ADHD, participants will finish the WFIRS-P both in baseline and follow-up
Behavior Rating Inventory of Executive Function (BRIEF)8 to 12 weeksto assess the improvement of ecological executive function in ADHD, participants will finish the BRIEF both in baseline and follow-up

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026