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

Sponsor
Peking University Sixth Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05229627
Collaborator
Hangzhou Normal University (Other)
250
96

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Multimodal Magnetic Resonance Imaging Study on the Neural Mechanisms of Remission in Children With ADHD Treated With Methylphenidate or Atomoxetine
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
healthy control

healthy controls, screened by K-SADS-PL

MPH induced Remission

patients show remission after 8-12 weeks of treatment with MPH

Drug: MPH
the drug would be prescribed to patients without any contraindication
Other Names:
  • Concerta
  • non responder to MPH

    patients don't show remission after 8-12 weeks of treatment with MPH

    Drug: MPH
    the drug would be prescribed to patients without any contraindication
    Other Names:
  • Concerta
  • ATX induced remission

    patients show remission after 8-12 weeks of treatment with ATX

    Drug: ATX
    the drug would be prescribed to patients without any contraindication
    Other Names:
  • Strattera
  • non responder to ATX

    patients don't show remission after 8-12 weeks of treatment with ATX

    Drug: ATX
    the drug would be prescribed to patients without any contraindication
    Other Names:
  • Strattera
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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.

    3. 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.

    4. side effect assessment [8 to 12 weeks]

      with clinical global impression scale

    Secondary Outcome Measures

    1. 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.

    2. 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.

    3. 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

    4. 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

    5. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking University Sixth Hospital
    • Hangzhou Normal University

    Investigators

    • Principal Investigator: Qingjiu Cao, PhD, Peking University Sixth Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qingjiu Cao, Assoc Prof. Dr., Peking University Sixth Hospital
    ClinicalTrials.gov Identifier:
    NCT05229627
    Other Study ID Numbers:
    • NSFC81471382
    First Posted:
    Feb 8, 2022
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Qingjiu Cao, Assoc Prof. Dr., Peking University Sixth Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2022