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

NCT05229627 | Unknown

• 1 other identifier: NSFC81471382
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ADHD

Keywords

multimodule MRI, remission, MPH, ATX, ADHD

Outcome Measures

Primary Outcomes (4)

• Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ)

  to define remission, using Swanson, Nolan and Pelham , Version Ⅳ Rating Scale (SNAP-Ⅳ), both in baseline and follow-up

  8 to 12 weeks

• Clinical Global Impressions-Improvement scale (CGI-I)

  to define remission, participants will assessed by CGI-I in follow-up, and Clinical Global Impressions-Severity scale (CGI-S) in baseline.

  8 to 12 weeks

• resting state functional magnetic resonance imaging (rs-fMRI)

  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.

  8 to 12 weeks

• side effect assessment

  with clinical global impression scale

  8 to 12 weeks

Secondary Outcomes (5)

• Structural magnetic resonance imaging (sMRI)

  8 to 12 week

• Diffusion Tensor Imaging (DTI)

  8 to 12 weeks

• WEISS Functional Impairment Rating Scale-parent report (WFIRS-P)

  8 to 12 weeks

• Behavior Rating Inventory of Executive Function (BRIEF)

  8 to 12 weeks

• The Cambridge Neuropsychological Tests Automated Battery（CANTAB）

  8 to 12 weeks

Study Arms (5)

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

non responder to MPH

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

Drug: MPH

ATX induced remission

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

Drug: ATX

non responder to ATX

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

Drug: ATX

Interventions

MPH DRUG

the drug would be prescribed to patients without any contraindication

Also known as: Concerta

MPH induced Remission; non responder to MPH

ATX DRUG

the drug would be prescribed to patients without any contraindication

Also known as: Strattera

ATX induced remission; non responder to ATX

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Sixth Hospital: lead
• Hangzhou Normal University: collaborator

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

5,10-dihydro-5-methylphenazine; Methylphenidate; Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines

Study Officials

• Qingjiu Cao, PhD

  Peking University Sixth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof. Dr.

Study Record Dates

• First Submitted: December 31, 2015
• First Posted: February 8, 2022
• Study Start: January 1, 2016
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: February 8, 2022

Record last verified: 2022-01