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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: ADHD
• Intervention / Treatment: Drug: MPH; Drug: 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

• Study Type: Observational
• Enrollment (Anticipated): 250

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Sixth Hospital
• Collaborators: Hangzhou Normal University
• Investigators: Principal Investigator: Qingjiu Cao, PhD, Peking University Sixth Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 31, 2015
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: multimodule MRI, remission, MPH, ATX, ADHD
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Adrenergic Uptake Inhibitors; Methylphenidate; Atomoxetine Hydrochloride
• Other Study ID Numbers: NSFC81471382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: the data would be published first and not yet decided to share with other research groups