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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05229627
• Other study ID #: NSFC81471382
• Status: Enrolling by invitation
• Start date: January 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: Peking University Sixth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• MPH
the drug would be prescribed to patients without any contraindication
• ATX
the drug would be prescribed to patients without any contraindication

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Sixth Hospital	Hangzhou Normal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Swanson, Nolan and Pelham , Version ? Rating Scale (SNAP-?)	to define remission, using Swanson, Nolan and Pelham , Version ? Rating Scale (SNAP-?), both in baseline and follow-up	8 to 12 weeks
Primary	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
Primary	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
Primary	side effect assessment	with clinical global impression scale	8 to 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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