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

NCT ID: NCT05229627

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2023-12-31

Brief Summary

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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

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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

Conditions

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ADHD

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy control

healthy controls, screened by K-SADS-PL

No interventions assigned to this group

MPH induced Remission

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

MPH

Intervention Type DRUG

the drug would be prescribed to patients without any contraindication

non responder to MPH

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

MPH

Intervention Type DRUG

the drug would be prescribed to patients without any contraindication

ATX induced remission

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

ATX

Intervention Type DRUG

the drug would be prescribed to patients without any contraindication

non responder to ATX

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

ATX

Intervention Type DRUG

the drug would be prescribed to patients without any contraindication

Interventions

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MPH

the drug would be prescribed to patients without any contraindication

Intervention Type DRUG

ATX

the drug would be prescribed to patients without any contraindication

Intervention Type DRUG

Other Intervention Names

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Concerta Strattera

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hangzhou Normal University

OTHER

Sponsor Role collaborator

Peking University Sixth Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qingjiu Cao

Assoc Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qingjiu Cao, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Sixth Hospital

Other Identifiers

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NSFC81471382

Identifier Type: -

Identifier Source: org_study_id

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