Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers

Seoul National University Childrens Hospital

Status and phase: Unknown; Phase 4

Conditions: Attention-deficit/Hyperactivity Disorder

Treatments: Drug: methylphenidate; Drug: atomoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT02623114

0720151002

Details and patient eligibility

About

The purpose of this study was to identify genetic, brain morphologic, and environmental biomarkers that contribute to the pathophysiology of attention-deficit/hyperactivity disorder (ADHD).

Full description

The investigators planned to recruit ADHD and healthy controls from the age of 6 to 17.

Genetic data including dopamine, norepinephrine, serotonin, neurotropic factors, glutamate-related genes will be genotyped.

Environmental disruptors including phthalate and cotinine will be analyzed. Brain MRI data including T1, diffusion tensor imaging (DTI), resting state functional MRI (rsfMRI) will be obtained.

Neuropsychological tests including continuous performance test, Stroop test, Children's color trail test, Wisconsin card sorting test will be conducted.

The investigators plan to identify biomarkers of ADHD using an integrative approach of genetic, environmental, neuroimaging and clinical data.

Enrollment: 400 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A diagnosis of attention-deficit/hyperactivity disorder confirmed using the Kiddie-Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version- Korean Version (K-SADS-PL-K).
• IQ over 70

Exclusion criteria

• Intelligence quotient (IQ) < 70
• A hereditary genetic disorder
• A current/past history of brain trauma, organic brain disorder, seizure, or any neurological disorder
• Autism spectrum disorder, communication disorder, or learning disorder
• Schizophrenia or any other childhood-onset psychotic disorder
• Major depressive disorder or bipolar disorder
• Tourette's syndrome or chronic motor/vocal tic disorder
• obsessive-compulsive disorder
• A history of methylphenidate treatment lasting more than 1 year or received within the previous 4 weeks

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Methylphenidate

Experimental group

Description:

ADHD patients with methylphenidate administration Generic names include concerta, metadata and penid. The initial dosage was fixed for 2 weeks and then adjusted according to the clinician's judgement. The patients visited the hospital at week 2,4,6,8,16,24, 9months, 12,15,18,21,24 months.

Treatment:

Drug: methylphenidate

Atomoxetine

Experimental group

Description:

ADHD patients with atomoxetine administration Generic names include strattera. The initial dosage was fixed for 2 weeks and then adjusted according to the clinician's judgement. The patients visited the hospital at week 2,4,6,8,16,24, 9months, 12,15,18,21,24 months.

Treatment:

Drug: atomoxetine