Clinical trial NCT02623114: Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers
Official title: Comprehensive Pathophysiological Study Based on the Core Neurocognitive Deficits and Development of Biological Markers of Treatment Response in Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Attention-deficit/Hyperactivity Disorder
Lead sponsor: Seoul National University Childrens Hospital
Sponsor class: OTHER
First posted: 2015-12-07
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment response measured by decrease in ADHD-RS scale
timeFrame: 6 months
measure: Treatment response measured by CGI-I score
timeFrame: 6 months
measure: Treatment response measured by changes in CPT score
timeFrame: 6 months
Secondary outcomes:
measure: Treatment response measured by decrease in ADHD-RS scale
timeFrame: 1 year
measure: Side effects measured using the side effect rating scale (SRS)
timeFrame: 1 year
measure: Treatment response measured by CGI-I score
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Boong-nyun Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: