Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers

NCT ID: NCT02623114

Last Updated: 2015-12-07

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

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Attention-deficit/Hyperactivity Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methylphenidate

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.

Group Type EXPERIMENTAL

methylphenidate

Intervention Type DRUG

The patients received a fixed dose of medication for 2 weeks. The dose was increased according to the clinician's judgment. The patients came to the hospital at week 2,4,6,8,16,24wks, 9, 12,15,18,21,24 months

Atomoxetine

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.

Group Type EXPERIMENTAL

atomoxetine

Intervention Type DRUG

The patients received a fixed dose of medication for 2 weeks. The dose was increased according to the clinician's judgment. The patients came to the hospital at week 2,4,6,8,16,24wks, 9, 12,15,18,21,24 months

Interventions

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methylphenidate

The patients received a fixed dose of medication for 2 weeks. The dose was increased according to the clinician's judgment. The patients came to the hospital at week 2,4,6,8,16,24wks, 9, 12,15,18,21,24 months

Intervention Type DRUG

atomoxetine

The patients received a fixed dose of medication for 2 weeks. The dose was increased according to the clinician's judgment. The patients came to the hospital at week 2,4,6,8,16,24wks, 9, 12,15,18,21,24 months

Intervention Type DRUG

Other Intervention Names

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concerta, metadate, penid strattera

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Childrens Hospital

OTHER

Sponsor Role lead

Responsible Party

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Booog Nyung Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Boong-nyun Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Children's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Johanna IH Kim, MD

Role: CONTACT

Facility Contacts

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Johanna Kim, MD

Role: primary

Other Identifiers

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0720151002

Identifier Type: -

Identifier Source: org_study_id