Identification of Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of ADHD

NCT ID: NCT02430896

Last Updated: 2019-07-05

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

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2020-12-31

Brief Summary

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The objective of this study is to identification of neuropsychological, genetic and neuroimaging markers and treatment response predictors of attention-deficit/hyperactivity disorder (ADHD). Participants who take the standardized pharmacotherapy (methylphenidate or atomoxetine) for ADHD will be observed for 52 weeks. They will do several neuropsychological, neuroimaging and genetic tests at visit 1\~6.

Detailed Description

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Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ADHD group

Children and adolescents who met the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) diagnostic criteria for ADHD and needed pharmacotherapy. Subjects will be taking Methylphenidate or Atomoxetine for 52 weeks.

Methylphenidate (MPH)

Intervention Type DRUG

Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.

Atomoxetine

Intervention Type DRUG

Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.

Normal control group

Children and adolescents will be recruited by advertisement, and will be assigned to normal group if they do not meet the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) diagnostic criteria for ADHD .

No interventions assigned to this group

Interventions

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Methylphenidate (MPH)

Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.

Intervention Type DRUG

Atomoxetine

Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.

Intervention Type DRUG

Other Intervention Names

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Metadate CD® Concerta® Medikinet Retard® Straterra®

Eligibility Criteria

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Inclusion Criteria

1. aged between 6 and 12 years
2. met the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) diagnostic criteria for ADHD and needed pharmacotherapy.
3. Informed consent

Exclusion Criteria

1. presence of intellectual disability or learning disorder
2. past and/or current history of bipolar disorder or psychosis or substance use disorder
3. past and/or current history of pervasive developmental disorder, organic mental disorder or other neurological disorder
4. presence of sever suicidal ideation
5. presence of tic disorder or obsessive-compulsive disorder whose symptoms needed pharmacotherapy
6. presence of family history with Tourette's Syndrome
7. took medication with methylphenidate or atomoxetine with last 6 month (or more than 3 month)
8. presence of severe medical condition (ex. cardiologic, liver, kidney, pulmonary, glaucoma)
9. took alpha 2 adrenergic receptor agonist, antidepressant, antipsychotics, benzodiazepine, modafinil, antiepileptic drug or dietary supplement that have a influence on Central Nervous System (CNS).
10. presence of possibility with pregnancy
11. especially for neuroimaging,

1. uncooperative with claustrophobia or body movement
2. metal material inside body that can't take off
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Won Kim

Assistant professor, department of psychiatry, Asan Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyo-Won Kim, Professor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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myungeun lee, BA

Role: CONTACT

+82-2-3010-7190

Sojung Park, BA

Role: CONTACT

+82-2-3010-7190

Facility Contacts

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Hyo-Won Kim, MD, PhD

Role: primary

82-3010-3414

Other Identifiers

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S2013-0373-0014

Identifier Type: -

Identifier Source: org_study_id

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