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

Asan Medical Center600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

Methylphenidate (MPH)DRUG

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

AtomoxetineDRUG

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Wide genome analysis regarding genetic polymorphisms as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD).

Genome wide case-control association analysis will be operated with qualified phenotype and assigned intermittent phenotype.

Time frame: visit 1 (-week 8)

Neuroimaging analysis as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD).

Thickness of cortex, anatomical relation will be compared with 3 tesla MRI. In addition, brain circuit for delayed aversion, delayed frustration, time processing and resting state.

Time frame: visit 1 (-week 8)

Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale).

Time frame: visit 1 (-week 8)

Neuropsychological markers as the treatment response predictable factor of ADHD using a complex neuropsychological test consisting of SSRT, delayed aversion, delayed frustration, time processing, ATA

Using a complex neuropsychological test consisting of The stop-signal reaction time (SSRT) task, delayed aversion, delayed frustration, time processing, Advanced tets of Attention (ATA).

Time frame: visit 1 (-week 8)

Comorbidity assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ

It is assessed using a composite measure consisting of Korean Personality Rating Scale for Children (K-PRC), Columbia Suicide Severity Rating Scale (C-SSRS), The Tic Severity Scale (TCGI), and The Developmental Coordination Disorder Questionnaire (DCDQ).

Time frame: visit1 (-week 8)

Central Contacts

myungeun lee, BA

CONTACT

+82-2-3010-7190 lme23@amc.seoul.kr

Sojung Park, BA

CONTACT

+82-2-3010-7190 sojung@amc.seoul.kr

Data from ClinicalTrials.gov

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