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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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 . |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate (MPH) | Drug | Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | 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). | 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). | visit1 (-week 8) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in treatment response effectiveness of pharmacotherapy at week12 | Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale). | visit 3 (week12) |
| Change from baseline in treatment response effectiveness of pharmacotherapy at week 24 |
Inclusion Criteria:
Exclusion Criteria:
presence of intellectual disability or learning disorder
past and/or current history of bipolar disorder or psychosis or substance use disorder
past and/or current history of pervasive developmental disorder, organic mental disorder or other neurological disorder
presence of sever suicidal ideation
presence of tic disorder or obsessive-compulsive disorder whose symptoms needed pharmacotherapy
presence of family history with Tourette's Syndrome
took medication with methylphenidate or atomoxetine with last 6 month (or more than 3 month)
presence of severe medical condition (ex. cardiologic, liver, kidney, pulmonary, glaucoma)
took alpha 2 adrenergic receptor agonist, antidepressant, antipsychotics, benzodiazepine, modafinil, antiepileptic drug or dietary supplement that have a influence on Central Nervous System (CNS).
presence of possibility with pregnancy
especially for neuroimaging,
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Total 600 children and adolescents will be enrolled in this study. 500 patients in psychiatric outpatient will be enrolled. 100 persons of healthy volunteers will be recruited via advertisements.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| myungeun lee, BA | Contact | +82-2-3010-7190 | lme23@amc.seoul.kr | |
| Sojung Park, BA | Contact | +82-2-3010-7190 | sojung@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hyo-Won Kim, Professor | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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whole blood sample for GWAS (Genome-Wide Association Study)
| Atomoxetine | Drug | Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks. |
|
|
Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale). |
| visit 4 (week 24) |
| Change from baseline in treatment response effectiveness of pharmacotherapy at week 36 | Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale). | visit 5 (week 36) |
| Change from baseline in treatment response effectiveness of pharmacotherapy at week 52 | Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale). | visit 6 (week 52) |
| Change from baseline in 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 at week 12 | 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). | visit 3 (week 12) |
| Change from baseline in 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 at week 52 | 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). | visit 6 (week 52) |
| Occurrence of comorbidity from baseline in assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ at week 12 | 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). | visit 3 (week 12) |
| Occurrence of comorbidity from baseline in assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ at week 52 | 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). | visit 6 (week 52) |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011437 | Propylamines |
| D000588 | Amines |