Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
Neuropsychological, neuroimaging, genetic markers, treatment response predictor
Brief summary
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.
Interventions
Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.
DRUGAtomoxetine
Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.
Sponsors
Asan Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wide genome analysis regarding genetic polymorphisms as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD). | visit 1 (-week 8) | Genome wide case-control association analysis will be operated with qualified phenotype and assigned intermittent phenotype. |
| Neuroimaging analysis as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD). | visit 1 (-week 8) | 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. |
| 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 | visit 1 (-week 8) | 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). |
| Comorbidity assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ | visit1 (-week 8) | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | visit 6 (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). |
| Change from baseline in treatment response effectiveness of pharmacotherapy at week12 | visit 3 (week12) | Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale). |
| Occurrence of comorbidity from baseline in assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ at week 52 | visit 6 (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). |
| Occurrence of comorbidity from baseline in assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ at week 12 | visit 3 (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). |
| Change from baseline in treatment response effectiveness of pharmacotherapy at week 24 | visit 4 (week 24) | Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale). |
| Change from baseline in treatment response effectiveness of pharmacotherapy at week 36 | visit 5 (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). |
| Change from baseline in treatment response effectiveness of pharmacotherapy at week 52 | visit 6 (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). |
| 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 | visit 3 (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). |
Countries
South Korea
Contacts
Primary Contactmyungeun lee, BA
Backup ContactSojung Park, BA
Outcome results
None listed