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

Study Overview
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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.

Official Title
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Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of Attention-Deficit/Hyperactivity Disorder (ADHD)

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: Methylphenidate (MPH)
* Drug: Atomoxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 6 and 12 years met the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) diagnostic criteria for ADHD and needed pharmacotherapy. Informed consent 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, uncooperative with claustrophobia or body movement metal material inside body that can't take off

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADHD group<br>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. | Drug: Methylphenidate (MPH)<br>* Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.<br>* Other names: Medikinet Retard®;Drug: Atomoxetine<br>* Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.<br>* Other names: Straterra®;|
| Normal control group<br>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 . | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropsychological, neuroimaging, genetic markers, treatment response predictor