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

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.

Full Title of Study: “Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of Attention-Deficit/Hyperactivity Disorder (ADHD)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2020

Interventions

  • Drug: Methylphenidate (MPH)
    • Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.
  • Drug: Atomoxetine
    • Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.

Arms, Groups and Cohorts

  • 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 .

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Asan Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hyo-Won Kim, Assistant professor, department of psychiatry, Asan Medical Center – Asan Medical Center
  • Overall Official(s)
    • Hyo-Won Kim, Professor, Principal Investigator, Asan Medical Center
  • Overall Contact(s)
    • myungeun lee, BA, +82-2-3010-7190, lme23@amc.seoul.kr

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