Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of Attention-Deficit/Hyperactivity Disorder (ADHD)
Overview
- Phase
- N/A
- Intervention
- Methylphenidate (MPH)
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Sponsor
- Asan Medical Center
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Wide genome analysis regarding genetic polymorphisms as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD).
- Last Updated
- 6 years ago
Overview
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.
Investigators
Hyo-Won Kim
Assistant professor, department of psychiatry, Asan Medical Center
Asan Medical Center
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Methylphenidate (MPH)
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.
Intervention: Atomoxetine
Outcomes
Primary Outcomes
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).