Attention-deficit/Hyperactivity Disorder
Conditions
Brief summary
The purpose of this study was to identify genetic, brain morphologic, and environmental biomarkers that contribute to the pathophysiology of attention-deficit/hyperactivity disorder (ADHD).
Detailed description
The investigators planned to recruit ADHD and healthy controls from the age of 6 to 17. Genetic data including dopamine, norepinephrine, serotonin, neurotropic factors, glutamate-related genes will be genotyped. Environmental disruptors including phthalate and cotinine will be analyzed. Brain MRI data including T1, diffusion tensor imaging (DTI), resting state functional MRI (rsfMRI) will be obtained. Neuropsychological tests including continuous performance test, Stroop test, Children's color trail test, Wisconsin card sorting test will be conducted. The investigators plan to identify biomarkers of ADHD using an integrative approach of genetic, environmental, neuroimaging and clinical data.
Interventions
DRUGmethylphenidate
The patients received a fixed dose of medication for 2 weeks. The dose was increased according to the clinician's judgment. The patients came to the hospital at week 2,4,6,8,16,24wks, 9, 12,15,18,21,24 months
DRUGatomoxetine
The patients received a fixed dose of medication for 2 weeks. The dose was increased according to the clinician's judgment. The patients came to the hospital at week 2,4,6,8,16,24wks, 9, 12,15,18,21,24 months
Sponsors
Seoul National University Childrens Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* A diagnosis of attention-deficit/hyperactivity disorder confirmed using the Kiddie-Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version- Korean Version (K-SADS-PL-K). * IQ over 70
Exclusion criteria
* Intelligence quotient (IQ) \< 70 * A hereditary genetic disorder * A current/past history of brain trauma, organic brain disorder, seizure, or any neurological disorder * Autism spectrum disorder, communication disorder, or learning disorder * Schizophrenia or any other childhood-onset psychotic disorder * Major depressive disorder or bipolar disorder * Tourette's syndrome or chronic motor/vocal tic disorder * obsessive-compulsive disorder * A history of methylphenidate treatment lasting more than 1 year or received within the previous 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response measured by decrease in ADHD-RS scale | 6 months | Changes in the Parent rated ADHD-Rating Scale - IV (ADHD-RS), which is an 18 item scale, with 9 items assessing inattention and 9 items assessing hyperactivity/impulsivity. It is the most widely used scale to measure symptom severity of attention-deficit/hyperactivity disorder. |
| Treatment response measured by CGI-I score | 6 months | The Clinical Global Impression - Improvement (CGI-I) scale is a clinician rated scale used to measure improvement in symptoms. It ranges from 1 to 7, with 1 meaning very much improved, and 7 meaning very much worse. |
| Treatment response measured by changes in CPT score | 6 months | The continuous performance test (CPT) is an objective measurement of ADHD symptom severity. It is a computerized test and the results are presented in 4 variables : omission errors, commission errors, response time, response time variability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response measured by decrease in ADHD-RS scale | 1 year | The ADHD-RS scale is described in primary outcome measures. |
| Side effects measured using the side effect rating scale (SRS) | 1 year | The side effect rating scale (SRS) is a parent rated scale, measuring side effects of multiple domains in the previous 2 week period. |
| Treatment response measured by CGI-I score | 1 year | The CGI-I scale is described in primary outcome measures. |
Countries
South Korea
Contacts
Primary ContactJohanna IH Kim, MD
Outcome results
None listed