Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers

Attention-deficit/Hyperactivity Disorder Clinical Trial

Official title:

Comprehensive Pathophysiological Study Based on the Core Neurocognitive Deficits and Development of Biological Markers of Treatment Response in Attention Deficit Hyperactivity Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02623114
• Other study ID #: 0720151002
• Status: Recruiting
• Phase: Phase 4
• First received: November 29, 2015
• Last updated: December 4, 2015
• Start date: May 2012
• Est. completion date: March 2017

Study information

• Verified date: December 2015
• Source: Seoul National University Childrens Hospital
• Contact: Johanna IH Kim, MD
• Email: iambabyvox[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• methylphenidate
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
• atomoxetine
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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Childrens Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response measured by decrease in ADHD-RS scale	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.	6 months	No
Primary	Treatment response measured by CGI-I score	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.	6 months	No
Primary	Treatment response measured by changes in CPT score	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.	6 months	No
Secondary	Treatment response measured by decrease in ADHD-RS scale	The ADHD-RS scale is described in primary outcome measures.	1 year	No
Secondary	Side effects measured using the side effect rating scale (SRS)	The side effect rating scale (SRS) is a parent rated scale, measuring side effects of multiple domains in the previous 2 week period.	1 year	Yes
Secondary	Treatment response measured by CGI-I score	The CGI-I scale is described in primary outcome measures.	1 year	No