Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers
Comprehensive Pathophysiological Study Based on the Core Neurocognitive Deficits and Development of Biological Markers of Treatment Response in Attention Deficit Hyperactivity Disorder
1 other identifier
interventional
400
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2012
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 29, 2015
CompletedFirst Posted
Study publicly available on registry
December 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedDecember 7, 2015
December 1, 2015
4.3 years
November 29, 2015
December 4, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Secondary Outcomes (3)
Treatment response measured by decrease in ADHD-RS scale
1 year
Side effects measured using the side effect rating scale (SRS)
1 year
Treatment response measured by CGI-I score
1 year
Study Arms (2)
Methylphenidate
EXPERIMENTALADHD patients with methylphenidate administration Generic names include concerta, metadata and penid. The initial dosage was fixed for 2 weeks and then adjusted according to the clinician's judgement. The patients visited the hospital at week 2,4,6,8,16,24, 9months, 12,15,18,21,24 months.
Atomoxetine
EXPERIMENTALADHD patients with atomoxetine administration Generic names include strattera. The initial dosage was fixed for 2 weeks and then adjusted according to the clinician's judgement. The patients visited the hospital at week 2,4,6,8,16,24, 9months, 12,15,18,21,24 months.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Children's Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Boong-nyun Kim, MD, PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 29, 2015
First Posted
December 7, 2015
Study Start
May 1, 2012
Primary Completion
August 1, 2016
Study Completion
March 1, 2017
Last Updated
December 7, 2015
Record last verified: 2015-12