Back to resultsAttention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers
Primary Purpose
Attention-deficit/Hyperactivity Disorder
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
methylphenidate
atomoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Attention-deficit/Hyperactivity Disorder
Eligibility Criteria
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
Sites / Locations
- Seoul National University Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Methylphenidate
Atomoxetine
Arm Description
ADHD 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.
ADHD 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Treatment response measured by decrease in ADHD-RS scale
The ADHD-RS scale is described in primary outcome measures.
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.
Treatment response measured by CGI-I score
The CGI-I scale is described in primary outcome measures.
Full Information
NCT ID
NCT02623114
First Posted
November 29, 2015
Last Updated
December 4, 2015
Sponsor
Seoul National University Childrens Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02623114
Brief Title
Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers
Official Title
Comprehensive Pathophysiological Study Based on the Core Neurocognitive Deficits and Development of Biological Markers of Treatment Response in Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Childrens Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-deficit/Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methylphenidate
Arm Type
Experimental
Arm Description
ADHD 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.
Arm Title
Atomoxetine
Arm Type
Experimental
Arm Description
ADHD 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.
Intervention Type
Drug
Intervention Name(s)
methylphenidate
Other Intervention Name(s)
concerta, metadate, penid
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
atomoxetine
Other Intervention Name(s)
strattera
Intervention Description
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
Primary Outcome Measure Information:
Title
Treatment response measured by decrease in ADHD-RS scale
Description
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.
Time Frame
6 months
Title
Treatment response measured by CGI-I score
Description
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.
Time Frame
6 months
Title
Treatment response measured by changes in CPT score
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Treatment response measured by decrease in ADHD-RS scale
Description
The ADHD-RS scale is described in primary outcome measures.
Time Frame
1 year
Title
Side effects measured using the side effect rating scale (SRS)
Description
The side effect rating scale (SRS) is a parent rated scale, measuring side effects of multiple domains in the previous 2 week period.
Time Frame
1 year
Title
Treatment response measured by CGI-I score
Description
The CGI-I scale is described in primary outcome measures.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna IH Kim, MD
Email
iambabyvox@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boong-nyun Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Children's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Kim, MD
12. IPD Sharing Statement
Learn more about this trial
Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers
We'll reach out to this number within 24 hrs