Attention-deficit/Hyperactivity Disorder Translational Center for Identifying Biomarkers

December 4, 2015 updated by: Booog Nyung Kim, Seoul National University Childrens Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Children's Hospital
        • Contact:
          • Johanna Kim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylphenidate
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.
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
Other Names:
  • concerta, metadate, penid
Experimental: Atomoxetine
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.
Drug: 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
Other Names:
  • strattera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment response measured by decrease in ADHD-RS scale
Time Frame: 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.
6 months
Treatment response measured by CGI-I score
Time Frame: 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.
6 months
Treatment response measured by changes in CPT score
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment response measured by decrease in ADHD-RS scale
Time Frame: 1 year
The ADHD-RS scale is described in primary outcome measures.
1 year
Side effects measured using the side effect rating scale (SRS)
Time Frame: 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.
1 year
Treatment response measured by CGI-I score
Time Frame: 1 year
The CGI-I scale is described in primary outcome measures.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Childrens Hospital

Investigators

  • Principal Investigator: Boong-nyun Kim, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

November 29, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 7, 2015

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0720151002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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