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Methylphenidate Treatment Response Study of Genetic Polymorphism in Attention Deficit Hyperactivity Disorder(ADHD)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Methylphenidate
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Polymorphism, Single Nucleotide, SLC6A2 protein, human, ADRA2A protein, human

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis made by DSM-IV and K-SADS-PL
  • IQ > 71

Exclusion Criteria:

  • genetic disorder
  • history of acquired brain injury
  • seizure disorder
  • other neurologic disorder
  • mental disorder, pervasive developmental disorder
  • obsessive-Compulsive disorder
  • communication disorder
  • learning disorder

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Methylphenidate

Arm Description

Outcomes

Primary Outcome Measures

Clinical Global Impression Scale-Improvement

Secondary Outcome Measures

ADHD rating scale

Full Information

First Posted
March 5, 2009
Last Updated
September 20, 2009
Sponsor
Seoul National University Hospital
Collaborators
Korea Health Industry Development Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00862108
Brief Title
Methylphenidate Treatment Response Study of Genetic Polymorphism in Attention Deficit Hyperactivity Disorder(ADHD)
Official Title
Functional Brain Markers and Predictors of Treatment Response Associated With Norepinephrine System Genes in ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital
Collaborators
Korea Health Industry Development Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether norepinephrine gene polymorphism affect to treatment response in ADHD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, Polymorphism, Single Nucleotide, SLC6A2 protein, human, ADRA2A protein, human

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylphenidate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Concerta OROS, Metadate CD, Penid
Intervention Description
mg/kg dose: 0.7~1.2mg/kg PO daily morning intake 8 weeks
Primary Outcome Measure Information:
Title
Clinical Global Impression Scale-Improvement
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
ADHD rating scale
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis made by DSM-IV and K-SADS-PL IQ > 71 Exclusion Criteria: genetic disorder history of acquired brain injury seizure disorder other neurologic disorder mental disorder, pervasive developmental disorder obsessive-Compulsive disorder communication disorder learning disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soo-Churl Cho, MD, PhD
Phone
82-2-2072-3648
Email
jewook.kang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo-Churl Cho, MD, PhD
Organizational Affiliation
Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-769
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo-Churl Cho, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Methylphenidate Treatment Response Study of Genetic Polymorphism in Attention Deficit Hyperactivity Disorder(ADHD)

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