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Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD) (NETADHD)

Primary Purpose

Attention Deficit Disorder With Hyperactivity, Methylphenidate, Pharmacogenetics

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
norepinephrine transporter polymorphism,
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD,, norepinephrine transporter, pharmacogenetics

Eligibility Criteria

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

Inclusion Criteria:

  • ADHD
  • Physically healthy

Exclusion Criteria:

  • Neurological illness
  • Concurrent additional psychiatric treatment
  • < IQ 70
  • Psychotic disorder
  • Major mood disorder needed other psychiatric medication
  • Significant suicidal ideation
  • Pervasive developmental disorder

Sites / Locations

  • Hallym University Sacred Heart Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

open label

Arm Description

Outcomes

Primary Outcome Measures

Korean ADHD Rating scale-parent version (KARS)

Secondary Outcome Measures

Barkely side effect rating scale

Full Information

First Posted
September 19, 2008
Last Updated
October 4, 2011
Sponsor
Hallym University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00757029
Brief Title
Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD)
Acronym
NETADHD
Official Title
Association Between Norepinephrine Transporter Polymorphism and Response of Methylphenidate
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hallym University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The noradrenergic system plays a known role in attentional systems and suspected causal role in attention deficit/hyperactivity disorder(ADHD).Methylphenidate also has been suspected as a inhibitor of norepinephrine transporter(SLC6A2). The investigators hypothesis is that norepinephrine transporter polymorphism is associated with responses and adverse effects of OROS-methylphenidate in treatment of ADHD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Methylphenidate, Pharmacogenetics
Keywords
ADHD,, norepinephrine transporter, pharmacogenetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
open label
Arm Type
Other
Intervention Type
Genetic
Intervention Name(s)
norepinephrine transporter polymorphism,
Other Intervention Name(s)
OROS methylphenidate (Concerta) monopharmacotherapy, dose : 18-54mg, duration : 8 weeks, genotyping : norepinephrine transporter (SLC6A2) polymorphism
Intervention Description
OROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism
Primary Outcome Measure Information:
Title
Korean ADHD Rating scale-parent version (KARS)
Time Frame
baseline,1,2,4,8 weeks
Secondary Outcome Measure Information:
Title
Barkely side effect rating scale
Time Frame
1,2,4,8weeks

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: ADHD Physically healthy Exclusion Criteria: Neurological illness Concurrent additional psychiatric treatment < IQ 70 Psychotic disorder Major mood disorder needed other psychiatric medication Significant suicidal ideation Pervasive developmental disorder
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
State/Province
Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

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Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD)

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