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

October 4, 2011 updated by: Hallym University Medical Center

Association Between Norepinephrine Transporter Polymorphism and Response of Methylphenidate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

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 Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Anyang, Gyeonggi-do, Korea, Republic of
        • Hallym University Sacred Heart Hospital

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 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: open label
Genetic: norepinephrine transporter polymorphism,
OROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism
Other Names:
  • OROS methylphenidate (Concerta) monopharmacotherapy
  • dose : 18-54mg
  • duration : 8 weeks
  • genotyping : norepinephrine transporter (SLC6A2) polymorphism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Korean ADHD Rating scale-parent version (KARS)
Time Frame: baseline,1,2,4,8 weeks
baseline,1,2,4,8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Barkely side effect rating scale
Time Frame: 1,2,4,8weeks
1,2,4,8weeks

Collaborators and Investigators

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

Sponsor

Hallym University Medical Center

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

October 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

September 19, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Estimate)

October 5, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NETADHD

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.

Subscribe