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

September 20, 2009 updated by: Seoul National University Hospital

Functional Brain Markers and Predictors of Treatment Response Associated With Norepinephrine System Genes in ADHD

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

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
      • Seoul, Korea, Republic of, 110-769
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Soo-Churl Cho, MD, PhD

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:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylphenidate
Drug: Methylphenidate
mg/kg dose: 0.7~1.2mg/kg PO daily morning intake 8 weeks
Other Names:
  • Concerta OROS
  • Metadate CD
  • Penid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression Scale-Improvement
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ADHD rating scale
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Korea Health Industry Development Institute

Investigators

  • Principal Investigator: Soo-Churl Cho, MD, PhD, Seoul National University College of Medicine

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

September 1, 2008

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 13, 2009

First Posted (Estimate)

March 16, 2009

Study Record Updates

Last Update Posted (Estimate)

September 22, 2009

Last Update Submitted That Met QC Criteria

September 20, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A080054

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