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Methylphenidate Treatment Response Study of Genetic Polymorphism in Attention Deficit Hyperactivity Disorder(ADHD)
This study is currently recruiting participants.
Verified by Seoul National University Hospital, March 2009
First Received: March 5, 2009   Last Updated: March 13, 2009   History of Changes
Sponsors and Collaborators: Seoul National University Hospital
Korea Health Industry Development Institute
Information provided by: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00862108
  Purpose

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


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Methylphenidate
Phase IV

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder
Drug Information available for: Methylphenidate Methylphenidate hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title: Functional Brain Markers and Predictors of Treatment Response Associated With Norepinephrine System Genes in ADHD

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Clinical Global Impression Scale-Improvement [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ADHD rating scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Methylphenidate: Experimental Drug: Methylphenidate
mg/kg dose: 0.7~1.2mg/kg PO daily morning intake 8 weeks

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862108

Contacts
Contact: Soo-Churl Cho, MD, PhD 82-2-2072-3648 jewook.kang@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-769
Principal Investigator: Soo-Churl Cho, MD, PhD            
Sponsors and Collaborators
Seoul National University Hospital
Korea Health Industry Development Institute
Investigators
Principal Investigator: Soo-Churl Cho, MD, PhD Seoul National University College of Medicine
  More Information

No publications provided

Responsible Party: Seoul National University Hospital ( Je-Wook, Kang )
Study ID Numbers: A080054
Study First Received: March 5, 2009
Last Updated: March 13, 2009
ClinicalTrials.gov Identifier: NCT00862108     History of Changes
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Attention Deficit Hyperactivity Disorder
Polymorphism, Single Nucleotide
SLC6A2 protein, human
ADRA2A protein, human
Polymorphism, Single Nucleotide

Study placed in the following topic categories:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias
Signs and Symptoms
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Norepinephrine
Hyperkinesis
Neurologic Manifestations
Dopamine Agents

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009