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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Korea Health Industry Development Institute
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00862108
First received: March 5, 2009
Last updated: September 20, 2009
Last verified: September 2009
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional Brain Markers and Predictors of Treatment Response Associated With Norepinephrine System Genes in ADHD

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Je-Wook, Kang, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00862108     History of Changes
Other Study ID Numbers: A080054
Study First Received: March 5, 2009
Last Updated: September 20, 2009
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

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

ClinicalTrials.gov processed this record on September 22, 2014