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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00862108
First Posted: March 16, 2009
Last Update Posted: September 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Korea Health Industry Development Institute
Information provided by:
Seoul National University Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • ADHD rating scale [ Time Frame: 8 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Je-Wook, Kang, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00862108     History of Changes
Other Study ID Numbers: A080054
First Submitted: March 5, 2009
First Posted: March 16, 2009
Last Update Posted: September 22, 2009
Last Verified: September 2009

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 Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents