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Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD) (NETADHD)
This study is currently recruiting participants.
Verified by Hallym University Medical Center, September 2008
First Received: September 19, 2008   No Changes Posted
Sponsored by: Hallym University Medical Center
Information provided by: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT00757029
  Purpose

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.


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Methylphenidate
Pharmacogenetics
Genetic: norepinephrine transporter polymorphism,
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Association Between Norepinephrine Transporter Polymorphism and Response of Methylphenidate

Resource links provided by NLM:


Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • Korean ADHD Rating scale-parent version (KARS) [ Time Frame: baseline,1,2,4,8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Barkely side effect rating scale [ Time Frame: 1,2,4,8weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: October 2005
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
open label Genetic: norepinephrine transporter polymorphism,
OROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757029

Contacts
Contact: Hyun Ju Hong, MD +82-31-380-3751 hongdr@chol.com

Locations
Korea, Republic of, Gyeonggi-do
Bundang Cha Hospital / Pochon Jungmum University Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of
Contact: Ki-Hwan Yook, MD            
Sponsors and Collaborators
Hallym University Medical Center
  More Information

No publications provided

Responsible Party: Department of Psychiatry Hallym University ( Hyun Ju Hong/ Assistant Professor )
Study ID Numbers: NETADHD
Study First Received: September 19, 2008
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00757029     History of Changes
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Hallym University Medical Center:
ADHD,
norepinephrine transporter
pharmacogenetics

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

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

ClinicalTrials.gov processed this record on September 10, 2009