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Sponsored by: |
Hallym University Medical Center |
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Information provided by: | Hallym University Medical Center |
ClinicalTrials.gov Identifier: | NCT00757029 |
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 |
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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 |
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 |
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open label |
Genetic: norepinephrine transporter polymorphism,
OROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism
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Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hyun Ju Hong, MD | +82-31-380-3751 | hongdr@chol.com |
Korea, Republic of, Gyeonggi-do | |
Bundang Cha Hospital / Pochon Jungmum University | Recruiting |
Seongnam, Gyeonggi-do, Korea, Republic of | |
Contact: Ki-Hwan Yook, MD |
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) |
ADHD, norepinephrine transporter pharmacogenetics |
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 |
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 |