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Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD) (NETADHD)

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ClinicalTrials.gov Identifier: NCT00757029
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : October 5, 2011
Sponsor:
Information provided by (Responsible Party):
Hallym University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Methylphenidate Pharmacogenetics Genetic: norepinephrine transporter polymorphism, Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Association Between Norepinephrine Transporter Polymorphism and Response of Methylphenidate
Study Start Date : October 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2010


Arm Intervention/treatment
open label Genetic: norepinephrine transporter polymorphism,
OROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism
Other Names:
  • OROS methylphenidate (Concerta) monopharmacotherapy
  • dose : 18-54mg
  • duration : 8 weeks
  • genotyping : norepinephrine transporter (SLC6A2) polymorphism



Primary Outcome Measures :
  1. Korean ADHD Rating scale-parent version (KARS) [ Time Frame: baseline,1,2,4,8 weeks ]

Secondary Outcome Measures :
  1. Barkely side effect rating scale [ Time Frame: 1,2,4,8weeks ]


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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:

  • 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

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): NCT00757029


Locations
Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
Hallym University Medical Center

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT00757029     History of Changes
Other Study ID Numbers: NETADHD
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: December 2010

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

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
Norepinephrine
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
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents