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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT00757029
First received: September 19, 2008
Last updated: October 4, 2011
Last verified: December 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Study Completion Date: August 2010
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
Other Names:
  • 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
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: NCT00757029

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

No publications provided

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT00757029     History of Changes
Other Study ID Numbers: NETADHD
Study First Received: September 19, 2008
Last Updated: October 4, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

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

ClinicalTrials.gov processed this record on September 30, 2014