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Genetic Polymorphism and OROS-Methylphenidate Treatment in Attention Deficit Hyperactivity Disorder(ADHD)

This study has been completed.
Hallym University Medical Center
Information provided by:
Bundang CHA Hospital Identifier:
First received: February 11, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
The purpose of this study is to examine whether genetic polymorphisms in drug transporters were associated with the side effects of OROS-methylphenidate medication in attention deficit/hyperactivity disorder(ADHD).

Condition Intervention Phase
Attention Deficit Hyperactivity Disorder Drug: OROS-methylphenidate (Concerta) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Genetic Polymorphism of Drug Transporters in OROS-Methylphenidate Treatment in Children and Adolescents With Attention Deficit Hyperactivity Disorder(ADHD)

Resource links provided by NLM:

Further study details as provided by Bundang CHA Hospital:

Primary Outcome Measures:
  • Barkley side effects rating scale [ Time Frame: weeks 1, 2,4,8 ]

Secondary Outcome Measures:
  • ADHD rating scale-Korean version; Clinical Global Impressions (CGI) of Severity and Improvement (CGI-S and CGI-I) [ Time Frame: 8 weeks ]

Enrollment: 150
Study Start Date: March 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: OROS-methylphenidate (Concerta)
    dose: 18mg, 27mg, 36mg, 45mg, 54mg/day, po duration: 8 weeks
    Other Name: Concerta
Detailed Description:
20 to 30% of children with attention deficit/hyperactivity disorder(ADHD) do not respond or could not tolerate methylphenidate treatment. Drug transporters such as multidrug resistant proteins(MDR) plays important role in the clearance of psychotropic drugs and their metabolites from brain tissue. It suggested that methylphenidate was a P-glycoprotein(encoded by MDR1 gene)substrate and showed inhibitory effects on the P-glycoprotein efflux function. Single nucleotide polymorphisms(SNP)in the MDR1 gene were analyzed in children and adolescents with OROS-methylphenidate treatment. The hypothesis is that MDR1(ABCB1) polymorphisms are associated with the side effects of OROS-methylphenidate.

Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ADHD
  • Must be able to swallow a capsule

Exclusion Criteria:

  • Pervasive developmental disorder
  • Mental retardation
  • Psychotic disorder
  • Bipolar disorder
  • Suicidality
  • Neurological disorder
  • Concurrent psychiatric treatment
  Contacts and Locations
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Please refer to this study by its identifier: NCT00842127

Korea, Republic of
Bundang CHA hospital
Seongnam, Kyonggi-do, Korea, Republic of, 463-712
Sponsors and Collaborators
Bundang CHA Hospital
Hallym University Medical Center
Principal Investigator: Ki-Hwan Yook, MD,PhD Department of psychiatry CHA university college of medicine
  More Information

Responsible Party: Ki-Hwan Yook, Bundang CHA hospital Identifier: NCT00842127     History of Changes
Other Study ID Numbers: GEPOROM
Study First Received: February 11, 2009
Last Updated: February 11, 2009

Keywords provided by Bundang CHA Hospital:
Multidrug resistance(MDR)polymorphism
OROS methylphenidate

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 processed this record on August 16, 2017