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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00842127
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : February 12, 2009
Hallym University Medical Center
Information provided by:
Bundang CHA Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: OROS-methylphenidate (Concerta) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : March 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Intervention Details:
  • Drug: OROS-methylphenidate (Concerta)
    dose: 18mg, 27mg, 36mg, 45mg, 54mg/day, po duration: 8 weeks
    Other Name: Concerta

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

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

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT00842127

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Korea, Republic of
Bundang CHA hospital
Seongnam, Kyonggi-do, Korea, Republic of, 463-712
Sponsors and Collaborators
Bundang CHA Hospital
Hallym University Medical Center
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Principal Investigator: Ki-Hwan Yook, MD,PhD Department of psychiatry CHA university college of medicine
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Responsible Party: Ki-Hwan Yook, Bundang CHA hospital Identifier: NCT00842127    
Other Study ID Numbers: GEPOROM
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 2009
Keywords provided by Bundang CHA Hospital:
Multidrug resistance(MDR)polymorphism
OROS methylphenidate
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
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