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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00842127
First Posted: February 12, 2009
Last Update Posted: February 12, 2009
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.
Collaborator:
Hallym University Medical Center
Information provided by:
Bundang CHA Hospital
  Purpose
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: 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)

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.
  Eligibility

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
Criteria

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
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): NCT00842127


Locations
Korea, Republic of
Bundang CHA hospital
Seongnam, Kyonggi-do, Korea, Republic of, 463-712
Sponsors and Collaborators
Bundang CHA Hospital
Hallym University Medical Center
Investigators
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
ClinicalTrials.gov Identifier: NCT00842127     History of Changes
Other Study ID Numbers: GEPOROM
A030001
First Submitted: February 11, 2009
First Posted: February 12, 2009
Last Update Posted: February 12, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
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