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

This study has been completed.
Sponsor:
Collaborator:
Hallym University Medical Center
Information provided by:
Bundang CHA Hospital
ClinicalTrials.gov Identifier:
NCT00842127
First received: February 11, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Bundang CHA Hospital:

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

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ki-Hwan Yook, Bundang CHA hospital
ClinicalTrials.gov Identifier: NCT00842127     History of Changes
Other Study ID Numbers: GEPOROM, A030001
Study First Received: February 11, 2009
Last Updated: February 11, 2009
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
 Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013