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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
OROS-methylphenidate (Concerta)
Sponsored by
Bundang CHA Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Methylphenidate, ADHD, Multidrug resistance(MDR)polymorphism, OROS methylphenidate

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bundang CHA hospital

Outcomes

Primary Outcome Measures

Barkley side effects rating scale

Secondary Outcome Measures

ADHD rating scale-Korean version; Clinical Global Impressions (CGI) of Severity and Improvement (CGI-S and CGI-I)

Full Information

First Posted
February 11, 2009
Last Updated
February 11, 2009
Sponsor
Bundang CHA Hospital
Collaborators
Hallym University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00842127
Brief Title
Genetic Polymorphism and OROS-Methylphenidate Treatment in Attention Deficit Hyperactivity Disorder(ADHD)
Official Title
Genetic Polymorphism of Drug Transporters in OROS-Methylphenidate Treatment in Children and Adolescents With Attention Deficit Hyperactivity Disorder(ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bundang CHA Hospital
Collaborators
Hallym University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Methylphenidate, ADHD, Multidrug resistance(MDR)polymorphism, OROS methylphenidate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
OROS-methylphenidate (Concerta)
Other Intervention Name(s)
Concerta
Intervention Description
dose: 18mg, 27mg, 36mg, 45mg, 54mg/day, po duration: 8 weeks
Primary Outcome Measure Information:
Title
Barkley side effects rating scale
Time Frame
weeks 1, 2,4,8
Secondary Outcome Measure Information:
Title
ADHD rating scale-Korean version; Clinical Global Impressions (CGI) of Severity and Improvement (CGI-S and CGI-I)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki-Hwan Yook, MD,PhD
Organizational Affiliation
Department of psychiatry CHA university college of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bundang CHA hospital
City
Seongnam
State/Province
Kyonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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