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

Genetic Polymorphism of Drug Transporters in OROS-Methylphenidate Treatment in Children and Adolescents With Attention Deficit Hyperactivity Disorder(ADHD)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00842127

Enrollment

150

Registered

2009-02-12

Start date

2006-03-31

Completion date

2008-08-31

Last updated

2009-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Methylphenidate, ADHD, Multidrug resistance(MDR)polymorphism, OROS methylphenidate

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.

Interventions

DRUGOROS-methylphenidate (Concerta)

dose: 18mg, 27mg, 36mg, 45mg, 54mg/day, po duration: 8 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Barkley side effects rating scale	weeks 1, 2,4,8

Secondary

Measure	Time frame
ADHD rating scale-Korean version; Clinical Global Impressions (CGI) of Severity and Improvement (CGI-S and CGI-I)	8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026