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

Phase 4
Completed
Conditions
Attention Deficit Hyperactivity Disorder
Registration Number
NCT00842127
Lead Sponsor
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).

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Barkley side effects rating scaleweeks 1, 2,4,8
Secondary Outcome Measures
NameTimeMethod
ADHD rating scale-Korean version; Clinical Global Impressions (CGI) of Severity and Improvement (CGI-S and CGI-I)8 weeks

Trial Locations

Locations (1)

Bundang CHA hospital

🇰🇷

Seongnam, Kyonggi-do, Korea, Republic of

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