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

Bundang CHA Hospital

Status and phase: Completed; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: OROS-methylphenidate (Concerta)

Study type: Interventional

Funder types: Other

Identifiers

NCT00842127

A030001

GEPOROM

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)