CYP2D6 Pharmacogenetics in Risperidone-Treated Children

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT00783783

Collaborator

Ohio State University (Other), Rainbow Babies and Children's Hospital (Other)

Enrollment

Location

30.9

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Risperidone is an important medication used to treat children with psychiatric illnesses or neurodevelopmental disorders, such as autism. Despite excellent symptom control, the potential for side effects is worrisome. Treating these disorders is difficult because not everyone responds the same way to the same risperidone dose. One reason for this is genetic differences in how people break down the drug. Understanding these differences will help clinicians choose a dose and better predict the response so patients will be treated successfully with a lower risk for side effects. This study will research these genetic differences in children with psychiatric or neurodevelopmental disorders. Hypothesis: The inter-patient variability in risperidone pharmacokinetics and exposure, adverse events, and clinical response in patients with psychiatric or neurodevelopmental disorders is associated with identifiable pharmacogenetic factors, such as CYP2D6 single nucleotide polymorphisms (SNPs).

Condition or Disease	Intervention/Treatment	Phase
Psychiatric Disorders Neurodevelopmental Disorders

Study Design

Study Type:

Observational

Actual Enrollment :

47 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

CYP2D6 PHARMACOGENETICS IN RISPERIDONE-TREATED CHILDREN AND ADOLESCENTS WITH PSYCHIATRIC OR NEURODEVELOPMENTAL DISORDERS

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Poor metabolizers Patients with CYP2D6 genotypes predictive of poor metabolizer phenotype
Non poor metabolizers Patients with CYP2D6 genotypes predictive of intermediate, extensive, or ultra-rapid metabolizer phenotypes

Outcome Measures

Primary Outcome Measures

association of common CYP2D6 polymorphisms with risperidone area under the curve [pre-dose (sample 1 = 0-30 minutes before first oral dose), and three at well-timed post-dose points (sample 2 = 15-30 minutes after dose; sample 3 = 60-90 minutes after dose; sample 4 = 4-6 hours after dose)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Previous risperidone PK study participation (CCHMC, Rainbow Babies and Children's Hospital or OSU)
CYP2D6 PM predicted phenotype
Actively taking risperidone
Under 18 years of age at time of enrollment
Signed, dated informed consent forms