CYP2D6 Pharmacogenetics in Risperidone-Treated Children

Study Overview
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Brief Summary
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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).

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

Conditions
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Psychiatric Disorders, Neurodevelopmental Disorders

Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Investigators are unable to contact the subject/legal guardian(s) Subject is no longer taking risperidone CYP2D6 predicted phenotype other than PM Subject is non-White, with respect to race, for PK study participation Subject is 18 years of age or older Subject is less than 5 years of age Subject is pregnant at the time of the full PK study Subject/legal guardian unwilling or unable to participate in the study

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychiatric disorders, Neurodevelopmental disorders, Autism, Risperidone, Pharmacogenetics, Pharmacokinetics