CYP2D6 Pharmacogenetics in Risperidone-Treated Children

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00783783

Enrollment

Registered

2008-11-03

Start date

2008-11-30

Completion date

2011-06-30

Last updated

2012-12-11

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

Conditions

Neurodevelopmental Disorders, Psychiatric Disorders

Keywords

Psychiatric disorders, Neurodevelopmental disorders, Autism, Risperidone, Pharmacogenetics, Pharmacokinetics

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

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

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

Design outcomes

Primary

Measure	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)

Countries

United States

Outcome results