CYP2D6 Pharmacogenetics in Risperidone-Treated Children

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).

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Key information

Conditions

Psychiatric Disorders Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

association of common CYP2D6 polymorphisms with risperidone area under the curve

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

Ohio State University
Rainbow Babies and Children's Hospital

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Nov 3, 2008
Registry last updated: Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed