Status:
COMPLETED
CYP2D6 Pharmacogenetics in Risperidone-Treated Children
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Ohio State University
Rainbow Babies and Children's Hospital
Conditions:
Psychiatric Disorders
Neurodevelopmental Disorders
Eligibility:
All Genders
3-18 years
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 effe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00783783
Start Date
November 1 2008
End Date
June 1 2011
Last Update
December 11 2012
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229