CYP2D6 Pharmacogenetics in Risperidone-Treated Children

Neurodevelopmental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783783
• Other study ID #: 2008-0659
• Secondary ID: SPR104683
• Status: Completed
• Phase: N/A
• First received: October 31, 2008
• Last updated: December 10, 2012
• Start date: November 2008
• Est. completion date: June 2011

Study information

• Verified date: December 2012
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Mental Disorders Diagnosed in Childhood
• Neurodevelopmental Disorders
• Psychiatric Disorders

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Ohio State University, Rainbow Babies and Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Aman MG, Vinks AA, Remmerie B, Mannaert E, Ramadan Y, Masty J, Lindsay RL, Malone K. Plasma pharmacokinetic characteristics of risperidone and their relationship to saliva concentrations in children with psychiatric or neurodevelopmental disorders. Clin Ther. 2007 Jul;29(7):1476-86. — View Citation

Cabovska B, Cox SL, Vinks AA. Determination of risperidone and enantiomers of 9-hydroxyrisperidone in plasma by LC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Jun 1;852(1-2):497-504. Epub 2007 Feb 15. — View Citation

Sherwin CM, Saldaña SN, Bies RR, Aman MG, Vinks AA. Population pharmacokinetic modeling of risperidone and 9-hydroxyrisperidone to estimate CYP2D6 subpopulations in children and adolescents. Ther Drug Monit. 2012 Oct;34(5):535-44. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No