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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


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
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