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CYP2D6 Pharmacogenetics in Risperidone-Treated Children

This study has been completed.
Sponsor:
Collaborators:
Ohio State University
Rainbow Babies
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00783783
First received: October 31, 2008
Last updated: December 10, 2012
Last verified: December 2012

October 31, 2008
December 10, 2012
November 2008
June 2011   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00783783 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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CYP2D6 Pharmacogenetics in Risperidone-Treated Children
CYP2D6 PHARMACOGENETICS IN RISPERIDONE-TREATED CHILDREN AND ADOLESCENTS WITH PSYCHIATRIC OR NEURODEVELOPMENTAL DISORDERS

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

DNA from blood, buccal swab, or saliva

Non-Probability Sample

Subjects will include up to 41 risperidone-treated children and adolescents with psychiatric or neurodevelopmental (ND) disorders who participated in one of two previous risperidone pharmacokinetics investigations.

To have a larger sample of poor metabolizer subjects, we plan to enroll at least 8 additional subjects who are on stable treatment with risperidone, and perform risperidone pharmacokinetics analyses. Prospectively enrolled subjects (n = 8) will be CYP2D6 poor metabolizers and will include White / Caucasian subjects, of any socioeconomic status, and will be recruited from inpatients or outpatients at Cincinnati Children's Hospital

  • Psychiatric Disorders
  • Neurodevelopmental Disorders
Not Provided
  • Poor metabolizers
    Patients with CYP2D6 genotypes predictive of poor metabolizer phenotype
  • Non poor metabolizers
    Patients with CYP2D6 genotypes predictive of intermediate, extensive, or ultra-rapid metabolizer phenotypes

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
3 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00783783
2008-0659, SPR104683
No
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
  • Ohio State University
  • Rainbow Babies
Principal Investigator: Shannon N Saldana, PharmD, MS Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP