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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
History of Changes
  Purpose

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).


Condition
Psychiatric Disorders
Neurodevelopmental Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CYP2D6 PHARMACOGENETICS IN RISPERIDONE-TREATED CHILDREN AND ADOLESCENTS WITH PSYCHIATRIC OR NEURODEVELOPMENTAL DISORDERS

Resource links provided by NLM:

Drug Information available for: Risperidone
U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

DNA from blood, buccal swab, or saliva


Enrollment: 47
Study Start Date: November 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783783

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Ohio State University
Rainbow Babies
Investigators
Principal Investigator: Shannon N Saldana, PharmD, MS Children's Hospital Medical Center, Cincinnati
  More Information

Publications:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00783783     History of Changes
Other Study ID Numbers: 2008-0659, SPR104683
Study First Received: October 31, 2008
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Psychiatric disorders
Neurodevelopmental disorders
Autism
 Risperidone
Pharmacogenetics
Pharmacokinetics

Additional relevant MeSH terms:
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 23, 2013