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CYP2D6 Pharmacogenetics in Risperidone-Treated Children

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ClinicalTrials.gov Identifier: NCT00783783
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : December 11, 2012
Sponsor:
Collaborators:
Ohio State University
Rainbow Babies and Children's Hospital
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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 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 or disease
Psychiatric Disorders Neurodevelopmental Disorders

Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CYP2D6 PHARMACOGENETICS IN RISPERIDONE-TREATED CHILDREN AND ADOLESCENTS WITH PSYCHIATRIC OR NEURODEVELOPMENTAL DISORDERS
Study Start Date : November 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

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

Group/Cohort
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



Primary Outcome Measures :
  1. 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) ]

Biospecimen Retention:   Samples With DNA
DNA from blood, buccal swab, or saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 and Children's Hospital
Investigators
Principal Investigator: Shannon N Saldana, PharmD, MS Children's Hospital Medical Center, Cincinnati

Publications:
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00783783     History of Changes
Other Study ID Numbers: 2008-0659
SPR104683
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

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

Additional relevant MeSH terms:
Disease
Mental Disorders
Problem Behavior
Neurodevelopmental Disorders
Pathologic Processes
Behavioral Symptoms
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents