CYP2D6 Pharmacogenetics in Risperidone-Treated Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Psychiatric Disorders Neurodevelopmental Disorders

Keywords

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Psychiatric disorders Neurodevelopmental disorders Autism Risperidone Pharmacogenetics Pharmacokinetics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Poor metabolizers

Patients with CYP2D6 genotypes predictive of poor metabolizer phenotype

No interventions assigned to this group

Non poor metabolizers

Patients with CYP2D6 genotypes predictive of intermediate, extensive, or ultra-rapid metabolizer phenotypes

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shannon N Saldana, PharmD, MS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.clinthera.2007.07.026.

Reference Type BACKGROUND

PMID: 17825699 (View on PubMed)

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. doi: 10.1016/j.jchromb.2007.02.007. Epub 2007 Feb 15.

Reference Type BACKGROUND

PMID: 17344104 (View on PubMed)

Sherwin CM, Saldana 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. doi: 10.1097/FTD.0b013e318261c240.

Reference Type RESULT

PMID: 22929407 (View on PubMed)

Other Identifiers

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SPR104683

Identifier Type: -

Identifier Source: secondary_id

2008-0659