Cost-effectiveness of CYP2D6 and CYP2C19 Genotyping in Psychiatric Patients in Curacao

NCT02713672 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2016-03-21

No results posted yet for this study

Summary

The cytochrome P450 (CYP) is a group of metabolic enzymes, from which the 2D6 and CYP2C19 polymorphisms are specifically related to the metabolism of psychiatric drugs. The prevalence of CYP2D6 and CYP2C19 polymorphisms differs among ethnicities. Depending on the number of functional alleles, individuals are classified as Poor Metabolizer (PM), Intermediate Metabolizer (IM), Extensive Metabolizer (EM) or Ultra Rapid Metabolizer (UM).

Research has suggested that PM genotype is a predisposing factor for antipsychotic-induced side-effects. Besides susceptibility for side effects and lower quality of life, also, a relationship between phenotype and costs of care has been shown.

Guidelines recommend that PM, IM and UM genotypes need dose adjustment, to optimize the effectiveness of the drug and/or to reduce side effects. No research has been done to investigate cost-effectiveness of implementation of genotyping in daily clinical psychiatric practice.

This study investigates the effectiveness of implementation of CYP2D6 and CYP2C19 genotyping in psychiatric patients in Curacao and analyzes the costs of genotyping versus health benefits.

Conditions

  • CYP2D6, Psychiatric Patients

Interventions

OTHER

Dose adjustment according to genotype

Patients in the intervention group received a dose adjustment according to their CYP2D6 or CYP2C19 genotype based on guidelines of the KNMP

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER
  • Parnassia

    collaborator UNKNOWN
  • Klinika Capriles

    collaborator UNKNOWN
  • Psychiaters Maatschap Antillen

    collaborator UNKNOWN
  • GGZ Centraal

    lead OTHER

Principal Investigators

  • Peter van Harten, Professor · GGZ Centraal

  • Wijbrand Hoek, Professor · Parnassia

  • David Vinkers, PhD · Maastricht University

  • Anne Koopmans, MD · Maastricht University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02713672 on ClinicalTrials.gov