Effects and cost-effectiveness of pharmacogenetic screening for XXXX among older adults starting therapy with @entity5080 or @entity906 : study protocol for a pragmatic randomized controlled trial (CYSCEtrial).

@entity1 @entity308 @entity137 @entity5320 @entity146 @entity5080 @entity906
BACKGROUND: @entity5080 and @entity906 are commonly used antidepressants for treatment of @entity308 in older @entity1 . Both drugs are metabolized by the polymorphic @entity5320 ( @entity5320 ) enzyme and guidelines for dose adaptations based on the @entity5320 genotype have been developed. The @entity5320 Screening Among Elderly (CYSCE) trial is designed to address the potential health and economic value of genotyping for @entity5320 in optimizing dose-finding of @entity5080 and @entity906 . METHODS/DESIGN: In a pragmatic randomized controlled trial, @entity1 diagnosed with a major @entity308 according to the DSM-IV and aged 60  years or older will be recruited from @entity146 centers across the Netherlands. After @entity5320 genotyping determined in peripheral blood obtained by finger-prick, @entity1 will be grouped into poor, intermediate, extensive, or ultrarapid metabolizers. @entity1 with deviant genotype (that is poor, intermediate or ultrarapid genotype) will be randomly allocated to an intervention group in which the genotype and dosing advice is communicated to the treating physician, or to a control group in which @entity1 receive care as usual. Additionally, an external reference group of @entity1 with the extensive metabolizer genotype is included. Primary outcome in all groups is time needed to obtain an adequate blood level of the antidepressant drug. Secondary outcomes include @entity137 measured by a shortened Antidepressant Side-Effects Checklist (ASEC), and cost-effectiveness of the screening. DISCUSSION: Results of this trial will guide policy-making with regard to pharmacogenetic screening prior to treatment with @entity5080 or @entity906 among older @entity1 with @entity308 . TRIAL REGISTRATION: ClinicalTrials.gov: NCT01778907 ; registration date: 22 January 2013.
