The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care

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dc.contributor.authorSaya, Sibel
dc.contributor.authorChondros, Patty
dc.contributor.authorAbela, Anastasia
dc.contributor.authorMihalopolous, Cathrine
dc.contributor.authorChatterton, Mary L.
dc.contributor.authorGunn, Jane
dc.contributor.authorChen, Timothy F.
dc.contributor.authorPolasek, Thomas M.
dc.contributor.authorDettmann, Elise
dc.contributor.authorBrooks, Rachel
dc.contributor.authorKing, Michelle
dc.contributor.authorSpencer, Luke
dc.contributor.authorAlphonse, Pavithran
dc.contributor.authorMilton, Shakira
dc.contributor.authorRamsay, Georgia
dc.contributor.authorSiviour, Zoe
dc.contributor.authorLiew, Jamie
dc.contributor.authorLy, Philip
dc.contributor.authorThoenig, Matthew
dc.contributor.authorSeychell, Raushaan
dc.contributor.authorLa Rocca, Floriana
dc.contributor.authorHesson, Luke B.
dc.contributor.authorMejias, Nydia
dc.contributor.authorSivertsen, Terri
dc.contributor.authorGalea, Melanie A.
dc.contributor.authorBousman, Chad
dc.contributor.authorEmery, Jon
dc.date.accessioned2023-05-21T00:03:32Z
dc.date.available2023-05-21T00:03:32Z
dc.date.issued2023-05-19
dc.date.updated2023-05-21T00:03:32Z
dc.description.abstractAbstract Background The evidence for the clinical utility of pharmacogenomic (PGx) testing is growing, and guidelines exist for the use of PGx testing to inform prescribing of 13 antidepressants. Although previous randomised controlled trials of PGx testing for antidepressant prescribing have shown an association with remission of depression in clinical psychiatric settings, few trials have focused on the primary care setting, where most antidepressant prescribing occurs. Methods The PRESIDE Trial is a stratified double-blinded randomised controlled superiority trial that aims to evaluate the impact of a PGx-informed antidepressant prescribing report (compared with standard prescribing using the Australian Therapeutic Guidelines) on depressive symptoms after 12 weeks, when delivered in primary care. Six hundred seventy-two patients aged 18–65 years of general practitioners (GPs) in Victoria with moderate to severe depressive symptoms, measured using the Patient Health Questionnaire-9 (PHQ-9), will be randomly allocated 1:1 to each arm using a computer-generated sequence. Participants and GPs will be blinded to the study arm. The primary outcome is a difference between arms in the change of depressive symptoms, measured using the PHQ-9 after 12 weeks. Secondary outcomes include a difference between the arms in change in PHQ-9 score at 4, 8 and 26 weeks, proportion in remission at 12 weeks, a change in side effect profile of antidepressant medications, adherence to antidepressant medications, change in quality of life and cost-effectiveness of the intervention. Discussion This trial will provide evidence as to whether PGx-informed antidepressant prescribing is clinically efficacious and cost-effective. It will inform national and international policy and guidelines about the use of PGx to select antidepressants for people with moderate to severe depressive symptoms presenting in primary care. Trial registration Australian and New Zealand Clinical Trial Registry ACTRN12621000181808. Registered on 22 February 2021.
dc.identifier.citationTrials. 2023 May 19;24(1):342
dc.identifier.urihttps://doi.org/10.1186/s13063-023-07361-6
dc.identifier.urihttps://hdl.handle.net/1880/116563
dc.identifier.urihttps://dx.doi.org/10.11575/PRISM/dspace/41406
dc.language.rfc3066en
dc.rights.holderThe Author(s)
dc.titleThe PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care
dc.typeJournal Article
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