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
Sibel Saya,
Patty Chondros,
Anastasia Abela,
Cathrine Mihalopolous,
Mary Lou Chatterton,
Jane Gunn,
Timothy F. Chen,
Thomas M. Polasek,
Elise Dettmann,
Rachel Brooks,
Michelle King,
Luke Spencer,
Pavithran Alphonse,
Shakira Milton,
Georgia Ramsay,
Zoe Siviour,
Jamie Liew,
Philip Ly,
Matthew Thoenig,
Raushaan Seychell,
Floriana La Rocca,
Luke B. Hesson,
Nydia Mejias,
Terri Sivertsen,
Melanie Anne Galea,
Chad Bousman,
Jon Emery
Affiliations
Sibel Saya
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Patty Chondros
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Anastasia Abela
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Cathrine Mihalopolous
School of Public Health and Preventive Medicine, Monash University Health Economics Group, Monash University
Mary Lou Chatterton
School of Public Health and Preventive Medicine, Monash University Health Economics Group, Monash University
Jane Gunn
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Timothy F. Chen
Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney
Thomas M. Polasek
Elise Dettmann
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Rachel Brooks
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Michelle King
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Luke Spencer
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Pavithran Alphonse
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Shakira Milton
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Georgia Ramsay
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Zoe Siviour
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Jamie Liew
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Philip Ly
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Matthew Thoenig
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Raushaan Seychell
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Floriana La Rocca
Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne
Abstract 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.
