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

Trials

Study Protocol

Thomas M. Polasek¹  Elise Dettmann²  Patty Chondros²  Jane Gunn²  Rachel Brooks³  Floriana La Rocca³  Raushaan Seychell³  Sibel Saya³  Zoe Siviour³  Philip Ly³  Jon Emery³  Jamie Liew³  Michelle King³  Luke Spencer³  Anastasia Abela³  Shakira Milton³  Matthew Thoenig³  Pavithran Alphonse³  Georgia Ramsay³  Chad Bousman⁴  Terri Sivertsen⁵  Melanie Anne Galea⁵  Luke B. Hesson⁶  Mary Lou Chatterton⁷  Cathrine Mihalopolous⁷  Timothy F. Chen⁸  Nydia Mejias⁹ 

[1] Certara, Princeton, NJ, USA;Centre for Medicine Use and Safety, Monash University, Melbourne, Australia;Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia;Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia;Centre for Cancer Research, University of Melbourne, Melbourne, Australia;Department of Medical Genetics, University of Calgary, Calgary, AB, Canada;Genetics Department, Douglass Hanly Moir Pathology, Sonic Healthcare, Sydney, NSW, Australia;Genetics Department, Douglass Hanly Moir Pathology, Sonic Healthcare, Sydney, NSW, Australia;School of Clinical Medicine, Faculty of Medicine, UNSW Sydney, Randwick, NSW, Australia;Kinghorn Centre for Clinical Genomics, Garvan Institute of Medical Research, Darlinghurst, NSW, Australia;School of Public Health and Preventive Medicine, Monash University Health Economics Group, Monash University, Melbourne, VIC, Australia;Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, 2006, Camperdown, NSW, Australia;Translational Software, Mercer Island, WA, USA;

关键词: Major depressive disorder;    Mental health;    Pharmacogenomics;    Primary care;    General practice;    Antidepressants;    Randomised controlled trial;   

DOI  :  10.1186/s13063-023-07361-6

 received in 2023-05-01, accepted in 2023-05-06,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsThe 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.DiscussionThis 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 registrationAustralian and New Zealand Clinical Trial Registry ACTRN12621000181808. Registered on 22 February 2021.

【 授权许可】

CC BY   
© The Author(s) 2023