Department of General Practice and Primary Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia.
Centre for Cancer Research, University of Melbourne, Melbourne, Australia.
Trials. 2023 May 19;24(1):342. doi: 10.1186/s13063-023-07361-6.
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.
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.
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.
Australian and New Zealand Clinical Trial Registry ACTRN12621000181808. Registered on 22 February 2021.
越来越多的证据表明药物基因组学（PGx）检测具有临床实用性，并且存在针对 13 种抗抑郁药的 PGx 检测使用指南。尽管先前针对抗抑郁药处方的 PGx 检测的随机对照试验表明，在临床精神科环境中与抑郁缓解有关，但很少有试验关注大多数抗抑郁药处方发生的初级保健环境。
PRESIDE 试验是一项分层双盲随机对照优效性试验，旨在评估在初级保健中提供的基于 PGx 的抗抑郁药处方报告（与使用澳大利亚治疗指南进行标准处方相比）对 12 周后抑郁症状的影响。来自维多利亚州的 672 名年龄在 18-65 岁之间的全科医生（GP）的患者，他们的抑郁症状中度至重度，使用患者健康问卷-9（PHQ-9）进行测量，将使用计算机生成的序列以 1:1 的比例随机分配到每个手臂。参与者和 GP 将对研究手臂不知情。主要结局是手臂之间在 12 周后使用 PHQ-9 测量的抑郁症状变化之间的差异。次要结局包括手臂之间 PHQ-9 评分在 4、8 和 26 周时的变化差异，12 周时缓解的比例，抗抑郁药物副作用特征的变化，抗抑郁药物的依从性，生活质量的变化和干预的成本效益。
该试验将提供关于 PGx 指导下的抗抑郁药处方是否具有临床疗效和成本效益的证据。它将为国家和国际政策和指南提供信息，以指导在初级保健中针对中度至重度抑郁症状的人群使用 PGx 选择抗抑郁药。
澳大利亚和新西兰临床试验注册处 ACTRN12621000181808。于 2021 年 2 月 22 日注册。
