Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the GUIDED trial: A large, patient- and rater-blinded, randomized, controlled study
Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the GUIDED trial: A large, patient- and rater-blinded, randomized, controlled study
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DOI：
10.1016/j.jpsychires.2019.01.003
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发表时间：
2019-04-01
影响因子：
4.8
通讯作者：
Dechairo, Bryan
中科院分区：
文献类型：
--
作者：
Greden, John F.;Parikh, Sagar V.;Dechairo, Bryan
目前对重度抑郁症（MDD）的处方实践产生有限的治疗成功。虽然药物基因组学可以通过识别遗传学上不合适的药物来改善结果，但迄今为止的研究范围有限。诊断为MDD且患者或临床医生报告对至少一种抗抑郁药反应不足的门诊患者（N = 1167）入组了用于改善抑郁决策的基因组学（GUIDED）试验，该试验是一项评估者和患者盲随机对照试验。患者被随机分配至常规治疗组（TAU）或药物基因组学指导干预组，其中临床医生可以获得药物基因组学检测报告，以告知药物选择（指导治疗）。认为药物与检测结果一致（“按指示使用”或“谨慎使用”检测类别）或不一致（"增加谨慎使用和更频繁监测“检测类别）。第8周后揭盲。主要结果是第8周症状改善[17项汉密尔顿抑郁量表（HAM-D17）的变化];次要结果是反应（HAM-D17下降>= 50%）和缓解（HAM-D17
Current prescribing practices for major depressive disorder (MDD) produce limited treatment success. Although pharmacogenomics may improve outcomes by identifying genetically inappropriate medications, studies to date were limited in scope. Outpatients (N = 1167) diagnosed with MDD and with a patient- or clinician-reported inadequate response to at least one antidepressant were enrolled in the Genomics Used to Improve DEpression Decisions (GUIDED) trial a rater and patient-blind randomized controlled trial. Patients were randomized to treatment as usual (TAU) or a pharmacogenomics-guided intervention arm in which clinicians had access to a pharmacogenomic test report to inform medication selections (guided-care). Medications were considered congruent ('use as directed' or 'use with caution' test categories) or incongruent ('use with increased caution and with more frequent monitoring' test category) with test results. Unblinding occurred after week 8. Primary outcome was symptom improvement [change in 17-item Hamilton Depression Rating Scale (HAM-D17)] at week 8; secondary outcomes were response (>= 50% decrease in HAM-D17) and remission (HAM-D17