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Prospective testing of a neurophysiologic biomarker for treatment decisions in major depressive disorder: The PRISE-MD trial
Journal of Psychiatric Research ( IF 4.8 ) Pub Date : 2020-02-26 , DOI: 10.1016/j.jpsychires.2020.02.028
Ian A. Cook , Aimee M. Hunter , Marissa M. Caudill , Michelle J. Abrams , Andrew F. Leuchter

Management of Major Depressive Disorder (MDD) might be improved by a biomarker to predict whether a selected medication is likely to lead to remission. We previously reported on a quantitative electroencephalogram-based biomarker, the Antidepressant Treatment Response (ATR) index, that integrated recordings at baseline and after one week of treatment. The present study prospectively tested whether treatment directed by the biomarker increased the likelihood of remission; we hypothesized that continued treatment with a drug predicted to lead to remission (i.e., high ATR values) would be associated with better outcomes than if the drug was predicted not to lead to remission (i.e., low ATR values). We enrolled 180 adult outpatients with unipolar MDD from the community. After one week of escitalopram treatment to determine the biomarker, stratified randomization (high vs. low ATR) was used to assign subjects to either continued escitalopram or a switch to bupropion as a blinded control condition, for seven additional weeks. For the 73 evaluable subjects assigned to continued escitalopram treatment, the remission rate was significantly higher for those in whom ATR had predicted remission versus non-remission (60.4% vs. 30.0%, respectively, p = 0.01). Accuracy was enhanced by combining 1-week depressive symptom change with ATR (68.6% vs 28.9%). This prospective validation study supports further development of the ATR biomarker, alone or together with early symptom change, to improve care by identifying individuals unlikely to remit with their current treatment, and support the decision to change treatment after one week rather than after failing a full, prolonged course of medication.



中文翻译:

对重大抑郁症的治疗决策进行神经生理生物标志物的前瞻性测试:PRISE-MD试验

可以通过生物标记物改善重度抑郁症(MDD)的管理,以预测所选药物是否可能导致缓解。我们之前曾报道过基于定量脑电图的生物标记物,即抗抑郁治疗反应(ATR)指数,该标记物在基线和治疗一周后进行了整合记录。本研究前瞻性地测试了由生物标志物指导的治疗是否增加了缓解的可能性。我们假设与预计药物不会导致症状缓解(即ATR值较低)相比,继续使用预计会导致症状缓解的药物(即ATR值较高)可以带来更好的治疗效果。我们从社区招募了180名单相MDD成人门诊患者。经过一周的依他普仑治疗以确定生物标志物后,分层随机分组(高ATR与低ATR)用于将受试者分配为继续服用依他普仑或改用安非他酮作为盲对照条件,再持续7周。对于被分配为继续接受依他普仑治疗的73位可评估受试者,ATR预测缓解与未缓解的受试者的缓解率显着更高(分别为60.4%和30.0%,p = 0.01)。通过将1周的抑郁症状改变与ATR相结合,可以提高准确性(68.6%对28.9%)。这项前瞻性验证研究支持单独或与早期症状改变一起进一步开发ATR生物标志物,以通过识别不太可能因当前治疗而缓解的个体来改善护理,并支持在一周后而不是在整个治疗失败后改变治疗的决定。 ,

更新日期:2020-02-26
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