Iosifescu Dan V, Neborsky Robert J, Valuck Robert J
Adult Psychopharmacology Program, Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
School of Medicine, University of California, San Diego, CA, USA; University of California, Los Angeles, CA, USA; Medical Corps, US Navy, USA.
Neuropsychiatr Dis Treat. 2016 Aug 25;12:2131-42. doi: 10.2147/NDT.S113712. eCollection 2016.
This study aims to determine whether Psychiatric Electroencephalography Evaluation Registry (PEER) Interactive (an objective, adjunctive tool based on a comparison of a quantitative electroencephalogram to an existing registry of patient outcomes) is more effective than the current standard of care in treatment of subjects suffering from depression.
This is an interim report of an ongoing, 2-year prospective, randomized, double blind, controlled study to evaluate PEER Interactive in guiding medication selection in subjects with a primary diagnosis of depression vs standard treatment. Subjects in treatment at two military hospitals were blinded as to study group assignment and their self-report symptom ratings were also blinded. Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR16) depression scores were the primary efficacy endpoint. One hundred and fifty subjects received a quantitative electroencephalography exam and were randomized to either treatment as usual or PEER-informed pharmacotherapy. Subjects in the control group were treated according to Veterans Administration/Department of Defense Guidelines, the current standard of care. In the experimental group, the attending physician received a PEER report ranking the subject's likely clinical response to on-label medications.
In this post hoc interim analysis subjects were separated into Report Followed and Report Not Followed groups - based on the concordance between their subsequent treatment and PEER medication guidance. We thus evaluated the predictive validity of PEER recommendations. We found significantly greater improvements in depression scores (QIDS-SR16 P<0.03), reduction in suicidal ideation (Concise Health Risk Tracking Scale-SR7 P<0.002), and post-traumatic stress disorder (PTSD) score improvement (PTSD Checklist Military/Civilian P<0.04) for subjects treated with PEER-recommended medications compared to those who did not follow PEER recommendations.
This interim analysis suggests that an objective tool such as PEER Interactive can help improve medication selection. Consistent with results of earlier studies, it supports the hypothesis that PEER-guided treatment offers distinct advantages over the current standard of care.
本研究旨在确定精神科脑电图评估登记系统(PEER)交互式工具(一种基于将定量脑电图与现有患者预后登记系统进行比较的客观辅助工具)在治疗抑郁症患者方面是否比当前的护理标准更有效。
这是一项正在进行的为期2年的前瞻性、随机、双盲、对照研究的中期报告,旨在评估PEER交互式工具在指导原发性抑郁症患者的药物选择方面与标准治疗的效果。在两家军事医院接受治疗的患者对研究组分配情况不知情,且他们的自我报告症状评分也处于盲态。抑郁症状快速自评量表(QIDS-SR16)抑郁评分是主要疗效终点。150名受试者接受了定量脑电图检查,并被随机分为常规治疗组或PEER指导的药物治疗组。对照组的受试者按照退伍军人事务部/国防部指南(当前的护理标准)进行治疗。在实验组中,主治医生收到一份PEER报告,该报告对受试者对标签上药物的可能临床反应进行了排名。
在这项事后中期分析中,根据受试者后续治疗与PEER药物指导的一致性,将受试者分为遵循报告组和未遵循报告组。因此,我们评估了PEER建议的预测效度。我们发现,与未遵循PEER建议的受试者相比,接受PEER推荐药物治疗的受试者在抑郁评分(QIDS-SR16,P<0.03)、自杀意念减少(简明健康风险追踪量表-SR7,P<0.002)和创伤后应激障碍(PTSD)评分改善(PTSD检查表-军事/平民版,P<0.04)方面有显著更大的改善。
这项中期分析表明,诸如PEER交互式工具这样的客观工具有助于改善药物选择。与早期研究结果一致,它支持这样的假设,即PEER指导的治疗比当前的护理标准具有明显优势。