Lii Theresa R, Smith Ashleigh E, Flohr Josephine R, Okada Robin L, Nyongesa Cynthia A, Cianfichi Lisa J, Hack Laura M, Schatzberg Alan F, Heifets Boris D
Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Department of Radiology, Stanford University School of Medicine, Stanford, CA, USA.
Nat Ment Health. 2023 Nov;1(11):876-886. doi: 10.1038/s44220-023-00140-x. Epub 2023 Oct 19.
Ketamine may have antidepressant properties, but its acute psychoactive effects complicate successful masking in placebo-controlled trials. We present a single-center, parallel-arm, triple-masked, randomized, placebo-controlled trial assessing the antidepressant efficacy of intravenous ketamine masked by surgical anesthesia (ClinicalTrials.gov, NCT03861988). Forty adult patients with major depressive disorder who were scheduled for routine surgery were randomized to a single infusion of ketamine (0.5 mg/kg) or placebo (saline) during usual anesthesia. All participants, investigators, and direct patient care staff were masked to treatment allocation. The primary outcome was depression severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at 1, 2, and 3 days post-infusion. After all follow-up visits, participants were asked to guess which intervention they received. A mixed-effects model showed no evidence of effect of treatment assignment on the primary outcome (-5.82, 95% CI -13.3 to 1.64, p=0.13). 36.8% of participants guessed their treatment assignment correctly; both groups allocated their guesses in similar proportions. In conclusion, a single dose of intravenous ketamine delivered during surgical anesthesia had no greater effect than placebo in acutely reducing the severity of depressive symptoms in adults with major depressive disorder. This trial successfully masked treatment allocation in moderate-to-severely depressed patients using surgical anesthesia. Although this masking strategy is impractical for most placebo-controlled trials, future studies of novel antidepressants with acute psychoactive effects should make efforts to fully mask treatment assignment in order to minimize subject-expectancy bias.
氯胺酮可能具有抗抑郁特性,但其急性精神活性效应使在安慰剂对照试验中成功设盲变得复杂。我们开展了一项单中心、平行组、三盲、随机、安慰剂对照试验,评估手术麻醉掩盖下静脉注射氯胺酮的抗抑郁疗效(ClinicalTrials.gov,NCT03861988)。40例计划进行常规手术的成年重度抑郁症患者在常规麻醉期间被随机分为单次输注氯胺酮(0.5mg/kg)或安慰剂(生理盐水)组。所有参与者、研究者和直接参与患者护理的工作人员均对治疗分配情况不知情。主要结局是输注后1天、2天和3天用蒙哥马利-艾斯伯格抑郁评定量表(MADRS)测量的抑郁严重程度。在所有随访结束后,要求参与者猜测他们接受的是哪种干预措施。混合效应模型显示,没有证据表明治疗分配对主要结局有影响(-5.82,95%CI -13.3至1.64,p=0.13)。36.8%的参与者正确猜出了他们的治疗分配情况;两组猜对的比例相似。总之,在手术麻醉期间单次静脉注射氯胺酮在急性减轻成年重度抑郁症患者的抑郁症状严重程度方面并不比安慰剂更有效。该试验成功地利用手术麻醉对中重度抑郁症患者的治疗分配进行了设盲。尽管这种设盲策略对大多数安慰剂对照试验来说不切实际,但未来对具有急性精神活性效应的新型抗抑郁药的研究应努力完全掩盖治疗分配情况,以尽量减少受试者预期偏差。