Suppr超能文献

手术麻醉掩盖下氯胺酮治疗抑郁症患者的随机试验。

Randomized trial of ketamine masked by surgical anesthesia in patients with depression.

作者信息

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

机构信息

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.

出版信息

Nat Ment Health. 2023 Nov;1(11):876-886. doi: 10.1038/s44220-023-00140-x. Epub 2023 Oct 19.

Abstract

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.

摘要

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。

相似文献

1
Randomized trial of ketamine masked by surgical anesthesia in patients with depression.
Nat Ment Health. 2023 Nov;1(11):876-886. doi: 10.1038/s44220-023-00140-x. Epub 2023 Oct 19.
2
Randomized Trial of Ketamine Masked by Surgical Anesthesia in Depressed Patients.
medRxiv. 2023 Jun 15:2023.04.28.23289210. doi: 10.1101/2023.04.28.23289210.
3
Efficacy of Intravenous Ketamine in Adolescent Treatment-Resistant Depression: A Randomized Midazolam-Controlled Trial.
Am J Psychiatry. 2021 Apr 1;178(4):352-362. doi: 10.1176/appi.ajp.2020.20010018. Epub 2021 Mar 3.
4
Efficacy of Intravenous Ketamine in Adolescent Treatment-Resistant Depression: A Randomized Midazolam-Controlled Trial.
Focus (Am Psychiatr Publ). 2022 Apr;20(2):241-251. doi: 10.1176/appi.focus.22020004. Epub 2022 Apr 22.
6
Ketamine and other glutamate receptor modulators for depression in bipolar disorder in adults.
Cochrane Database Syst Rev. 2015 Sep 29(9):CD011611. doi: 10.1002/14651858.CD011611.pub2.
8
Ketamine and other glutamate receptor modulators for depression in adults.
Cochrane Database Syst Rev. 2015 Sep 23(9):CD011612. doi: 10.1002/14651858.CD011612.pub2.
9
A Novel, Brief, Fully Automated Intervention to Extend the Antidepressant Effect of a Single Ketamine Infusion: A Randomized Clinical Trial.
Am J Psychiatry. 2022 Dec 1;179(12):959-968. doi: 10.1176/appi.ajp.20220216. Epub 2022 Sep 21.
10
Ketamine for postoperative avoidance of depressive symptoms: the K-PASS feasibility randomised trial.
BJA Open. 2023 Dec 15;9:100245. doi: 10.1016/j.bjao.2023.100245. eCollection 2024 Mar.

引用本文的文献

3
What are set and setting: Reducing vagueness to improve research and clinical practice.
J Psychopharmacol. 2025 May 26:2698811251337372. doi: 10.1177/02698811251337372.
5
Opioids diminish the placebo antidepressant response: Observational post hoc findings from a randomized controlled ketamine trial.
J Affect Disord. 2025 Jul 15;381:200-204. doi: 10.1016/j.jad.2025.04.008. Epub 2025 Apr 2.
6
Addressing blinding in classic psychedelic studies with innovative active placebos.
Int J Neuropsychopharmacol. 2025 Apr 11;28(4). doi: 10.1093/ijnp/pyaf023.
7
Acute Subjective Experiences of Intravenous Ketamine Therapy Among Medically Hospitalized Patients with Alcohol Use Disorder.
Psychedelic Med (New Rochelle). 2024 Jun 17;2(2):116-126. doi: 10.1089/psymed.2023.0066. eCollection 2024 Jun.
8
Licit use of illicit drugs for treating depression: the pill and the process.
J Clin Invest. 2024 Jun 17;134(12):e180217. doi: 10.1172/JCI180217.
10
The role of ketamine and its enantiomer in managing depression and pain in cancer patients: A narrative review.
J Anesth Transl Med. 2024 Dec;3(4):155-165. doi: 10.1016/j.jatmed.2024.10.005. Epub 2024 Nov 29.

本文引用的文献

1
The antidepressant actions of ketamine and its enantiomers.
Pharmacol Ther. 2023 Jun;246:108431. doi: 10.1016/j.pharmthera.2023.108431. Epub 2023 May 3.
4
5
Ketamine triggers a switch in excitatory neuronal activity across neocortex.
Nat Neurosci. 2023 Jan;26(1):39-52. doi: 10.1038/s41593-022-01203-5. Epub 2022 Nov 24.
6
Is good science leading the way in the therapeutic use of psychedelic drugs?
Psychol Med. 2022 Oct;52(14):2849-2851. doi: 10.1017/S0033291722003191. Epub 2022 Oct 19.
7
A Novel, Brief, Fully Automated Intervention to Extend the Antidepressant Effect of a Single Ketamine Infusion: A Randomized Clinical Trial.
Am J Psychiatry. 2022 Dec 1;179(12):959-968. doi: 10.1176/appi.ajp.20220216. Epub 2022 Sep 21.
8
Expectancy in placebo-controlled trials of psychedelics: if so, so what?
Psychopharmacology (Berl). 2022 Oct;239(10):3047-3055. doi: 10.1007/s00213-022-06221-6. Epub 2022 Sep 5.
9
Active mechanisms of ketamine-assisted psychotherapy: A systematic review.
J Affect Disord. 2022 Oct 15;315:105-112. doi: 10.1016/j.jad.2022.07.030. Epub 2022 Jul 26.
10
Mediation of the behavioral effects of ketamine and (2R,6R)-hydroxynorketamine in mice by kappa opioid receptors.
Psychopharmacology (Berl). 2022 Jul;239(7):2309-2316. doi: 10.1007/s00213-022-06118-4. Epub 2022 Apr 23.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验