一氧化二氮对重度抑郁症的抗抑郁作用：一项2b期随机临床试验

IF 3.7 Q2 NEUROSCIENCES

Biological psychiatry global open science Pub Date : 2025-04-15 DOI:10.1016/j.bpsgos.2025.100504

Paul S. Myles , Jayashri Kulkarni , Jessica Kasza , Sophie Wallace , Carolyn Deng , Alisa Turbić , Verna Aykanat , Charles R. Conway , Frank Brown , Royce Lee , Robert D. Gibbons , Peter Nagele

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引用次数: 0

摘要

氧化亚氮（笑气）是一种NMDA受体拮抗剂。在目前的研究中，我们的目的是研究一氧化二氮对成人重度抑郁症（MDD）的疗效、安全性和可能的最佳剂量。方法：在这项2b期随机双盲试验中，81例重度抑郁症患者按1:1的比例被分配接受氧化亚氮或氧气/空气（对照组）治疗；亚氮组进一步随机分配到50%或25%的吸入氧化亚氮。所有参与者每隔1周接受4次1小时的治疗，并随访4周。主要结果是在4个疗程中21项汉密尔顿抑郁评定量表（HAM-D）的变化。次要结局包括缓解（HAM-D≤7分）、计算机适应测试-抑郁量表（CAT-DI）和计算机适应测试-自杀量表（CAT-SS）。结果在治疗4周内，氧化亚氮组HAM-D评分的平均变化低于对照组（- 1.9 [95% CI, - 3.9至0.0],p = 0.051）。第一周，氧化亚氮组39例患者中15例（38%）缓解，对照组39例患者中5例（13%）缓解（p = 0.031）。CAT-DI评分的平均变化为- 7.7 (95% CI, - 14.1 ~ - 1.4), p = 0.017；CAT-SS评分的平均变化为- 8.3 (95% CI, - 14.4至- 2.1),p = 0.008，均有利于氧化亚氮。结论在这项研究中，我们证实了一氧化二氮可能对重度抑郁症患者有有益的抗抑郁作用。

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Antidepressant Effects of Nitrous Oxide in Major Depressive Disorder: A Phase 2b Randomized Clinical Trial

Background

Nitrous oxide (“laughing gas”) is an NMDA receptor antagonist. In the current study, our aim was to investigate the efficacy, safety, and likely optimal dose of nitrous oxide in adults with major depressive disorder (MDD).

Methods

In this phase 2b randomized, double-blind trial, 81 patients with MDD were allocated on a 1:1 basis to receive nitrous oxide or oxygen/air (control); the nitrous group was further randomized to either 50% or 25% inspired nitrous oxide. All participants received four 1-hour-long treatment sessions at 1-week intervals and were followed for an additional 4 weeks. The primary outcome was the change in the 21-item Hamilton Depression Rating Scale (HAM-D) over the 4 treatment sessions. Secondary outcomes included remission (HAM-D ≤7 points), the Computerized Adaptive Test-Depression Inventory (CAT-DI) and Computerized Adaptive Test-Suicide Scale (CAT-SS).

Results

The mean averaged change in HAM-D scores over the 4 weeks of treatment was lower with nitrous oxide than with control (−1.9 [95% CI, −3.9 to 0.0], p = .051). In the first week, 15 of 39 (38%) in the nitrous oxide group and 5 of 39 (13%) in the control group were remitted (p = .031). The mean averaged change in CAT-DI scores was −7.7 (95% CI, −14.1 to −1.4), p = .017; the mean averaged change in CAT-SS scores was −8.3 (95% CI, −14.4 to −2.1), p = .008, both favoring nitrous oxide.