Trial PaperDepressive DisordersMajor Depressive Disorder (MDD)Treatment-Resistant Depression (TRD)Safety & Risk ManagementNitrous OxidePlacebo

Nitrous Oxide for Treatment-Resistant Major Depression: a Proof-of-Concept Trial

This double-blind, placebo-controlled, within-subjects proof-of-concept study (n=20) investigated the antidepressant efficacy of inhaled nitrous oxide (50/50 nitrous oxide/oxygen vs. 50/50 nitrogen/oxygen) in patients with treatment-resistant depression (TRD). Nitrous oxide resulted in treatment response in 20% of patients and symptom remission in 15%, an effect size comparable to that of ketamine.

Authors

  • Nagele, P.
  • Duma, A.
  • Kopec, M.

Published

Biological Psychiatry
individual Study

Abstract

Background

N-methyl-D-aspartate receptor antagonists, such as ketamine, have rapid antidepressant effects in patients with treatment-resistant depression (TRD). We hypothesized that nitrous oxide, an inhalational general anesthetic and N-methyl-D-aspartate receptor antagonist, may also be a rapidly acting treatment for TRD.

Methods

In this blinded, placebo-controlled crossover trial, 20 patients with TRD were randomly assigned to 1-hour inhalation of 50% nitrous oxide/50% oxygen or 50% nitrogen/50% oxygen (placebo control). The primary endpoint was the change on the 21-item Hamilton Depression Rating Scale (HDRS-21) 24 hours after treatment.

Results

Mean duration of nitrous oxide treatment was 55.6 ± 2.5 (SD) min at a median inspiratory concentration of 44% (interquartile range, 37%-45%). In two patients, nitrous oxide treatment was briefly interrupted, and the treatment was discontinued in three patients. Depressive symptoms improved significantly at 2 hours and 24 hours after receiving nitrous oxide compared with placebo (mean HDRS-21 difference at 2 hours, −4.8 points, 95% confidence interval [CI], −1.8 to −7.8 points, p = .002; at 24 hours, −5.5 points, 95% CI, −2.5 to −8.5 points, p < .001; comparison between nitrous oxide and placebo, p < .001). Four patients (20%) had treatment response (reduction ≥50% on HDRS-21) and three patients (15%) had a full remission (HDRS-21 ≤ 7 points) after nitrous oxide compared with one patient (5%) and none after placebo (odds ratio for response, 4.0, 95% CI, .45-35.79; OR for remission, 3.0, 95% CI, .31-28.8). No serious adverse events occurred; all adverse events were brief and of mild to moderate severity.

Conclusions

This proof-of-concept trial demonstrated that nitrous oxide has rapid and marked antidepressant effects in patients with TRD.

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Research Summary of 'Nitrous Oxide for Treatment-Resistant Major Depression: a Proof-of-Concept Trial'

Introduction

Treatment-resistant depression (TRD) is described as a severe form of major depressive disorder in which patients fail multiple standard antidepressant treatments and face poor long-term prognosis; the authors note that about one in three patients with major depression meet criteria for TRD. The NMDA (N-methyl-D-aspartate) receptor has been implicated in depression neurobiology, and earlier studies have shown that NMDA receptor antagonists such as ketamine can produce rapid antidepressant effects at subanesthetic doses. Given a similar primary mechanism of action, nitrous oxide was proposed as a candidate rapid-acting treatment for TRD because it is an inhalational general anaesthetic that acts as a noncompetitive NMDA receptor inhibitor. Nagele and colleagues therefore conducted a proof-of-concept clinical trial to test whether a single session of nitrous oxide inhalation produces immediate (2-hour) and sustained (24-hour) antidepressant effects in well-characterised patients with TRD. The trial aimed to detect an early efficacy signal that could justify larger studies and to collect preliminary safety and tolerability data in this population.

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Study Details

References (4)

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