A phase 2 trial of inhaled nitrous oxide for treatment-resistant major depression.

Autor:	Nagele P; Department of Anesthesia and Critical Care, University of Chicago, Chicago, IL 60637, USA. nagelep@uchicago.edu., Palanca BJ; Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO 63110, USA., Gott B; Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110, USA., Brown F; Department of Anesthesia and Critical Care, University of Chicago, Chicago, IL 60637, USA., Barnes L; Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110, USA., Nguyen T; Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO 63110, USA., Xiong W; Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110, USA., Salloum NC; Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110, USA., Espejo GD; Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110, USA., Lessov-Schlaggar CN; Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110, USA., Jain N; Department of Anesthesia and Critical Care, University of Chicago, Chicago, IL 60637, USA., Cheng WWL; Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO 63110, USA., Komen H; Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO 63110, USA., Yee B; Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO 63110, USA., Bolzenius JD; Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO 63110, USA., Janski A; Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110, USA., Gibbons R; Center for Health Statistics, University of Chicago, Chicago, IL 60637, USA., Zorumski CF; Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110, USA.; Taylor Family Institute for Innovative Psychiatric Research, Washington University School of Medicine, St. Louis, MO 63110, USA., Conway CR; Department of Psychiatry, Washington University School of Medicine, St. Louis, MO 63110, USA.; Taylor Family Institute for Innovative Psychiatric Research, Washington University School of Medicine, St. Louis, MO 63110, USA.
Jazyk:	angličtina
Zdroj:	Science translational medicine [Sci Transl Med] 2021 Jun 09; Vol. 13 (597).
DOI:	10.1126/scitranslmed.abe1376
Abstrakt:	Nitrous oxide at 50% inhaled concentration has been shown to improve depressive symptoms in patients with treatment-resistant major depression (TRMD). Whether a lower concentration of 25% nitrous oxide provides similar efficacy and persistence of antidepressant effects while reducing the risk of adverse side effects is unknown. In this phase 2 clinical trial (NCT03283670), 24 patients with severe TRMD were randomly assigned in a crossover fashion to three treatments consisting of a single 1-hour inhalation with (i) 50% nitrous oxide, (ii) 25% nitrous oxide, or (iii) placebo (air/oxygen). The primary outcome was the change on the Hamilton Depression Rating Scale (HDRS-21). Whereas nitrous oxide significantly improved depressive symptoms versus placebo ( P = 0.01), there was no difference between 25 and 50% nitrous oxide ( P = 0.58). The estimated differences between 25% and placebo were -0.75 points on the HDRS-21 at 2 hours ( P = 0.73), -1.41 points at 24 hours ( P = 0.52), -4.35 points at week 1 ( P = 0.05), and -5.19 points at week 2 ( P = 0.02), and the estimated differences between 50% and placebo were -0.87 points at 2 hours ( P = 0.69), -1.93 points at 24 hours ( P = 0.37), -2.44 points at week 1 ( P = 0.25), and -7.00 points at week 2 ( P = 0.001). Adverse events declined substantially with dose ( P < 0.001). These results suggest that 25% nitrous oxide has comparable efficacy to 50% nitrous oxide in improving TRMD but with a markedly lower rate of adverse effects. (Copyright © 2021 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu