Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies

Phase 2 Completed 24 enrolled Washington University School of Medicine Brain & Behavior Research Foundation · collab

RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of the study aims to determine whether different concentrations of nitrous oxide (N2O) have different antidepressant effects for adults with treatment-resistant major depression.

Timeline

Start: 2016-11-22
Primary completion: 2020-02-18
Completion: 2020-02-18

Outcome

Missed primary endpoint

registry analysis (superiority test); 25% Nitrous Oxide vs Placebo Gas; p = 0.55; Mean Difference (Net) -0.75; t-test, 2 sided NCT03283670 ↗

Publications

de Leon VC, Kumar A, Nagele P, Palanca BJ, Gott B, Janski A, Zorumski CF, Conway CR. Nitrous Oxide Reduced Suicidal Ideation in Treatment-Resistant Major Depression in Exploratory Analysis. J Clin Psychiatry. 2023 Aug 16;84(5):22br14725. doi: 10.4088/JCP.22br14725. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nitrous Oxide	Other / unclassified	25 %	Inhaled
Subject	Nitrous Oxide	Other / unclassified	50 %	Inhaled