drugset / Trial / NCT04957368

Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial

NCT04957368

Phase 4 Completed 40 enrolled Unity Health Toronto
RandomizedParallel-groupTriple-blindOther

Summary

The purpose of the study is to investigate a short-term treatment option for major depressive disorders by administering nitrous oxide gas. At this time, the main purpose is to complete a feasibility study with 40 participants suffering from treatment-resistant depression. Participants will be randomized to (1) Study group: Nitrous oxide (inhaled) + solution of saline (injected) and the (2) Control group: Oxygen (inhaled) + Midazolam (injected) as an Active Placebo.

Timeline

Start
2021-11-03
Primary completion
2024-02-27
Completion
2024-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitrous Oxide Other / unclassified 50 % Inhaled
Comparator Oxygen Other / unclassified 50 % Inhaled
Comparator Midazolam Small molecule 0.02 mg/kg Intravenous