NCT04957368

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment Resistant Depression
• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Nitrous Oxide 99 %	Nitrous oxide will be administered at an inspiratory concentration of 50% with concurrent intravenous saline (100ml) for one hour.
DRUG	Oxygen + Midazolam	Oxygen will be administered at 50% with intravenous midazolam (0.02mg/kg in 100ml) for one hour

Timeline

• Start date: 2021-11-03
• Primary completion: 2024-02-27
• Completion: 2024-02-27
• First posted: 2021-07-12
• Last updated: 2024-05-08

Locations

1 site across 1 country: Canada