drugset

drugset / Trial / NCT07262008

Sustained Mood Improvement With Laughing Gas Exposure

NCT07262008 ↗

Phase 3 Not yet recruiting 120 enrolled Women's College Hospital Anesthesia Clinical Trials Unit (Department of Anesthesia and Pain Management) · collab Canadian Institutes of Health Research (CIHR) · collab Sunnybrook Health Sciences Centre · collab Unity Health Toronto · collab University Health Network, Toronto · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Multi-centre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of nitrous oxide on reducing symptoms of depression in patients with treatment resistant depression.

Timeline

Start: 2026-02-01
Primary completion: 2027-02-01
Completion: 2028-09-01

Publications

Background Ladha KS, Lee J, Mattina GF, Pazmino-Canizares J, Wijeysundera DN, Nezhad FG, Tassone VK, Adamsahib F, Lou W, Kennedy S, Bhat V; SMILE Study Investigators. Sustained mood improvement with laughing gas exposure (SMILE): a randomised, placebo-controlled pilot trial of nitrous oxide for treatment-resistant depression. BJPsych Open. 2025 Sep 12;11(5):e208. doi: 10.1192/bjo.2025.10823.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Midazolam	Small molecule	0.02 mg/kg	Intravenous
Subject	Nitrous Oxide	Other / unclassified	50 %	Inhaled
Comparator	Oxygen	Other / unclassified	100 %	Inhaled

Indications