Antidepressant Effects of Nitrous Oxide

PHASE2RecruitingINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

June 30, 2021

Primary Completion Date

October 1, 2026

Study Completion Date

December 1, 2026

Conditions
Major Depressive DisorderTreatment Resistant Depression
Interventions
DRUG

Nitrous oxide gas for inhalation

"60-minute sessions of inhaled 50% nitrous oxide in oxygen (FiO2 0.5) or 25% nitrous oxide in oxygen (FiO2 0.75), administered weekly for 4-weeks.~Administration will be under the direct supervision of a licensed practitioner who is experienced in the use and administration of the study drug, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken (MD, or CRNA); with study patient monitoring of pulse oximetry, heart rate, respiratory, non-invasive blood pressure, and end-tidal carbon dioxide."

DRUG

Placebo

"60-minute sessions of inhaled oxygen-air mixture (FiO2 ≈0.3) to be administered weekly for 4-weeks.~Administration will be under the direct supervision of a licensed practitioner who is experienced in the use and administration of the study drug, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken (MD, or CRNA); with study patient monitoring of pulse oximetry, heart rate, respiratory, non-invasive blood pressure, and end-tidal carbon dioxide."

Trial Locations (2)

3004

RECRUITING

The Alfred Hospital, Melbourne

60637

RECRUITING

University of Chicago Medicine, Chicago

All Listed Sponsors
collaborator

The Alfred

OTHER

lead

University of Chicago

OTHER