Antidepressant Effects of Nitrous Oxide

Summary

To evaluate the acute and sustained antidepressant effects of nitrous oxide in people with major depressive disorder; and further evaluate these effects by identifying the optimal dose and regimen to guide current practice, and to plan a future large pragmatic trial.

Conditions

• Major Depressive Disorder
• Treatment 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.

Sponsors & Collaborators

• The Alfred

  collaborator OTHER

• University of Chicago

  lead OTHER

Principal Investigators

• Peter Nagele, MD, MSc · University of Chicago, Department of Anesthesia and Critical Care

• Paul Myles, MD · The Alfred Hospital, Department of Anesthesiology and Perioperative Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-30

Primary Completion

2026-02-27

Completion

2026-02-27

FDA Drug

Yes

Countries

• United States
• Australia

Study Locations