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RecruitingPhase 2NCT05357040

Antidepressant Effects of Nitrous Oxide

Evaluation of the Antidepressant Effects of Nitrous Oxide in People With Major Depressive Disorder

Sponsor

University of Chicago

Enrollment

172 participants

Start Date

Jun 30, 2021

Study Type

INTERVENTIONAL

Conditions

Major Depressive DisorderTreatment Resistant Depression

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether nitrous oxide (laughing gas) can help treat depression that hasn't responded well to other treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with major depression (without psychosis) - Your depression score is above a certain threshold on a standard rating scale **You may NOT be eligible if...** - You have a history of bipolar disorder, schizophrenia, or schizoaffective disorder - You currently have obsessive-compulsive disorder or panic disorder - You have active thoughts of suicide - You have had a substance use disorder in the past 12 months (excluding nicotine) - You received ketamine or similar drugs in the last 3 months - You are currently receiving electroconvulsive therapy (ECT) - You are pregnant or breastfeeding - You have a serious lung condition or other contraindications to nitrous oxide (such as vitamin B12 deficiency, pneumothorax, or elevated brain pressure) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNitrous 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.

DRUGPlacebo

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.

Locations(2)

University of Chicago Medicine

Chicago, Illinois, United States

The Alfred Hospital

Melbourne, Victoria, Australia

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NCT05357040

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