Nitrous Oxide for Acute Suicidality

Recruiting in Palo Alto (17 mi)

Overseen by Peter Nagele, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Chicago

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing whether inhaling nitrous oxide gas, along with regular treatment, can quickly reduce suicidal thoughts in patients who are in immediate danger. The gas works by affecting brain chemicals to improve mood rapidly. Researchers hope it will be a safe and effective way to help these patients with minimal side effects. Nitrous oxide has been used for over a century in various medical fields for pain relief and sedation, and recent studies suggest it may be effective for depression that hasn't improved with other treatments.

Research Team

Peter Nagele, MD, MSc

Principal Investigator

University of Chicago, Department of Anesthesia and Critical Care

Eligibility Criteria

This trial is for adults aged 18-65 who are acutely suicidal, have non-psychotic major depressive disorder, and are in the emergency department. It's not for those with certain mental health disorders (like schizophrenia or bipolar), severe substance use issues, significant lung disease, pregnant/breastfeeding women, recent NMDA-receptor antagonist treatment users, or specific vitamin deficiencies.

Inclusion Criteria

I am between 18-65 years old, feeling very suicidal, and have major depression without psychosis.

Exclusion Criteria

I am able and willing to give consent for the study.

I haven't taken NMDA-receptor blockers like ketamine in the last two weeks.

Any other factor that in the investigators' judgment may affect patient safety or compliance

Treatment Details

Interventions

• Nitrous oxide gas for inhalation (Other)
• Placebo (Other)

Trial Overview The study tests if inhaling nitrous oxide gas can help people with acute suicidality and depression in the ED compared to a placebo. Both groups also receive standard care. Participants don't know which treatment they get as it's a double-blind RCT.

Participant Groups

Group I: Treatment; Nitrous Oxide 50% Active Control 1 Intervention

A single 45-minute session of inhaled 50% nitrous oxide.

Group II: Control; Oxygen-air mixture Placebo Group 1 Intervention

A single 45-minute session of inhaled Oxygen-air mixture

Nitrous oxide gas for inhalation is already approved in Canada for the following indications:

Approved in Canada as Nitrous Oxide for:

• Anesthesia
• Pain relief

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago