What side effects are associated with this type of intervention?

Common treatments for suicidal thoughts include pharmacotherapy with antidepressants, electroconvulsive therapy (ECT), and emerging treatments like inhaled nitrous oxide (N2O). Antidepressants, such as SSRIs, can cause side effects like nausea, insomnia, and sexual dysfunction. ECT, while effective, may lead to short-term memory loss and confusion. Inhaled N2O, being studied for its rapid antidepressant effects, can cause dizziness, nausea, and in rare cases, neurotoxicity with prolonged exposure. Patients should discuss these potential side effects with their healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

As of now, there are no specific FDA approvals for the use of inhaled nitrous oxide (N2O) for the treatment of suicidal thoughts. However, ketamine, an anesthetic with rapid-acting antidepressant properties, has been approved in the form of esketamine (Spravato) for treatment-resistant depression and acute suicidal ideation. This approval highlights the potential of anesthetic agents in managing severe depressive symptoms and suicidal thoughts.

What other types of research exist?

Promising novel alternatives to inhaled N2O for treating suicidal thoughts include psilocybin and ketamine. Both have shown potential in clinical trials for rapidly reducing symptoms of depression and suicidal ideation.

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Nitrous Oxide for Acute Suicidality

Phase 2

Waitlist Available

Led By Peter Nagele, MD, MSc

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30-minutes to 1-hour from intervention conclusion

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Nitrous oxide may cause side effects like dizziness, nausea, headaches, or increased risk of falls due to its sedative properties. Long-term use can lead to vitamin B12 deficiency but this is less likely with short-term medical use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 30-minutes to 1-hour from intervention conclusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 30-minutes to 1-hour from intervention conclusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30-minutes to 1-hour from intervention conclusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment Response Based on Changes in Computerized Adaptive Testing Scores

Secondary study objectives

Rapid Treatment Response

Sustained Treatment Response

Treatment Compliance

+1 more

Other study objectives

Adverse Events

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treatment; Nitrous Oxide 50%Active Control1 Intervention

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

Group II: Control; Oxygen-air mixturePlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nitrous Oxide (N2O) is an anesthetic and analgesic that modulates NMDA receptors in the brain, leading to rapid antidepressant effects. This is crucial for patients with suicidal thoughts as it provides immediate relief, which is essential in emergency settings to prevent self-harm. Similar treatments, like ketamine, also act on NMDA receptors, offering quick stabilization and allowing time for additional therapeutic measures.