N2O for Acute Suicidality and Depression in the ED

Launched by UNIVERSITY OF CHICAGO · Jan 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of inhaled nitrous oxide (N2O), commonly known as laughing gas, to help people who are feeling very suicidal or are struggling with severe depression that hasn't improved with other treatments. The researchers want to see if N2O can be safely used in an emergency department setting alongside the usual care that these patients receive. This trial is designed to compare the effects of N2O with a placebo (a substance that has no therapeutic effect) to understand how well this treatment works and how well patients tolerate it.

To be eligible for the study, participants need to be between 18 and 65 years old and must have a history of major depressive disorder while also feeling acutely suicidal. However, there are some important exclusions: individuals with certain serious mental health conditions, those who cannot give consent, and patients with significant lung issues or specific health conditions that would make using N2O unsafe cannot participate. If someone does join the study, they can expect to receive either the N2O treatment or a placebo while continuing to receive standard care in the emergency department. It's important to note that this trial is not yet recruiting participants, so those interested will need to wait for further announcements.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients 18-65 years of age, acutely suicidal, presenting to the adult emergency department with documented history of non-psychotic major depressive disorder.
• Exclusion Criteria:
• • Current psychotic or catatonic symptoms as determined by the hospital care team.
• • Unable or unwilling to give consent for study participation (ability to provide consent will be established by treating physician)
• • Lifetime DSM-V (medical history) diagnoses of schizophrenia, schizoaffective disorders, bipolar disorder, obsessive-compulsive disorder, and panic disorders.
• • Meets current DSM-V substance use disorder of greater than mild severity (other than nicotine or marijuana)
• • Significant pulmonary disease and/or requiring supplemental oxygen.
• • Administration of other NMDA-receptor antagonist treatment (e.g., ketamine) within two weeks of entry into study.
• • Contraindications for N2O (pneumothorax, bowel obstruction, middle ear occlusion, elevated intracranial pressure)
• • Chronic cobalamin and/or folate deficiency treated with folic acid or vitamin B12.
• • Women who are pregnant or breastfeeding
• • Any other factor that in the investigators' judgment may affect patient safety or compliance.