N2O for Acute Suicidality and Depression in the ED

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigators are conducting this double-blind, randomized control trial (RCT), to compare inhaled N2O+ treatment as usual (TAU) versus inhaled placebo+TAU; demonstrating the feasibility and tolerability of the intervention in an emergency department (ED) setting on an acutely suicidal population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Nitrous Oxide

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.