University of Chicago
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.
Suicidal Ideation
Major Depressive Disorder
Treatment Resistant Depression
Nitrous oxide gas for inhalation
Placebo
Phase 2
Past studies have shown that a single dose of ketamine, an NMDA- receptor antagonist has fast and long lasting anti-depressant effect. Although a promising antidepressant and potential anti-suicidal agent, ketamine has very significant side effects including: dissociation, hallucinations, delusional thinking, cognitive impairment, and significant sympathetic nervous system activation. Nitrous Oxide (N2O) is an NMDA-receptor antagonist with a well-known safety profile used as an analgesic. In a proof-of-concept pilot study, this study's investigator recently demonstrated that N2O also has rapid and marked antidepressant effects in patients with severe treatment-resistant depression (TRD); further sub-analyses showed N2O significantly reduced suicidal ideation (SI). While N2O administration may lead to a reduction in SI, it remains unknown whether severely suicidal patients requiring hospitalization on inpatient psychiatric units would benefit. Investigators hypothesize that N2O will rapidly and safely dampen suicidal thinking with minimal side effects in this population. Participants will be randomized to receive either N2O or placebo. The study intervention is in tandem with prescribed treatment-as-usual (TAU) by emergency department physicians relating to diagnosis (depression, anxiety, suicidal ideation); which typically involves anxiolytic medications and/or brief psychotherapy administered by care team psychiatry providers. Study intervention response will be assessed using a self-administered psychiatric diagnostic tool (Computerized Adaptive Testing Mental Health [CAT-MH] scores relating to suicide, depression, and anxiety; to determine whether a single 45-minute inhalation of nitrous oxide vs placebo reduces symptoms.}}
Study Type : | Interventional |
Estimated Enrollment : | 50 participants |
Masking : | Double |
Primary Purpose : | Treatment |
Official Title : | Inhaled Nitrous Oxide for Acute Suicidality and Depression in the Emergency Department |
Actual Study Start Date : | July 1, 2023 |
Estimated Primary Completion Date : | June 1, 2024 |
Estimated Study Completion Date : | July 1, 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Treatment; Nitrous Oxide 50% A single 45-minute session of inhaled 50% nitrous oxide. |
Drug: Nitrous oxide gas for inhalation |
Placebo Comparator: Control; Oxygen-air mixture A single 45-minute session of inhaled Oxygen-air mixture |
Drug: Placebo |
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
University of Chicago Medicine
Chicago, Illinois, United States, 60637