Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05710887
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-01-11
Brief Title:
N2O for Acute Suicidality and Depression in the ED
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Inhaled Nitrous Oxide for Acute Suicidality and Depression in the Emergency Department
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigators are conducting this double-blind randomized control trial RCT to compare inhaled N2O treatment as usual TAU versus inhaled placeboTAU demonstrating the feasibility and tolerability of the intervention in an emergency department ED setting on an acutely suicidal population
Detailed Description:
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 studys 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 andor 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
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 studys 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None