N2O for Acute Suicidality & Depression in the ED

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 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 Design

Related Conditions & MeSH terms

Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Major Depressive Disorder
Suicidal Ideation
Treatment Resistant Depression

Clinical Trial Details

NCT number	NCT05710887
Study type	Interventional
Source	University of Chicago
Contact	Frank Brown
Phone	773-834-5778
Email	ftbrownjr@uchicagomedicine.org
Status	Not yet recruiting
Phase	Phase 2
Start date	October 1, 2024
Completion date	December 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05537558` - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated	`NCT02192099` - Open Label Extension for GLYX13-C-202, NCT01684163	Phase 2
Completed	`NCT03142919` - Lipopolysaccharide (LPS) Challenge in Depression	Phase 2
Recruiting	`NCT05547035` - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders	N/A
Terminated	`NCT02940769` - Neurobiological Effects of Light on MDD	N/A
Recruiting	`NCT05892744` - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression	Phase 4
Recruiting	`NCT05537584` - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment	Phase 4
Active, not recruiting	`NCT05061706` - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder	Phase 3
Completed	`NCT04479852` - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder	Phase 2
Recruiting	`NCT04032301` - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans	Phase 1
Recruiting	`NCT05527951` - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study	N/A
Completed	`NCT03511599` - Cycloserine rTMS Plasticity Augmentation in Depression	Phase 1
Recruiting	`NCT04392947` - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation	N/A
Recruiting	`NCT05895747` - 5-HTP and Creatine for Depression R33 Phase	Phase 2
Recruiting	`NCT05273996` - Predictors of Cognitive Outcomes in Geriatric Depression	Phase 4
Recruiting	`NCT05813093` - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression	N/A
Recruiting	`NCT05135897` - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation	`NCT04509102` - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder	Early Phase 1
Recruiting	`NCT06026917` - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)	Phase 4
Recruiting	`NCT06145594` - EMA-Guided Maintenance TMS for Depression	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

N2O for Acute Suicidality and Depression in the ED

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms