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Nitrous Oxide for Acute Suicidality

Phase 2
Waitlist Available
Led By Peter Nagele, MD, MSc
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30-minutes to 1-hour from intervention conclusion
Awards & highlights

Study Summary

This trial is testing a new treatment for suicide in the emergency room to see if it works & is safe.

Who is the study for?
This trial is for adults aged 18-65 who are acutely suicidal, have non-psychotic major depressive disorder, and are in the emergency department. It's not for those with certain mental health disorders (like schizophrenia or bipolar), severe substance use issues, significant lung disease, pregnant/breastfeeding women, recent NMDA-receptor antagonist treatment users, or specific vitamin deficiencies.Check my eligibility
What is being tested?
The study tests if inhaling nitrous oxide gas can help people with acute suicidality and depression in the ED compared to a placebo. Both groups also receive standard care. Participants don't know which treatment they get as it's a double-blind RCT.See study design
What are the potential side effects?
Nitrous oxide may cause side effects like dizziness, nausea, headaches, or increased risk of falls due to its sedative properties. Long-term use can lead to vitamin B12 deficiency but this is less likely with short-term medical use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30-minutes to 1-hour from intervention conclusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30-minutes to 1-hour from intervention conclusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment Response Based on Changes in Computerized Adaptive Testing Scores
Secondary outcome measures
Rapid Treatment Response
Sustained Treatment Response
Treatment Compliance
+1 more
Other outcome measures
Adverse Events

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment; Nitrous Oxide 50%Active Control1 Intervention
A single 45-minute session of inhaled 50% nitrous oxide.
Group II: Control; Oxygen-air mixturePlacebo Group1 Intervention
A single 45-minute session of inhaled Oxygen-air mixture

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,003 Previous Clinical Trials
819,699 Total Patients Enrolled
Peter Nagele, MD, MScPrincipal InvestigatorUniversity of Chicago, Department of Anesthesia and Critical Care
4 Previous Clinical Trials
743 Total Patients Enrolled

Media Library

Nitrous oxide gas for inhalation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05710887 — Phase 2
Suicidal Thoughts Research Study Groups: Treatment; Nitrous Oxide 50%, Control; Oxygen-air mixture
Suicidal Thoughts Clinical Trial 2023: Nitrous oxide gas for inhalation Highlights & Side Effects. Trial Name: NCT05710887 — Phase 2
Nitrous oxide gas for inhalation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05710887 — Phase 2
Suicidal Thoughts Patient Testimony for trial: Trial Name: NCT05710887 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment include participants over the age of sixty-five?

"The minimum and maximum age for enrollment in this medical trial have been set at 18 years old and 65 respectively, conforming to the inclusion criteria."

Answered by AI

Which individuals are considered eligible to participate in this trial?

"In order to be eligible for this study, applicants must demonstrate suicidal ideation and have a maximum age of 65 years. The trial is hoping to enrol 50 participants in total."

Answered by AI

What are the potential risks associated with exposure to Nitrous Oxide 50%?

"Due to the Phase 2 status of this treatment, there is some evidence confirming its safety but none proving efficacy; thus it receives a score of 2."

Answered by AI

Is this research effort currently accepting new participants?

"As per the clinicaltrials.gov listing, this medical trial is not presently accepting new applicants--the study was first posted on May 1st 2023 and last updated on January 25th 2023. However, there are over 1300 other trials actively recruiting participants at present."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What site did they apply to?
University of Chicago Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Tried meds, therapy, ect, tms, spravato, iv ketamine.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
N2O for Acute Suicidality and Depression in the ED
2023. "N2O for Acute Suicidality and Depression in the ED". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05710887.
~5 spots leftby Jun 2024
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