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NMDA-antagonist

Nitrous Oxide for Depression

Phase 2
Recruiting
Led By Paul Myles, MD
Research Sponsored by Bayside Health
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 24 hours
Awards & highlights
All Individual Drugs Already Approved

Summary

This trialis researching if nitrous oxide can be used to reduce symptoms of Major Depressive Disorder (MDD). A single dose of nitrous oxide may have a fast and long-lasting effect and is safer to administer than other alternatives.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in HDRS-21 score
Secondary study objectives
Computerized Adaptive Test-Depression Inventory (CAT-DI)
Computerized Adaptive Test-Suicide Scale (CAT-SS)
Dose effect of nitrous oxide using treatment-by-dose interaction term in a logistic regression model
+5 more
Other study objectives
Adverse events

Side effects data

From 2018 Phase 4 trial • 63 Patients • NCT03085563
7%
hypoxia
2%
paradoxical reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intranasal Midazolam
Nitrous Oxide

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nitrous Oxide 50% or 25%Experimental Treatment1 Intervention
Nitrous oxide at an inhaled concentration of 50% or 25%
Group II: PlaceboPlacebo Group1 Intervention
Oxygen-air mixture
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitrous oxide
FDA approved

Find a Location

Who is running the clinical trial?

Bayside HealthLead Sponsor
111 Previous Clinical Trials
35,674 Total Patients Enrolled
5 Trials studying Depression
318 Patients Enrolled for Depression
Paul Myles, MDPrincipal InvestigatorThe Alfred
1 Previous Clinical Trials
172 Total Patients Enrolled
1 Trials studying Depression
172 Patients Enrolled for Depression

Media Library

Nitrous Oxide (NMDA-antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03869736 — Phase 2
Depression Research Study Groups: Nitrous Oxide 50% or 25%, Placebo
Depression Clinical Trial 2023: Nitrous Oxide Highlights & Side Effects. Trial Name: NCT03869736 — Phase 2
Nitrous Oxide (NMDA-antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03869736 — Phase 2
Depression Patient Testimony for trial: Trial Name: NCT03869736 — Phase 2
~25 spots leftby Nov 2025
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