CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
EMONO +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05007028
NCT05007028N/ACompleted

Nitrous Oxide for Late-Life Depression : a Randomized Controlled Trial With Comparator - PROTO-BRAIN

University Hospital, Tours·interventional·Posted Aug 16, 2021·Updated Nov 24, 2025

In Brief

A clinical study evaluating EMONO and Medical Air for Late-Life Depression and Resistant Depression, Treatment. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Resistant Depression is a common condition in older adults and there is an urgent need for novel antidepressant in this population. Nitrous Oxide (N2O) has recently shown rapid antidepressant effect in midlife depression but no study has currently investigated the efficacy and safety of N2O in Late-Life Depression (LLD), while N2O may prove to be an ideal treatment for LLD because of glutamatergic antagonism and cerebrovascular effects and also a relatively good safety profile. The goal of our study is to compare changes in depressive symptoms after 2 hours, 24 hours, 1 week and 2 week of a 1-hour exposure to EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) versus Medical Air. Secondary Objectives include comparing differences in neuroimaging measures between 3 groups (responders and non-responders in the EMONO group, and patients in the control group).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 16, 2021
Enrollment StartNov 16, 2021
Primary CompletionDec 19, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 4.9 years ago

Interventions

EMONOdrug

Exposure to 1 hour of EMONO via facial mask

Medical Airdrug

Exposure to 1 hour of Medical Air via facial mask