Efficacy of EMONO as an add-on Therapy to Conventional An... | NCT06382389

ID	Type	Description	Link
2023-504691-18-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2026Estimated

Primary Completion Date

Sep 2028Estimated

Completion Date

Sep 2028Estimated

First Submitted Date

Apr 19, 2024

First Submission Date that Met QC Criteria

Apr 19, 2024

First Posted Date

Apr 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2026

Last Update Posted Date

Jun 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Depression in neurocognitive disorders (Alzheimers' disease and related disoders) is a highly prevalent condition, especially in nursing homes. While it is associated with significant distress, the current conventional antidepressants have shown only modest efficacy and exposed to potentially severe side effects.

Recent evidence suggests that nitrous oxide (N2O) in its most commonly used packaging of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) has rapid antidepressant properties and a good safety profile. However, no study has investigating the antidepressant effect of EMONO in a population of depressed older adults with moderate to severe neurocognitive disorders in nursing homes.

The principal goal of the PROTO-EHPAD study is to compare the changes in depressive symptoms in such individuals in a randomized controlled trial with a follow up period of 8 weeks, with a dosage escalation procedure.

Detailed Description

Participants will be exposed to 3 sessions of EMONO (or Medical Air), with intervals of 1 week between sessions : a first session of 20 minutes, a second of 40 minutes one week later and a final session of 60 minutes one week later. Efficacy will be assessed 1 week after each session and 4 weeks after the last session.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EMONO	Experimental	Equimolar Mixture of Oxygen and Nitrous Oxide (50%O2 / 50%N2O) Active drug: Nitrous Oxide	Drug: EMONO
medical air	Active Comparator	Comparator : medical Air (78% N2 / 22% O2)	Drug: Medical air

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EMONO	Drug	Exposure of Emono via facial mask	EMONO	Nitrous oxide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in the CORNELL depression severitý scale between S4 (one week after the last administration of MEOPA or medical air) and S1 (baseline).	The CORNELL is a validated scale specifically designed for depression in major neurocognitive disorders	baseline, week 4

Secondary Outcomes

Measure	Description	Time Frame
CORNELL scale and GDS scale at weeks 1, 2, 3, 4 and 8	The Geriatric Depression Scale is a self assessed scale for depression in older individuals	baseline, weeks 1, 2, 3, 4 and 8
CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women aged 60 and over living in nursing home
Diagnosis of major neurocognitive disorder according to DSM-V for at least 6 month
MMSE <= 20/30
NPI depression >= 4/12
Patient, family and legal representive consent where applicable Person affiliated to a social security schem

Exclusion Criteria:

NPI agitation > 6/12
Unstable somatic pathology (in particular unstable neurological or cardiological pathologies at risk of interfering with the diffusion of MEOPA) and any unexplained recent neurological abnormality.
Contraindications to the use of MEOPA
Patients who have already been treated with MEOPA in the 6 months prior to inclusion, for example for painful treatment
Sub-physiological plasma vitamin B12 or B9 concentration (below the lower limit of the laboratory value).
A person participating in a clinical drug study or in a period of exclusion from any clinical study due to previous participation
Personne participant à une étude clinique médicamenteuse ou en période d'exclusion de toute étude clinique du fait d'une précédente participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003863	Depression
D019965	Neurocognitive Disorders

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders

ID	Term
D009589	Nitrogen Oxides
D005740	Gases
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D010087	Oxides
D017601	Oxygen Compounds
D001272	Atmosphere
D004777	Environment
D055669	Ecological and Environmental Phenomena
D001686	Biological Phenomena
D008685	Meteorological Concepts
D004778	Environment and Public Health