Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders: a Randomized Controlled Trial-

Depression Clinical Trial

— PROTO-EHPAD  

Official title:

Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06382389
• Other study ID #: DR220204
• Secondary ID: 2023-504691-18-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Neurocognitive Disorders

Intervention

Drug:
• EMONO
Exposure of Emono via facial mask
• Medical air
exposure to Medical Air

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the CORNELL depression severity´ 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	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
Secondary	CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8	CGI assesses the clinical global impression of the clinician	baseline, weeks 1, 2, 3, 4 and 8
Secondary	The measurement of well-being by the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8	EVIBE is a visual analog scale specifically designed to measure well being in major cognitive disorders	baseline, weeks 1, 2, 3, 4 and 8
Secondary	Collection of adverse events at all study visits	any adverse events will be collected	baseline, weeks 1, 2, 3, 4 and 8