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-

NCT06382389 | Not Yet Recruiting Phase 2

• 2 other identifiers: DR2202042023-504691-18-00
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression; Neurocognitive Disorders

Keywords

Nitrous Oxide

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• CORNELL scale and GDS scale at weeks 1, 2, 3, 4 and 8

  baseline, weeks 1, 2, 3, 4 and 8

• CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8

  baseline, weeks 1, 2, 3, 4 and 8

• The measurement of well-being by the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8

  baseline, weeks 1, 2, 3, 4 and 8

• Collection of adverse events at all study visits

  baseline, weeks 1, 2, 3, 4 and 8

Study Arms (2)

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

EMONO DRUG

Exposure of Emono via facial mask

Also known as: Nitrous oxide

EMONO

Medical air DRUG

exposure to Medical Air

Also known as: comparator

medical air

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Sub-physiological plasma vitamin B12 or B9 concentration (below the lower limit of the laboratory value).

Sponsors & Collaborators

• University Hospital, Tours: lead

MeSH Terms

Conditions

Depression; Neurocognitive Disorders

Interventions

Nitrous Oxide; Air

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignement

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share