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NCT Number: NCT06382389

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 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMONO

Drug

Exposure of Emono via facial mask

Other names: Nitrous oxide

Medical Air

Drug

exposure to Medical Air

Other names: comparator

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).

    Time frame: baseline, week 4

    The CORNELL is a validated scale specifically designed for depression in major neurocognitive disorders

Secondary outcomes

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

    Time frame: baseline, weeks 1, 2, 3, 4 and 8

    The Geriatric Depression Scale is a self assessed scale for depression in older individuals

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

    Time frame: baseline, weeks 1, 2, 3, 4 and 8

    CGI assesses the clinical global impression of the clinician

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

    Time frame: baseline, weeks 1, 2, 3, 4 and 8

    EVIBE is a visual analog scale specifically designed to measure well being in major cognitive disorders

  4. Collection of adverse events at all study visits

    Time frame: baseline, weeks 1, 2, 3, 4 and 8

    any adverse events will be collected

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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

Acronym: PROTO-EHPAD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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