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.
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
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
Parallel
EMONO
DrugExposure of Emono via facial mask
Medical air
Drugexposure to Medical Air
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
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
CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8
CGI assesses the clinical global impression of the clinician
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
Collection of adverse events at all study visits
any adverse events will be collected
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