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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
Exposure of Emono via facial mask
exposure 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
Time frame: baseline, week 4
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
Time frame: baseline, weeks 1, 2, 3, 4 and 8
CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8
CGI assesses the clinical global impression of the clinician
Time frame: 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
EVIBE is a visual analog scale specifically designed to measure well being in major cognitive disorders
Time frame: baseline, weeks 1, 2, 3, 4 and 8
Collection of adverse events at all study visits
any adverse events will be collected
Time frame: baseline, weeks 1, 2, 3, 4 and 8
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