Nitrous oxide; Oxygen for Major neurocognitive disorder | Depressive symptoms

Inclusion criteria

• {"criterion_text":"- Men and women aged 60 and over living in nursing homes\n- Diagnosis of major neurocognitive disorder according to DSM-V for at least 6 months\n- MMSE <= 20/30\n- NPI depression >= 4/12\n- Patients resistant to at least one well-tolerated antidepressant as assessed by the MGH-ATRQ scale.\n- Patient, family and legal representive consent where applicable\n- Person affiliated to a social security scheme\n- a person participating in a clinical drug study or in a period of exclusion from any clinical study due to previous participation."}

Exclusion criteria

• {"criterion_text":"- NPI agitation > 6/12\n- 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.\n- Contraindications to the use of MEOPA\n- Patients who have already been treated with MEOPA in the 6 months prior to inclusion, for example for painful treatment\n- Sub-physiological plasma vitamin B12 or B9 concentration (below the lower limit of the laboratory value).\n- A person participating in a clinical drug study or in a period of exclusion from any clinical study due to previous participation.\n- Supra-physiological plasma homocysteine concentration (above the upper limit of the analysis laboratory's value)"}

Primary endpoints

• {"endpoint_text":"- Changes in the CORNELL depression severitý scale between S4 (one week after the last administration of MEOPA or medical air) and S1 (baseline).","definition_or_measurement_approach":"Change from baseline (S1) to S4 (one week after last administration) on the CORNELL depression severity scale."}

Secondary endpoints

• {"endpoint_text":"- CORNELL scale and GDS scale at weeks 1, 2, 3, 4 and 8","definition_or_measurement_approach":"Assessment of CORNELL and GDS scales at weeks 1, 2, 3, 4 and 8 to evaluate depressive symptom changes over time."}
• {"endpoint_text":"- CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8","definition_or_measurement_approach":"Assessment of Clinical Global Impression - Severity and Improvement at weeks 1, 2, 3, 4 and 8."}
• {"endpoint_text":"- The NPI scale for the frequency and severitý of the 12 most frequent psychobehavioural disorders in TNC at weeks 1, 4 and 8.","definition_or_measurement_approach":"Neuropsychiatric Inventory (NPI) frequency and severity assessment at weeks 1, 4 and 8."}
• {"endpoint_text":"- The measurement of well-being by the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8.","definition_or_measurement_approach":"EVIBE visual analogue scale measured at weeks 1, 2, 3, 4 and 8 to assess perceived well-being."}
• {"endpoint_text":"- Collection of adverse events at all study visits.","definition_or_measurement_approach":"Safety assessment via collection and recording of adverse events at each study visit."}

France

Earliest CTIS Part Ii Submission Date

18-03-2024

Latest Decision Or Authorization Date

03-04-2024

Processing Time Days

16

Number Of Sites

1

Number Of Participants

96

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire De Tours

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"DGOS","duties_or_roles":"Monetary support","organisation_type":""}