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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504691-18-00

Acronym

DR220204

Enrollment

Registered

2024-04-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychiatry

Brief summary

Changes in the CORNELL depression severitý scale between S4 (one week after the last administration of MEOPA or medical air) and S1 (baseline).

Detailed description

CORNELL scale and GDS scale at weeks 1, 2, 3, 4 and 8, CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8, The NPI scale for the frequency and severitý of the 12 most frequent psychobehavioural disorders in TNC at weeks 1, 4 and 8., The measurement of well-being by the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8., Collection of adverse events at all study visits.

Interventions

DRUGKALINOX 50%/50%

DRUGgaz medicinal comprime

DRUGMedical Air

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Changes in the CORNELL depression severitý scale between S4 (one week after the last administration of MEOPA or medical air) and S1 (baseline).	—

Secondary

Measure	Time frame
CORNELL scale and GDS scale at weeks 1, 2, 3, 4 and 8, CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8, The NPI scale for the frequency and severitý of the 12 most frequent psychobehavioural disorders in TNC at weeks 1, 4 and 8., The measurement of well-being by the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8., Collection of adverse events at all study visits.	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026