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

Phase 1

• Conditions: psychiatry; MedDRA version: 21.1Level: LLTClassification code: 10048598Term: Cognitive disorders Class: 10029205; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: CTIS2023-504691-18-00
• Lead Sponsor: Centre Hospitalier Regional Universitaire De Tours

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the changes in depressive symptomatology at 4 weeks after baseline between the MEOPA group and the placebo group (medical air), in a population of nursing-home residents with neurognitive disorders and significant depressive symptoms, resistant to at least one conventional antidepressant;Secondary Objective: Compare changes in baseline depressive symptomatology at 8 weeks between the two groups. 2.Compare changes in baseline clinical global impression at 8 weeks between the two groups 3.Compare changes in baseline psychobehavioural symptoms at 8 weeks between the two groups. 4.To compare changes in perceived well-being from baseline to 8 weeks between the two groups 5.Evaluate the safety profile of MEOPA specific to this use.;Primary end point(s): Changes in the CORNELL depression severity´ scale between S4 (one week after the last administration of MEOPA or medical air) and S1 (baseline).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):CORNELL scale and GDS scale at weeks 1, 2, 3, 4 and 8;Secondary end point(s):CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8;Secondary end point(s):The NPI scale for the frequency and severity´ of the 12 most frequent psychobehavioural disorders in TNC at weeks 1, 4 and 8.;Secondary end point(s):The measurement of well-being by the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8.;Secondary end point(s):Collection of adverse events at all study visits.