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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"
EU CTIS ID: 2023-504691-18-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
- Supra-physiological plasma homocysteine concentration (above the upper limit of the analysis laboratory's value)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.