AuthorisedTherapeutic exploratory (Phase II)Interventional

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

This study is looking into whether adding a new treatment called EMONO to the usual antidepressants can help older people in care homes who are feeling sad or down (depressed) and also have memory conditions, like dementia. The study is in an early stage (Phase II), meaning researchers are exploring if EMONO is effective and safe. They will compare how much depression symptoms change in people receiving EMONO plus their regular antidepressants, versus those receiving a dummy treatment or medical air alongside their regular antidepressants. The main way they'll measure this is by using a special questionnaire that helps understand how severe someone's depression is, looking at changes over a few weeks.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Enrolment target

Start

03 Apr 2024

psychiatry

What is this study about?

This research study, called EMONO, is investigating a new way to help older people in care homes who are experiencing depression alongside memory problems. Depression can make daily life very difficult, and this study aims to find out if adding a particular treatment, EMONO, to their current antidepressant medication can make a difference. EMONO involves using medical gas mixtures (like KALINOX, which is often used to help with pain or anxiety, or just medical air).

The main goal is to see if EMONO helps reduce feelings of sadness, low mood, and other symptoms of depression. Researchers will carefully measure these changes using specific questionnaires designed to assess depression severity over time. By doing this, they hope to learn if EMONO could be a helpful additional treatment option for this group of people.

This is a Phase II study, which means it's an early-stage trial. The main purpose at this stage is to explore if the treatment works and is safe. The results will help determine if further, larger studies should be done. It's a randomised controlled trial, meaning some participants will receive EMONO, while others will receive a dummy treatment or medical air. This helps researchers compare the effects fairly.

Key takeaways

Tests a new treatment (EMONO) for depression.
Aimed at older care home residents with memory issues and depression.
EMONO is given with existing antidepressants.
Compares EMONO to a dummy treatment (medical air).
Study lasts roughly eight weeks with regular assessments.
Helps researchers understand if EMONO is effective and safe.

Who may be eligible?

To be able to join this study, participants must be older people who are living in a care home and are currently experiencing symptoms of depression. They also need to have some form of memory problems, often referred to as neurocognitive disorders.

There are no specific age limits; both younger and older adults could potentially take part. The study is open to everyone, regardless of whether they are male or female. The research team will review each person carefully to make sure the study is right for them and that they meet all safety requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you living in a care home?
Do you currently experience symptoms of depression?
Do you have memory problems (neurocognitive disorder)?
Are you currently taking antidepressant medication?

Answer every question to see your result.

What does participation involve?

If you join this study, you would continue taking your usual antidepressants. In addition, you would receive either the EMONO treatment (a special medical gas mixture) or a control treatment (a dummy treatment or medical air) for a short period. You would have several visits to the care home where researchers would use questionnaires, like the CORNELL scale and GDS scale, to check your mood and depression levels. They would also ask about your general well-being using a visual scale and monitor for any side effects. These assessments would happen at different times over approximately eight weeks. The exact number of treatments and assessment visits will be explained in full detail by the study team.

Potential risks and benefits

Participating in any study has potential benefits and risks. You might not directly benefit from taking part, but the information gained could help others in the future. The EMONO treatment involves medical gases, so there could be temporary side effects like dizziness or nausea, which the study team will monitor closely. All care will be taken to ensure your safety and comfort. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is EMONO?

EMONO is a new treatment being studied, which involves using a specific medical gas mixture (like KALINOX) as an add-on to existing antidepressant medications.

Who is this study for?

This study is for older people living in care homes who have depression and memory problems (neurocognitive disorders).

What is a 'randomised controlled trial'?

This means that you would be randomly assigned to receive either the EMONO treatment or a control treatment (like medical air), to fairly compare their effects.

How long does the study last?

The main part of the study involves assessments and possibly treatment over approximately eight weeks, but the study team will provide full details.

Will I know if I'm getting EMONO or the control?

No, to make sure the results are fair, neither you nor the study staff will know which treatment you are receiving until after the study is over.