Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Nitrous Oxide and Oxygen for Treating Depression in Nursing Home Residents with Neurocognitive Disorders

Registered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for residents in nursing homes who have significant depressive symptoms and a type of memory and thinking problem known as neurocognitive disorder. The treatment being tested is called EMONO, which is a combination of two gases, nitrous oxide and oxygen, used as an add-on therapy to conventional antidepressants. The study will compare the effects of EMONO with a placebo, which in this case is Medical Air, a mixture of nitrogen and oxygen.

The purpose of the study is to see if EMONO can help improve depressive symptoms in people who have not responded well to at least one standard antidepressant. Participants will receive the treatment through inhalation, which means breathing in the gas. The study will last for several weeks, during which participants will be monitored for changes in their depressive symptoms and overall well-being. The main focus will be on how symptoms change from the start of the study to four weeks later.

Throughout the study, participants will have regular check-ups to assess their mood and any side effects they might experience. The study aims to provide valuable information on whether EMONO can be a helpful addition to existing treatments for depression in people with neurocognitive disorders. This research could lead to better treatment options for those living with these challenging conditions.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, living situation, and medical history.

    Consent is required from the patient, family, or legal representative where applicable.

  2. Step 2

    Baseline assessment

    Initial assessments are conducted to establish a baseline for depressive symptoms using the CORNELL depression severity scale.

    Other scales such as the GDS, CGI-S, and CGI-I are also used to evaluate the patient's condition.

  3. Step 3

    Treatment phase

    Patients receive either EMONO (a combination of nitrous oxide and oxygen) or a placebo (medical air) through inhalation.

    The treatment is administered over a period of 4 weeks.

  4. Step 4

    Weekly assessments

    Weekly assessments are conducted using the CORNELL scale, GDS scale, and other relevant measures.

    The frequency and severity of psychobehavioural disorders are evaluated using the NPI scale at weeks 1, 4, and 8.

  5. Step 5

    Well-being measurement

    The patient's well-being is measured using the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8.

  6. Step 6

    Adverse events monitoring

    Any adverse events are recorded at all study visits to ensure patient safety.

  7. Step 7

    Final assessment

    A final assessment is conducted one week after the last administration of the treatment to compare changes in depressive symptoms from the baseline.

Who can join the trial?

8 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. A neurocognitive disorder affects memory, thinking, and behavior.
  • MMSE score of 20 or less out of 30. MMSE stands for Mini-Mental State Examination, a test that checks mental functions like memory and understanding.
  • NPI depression score of 4 or more out of 12. NPI stands for Neuropsychiatric Inventory, which measures symptoms like depression.
  • Patients who have not improved with at least one well-tolerated antidepressant, as assessed by the MGH-ATRQ scale. This scale helps to check if antidepressants are working.
  • Consent from the patient, family, and legal representative, if needed
  • Person must be affiliated with a social security scheme
  • Person participating in a clinical drug study or in a period of exclusion from any clinical study due to previous participation

Who cannot join the trial?

7 criteria

  • Patients who do not have **neurocognitive disorders**. This means conditions that affect memory, thinking, and reasoning.
  • Patients who do not have **significant depressive symptoms**. This refers to severe feelings of sadness or hopelessness.
  • Patients who have not tried at least one **conventional antidepressant** without success. Conventional antidepressants are common medications used to treat depression.
  • Patients who are not residents of a nursing home.
  • Patients who are under 18 years old.
  • Patients who are not willing to participate in the study.
  • Patients who have any other medical condition that the study doctors think would make it unsafe for them to participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • EMONO

    is being studied as an additional treatment to standard antidepressants. It is used to see if it can help reduce depressive symptoms in nursing-home residents who have neurocognitive disorders and have not responded well to at least one conventional antidepressant.

  • Conventional Antidepressants

    are medications that are typically used to treat depression. In this trial, they are used as a standard treatment to which EMONO is added to see if there is an improvement in depressive symptoms.

What is already known about the treatment

EMONO – EMONO is administered as an inhaled gas, typically used as an add-on therapy to conventional antidepressants. It is currently being studied in clinical trials for its effectiveness in treating depressive symptoms in nursing-home residents with neurocognitive disorders. The main therapeutic indication is for depression, particularly in cases where traditional antidepressants have not been fully effective. At the molecular level, EMONO is believed to modulate neurotransmitter activity, potentially enhancing mood and cognitive function. It is classified pharmacologically as a psychoactive gas.

Investigated diseases

Major Depressive Disorder – This is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can affect how a person feels, thinks, and handles daily activities. Symptoms may include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The disorder can vary in severity and duration, with some individuals experiencing recurrent episodes. It often requires a comprehensive approach to manage symptoms effectively.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IITrial ID2023-504691-18-00Protocol codeDR220204Estimated enrolment96 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).