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

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What is this study about?

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.

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 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 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 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 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 adverse events monitoring

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

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Centre Hospitalier Regional Universitaire De Tours Tours France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.05.2026

Trial locations

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.

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 ID:
2023-504691-18-00
Protocol code:
DR220204
Trial Phase:
Therapeutic exploratory (Phase II)

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