Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Nitrous Oxide in Resistant Depression in Elderly Subjects: A Randomized, Double-blind, Comparator Trial

This research study is looking into a new treatment for depression that hasn't responded to usual therapies in older people. The treatment involves a gas mixture called KALINOX, which contains nitrous oxide (sometimes known as 'laughing gas'). Participants will receive either this gas mixture or medical air. Doctors will carefully measure changes in their depression symptoms using a special scale over two weeks. They will also check on other health aspects, including brain changes and potential side effects. The aim is to see if KALINOX can be a safe and effective option for those struggling with stubborn depression in later life.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Enrolment target

Start

12 Nov 2024

Resistant Depression in the Elderly Subject

What is this study about?

This clinical trial is designed to investigate a potential new treatment for older adults who have depression that hasn't gotten better with standard medications or therapies. This type of depression is often called 'resistant depression'. The treatment being tested is a gas mixture called KALINOX, which has nitrous oxide as one of its main ingredients – you might know nitrous oxide as 'laughing gas', which is sometimes used for pain relief or sedation during medical procedures.

The main goal of this study is to see if KALINOX can reduce the severity of depression in these older patients, compared to receiving plain medical air. Researchers will be carefully tracking participants' mood and depression symptoms using a well-known scale called the MADRS. They'll measure this at the start of the study, and then at several points over the following two weeks. This helps them understand how quickly and effectively the treatment might be working.

Beyond just mood, the study also plans to look at other important aspects. This includes examining brain health using MRI scans to check blood flow, brain volume, and how different parts of the brain connect and light up. They will also use other questionnaires to get a full picture of how symptoms change and to carefully monitor for any potential side effects. The hope is to find a new, effective way to help older people who are struggling with persistent depression.

Key takeaways

This study is testing a gas mixture (KALINOX) for resistant depression in older adults.
It aims to see if KALINOX is better than plain air for improving mood.
Participation involves receiving the gas and undergoing various assessments, including brain scans.
The study lasts about two weeks.
Patients can withdraw at any time without affecting their medical care.

Who may be eligible?

This study is looking for both men and women aged 18 and older. While the study title mentions 'elderly subjects', the eligibility criteria state that participants can be any age from 18 years upwards.

The most important thing is that participants have what doctors call 'resistant depression'. This means that they have tried other treatments for their depression, but these haven't worked well enough to improve their symptoms.

Before joining, a team of doctors and nurses will closely review your medical history and current health to make sure the study is a safe and suitable option for you. They will explain all the requirements in detail.

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 18 years old or older?
Have you been diagnosed with depression that hasn't responded well to other treatments?
Are you able to attend regular appointments for assessments?
Are you comfortable with the idea of receiving a gas treatment and having brain scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have an initial assessment. Then, you would receive either the KALINOX gas mixture or medical air. During the study, your depression symptoms will be assessed at different times: at the very beginning, then two hours, 24 hours, one week, and two weeks after receiving the treatment.

Beyond these regular check-ups, you would also undergo specific tests to monitor your brain health. These might include special ultrasound scans and MRI scans of your brain to look at things like blood flow and brain structure. You would also complete various questionnaires about your mood and any side effects you might experience. The total duration of your active participation in the study is expected to be around two weeks, with a follow-up period to ensure your well-being.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit if the KALINOX gas mixture helps reduce your depression symptoms, offering an alternative when other treatments haven't worked. However, there's no guarantee it will help you, and you might receive the medical air which is not expected to have any effect on depression. Potential risks could include side effects from the KALINOX gas itself (like lightheadedness or nausea), or from the tests like MRI scans, although these are generally safe procedures. All potential risks will be thoroughly explained to you before you agree to participate. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical 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 'resistant depression'?

Resistant depression means that your depression hasn't improved much, even after trying several different treatments like medications or talking therapies.

What is KALINOX?

KALINOX is a medical gas mixture that contains nitrous oxide, sometimes called 'laughing gas', which is used in medical settings for its effects.

What is a 'comparator group'?

A comparator group is a group of people in the study who receive a standard treatment or a 'dummy' treatment (like medical air in this case) instead of the new treatment being tested. This helps researchers see if the new treatment actually works better.

Will I know if I'm getting the active gas or plain air?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know who is getting the KALINOX and who is getting the plain medical air. This helps ensure the results are fair and unbiased.

How long will I be involved in the study?

Your active involvement, including treatments and assessments, will last for about two weeks, with some follow-up checks.