Not yet recruitingPHASE3INTERVENTIONAL

Evaluation of the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.

This research is a Phase 3 study investigating a treatment called rituximab for certain mental health conditions, including psychosis and bipolar disorder. It focuses on individuals whose mental health issues may be caused by their immune system mistakenly attacking healthy parts of their body, specifically when a special antibody (NMDAr-Ac) is found in their blood. The study aims to find out if adding rituximab to standard mental health treatments works better than standard treatments alone for these patients. Rituximab is a type of 'immunomodulatory' treatment, meaning it helps to adjust the immune system's activity. The study will carefully check how well this treatment improves patients' symptoms and overall well-being. This is a crucial step in understanding if immune-targeting treatments could offer new hope for some mental health disorders.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

University Hospital, Bordeaux

Enrolment target

174

Start

15 Oct 2023

Estimated completion

15 Dec 2026

Mental Disorder

What is this study about?

This study, called a Phase 3 clinical trial, is trying to find out if a treatment called rituximab can help people with certain mental health conditions. Specifically, it's looking at conditions like psychosis and bipolar disorder where there's a strong belief that the person's immune system might be involved. This means the body's defence system, which usually fights off germs, might be accidentally attacking healthy parts of the brain. The study is particularly interested in people who have a specific marker in their blood – an antibody called NMDAr-Ac, which suggests this immune system involvement.

The main goal is to see if adding rituximab to the usual care for these mental health conditions works better than just the usual care alone. Rituximab is a type of medicine that can change how the immune system works. By calming down the overactive immune response, researchers hope to see an improvement in mental health symptoms. This is an important area of research because if successful, it could open up new ways to treat mental health conditions for some people.

To make sure the study results are reliable, researchers will use special tests to confirm the presence of these immune system markers in patients' blood. This will help them understand exactly which patients might benefit most from this treatment. The study is a 'randomised' trial, which means people will be put into different groups by chance – some will get rituximab plus usual care, and others will get usual care only. This helps to get a clear picture of the treatment's effects.

Key takeaways

This study explores a new treatment (rituximab) for psychosis and bipolar disorder.
It focuses on patients whose conditions might be linked to an overactive immune system.
The treatment aims to calm the immune system to improve mental health.
It's a Phase 3 trial, meaning it's a key step towards potentially new treatments.
It combines rituximab with standard mental health care.

Who may be eligible?

This study is looking for adults and children over 6 years old who have recently experienced a first episode or a new bout of psychosis or bipolar disorder. A key requirement is that specialised blood tests must show that your immune system is making specific antibodies (NMDAr-Ac) that could be linked to your condition. You would also need to meet certain health criteria, which your doctor would check.

There are also reasons why someone might not be able to join the study. For example, if you have certain genetic conditions, severe neurological problems, or ongoing mental health issues that are already well-controlled with existing medication. You also wouldn't be able to join if you're allergic to rituximab, have certain blood conditions, severe heart problems, or infections like Hepatitis B or HIV. Women who are pregnant or breastfeeding cannot take part, and if you could become pregnant, you would need to use effective contraception during and for a year after the study.

Other reasons for not being able to participate include having certain cancers, recently receiving specific vaccinations, or being involved in another clinical trial within the last month. Anyone who has been treated with rituximab in the past year or has a history of serious infections would also be excluded.

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 aged 6 or over?
Have you recently experienced a first episode or new bout of psychosis or bipolar disorder?
Have you had blood tests that show specific immune system markers (NMDAr-Ac)?
Are you generally in good health, without severe heart, blood, or infectious diseases?
If you could become pregnant, are you able to use effective contraception?
Have you not received rituximab in the last year or other experimental drugs recently?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the study treatment (rituximab) in addition to your usual mental health care. Rituximab is given as an infusion, meaning it's delivered directly into your bloodstream, usually in a hospital or clinic setting. You would have regular check-ups with the study team, which would include physical examinations, blood tests, and assessments of your mental health symptoms using specific questionnaires. These appointments are important for monitoring your health and the effects of the treatment.

The total duration of your participation in the study, including all treatments and follow-up assessments, would be clearly explained to you by the study team. You would likely have several visits over a period of time, with the final follow-up perhaps a year or more after the last rituximab dose. The exact schedule of visits and tests would be provided in detail if you were considering joining.

Potential risks and benefits

Participating in this study might offer the potential benefit of trying a new treatment that could improve your mental health symptoms, especially if your condition is linked to an immune system issue. However, there are also potential risks associated with rituximab, such as allergic reactions, increased risk of infections, and other side effects that your doctor would discuss with you. As with all clinical trials, there's no guarantee that the treatment will help everyone. You have the full right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Centre Hospitalier Charles Perrens
Verified postcode
Bordeaux, France
CHU de Bordeaux
Verified postcode
Bordeaux, France
Centre hospitalier le Vinatier
Verified postcode
Bron, France
CHU de Clermond Ferrand
Verified postcode
Clermont-Ferrand, France
APHP Louis Mourier
Verified postcode
Colombes, France
APHP Henri Mondor
Verified postcode
Créteil, France
APHP Kremlin Bicetre
Verified postcode
Le Kremlin-Bicêtre, France
CHU de Montpellier
Verified postcode
Montpellier, France
CHU de Strasbourg
Verified postcode
Strasbourg, France

Common questions

What is 'immunomodulatory treatment'?

It's a type of treatment that helps to adjust or change how your body's immune system works, either by calming it down or making it more active.

What is NMDAr-Ac?

NMDAr-Ac is a specific antibody, a type of protein made by your immune system. In some cases, it can mistakenly attack parts of your brain, which scientists believe might contribute to certain mental health conditions.

Will I still receive my usual mental health care?

Yes, if you join this study, rituximab would be given in addition to the standard mental health treatments you already receive or would normally be prescribed.

What phase is this study in?

This is a Phase 3 study, which means it's one of the final steps before a new treatment might be considered for wider use, after showing promise in earlier phases.

Can children take part in this study?

Yes, children aged 6 and over may be able to participate if they meet all the other study requirements and their parents or legal guardians provide consent.

How to find out more

Frédéric VILLEGA, MD, PhD

frederic.villega@chu-bordeaux.fr +33 (0)5 56 79 56 41 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.