Study on Rituximab for Patients with Mental Disorders and Autoimmunity

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What is this study about?

This clinical trial is focused on studying certain mental disorders that are believed to be linked to the immune system. The treatment being tested is called rituximab, which is a type of medication that helps to modify the immune system. Rituximab is given as an infusion, which means it is administered directly into the bloodstream through a vein. The purpose of this study is to evaluate how effective this treatment is when added to the usual psychiatric care that patients are already receiving.

The study will involve participants who have been diagnosed with mental disorders and have shown signs of an immune system problem. Participants will receive either the rituximab treatment or a placebo, in addition to their regular psychiatric care. The study will last for several months, and during this time, participants will be monitored to see if their psychiatric symptoms improve. The main goal is to see if there is a reduction in symptoms after three months of treatment.

Throughout the study, participants will undergo various assessments to measure their mental health and overall functioning. These assessments will help researchers understand the impact of rituximab on mental disorders and whether it can be a beneficial addition to standard treatments. The study will also track any side effects or adverse events that occur during the trial to ensure the safety of the participants.

1 initial assessment

Upon joining the clinical trial, an initial assessment is conducted to confirm eligibility. This includes evaluating the presence of psychotic disorders using specific scales: the PANSS scale for adults and adolescents, and the Kiddie sads-PL scale for children.

Informed consent is required from the patient or their legal representatives to proceed with the trial.

2 step 1 participation

Eligible participants begin step 1 of the trial. This involves ongoing psychiatric care, which may include standard psychotropic treatment.

The primary goal is to assess the remission of psychiatric symptoms over a period of 3 months. For adults and adolescents, a 20% decrease from baseline on the BPRS-E scale is targeted. For children, a 25% decrease from baseline on the ABC scale is aimed for.

3 step 2 eligibility assessment

Participants who meet the criteria for step 1 undergo further assessment for step 2. This includes a biological diagnosis of pathogenic CNS autoantibodies in the blood and a score greater than 3 on the MDC scale.

A normal ECG is required if there is a history of heart disease. Informed consent is again required for step 2.

4 step 2 participation

Participants in step 2 receive immunotherapy with rituximab, administered as a solution for infusion. The specific dosage and frequency are determined by the trial protocol.

Women of childbearing potential must use effective contraception during the trial and for at least 12 months after the last administration of rituximab.

5 monitoring and evaluation

Throughout the trial, participants are monitored for the persistence of autoimmunity and the remission of psychiatric symptoms at various intervals, including 1 month, 6 months, and 12 months.

Secondary assessments include general functioning, cognitive abilities, neurological evaluations, and the measurement of psychotic disorders using various scales such as GAF, MOCA, KREBS, BUSH, MADRS, YMRS, CDRS, and CGI scales.

6 completion and follow-up

Upon completion of the trial, participants undergo a final evaluation to assess the overall outcomes and any adverse events experienced during the trial.

The trial is estimated to conclude by December 15, 2027, with follow-up assessments as required by the trial protocol.

Who Can Join the Study?

Adults and adolescents aged 17 years or older experiencing their first episode or a relapse of psychotic disorders, with or without standard medication.
Children aged between 6 and 16 years experiencing their first episode or a relapse of psychotic disorders, with or without standard medication.
Must provide informed consent for participation, either by the patient or their legal representative. Informed consent means understanding the study and agreeing to participate.
For the second part of the study, participants must meet the initial criteria and have a biological diagnosis showing the presence of harmful CNS autoantibodies in the blood. CNS autoantibodies are proteins that mistakenly attack the brain and nervous system.
For the second part, a score greater than 3 on the MDC scale is required. The MDC scale is a tool used to measure certain symptoms.
For the second part, participants with a history of heart disease must have a normal ECG. An ECG is a test that checks the heart’s electrical activity.
For the second part, women who can become pregnant must use effective birth control during the study and for at least 12 months after the last dose of the study medication, rituximab.

Who Cannot Join the Study?

Patients with any other serious medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of severe allergic reactions to any medication.
Patients who are currently participating in another clinical trial.
Patients who have a substance abuse problem that is not under control.
Patients who have had a major surgery within the last 3 months.
Patients with unstable psychiatric conditions that require immediate intervention.
Patients who are unable to provide informed consent due to cognitive impairment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Hospitalier Le Vinatier	Bron	France
Centre Hospitalier Charles Perrens	Bordeaux	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hopital Beaujon	Clichy	France
Hzehiqnw cklnel Hzgpt Maiyxr is Akhbnbcd	Aurillac	France
Hvyryjjj Uashuszoplkelx Savtblkjgg &zuwctz Hwakhni dk Haircndhkif	STRASBOURG, Alsace	France
Cka Khiqpfj Bohfhon	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.10.2024

Trial locations

Investigated drugs:

Rituximab

Immunotherapy is a type of treatment that helps the body’s immune system fight diseases. In this trial, it is used to help patients with psychiatric disorders who have been found to have issues with their immune system. The goal is to see if this therapy can improve their mental health symptoms when added to their regular psychiatric care.

Investigated diseases:

Mental disorder

Mental Disorder – Mental disorders are conditions that affect a person’s thinking, feeling, mood, or behavior. They can be occasional or long-lasting and can affect a person’s ability to relate to others and function each day. The progression of mental disorders varies widely depending on the specific condition and individual factors. Some disorders may have periods of remission and relapse, while others may be more consistent over time. Symptoms can range from mild to severe and may include changes in mood, personality, personal habits, and social withdrawal. The course of a mental disorder can be influenced by factors such as stress, trauma, and genetic predisposition.

Trial ID:

2024-518259-49-00

Protocol code:

CHUBX 2019/59

NCT ID:

NCT05946486

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Rituximab for Patients with Mental Disorders and Autoimmunity

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