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Study on Rituximab for Adults with Schizophrenia Spectrum Disorder

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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 the medication Rituximab on adults diagnosed with Schizophrenia Spectrum Disorder. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves, often leading to symptoms like hallucinations, delusions, and disorganized thinking. The purpose of the study is to determine if patients with schizophrenia show improvement after receiving Rituximab, which is an immunomodulatory drug that works by targeting specific proteins in the immune system.

Participants in the study will receive Rituximab through an infusion, which means the medication is delivered directly into the bloodstream via a vein. The study will compare the effects of Rituximab with a placebo to see if there is a significant difference in the improvement of symptoms. The trial will last for several weeks, during which participants will be monitored for changes in their condition. The main goal is to see if there is at least a 30% improvement in symptoms as measured by a standard scale used to assess schizophrenia.

Throughout the study, various assessments will be conducted to evaluate the participants' mental health and overall well-being. These assessments include interviews and questionnaires that measure the severity of symptoms and the impact on daily life. The study aims to provide valuable insights into whether Rituximab can be an effective treatment option for individuals with schizophrenia, potentially leading to better management of the condition in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age (18 to 55 years), duration of illness (over 1 year), and a diagnosis of schizophrenia spectrum disorder (SSD).
Participants must be lucid and oriented when providing consent and have not sufficiently recovered from previous treatments.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements. This includes the Positive and Negative Syndrome Scale (PANSS) to evaluate symptom severity, and the Clinical Global Impression-Severity scale (CGI-S) to assess overall clinical severity.
Step 3
Treatment administration
Participants receive an intravenous infusion of rituximab, an immunomodulatory drug, or a placebo (NaCl).
The treatment aims to improve symptoms by at least 30% as measured by PANSS, with a clinician-rated improvement score of 1 or 2 on the Clinical Global Impression-Improvement scale (CGI-I) at week 12.
Step 4
Ongoing assessments
Throughout the study, regular assessments are conducted to monitor progress. These include the Personal and Social Performance Scale (PSP) to evaluate functioning in daily activities and relationships, and the Patient’s Global Evaluation (PGE) for self-reported improvement.
Health status is also self-evaluated using a visual analogue scale (VAS-health).
Step 5
Final evaluation
At the end of the study, a final evaluation is performed to measure changes in symptoms and overall health.
The study examines changes in brain activity and morphology, as well as inflammatory markers, to assess treatment response.

Who can join the trial?

7 criteria

Must be between 18 and 55 years old.
Must have had a psychiatric illness for more than 1 year.
Must be diagnosed with Schizophrenia spectrum disorder (SSD) according to the Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5).
If female and at risk of pregnancy, must be willing to use birth control methods or abstain from sexual activity if it is a normal and preferred lifestyle.
Must be clear-headed and aware of who they are, where they are, the time, and the situation when agreeing to participate in the study.
Must not have fully recovered from previous treatments with antipsychotic medications.
Must have a minimum score of 4 in the CGI-Severity scale at the start of the study. This scale measures the severity of the illness.

Who cannot join the trial?

10 criteria

Patients who do not have a diagnosis of schizophrenia spectrum disorder (SSD) cannot participate. This is a group of mental health conditions that affect how a person thinks, feels, and behaves.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who are not able to provide informed consent, meaning they cannot understand the study and agree to participate, cannot be included.
Patients who have any medical condition that might interfere with the study or make it unsafe for them to participate cannot be included.
Patients who are currently participating in another clinical trial cannot join this study.
Patients who have a known allergy or reaction to the study medication, rituximab, cannot participate. Rituximab is a medication that affects the immune system.
Patients who are pregnant or breastfeeding cannot participate, as the study medication might affect the baby.
Patients who have a history of substance abuse, which means using drugs or alcohol in a way that is harmful, cannot participate.
Patients who have a serious medical condition that is not stable or controlled cannot participate, as it might affect their safety or the study results.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Region Vaermland
Verified
Karlstad, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden
Vaestra Goetalandsregionen
Verified
Vänersborg, Sweden

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Investigated drugs

Rituximab is a medication used in this trial to treat adults with a psychotic disorder, specifically those diagnosed with schizophrenia spectrum disorder. It works by targeting and reducing certain immune cells in the body, which may help in reducing symptoms of the disorder. The goal of using rituximab in this study is to see if it can lead to significant improvement in the patients' condition over a period of 12 weeks.

Rituximab

What is already known about the treatment

Rituximab – Rituximab is administered intravenously and is currently being studied for its potential benefits in treating schizophrenia spectrum disorder (SSD). It is an established medication in medical literature, primarily used for conditions involving the immune system. The main therapeutic indication in this trial is to assess its effectiveness in improving symptoms of SSD. Rituximab works by targeting and depleting CD20-positive B cells, which are part of the immune system. It is classified as an immunomodulatory drug, specifically an anti-CD20 antibody.

Investigated diseases

Schizophrenia Spectrum Disorder – Schizophrenia Spectrum Disorder (SSD) is a mental health condition characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. Individuals with SSD may experience hallucinations, delusions, disorganized thinking, and impaired functioning in daily life. The disorder can manifest in various forms, with symptoms ranging from mild to severe. It often involves episodes of psychosis, where the person loses touch with reality. SSD can affect a person's ability to maintain relationships and perform tasks at work or school. The progression of the disorder can vary, with some individuals experiencing periods of improvement and others facing persistent challenges.