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RecruitingTherapeutic exploratory (Phase II)Interventional

A randomized controlled trial with Rituximab for Psychotic disorder in adults

Schizophrenia spectrum disorders can cause distressing symptoms that affect everyday life, relationships, and independent living. This clinical trial is testing a medicine called rituximab to see if it can help reduce these symptoms and improve quality of life for adults living with a psychotic illness. Rituximab is an established medicine used for other conditions, but researchers are exploring if it may also benefit brain health and mental well-being. During the study, doctors will track changes using structured symptom interviews, known as the PANSS assessment. They will also look at how well participants manage daily tasks, self-care, and social relationships. Feedback from both doctors and close family members will be used to judge whether the treatment helps people feel noticeably better. The study is open to adults aged 18 and over with a diagnosed psychotic disorder.

At a glance

Status
Recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Region Oerebro Laen
Enrolment target
120
Start
27 Aug 2024

What is this study about?

Living with a schizophrenia spectrum disorder can be challenging. People may experience symptoms like hearing voices, unusual thoughts, loss of motivation, or difficulty expressing emotions. Standard treatments do not work well for everyone, which is why researchers are exploring new ways to treat these conditions. This study is testing whether a drug called rituximab can help relieve psychotic symptoms.

Rituximab is a medication already used in medicine to treat certain immune system conditions. Scientists are interested in rituximab because research suggests the immune system and inflammation might play a role in some mental health conditions, including psychosis. By testing rituximab in a controlled study, researchers hope to see if targeting the immune system can help the brain heal and lessen symptoms.

To find out if rituximab works, doctors will use thorough mental health checks. The main assessment is called the PANSS interview, where doctors carefully rate symptoms such as mood, unusual experiences, and general well-being. They will also check if participants find it easier to carry out daily tasks, care for themselves, and connect with friends and family.

Key takeaways

  • This phase 2 trial tests whether rituximab can help adults with schizophrenia spectrum disorders.
  • Open to adults aged 18 and over of all genders.
  • Researchers will measure symptoms, daily functioning, and quality of life using regular clinical interviews.
  • Carers or family members may also provide feedback on how you are progressing.
  • Participation is voluntary and does not replace your right to standard medical care.

Who may be eligible?

This study is designed for adults aged 18 and older who have been diagnosed with a schizophrenia spectrum disorder or related psychotic illness. Both men and women are welcome to take part.

While the trial is open to adults of all ages, you will need a full health check by the research team first. People with certain serious medical conditions or those taking medicines that cannot be safely mixed with rituximab may not be able to join. The study team will review your full medical history before deciding if it is safe for you to take part.

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.

  1. You are aged 18 or older.
  2. You have a diagnosed schizophrenia spectrum or psychotic disorder.
  3. You are willing to attend clinic visits and complete 45-minute symptom interviews.
  4. You are open to receiving rituximab under medical supervision.
  5. You are happy for researchers to check your general health and medical history.
Answer every question to see your result.

What does participation involve?

Taking part involves receiving the study medicine and attending regular clinic appointments. Rituximab is typically given as a drip into a vein under medical supervision. During your visits, researchers will carry out gentle, 45-minute interviews to ask about your symptoms, mood, and daily life over the previous week. They will also assess how you are managing everyday activities, like self-care and socialising. With your permission, researchers may also ask a close family member or carer how you are doing. The medical team will monitor your physical health and mental well-being closely throughout the study.

Potential risks and benefits

Taking part may help improve your symptoms and could help doctors find better treatments for others in the future. However, there is no guarantee that rituximab will help you personally. Like all medications, rituximab can cause side effects, such as infusion reactions or a higher chance of infections. The medical team will monitor you carefully to keep you safe. Joining the trial is entirely voluntary, and you are free to withdraw at any time without it affecting your usual NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Sweden

Common questions

What is rituximab?

Rituximab is a medicine usually used to treat immune conditions and certain blood disorders. Researchers are studying whether it can also help reduce inflammation linked to psychosis.

What happens during the symptom interview?

A trained professional will spend about 45 minutes asking gentle questions about your thoughts, feelings, and daily experiences over the past week.

Will my family or carers be involved?

With your consent, the team may ask a close family member or carer for their views on how your symptoms and daily living have changed.

Do I have to stop my current treatment?

You should never stop any prescribed medication without speaking to your doctor. The research team will discuss how this study fits alongside your current care.

Can I change my mind after joining?

Yes. Taking part is completely voluntary, and you can withdraw at any point without giving a reason and without harming your usual medical care.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "A randomized controlled trial with Rituximab for Psychotic d…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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