Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr Francis Dowling
-
francis.dowling@nhs.net


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - IVIG and rituximab in antibody-associated psychosis - SINAPPS2

IVIG and rituximab in antibody-associated psychosis - SINAPPS2

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Antibody-associated psychosis


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Psychosis is a mental health condition that causes people to see reality differently, causing hallucinations or delusions. There is some evidence that, rarely, psychosis may be caused by a particular kind of antibody in the blood that affects the brain. Antibodies are molecules which the body makes to fight infections. There is some evidence that getting rid of these antibodies may improve the symptoms of psychosis. Immunotherapy could be helpful for patients with psychosis. Immunotherapy is a type of treatment that aims to boost the body’s natural defences to fight cancer. The trial combines the rapid-action treatment (IVIG) to induce symptom remission (stop it from returning), with a longer-action therapy (rituximab) to maintain remission. The aim of this study is to examine if immunotherapy is an effective treatment for antibody-associated psychosis, either in first episode psychosis (FEP) or relapse following remission, alongside antipsychotic medication if required.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

12 Oct 2017 31 Mar 2026

Publications

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31174586 protocol (added 10/06/2019)

After a screening and baseline examination to assess the severity of their symptoms and to follow adverse events, participants are randomly allocated to one of two groups. Those in the first group receive IVIG (two grams per kilogram over four days) followed by two infusions of one gram of rituximab around day 30 (14 days after their first infusion). Those in the second group receive the same treatment but with a placebo (a dummy) medication. Participants undergo a number of assessments including a physician examination, laboratory tests, clinical and cognitive (mental) tests to assess if immunotherapy can help treat psychosis.


Adults aged 18 to 70 years old who have had an episode of psychosis within the last two weeks.

You can take part if:



You may not be able to take part if:


1. Duration of current episode of psychosis greater than 24 months2. Alternative co-existing severe neurological disease, including tumour, hippocampal sclerosis with refractory epilepsy, probable dementia with evidence of atrophy on brain imaging, moderate or severe learning disability3. Any evidence of a current acute encephalopathy (for instance coma, seizures)4. Hepatitis B, Hepatitis C or HIV positivity; severe hypogammaglobulinaemia5. Previous malignancy (to be usually excluded unless agreed with CI)6. Pregnant, breast feeding or inadequate contraception if female7. Hypersensitivity or absolute contra-indication to any study medication, murine proteins or excipients8. Live vaccine within last three months9. Previous treatment with rituximab in the past 12 months10. Severe infection and severe heart failure11. Any other medical illness or disability that, in the opinion of the investigator, would compromise effective study participation12. Concurrent enrolment in other CTIMPs


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Queen Elizabeth Hospital
    Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Salford Royal
    Stott Lane
    Salford
    M6 8HD
  • Royal Devon University Healthcare NHS Foundation Trust
    Royal Devon University NHS Ft Barrack Road
    Exeter
    EX2 5DW
  • NIHR Nottingham Biomedical Research Centre
    Queens Medical Centre Derby Road
    Nottingham
    NG7 2UH
  • Addenbrooke's Hospital (lead site)
    Hills Road
    Cambridge
    CB2 0QQ
  • John Radcliffe Hospital
    Headley Way Headington
    Oxford
    OX3 9DU
  • King's College Hospital
    Suite 5 First Floor Golden Jubilee Wing Denmark Hill
    London
    SE5 9RS
  • Oxford Health NHS Foundation Trust
    Littlemore Mental Health Centre Sandford Road Littlemore
    Oxford
    OX4 4XN
  • New Victoria Hospital
    55 Grange Road
    Glasgow
    G42 9LL
  • Central Sheffield University Hospitals NHS Trust
    Royal Hallamshire Hospital Glossop Road
    Sheffield
    S10 2JF

Participants may benefit from improvement in psychosis. There is a risk of discomfort when giving blood. Participating in this study may increase the number of clinic/hospital appointments participants attend and may require an inpatient stay in hospital of up to 4 days.

Mr Francis Dowling
-
francis.dowling@nhs.net



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge and funded by Medical Research Council.




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Read full details for Trial ID: ISRCTN11177045

Or CPMS 32531

Last updated 11 March 2025

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