IVIG and rituximab in antibody-associated psychosis - SINAPPS2

Phase 2

• Conditions: Antibody-associated psychosis; Mental and Behavioural Disorders

• Registration Number: ISRCTN11177045
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-02
• Last Update Posted: 15 April 2024
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Acute psychosis >2 weeks. This may either be the first episode or relapse after remission (remission defined as PANSS=3 on PANSS items P1, G9, P3, P2, G5, N1, N4, N6 for previous six months)
2. Serum or CSF neuronal membrane autoantibodies at pathological levels (including NMDAR, LGI1 and other)
3. Aged 18-70 years
4. Psychosis symptomatic as defined by PANSS =4 on P1, G9, P3, P2, G5, N1, N4, N6.
5. Patient or legal representative is willing and able to provide informed consent

Exclusion Criteria

1. Duration of current episode of psychosis greater than 24 months
2. 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 disability
3. Any evidence of a current acute encephalopathy (for instance coma, seizures)
4. Hepatitis B, Hepatitis C or HIV positivity; severe hypogammaglobulinaemia
5. Previous malignancy (to be usually excluded unless agreed with CI)
6. Pregnant, breast feeding or inadequate contraception if female
7. Hypersensitivity or absolute contra-indication to any study medication, murine proteins or excipients
8. Live vaccine within last three months
9. Previous treatment with rituximab in the past 12 months
10. Severe infection and severe heart failure
11. Any other medical illness or disability that, in the opinion of the investigator, would compromise effective study participation
12. Concurrent enrolment in other CTIMPs

Study & Design

• Study Type: Interventional
• Study Design: Not specified