SINAPPS2 is a phase II ongoing clinical trial aiming to test the efficacy and safety of immunotherapy (intravenous immunoglobulin combined with rituximab) vs placebo treatment in people with acute symptoms of psychosis and anti-neuronal membrane antibodies.
A randomised phase II double-blinded placebo-controlled trial of intravenous immunoglobulins and rituximab in patients with antibody-associated psychosis.
The increasing evidence of the role of antibodies and the immune system in causing symptoms of psychosis and schizophrenia is inconsistent.
We propose that in some patients the cause of psychosis may be antibodies binding to neuronal membrane targets (NMDAR, LGI1, CASPR2, GABA-A and other), especially NMDA receptors, in the brain.
The hypothesis underlying the SINAPPS2 trial is that these antibodies may be pathogenic and responsible for isolated psychosis (antibody-associated psychosis).
We are conducting the SINAPPS2 trial to test if immunotherapy is an effective treatment for antibody-associated psychosis.
Adult patients (16-70 years old) with psychosis and serum or CSF anti-neuronal membrane autoantibodies at pathological levels are invited to one of the NHS hospitals participating in the study, where they are assessed and assisted by a team of SINAPPS2 clinicians and researchers. Eligible patients are randomly allocated to receive either intravenous immunoglobulin combined with rituximab or placebo treatment and they will be followed for at least 12 months.
Recruitment began in September 2017 and it will run until end of March 2026.
There are currently ten active SINAPPS2 sites located in different NHS acute hospitals across England and Scotland.
1. Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge
2. John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford
3. National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust, London
4. Royal Devon and Exeter Hospital, Royal Devon and Exeter NHS Foundation Trust, Exeter
5. King’s College Hospital, King’s College Hospital NHS Foundation Trust, London
6. Queens Medical Centre, Nottingham University Hospitals NHS Foundation Trust, Nottingham
7. The Walton Centre NHS Foundation Trust, Liverpool
8. Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield
9. Salford Royal Hospital, Salford Royal NHS Foundation Trust, Salford
10. Greater Glasgow and Clyde Health Board, Queen Elizabeth University Hospital, Glasgow
The SINAPPS2 trial is funded by Medical Research Council, Developmental Pathway Funding Scheme: MR/N019067/1