Immunotherapy for antibody-associated psychosis
A Randomised Phase II Double-blinded Placebo-controlled Trial of Intravenous Immunoglobulins and Rituximab in Patients with Antibody-associated Psychosis (SINAPPS2)
This study is testing if a combination of two immunotherapy treatments can help people with acute psychosis caused by certain antibodies feel better and stay well.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 16 Years to 70 Years |
| Sex | All |
| Sponsor | University of Cambridge Academic / other |
| Drugs / interventions | rituximab, immunotherapy |
| Locations | 10 sites (Cambridge and 9 other locations) |
| Trial ID | NCT03194815 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of immunotherapy, specifically intravenous immunoglobulin (IVIG) and rituximab, in treating patients with acute psychosis linked to anti-neuronal membranes. The study is designed as a randomized, double-blinded, placebo-controlled trial to ensure unbiased results. Participants will receive a cycle of IVIG followed by rituximab infusions, aiming to induce and maintain remission from psychosis symptoms. The trial also assesses the safety of this treatment approach for the targeted patient population.
Who should consider this trial
Good fit: Ideal candidates include individuals experiencing acute psychosis for more than two weeks with detectable neuronal membrane autoantibodies.
Not a fit: Patients with chronic psychosis lasting over 24 months or those with severe neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from antibody-associated psychosis.
How similar studies have performed: Previous studies exploring immunotherapy for similar conditions have shown promising results, suggesting potential efficacy in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute psychosis \>2 weeks. This may either be first episode or relapse after remission (remission defined as having mild or absent symptoms of psychosis for at least 6 months) * Serum or CSF neuronal membrane autoantibodies at pathological levels (including NMDAR, LGI1 and other) * Psychosis symptoms as defined by PANSS ≥4 on at least one of the following items: P1, P2, P3, N1, N4, N6, G5 and G9. Exclusion Criteria: * Current episode of psychosis greater than 24 months duration * Co-existing severe neurological disease * Evidence of current acute encephalopathy * Hepatitis or HIV infection, pregnancy * Contraindications to any trial drug * Concurrent enrolment in another CTIMP
Where this trial is running
Cambridge and 9 other locations
- Cambridge University Hospitals NH Foundation Trust — Cambridge, United Kingdom (Recruiting)
- Royal Devon and Exeter NHS Foundation Trust — Exeter, United Kingdom (Recruiting)
- NHS Greater Glasgow and Clyde — Glasgow, United Kingdom (Recruiting)
- The Walton Centre NHS Foundation Trust — Liverpool, United Kingdom (Recruiting)
- University College London Hospitals Nhs Foundation Trust — London, United Kingdom (Recruiting)
- King's College Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
- Salford Royal NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
- Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom (Recruiting)
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (Recruiting)
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Alasdair Coles, PhD FRCP — University of Cambridge, UK
- Study coordinator: Alastdair Coles, PhD FRCP
- Email: ajc1020@medschl.cam.ac.uk
- Phone: +44 (0)1223 762016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.