IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2 (SINAPPS2)
Autoimmune Encephalitis / Posted 2 years ago
A randomised phase II double-blinded placebo-controlled trial designed to explore the utility of immunotherapy for patients with acute psychosis associated with anti-neuronal membranes (NMDA-receptor or Voltage Gated Potassium Channel).
Primary objective: To test the efficacy of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes.
Secondary objective: To test safety of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes.
Inclusion Criteria :
Ages Eligible for Study: 16 Years to 60 Years (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
- 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
- Study end date : 01/03/2024
- Wales-Based Study Contact : Please speak to your clinician
- Principal Investigator : Alasdair Coles, PhD FRCP University of Cambridge, UK