IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2 (SINAPPS2)

 Autoimmune Encephalitis / Posted 3 weeks 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 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
  • 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
Contact details

England

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