Study of Immunotherapy in Autoantibody Positive Psychosis (SINAPPS-1)
Schizophrenia, Psychosis, Auto Immune Disorders
About this trial
This is an interventional other trial for Schizophrenia focused on measuring Schizophrenia, Psychosis, Mental Health, Autoimmunity, Psychoneuroimmunology
Eligibility Criteria
Inclusion Criteria:
- Acute psychosis
- Serum and/or Cerebrospinal flud (CSF) neuronal membrane autoantibodies (including N-methyl-D-aspartate receptor (NMDAR), Voltage gated potassium channel (VGKC), Leucine-rich, glioma inactivated 1,(LGI1), gamma-aminobutyric acid (GABA [A]) receptor)
- Positive and Negative Syndrome Scale (PANSS) >4 on items of positive psychotic symptoms
Exclusion Criteria:
- current symptoms greater than 2 years duration,
- co-existing severe neurological disease
Sites / Locations
- University Hospitals Birmingham
- Cambridge University Hospitals
- Nottingham University Hospitals
- Oxford University Hospitals
- University Hospitals Southampton
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Intravenous Immunoglobulin (IVIG)
Plasma Pheresis / Plasma Exchange (PLEX)
Intravenous Immunoglobulin IVIG is a pooled blood product from 3000-100,000 human blood donors with direct immunomodulatory effects. IVIG will be given at a dose of 2g/kg over 4 days. Dosing at 2g/kg is established in neurological disorders, with limited evidence that lower doses are less effective although adequate dosing studies have not been performed.
Plasma Exchange (PLEX) is a procedure in which the subject's blood is passed through a medical device which separates out plasma from the other blood components, and replaces the plasma with albumin or plasma or other colloid. PLEX therefore removes circulating pathogenic antibodies, and its use was first reported in myasthenia gravis in 1976, and furthermore therapeutic benefit after PLEX supports an antibody mediated pathogenesis of disease. In PLEX, 200-250 mL plasma per kg body weight is exchanged typically over 7-14 days using 5% albumin as replacement, often at alternate days which increases the amount of immunoglobulin removed due to equilibrium effects . PLEX modality (centrifugation or filtration), type of anticoagulation, and dose scheduling will be determined by local centre practice