An unblinded study of the feasibility of delivering immunotherapy in patients with acute psychosis associated with anti-neuronal membrane auto-antibodies.
The SINAPPS1 study was a multicentre, uncontrolled, open-label feasibility study and it was conducted in five NHS hospitals across England.
SINAPPS1 included adult patients with acute psychosis symptoms for at least one week in first episode or relapse. If in relapse patients should have been well prior to current episode of psychosis. Eligible patients had psychosis and NMDAR, VGKC-complex, LGI1, CASPR2, GABA-A and other emerging autoantibodies in serum or cerebrospinal fluid.
Patients with duration of untreated psychosis or of psychosis symptoms greater than 24 months, with co-existing severe neurological disease, Hepatitis B, C, HIV, previous malignancy, pregnancy, allergy to a study medication, or live vaccine within last 4 weeks were not included.
We offered immunotherapy, in the form of either plasma exchange or immunoglobulin. Participants’ demographic, clinical history, concomitant medication, severity of symptoms and functioning was assessed at baseline and at six months.
The primary outcome measure was the proportion of antibody associated psychosis patients who complete their treatment within two weeks from decision to treat.
SINAPPS1 completed recruitment in July 2017 and the report on findings will be published in 2018
SINAPPS1 was funded by the Stanley Medical Research Institute. The study received approval by the South Central - Oxford C Research Ethics Committee (REC reference 15/SC/0219).
SINAPPS1 was a study of the feasibility of plasmapheresis or intravenous immunoglobulin, combined with corticosteroids, in patients with acute psychosis and anti-neuronal membrane auto-antibodies. The aim of SINAPPS1 was to investigate delivering immunotherapy to this patient group in general hospital settings.
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