drugset / Trial / NCT02449746

Study of Immunotherapy in Autoantibody Positive Psychosis

NCT02449746

RandomizedParallel-groupOpen-labelOther

Summary

Psychosis is a mental health problem that causes people to perceive or interpret things differently from those around them, often involving hallucinations or delusions. Psychosis and schizophrenia are common disorders which predominantly affect younger adults. Recently, the investigators discovered that 5-10% of people with psychosis have antibodies in the blood that are capable of targeting the surface of brain cells, specific to the N-methyl-D-aspartate (NMDA) receptor or voltage gated potassium channel complex, which the investigators believe may be causing the problem. Those positive for antibodies may have a problem with their immune system and this may prevent their brain from working normally. This trial aims to test the feasibility of removing or reducing the antibodies in patients' blood, using immunotherapy, and see if this improves symptoms of psychosis. Immunotherapy in this feasibility study will involve giving all patients steroid tablets and half of them will also receive a drug called "intravenous immunoglobulin" whereas the other half will have a procedure called "plasma exchange". The feasibility study is designed to identify which method of immunotherapy is most suitable for use in this patient population. Results from this will inform on the methodology used for a proposed larger randomised control trial.

Timeline

Start
2015-08
Primary completion
2017-08
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Immune Globulin Intravenous (Human) Protein / enzyme biologic 2 g/kg Intravenous