SINAPPS2 Trial Procedures
Please note that the following information, while true and detailed, is not exhaustive of the study procedures. A full Participant Information Sheet will be given to potential trial participants and a researcher and neurologist will be available to discuss the details of the trial before an offer of participation.
SINAPPS2 PROCEDURES AND ACTIVITIES
Before the treatment
Potential participants will be informed about the trial by the trial neurologist or researcher, and they will have the opportunity to ask questions. They will be invited to a participating NHS hospital to be screened for eligibility by a neurologist and researchers. If the potential participant agrees to participate they will attend an appointment in the hospital or clinical research facility for blood tests; a physical examination will be carried out by a physician; and an interview will be administered by the SINAPPS2 researcher. Eligible patients will be invited for further clinical and research assessments such as a medical examination and a research interview before the trial treatment.
What do placebo-controlled, randomised and double-blind mean?
This trial is a ‘placebo-controlled’ trial, which means that half of the participants taking part will be treated with immunotherapy, and half will be given a placebo. A placebo is sometimes called a ‘dummy treatment’ – it looks the same as the actual treatment but does not contain any of the active ingredients and will have no effect on study participants. Allocation to either group will be randomly decided using an electronic randomisation system.
Neither participants or clinical and research team will not know if they have been assigned to the ‘active treatment’ (Immunotherapy), or the placebo until the end of the trial. Both participants and trial team will be ‘blind’ about given medication and we call this ‘double-blinded’.
The trial treatment/placebo will be given intravenously in a hospital or a clinical research facility over a maximum of six days, distributed through a period of about two months. The first of the two medications (or placebo) will be given intravenously (through a drip) over the course of several consecutive days. The second medication (or placebo) will also be given through a drip twice over the course of one day.
Participants will continue receiving their standard psychiatric treatment including antipsychotic medication as prescribed by their psychiatrist.
After the treatment
Trial participants will be followed monthly by phone or at clinical visits to hospital. The follow-up contacts will include clinical assessments by neurologists, blood samples and research interviews.