SINAPPS2: a randomized double blind placebo-controlled clinical trial

Please note that the following information, while true and detailed, is not exhaustive of the study procedures. A full Patient 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 where they will do blood tests; a physical examination will be carried out by a physician; and an interview will be administered by the SINAPPS2 researcher.

 

Before the treatment eligible patients will be invited for further clinical and research assessments such as a medical examination and a research interview to obtain information on clinical and cognitive characteristics. Before the treatment we will obtain initial information and monitor the participant's general health.

 

 

What do placebo-controlled, randomized 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 you. 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’.

 

 

Treatment

 

The trial treatment/placebo will be given intravenously in a hospital or a clinical research facilityover a maximum of 6 days, distributed through a period of about 2 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 usual 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.

 

The participants will complete their study participation 12 to 18 months after the treatment.

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