SINAPPS 2: a randomized double blind placebo-controlled clinical trial - eligibility and procedures

Please note that the following information, while true and detailed, are not exhaustive of the study procedures. A full information sheet will be given and a researcher will be available to discuss the details of the trial before a formal offer of participation to the study is made.

 

 

Please refer to the information below for a more detailed explanation of the inclusion and exclusion criteria, as well as an explanation of the study methods and procedures.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SINAPPS2 INCLUSION AND EXCLUSION CRITERIA

 

To be eligible to participate in SINAPPS2, all of the criteria below must be met:

 

  • Presenting symptoms of psychosis for more than 2 weeks but less than 2 years. This can be either a first episode or a relapse. In case of a relapse, there must have been at least 6 months of recovery between the previous and the current episode.

 

  • Positive to presence of anti-neuronal membrane autoantibodies (NMDAR, LGI1 and others) within the last 2 months.

 

  • Aged 18-70 years

 

 

However, even if meeting all of the above, individuals will not be able to take part in the study if any of the following is true:

 

  • The duration of the current episode of psychosis is longer than 24 months.

 

  • Suffer from a severe neurological disease or other specific medical conditions.

 

  • Any evidence of a current acute encephalopathy (for instance coma, seizures).

 

  • Hepatitis B, Hepatitis C or HIV positivity.

 

  • Live vaccine within last 3 months.

 

  • Previous treatment with rituximab in the past 12 months.

 

Other exclusion criteria will be assessed during the first visit.

 

 

WHAT DO RANDOMIZED, DOUBLE-BLIND AND PLACEBO CONTROLLED MEAN?

 

This study will test the efficacy of two drugs in treating antibody-mediated symptoms of psychosis. These drugs are already used in NHS as first line treatment for many other conditions. As the efficacy of these medications hasn't been confirmed yet for treating symptoms of psychosis, there are certain procedures that must be followed to ensure that the results are as unbiased as possible.

 

Participants will be divided in two groups. One of the two groups will receive the real medications, while the other group will receive a "dummy treatment": a substance that has no therapeutic effect. This kind of substance is commonly called "placebo". This procedure is a standard research procedure for this kind of studies.

 

Participants will be randomly assigned to one of these two groups, and no one will be able to influence to which group a participant is assigned. This procedure is called "randomization" and increases reliability of the results.

 

Additionally, neither the participants, nor the researchers or the doctors involved in the care of the patient will know whether the patient received the placebo treatment or the real drugs. This condition is a common research method called double-blind. This is to make sure that researchers are as objective as possible when collecting data.

 

 

SINAPPS2 PROCEDURES AND PROGRESSION

 

The treatment itself will be given over a maximum of 6 days, distributed through a period of about 50 days. The participant involvement overall will last for 12 or 18 months. Most of the contact after the treatment will consist of short monthly phone calls, with quarterly visits to the clinics for a medical review. Below is a short chart representing the various steps of the study, along with a more detailed explanation for each visit.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Visit 1: Potential participants will be invited to talk about the study, and answer any question the potential participants might have.

If the potential participants agrees to participate we will do blood tests, physical examination carried out by a local physician and a brief interview to ensure eligibility.

 

Visit 2: Maximum 4 weeks after the first meeting, there will be a longer visit to collect initial information and monitor participant's general health.

 

Visits 3: This is the first treatment session. The first of the two medications (or placebo) will be given through a drip over the course of 2 to 4 days.

 

Visits 4 & 5: Between 3 and 4 weeks later the participant will be invited to Visit 4 to receive the second medication (or placebo), again through a drip. This time the medication will be given over the course of one day.

After 2 to 3 weeks visit 5 will take place, with another infusion of the second medication, again using a drip and over the course of one day.

 

Visits 6, 7, 8, (9): After a month from the last visit, the participant will be invited again to the clinic to be seen by a clinician and having an interview with the local researcher. These visits will take place every 3 months.

 

Phone interviews: Additionally, the participant will receive a monthly phone call from a local researcher. The researcher will carry out a brief interview (approximately 30 minutes) and will collect feedback from the participant.

 

After 12 to 18 months since the first visit, the participant will have completed their study participation.

 

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