Information for participants

First Episode Psychosis is when a person experiences psychotic symptoms (for example hallucinations and delusions) for the first time. Standard NHS care helps to treat psychotic symptoms, but young people may still struggle to return to previous social and work roles. We think this could be related to depression experienced after First Episode Psychosis.

This trial is run by the University of Birmingham, and it is funded by the National Institute for Health Research, a UK health and social care research agency.

It is important that any new way of managing First Episode Psychosis is tested and shown to work. Prescribing the antidepressant sertraline to people with First Episode Psychosis is not common in the NHS at the moment. This is a trial to see if taking sertraline for the first 6 months as a preventative measure can reduce the chances of depression. This can only be tested as part of a trial where some people get sertraline and some don't, and results are compared in the two groups.

Sertraline is a commonly used antidepressant and the standard dose for people aged over 18 years. It has been shown to work in the prevention of depression in other conditions. 

•    The research team will check if you are eligible to take part (screening).
•    You are only included in screening and the main study if you formally agree to take part (give “informed consent”).  
•    After giving informed consent, you will be asked some questions about you, your health and your medical history.
•    If you are still eligible, a computer will randomly allocate you to one of two groups. There is a 50:50 chance that you may or may not get sertraline. Unless really needed, no one will know for the first 6 months whether you get sertraline or not. If you don't get sertraline, you will get a placebo that looks just the same.
•    We will visit you monthly for 6 months and then once at 12 months to ask you how you have been, plus a blood sample taken at 1 month only. If necessary these visits may be done by phone or video call.

No, this is entirely up to you. Taking part is voluntary. You do not have to take part if you do not want to. It will not affect your standard care in any way. There is a £40 reimbursement for your time at the screening and baseline visit and £20 reimbursement at each visit at 1, 6 and 12 months.

We will only use information from you and your medical records that we need for this study. We will let very few people know your name or contact details, and only if they really need it for this study. Everyone involved in the study will keep your data safe and secure. We will also follow all privacy rules. At the end of the study we will save some of the data in case we need to check it and for future research. We will make sure no-one can work out who you are from the reports we write.

You can see our participant information sheets, with further details about the trial here (ADEPP Screening Information Sheet) and here (ADEPP Information Sheet). You can contact your clinical care team, or you can email us (the details are on our contact page) and we can let you know if the trial is being run in your area.