The ADEPP study is trying to find out if an antidepressant called sertraline can help prevent depression in people who have experienced a psychotic episode for the first time.
A psychotic episode can be a traumatic and frightening experience.
40% of patients will also experience depression and anxiety after a first episode of psychosis.
Typical standard care helps to treat psychotic symptoms but young people often struggle to return to their previous work and social lives. We think this may be related to depression.
Sertraline is already used in the NHS for the treatment and prevention of depression in other conditions.
This study will recruit patients from across England and Wales.
Half will receive the antidepressant Sertraline Half will receive a placebo, which contains no medicine.
This enables us to compare the effect of the active treatment sertraline with any effect that may be because someone thinks they have had the active treatment or of any additional monitoring.
This is done in most good medication trials. No one will choose which treatment they receive. It will be decided randomly.
We are inviting you to take part because you have experienced First Episode Psychosis.
If you are interested, we will ask you some questions to see if you are eligible for the study.
If you are, we will ask you to consent to take part.
The research team will ask you some more questions about your health and medical history, and you will be allocated your medication to take every day for 6 months.
You may or may not benefit directly from this medication but you’ll be helping us improve the care for people with psychosis in the future.
As with any drug, there are possible minor side effects which will be monitored closely, but serious complications are very rare.
We will also monitor your mood and recovery, which may be helpful for you and your care team to be aware of.
To assess your progress we will arrange a series of meetings somewhere convenient for you.
These will be monthly for the first 6 months. Then a final meeting at 12 months.
At the 1 month visit, we would like to take a blood sample from you to check the level of sertraline in your blood.
At the 6 month visit we will let you know which medicine you were taking.
Your care team will then decide with you whether to start treatment with Sertraline if you were in the placebo group, or continue or stop if you were in the Sertraline group.
Participants will be given £20 as a thank you for each of the 4 longer visits. Taking part in this study is voluntary and you can leave at any time.
If you decide not to take part, your normal care will continue.
All data will be anonymised and managed legally and securely.
If you have any questions please contact a member of the research team.