ADEPP
Research type
Research Study
Full title
Antidepressant for the prevention of DEPression following first episode Psychosis trial
IRAS ID
279574
Contact name
Rachel Upthegrove
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2020-002787-32
ISRCTN Number
ISRCTN12682719
Duration of Study in the UK
4 years, 1 months, 31 days
Research summary
First episode of psychosis (FEP) typically begins in the late teens or early 20s and is diagnosed by the presence of hallucinations and delusions. Medication and cognitive behavioural therapy help to treat these symptoms, but young people struggle to return to previous social and work roles, have suicidal thoughts and are at high risk of relapse. These are related to depression experienced after FEP. 40% of people who have experienced FEP will become depressed.
Antidepressant medication is effective for treating depression in established schizophrenia, and robust evidence suggests that using antidepressants in young people over the age of 18 along with medication for psychosis is safe. However, we want to know whether antidepressant medication can reduce the risk of depression happening at all after FEP, and whether by preventing depression we can improve recovery and reduce relapse.
We will compare two groups of young people who have had FEP. One group will be given a highly effective antidepressant medication (sertraline) while the other will receive a placebo (‘sugar pill’), to take once a day for 6 months. In all other ways the two groups will receive the same types of support from Early Intervention of Psychosis Services (EIP).
The study will recruit 508 young people from the UK who have FEP. The main outcome evaluated will be the number of new depression cases at 6 months. A number of other key outcomes such as acceptability of the intervention, cost effectiveness and side-effects of antidepressant medication, recovery, suicidal thoughts/behaviour, anxiety, and relapse will be assessed.
We will monitor people in the study closely and if at any time a participant is thought to have depression, their multi-disciplinary team will assess them and decide if they need to stop taking trial medication, and their illness be more actively managed.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0216
Date of REC Opinion
2 Nov 2020
REC opinion
Further Information Favourable Opinion