Title

Antidepressant for the prevention of DEPression following first episode Psychosis trial (ADEPP)

Objectives

To establish the effectiveness and cost-effectiveness of an antidepressant medication (sertraline) for the prevention of a depressive episode following first episode psychosis (FEP).

Trial Design

Multi-centre randomised, double-blind, placebo controlled trial with an internal pilot study.

Participant Population and Sample Size

508 participants will be recruited from Early Intervention in Psychosis services in England and Wales within 3 months of FEP treatment onset.

Primary outcome measure

The primary outcome will be the number of new cases of depression as indicated by a CDSS score >5 and confirmed by MINI diagnostic interview in each treatment arm over the 6-month intervention phase.