ADEPP

ADEPP logo

 

The ADEPP study is a randomised controlled trial with an internal pilot looking at the use of antidepressant for the prevention of depression following first episode psychosis

The aim of the ADEPP trial is to establish the effectiveness and cost effectiveness of an antidepressant medication (sertraline) for the prevention of a depressive episode following first episode psychosis.

This page explains the ADEPP study for researchers who are taking part in the study, or who are considering doing so. A summary for participants is here.

Latest news

 ADEPP is recruiting participants now (within England and Wales) and looking for more early intervention services to join us! Please visit https://adepp-study.digitrial.com/ to watch our animated information video.

Design

ADEPP is multi-centre, double-blinded, two arms randomised placebo controlled trial with an internal pilot study.

Aim of the Study

The aim of the internal pilot study is to determine the acceptability, retention and adherence of the study design.

The aim of the main study is to establish the effectiveness and cost effectiveness of an antidepressant medication (sertraline) for the prevention of a depressive episode following first episode psychosis (FEP).

Setting

Early Intervention in Psychosis Services (EIP) in England and Wales.

Target Population

People aged between 18-65 years of age, diagnosed with FEP and within 12 months of inital treatment for FEP.

Intervention

People consented to take part will be randomised between sertraline or placebo. Both groups will take their allocated intervention once a day for 6 months in addition to their usual treatment antipsychotic medication.

Measurement of outcomes

Primary outcome measure:

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

Secondary outcome measures:

  • Positive and Negative Syndrome Scale (PANNS)
  • Suicidal Behaviours Questionnaire- Revised (SBQ-R)
  • State-Trait Anxiety Inventory (STAI)
  • Generalised Anxiety Disorder Assessment (GAD-7)
  • Relapse of psychosis as identified by PANSS Positive subscale
  • Functioning: Global Assessment of Function (GAF)
  • Functional Remission of General Schizophrenia (FROGS)
  • Social and Occupational Functioning Assessment Scale (SOFAS)
  • Quality of life: EQ-5D-5L and ICEpop CAPability measure for Adults (ICECAP-A)
  • Quick Inventory of Depression Scale- Self Rating (QIDS-SR)
  • Side effect measures: Barnes Akathisia Scale (BARS); Antipsychotic non-neurological side effects rating scale- compiled (ANNSERS-c) ; Simpson Angus Scale (SAS)
  • Adverse Events
  • Healthcare Resource Usage

More information...

Funder: National Institute of Health Research (HTA programme ref. NIHR127700)

Sponsor: University of Birmingham

REC: 20/EM/0216

EudraCT no.: 2020-002787-32