For Researchers: About the Study

This page explains the ADEPP study for researchers who are taking part in the study, or who are considering doing so.

Details and documents for researchers can be found here: https://www.birmingham.ac.uk/adepp

Study details

  • Design

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

  • 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 initial 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

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.

  • 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

Recruitment chart

Recruitment target: 452

Current Actual : 94

Participating centres

UK

  • North West
  • West Midlands
  • Wales
  • Warwickshire
  • East Midlands
  • Worcestershire/Herefordshire
  • Oxford
  • Shropshire
  • London
  • Cornwall
  • Gloucestershire
  • Southampton

Study team

Professor Rachel Upthegrove MBBS, FRCPsych, PhD

School of Psychology
Professor of Psychiatry and Youth Mental Health
Consultant Psychiatrist Early Intervention in Psychosis

Rachel is Professor of Psychiatry and Youth Mental Health at the University of Birmingham, and Consultant Psychiatrist in the Birmingham Early Intervention Services. Her research Interest is within the field of major mental illness; particularly schizophrenia and co-morbid depression in early phases of illness. Recent projects have developed the investigation of inflammatory models of psychosis and machine learning in prognostic indicators in early phases of developing mental ill health.

Find out more

Ben Watkins, BSc (Hons)

Senior Trial Manager, University of Birmingham

Ben is a senior trial manager at Birmingham Clinical Trials Unit based at the University of Birmingham. He has over 10 years of experience managing clinical trials in both an NHS and academic setting in a range of clinical specialities.