Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial
Edward R. Palmer,
Siân Lowri Griffiths,
Ben Watkins,
Tyler Weetman,
Ryan Ottridge,
Smitaa Patel,
Rebecca Woolley,
Sarah Tearne,
Pui Au,
Eleanor Taylor,
Zara Sadiq,
Hareth Al-Janabi,
Barnaby Major,
Charlotte Marriott,
Nusrat Husain,
Mohammad Zia Ul Haq Katshu,
Domenico Giacco,
Nicholas M. Barnes,
James T. R. Walters,
Thomas R. E. Barnes,
Max Birchwood,
Richard Drake,
Rachel Upthegrove
Affiliations
Edward R. Palmer
Institute for Mental Health, School of Psychology, University of Birmingham
Siân Lowri Griffiths
Institute for Mental Health, School of Psychology, University of Birmingham
Ben Watkins
Birmingham Clinical Trials Unit, University of Birmingham
Tyler Weetman
Institute for Mental Health, School of Psychology, University of Birmingham
Ryan Ottridge
Birmingham Clinical Trials Unit, University of Birmingham
Smitaa Patel
Birmingham Clinical Trials Unit, University of Birmingham
Rebecca Woolley
Birmingham Clinical Trials Unit, University of Birmingham
Sarah Tearne
Birmingham Clinical Trials Unit, University of Birmingham
Pui Au
Birmingham Clinical Trials Unit, University of Birmingham
Eleanor Taylor
Birmingham Clinical Trials Unit, University of Birmingham
Zara Sadiq
Early Intervention Service, Birmingham Women’s and Children’s NHS Trust
Hareth Al-Janabi
Health Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham
Barnaby Major
Herefordshire and Worcestershire Health and Care NHS Trust
Charlotte Marriott
Herefordshire and Worcestershire Health and Care NHS Trust
Nusrat Husain
Division of Psychology and Mental Health, University of Manchester
Mohammad Zia Ul Haq Katshu
Institute of Mental Health, Division of Mental Health and Neurosciences University of Nottingham
Domenico Giacco
Division of Health Sciences, Warwick Medical School, University of Warwick
Nicholas M. Barnes
Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham
James T. R. Walters
Centre for Neuropsychiatric Genetics and Genomics, Division of Psychological Medicine and Clinical Neurosciences, Cardiff University
Thomas R. E. Barnes
Division of Psychiatry, Imperial College London
Max Birchwood
Division of Health Sciences, Warwick Medical School, University of Warwick
Richard Drake
Division of Psychology and Mental Health, University of Manchester
Rachel Upthegrove
Institute for Mental Health, School of Psychology, University of Birmingham
Abstract Background Depressive episodes are common after first-episode psychosis (FEP), affecting more than 40% of people, adding to individual burden, poor outcomes, and healthcare costs. If the risks of developing depression were lower, this could have a beneficial effect on morbidity and mortality, as well as improving outcomes. Sertraline is a selective serotonin reuptake inhibitor and a common first-line medication for the treatment of depression in adults. It has been shown to be safe when co-prescribed with antipsychotic medication, and there is evidence that it is an effective treatment for depression in established schizophrenia. We present a protocol for a multi-centre, double-blind, randomised, placebo-controlled clinical trial called ADEPP that aims to investigate the efficacy and cost-effectiveness of sertraline in preventing depression after FEP. Methods The recruitment target is 452 participants between the ages of 18 and 65 years who are within 12 months of treatment initiation for FEP. Having provided informed consent, participants will be randomised to receive either 50 mg of sertraline daily or matched placebo for 6 months, in addition to treatment as usual. The primary outcome measure will be a comparison of the number of new cases of depression between the treatment and placebo arms over the 6-month intervention phase. Secondary outcomes include suicidal behaviour, anxiety, rates of relapse, functional outcome, quality of life, and resource use. Discussion The ADEPP trial will test whether the addition of sertraline following FEP is a clinically useful, acceptable, and cost-effective way of improving outcomes following FEP. Trial registration ISRCTN12682719 registration date 24/11/2020.
