Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial

Trials

Study Protocol

Sarah Tearne¹  Pui Au¹  Ryan Ottridge¹  Smitaa Patel¹  Eleanor Taylor¹  Rebecca Woolley¹  Ben Watkins¹  James T. R. Walters²  Max Birchwood³  Domenico Giacco⁴  Thomas R. E. Barnes⁵  Richard Drake⁶  Nusrat Husain⁷  Zara Sadiq⁸  Hareth Al-Janabi⁹  Charlotte Marriott^1,10  Barnaby Major^1,10  Siân Lowri Griffiths^1,11  Edward R. Palmer^1,12  Tyler Weetman^1,13  Rachel Upthegrove^1,13  Nicholas M. Barnes^1,14  Mohammad Zia Ul Haq Katshu^1,15 

[1] Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK;Centre for Neuropsychiatric Genetics and Genomics, Division of Psychological Medicine and Clinical Neurosciences, Cardiff University, Cardiff, Wales, UK;Division of Health Sciences, Warwick Medical School, University of Warwick, Warwick, UK;Division of Health Sciences, Warwick Medical School, University of Warwick, Warwick, UK;Coventry and Warwickshire Partnership NHS Trust, Coventry, UK;Division of Psychiatry, Imperial College London, London, UK;Division of Psychology and Mental Health, University of Manchester, Manchester, UK;Division of Psychology and Mental Health, University of Manchester, Manchester, UK;Mersey Care NHS Foundation Trust, Merseyside, UK;Early Intervention Service, Birmingham Women’s and Children’s NHS Trust, Birmingham, UK;Health Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK;Herefordshire and Worcestershire Health and Care NHS Trust, Worcester, UK;Institute for Mental Health, School of Psychology, University of Birmingham, Birmingham, UK;Institute for Mental Health, School of Psychology, University of Birmingham, Birmingham, UK;Birmingham and Solihull Mental Health Foundation Trust, Birmingham, UK;Early Intervention Service, Birmingham Women’s and Children’s NHS Trust, Birmingham, UK;Institute for Mental Health, School of Psychology, University of Birmingham, Birmingham, UK;Early Intervention Service, Birmingham Women’s and Children’s NHS Trust, Birmingham, UK;Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK;Institute of Mental Health, Division of Mental Health and Neurosciences University of Nottingham, Nottingham, UK;Nottinghamshire Healthcare National Health Service Foundation Trust, Nottingham, UK;

关键词: Prevention;    Depression;    Antidepressant;    Functioning;    First-episode psychosis;   

DOI  :  10.1186/s13063-023-07499-3

 received in 2023-04-14, accepted in 2023-07-06,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundDepressive 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.MethodsThe 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.DiscussionThe 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 registrationISRCTN12682719 registration date 24/11/2020.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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