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

Palmer, Edward R., Griffiths, Siân Lowri, Watkins, Ben, Weetman, Tyler, Ottridge, Ryan, Patel, Smitaa, Woolley, Rebecca, Tearne, Sarah, Au, Pui, Taylor, Eleanor, Sadiq, Zara, Al-Janabi, Hareth, Major, Barnaby, Marriott, Charlotte, Husain, Nusrat, Katshu, Mohammad Zia Ul Haq, Giacco, Domenico, Barnes, Nicholas M., Walters, James T. R. ORCID: https://orcid.org/0000-0002-6980-4053, Barnes, Thomas R. E., Birchwood, Max, Drake, Richard and Upthegrove, Rachel 2023. Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial. Trials 24 (1) , 646. 10.1186/s13063-023-07499-3

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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.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	MRC Centre for Neuropsychiatric Genetics and Genomics (CNGG) Medicine
Additional Information:	License information from Publisher: LICENSE 1: URL: http://creativecommons.org/licenses/by/4.0/, Type: open-access
Publisher:	BioMed Central
ISSN:	1745-6215
Date of First Compliant Deposit:	9 October 2023
Date of Acceptance:	6 July 2023
Last Modified:	22 Nov 2023 14:35
URI:	https://orca.cardiff.ac.uk/id/eprint/163063

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