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

doi:10.1186/s13063-023-07499-3

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. BarnesMax Birchwood, Richard Drake, Rachel Upthegrove^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	646
Journal	Trials
Volume	24
Issue number	1
DOIs	https://doi.org/10.1186/s13063-023-07499-3
Publication status	Published - 6 Oct 2023

Keywords

Depression
First-episode psychosis
Antidepressant
Prevention
Functioning

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Palmer, E. R., Griffiths, S. L., Watkins, B., Weetman, T., Ottridge, R., Patel, S., Woolley, R., Tearne, S., Au, P., Taylor, E., Sadiq, Z., Al-Janabi, H., Major, B., Marriott, C., Husain, N., Katshu, M. Z. U. H., Giacco, D., Barnes, N. M., Walters, J. T. R., ... Upthegrove, R. (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), Article 646. https://doi.org/10.1186/s13063-023-07499-3

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

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.",

keywords = "Depression, First-episode psychosis, Antidepressant, Prevention, Functioning",

author = "Palmer, {Edward R.} and Griffiths, {Si{\^a}n Lowri} and Ben Watkins and Tyler Weetman and Ryan Ottridge and Smitaa Patel and Rebecca Woolley and Sarah Tearne and Pui Au and Eleanor Taylor and Zara Sadiq and Hareth Al-Janabi and Barnaby Major and Charlotte Marriott and Nusrat Husain and Katshu, {Mohammad Zia Ul Haq} and Domenico Giacco and Barnes, {Nicholas M.} and Walters, {James T. R.} and Barnes, {Thomas R. E.} and Max Birchwood and Richard Drake and Rachel Upthegrove",

year = "2023",

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Palmer, ER, Griffiths, SL, Watkins, B, Weetman, T, Ottridge, R, Patel, S, Woolley, R, Tearne, S, Au, P, Taylor, E, Sadiq, Z, Al-Janabi, H, Major, B, Marriott, C, Husain, N, Katshu, MZUH, Giacco, D, Barnes, NM, Walters, JTR, Barnes, TRE, Birchwood, M, Drake, R & Upthegrove, R 2023, 'Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial', Trials, vol. 24, no. 1, 646. https://doi.org/10.1186/s13063-023-07499-3

TY - JOUR

T1 - Antidepressants for the prevention of depression following first-episode psychosis (ADEPP)

T2 - study protocol for a multi-centre, double-blind, randomised controlled trial

AU - Palmer, Edward R.

AU - Griffiths, Siân Lowri

AU - Watkins, Ben

AU - Weetman, Tyler

AU - Ottridge, Ryan

AU - Patel, Smitaa

AU - Woolley, Rebecca

AU - Tearne, Sarah

AU - Au, Pui

AU - Taylor, Eleanor

AU - Sadiq, Zara

AU - Al-Janabi, Hareth

AU - Major, Barnaby

AU - Marriott, Charlotte

AU - Husain, Nusrat

AU - Katshu, Mohammad Zia Ul Haq

AU - Giacco, Domenico

AU - Barnes, Nicholas M.

AU - Walters, James T. R.

AU - Barnes, Thomas R. E.

AU - Birchwood, Max

AU - Drake, Richard

AU - Upthegrove, Rachel

PY - 2023/10/6

Y1 - 2023/10/6

N2 - 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.

AB - 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.

KW - Depression

KW - First-episode psychosis

KW - Antidepressant

KW - Prevention

KW - Functioning

U2 - 10.1186/s13063-023-07499-3

DO - 10.1186/s13063-023-07499-3

M3 - Article

SN - 1745-6215

VL - 24

JO - Trials

JF - Trials

IS - 1

M1 - 646

ER -

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

Abstract

Keywords

UN SDGs

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