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 mortalit...
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07499-3 |
| _version_ | 1827708519785168896 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Edward R. Palmer |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T17:05:47Z |
| format | Article |
| id | doaj.art-44f228a1a8da45fc9e082bf89cc9d09d |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-10T17:05:47Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-44f228a1a8da45fc9e082bf89cc9d09d2023-11-20T10:49:59ZengBMCTrials1745-62152023-10-0124111610.1186/s13063-023-07499-3Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trialEdward R. Palmer0Siân Lowri Griffiths1Ben Watkins2Tyler Weetman3Ryan Ottridge4Smitaa Patel5Rebecca Woolley6Sarah Tearne7Pui Au8Eleanor Taylor9Zara Sadiq10Hareth Al-Janabi11Barnaby Major12Charlotte Marriott13Nusrat Husain14Mohammad Zia Ul Haq Katshu15Domenico Giacco16Nicholas M. Barnes17James T. R. Walters18Thomas R. E. Barnes19Max Birchwood20Richard Drake21Rachel Upthegrove22Institute for Mental Health, School of Psychology, University of BirminghamInstitute for Mental Health, School of Psychology, University of BirminghamBirmingham Clinical Trials Unit, University of BirminghamInstitute for Mental Health, School of Psychology, University of BirminghamBirmingham Clinical Trials Unit, University of BirminghamBirmingham Clinical Trials Unit, University of BirminghamBirmingham Clinical Trials Unit, University of BirminghamBirmingham Clinical Trials Unit, University of BirminghamBirmingham Clinical Trials Unit, University of BirminghamBirmingham Clinical Trials Unit, University of BirminghamEarly Intervention Service, Birmingham Women’s and Children’s NHS TrustHealth Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of BirminghamHerefordshire and Worcestershire Health and Care NHS TrustHerefordshire and Worcestershire Health and Care NHS TrustDivision of Psychology and Mental Health, University of ManchesterInstitute of Mental Health, Division of Mental Health and Neurosciences University of NottinghamDivision of Health Sciences, Warwick Medical School, University of WarwickInstitute of Clinical Sciences, College of Medical and Dental Sciences, University of BirminghamCentre for Neuropsychiatric Genetics and Genomics, Division of Psychological Medicine and Clinical Neurosciences, Cardiff UniversityDivision of Psychiatry, Imperial College LondonDivision of Health Sciences, Warwick Medical School, University of WarwickDivision of Psychology and Mental Health, University of ManchesterInstitute for Mental Health, School of Psychology, University of BirminghamAbstract 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.https://doi.org/10.1186/s13063-023-07499-3PreventionDepressionAntidepressantFunctioningFirst-episode psychosis |
| spellingShingle | 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 Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial Trials Prevention Depression Antidepressant Functioning First-episode psychosis |
| title | Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial |
| title_full | Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial |
| title_fullStr | Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial |
| title_full_unstemmed | Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial |
| title_short | Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial |
| title_sort | antidepressants for the prevention of depression following first episode psychosis adepp study protocol for a multi centre double blind randomised controlled trial |
| topic | Prevention Depression Antidepressant Functioning First-episode psychosis |
| url | https://doi.org/10.1186/s13063-023-07499-3 |
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