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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; Barnes, Thomas R E; Birchwood, Max; Drake, Richard; Upthegrove, Rachel.
Afiliación
  • Palmer ER; Institute for Mental Health, School of Psychology, University of Birmingham, Birmingham, UK.
  • Griffiths SL; Birmingham and Solihull Mental Health Foundation Trust, Birmingham, UK.
  • Watkins B; Early Intervention Service, Birmingham Women's and Children's NHS Trust, Birmingham, UK.
  • Weetman T; Institute for Mental Health, School of Psychology, University of Birmingham, Birmingham, UK.
  • Ottridge R; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
  • Patel S; Institute for Mental Health, School of Psychology, University of Birmingham, Birmingham, UK.
  • Woolley R; Early Intervention Service, Birmingham Women's and Children's NHS Trust, Birmingham, UK.
  • Tearne S; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
  • Au P; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
  • Taylor E; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
  • Sadiq Z; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
  • Al-Janabi H; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
  • Major B; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
  • Marriott C; Early Intervention Service, Birmingham Women's and Children's NHS Trust, Birmingham, UK.
  • Husain N; Health Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
  • Katshu MZUH; Herefordshire and Worcestershire Health and Care NHS Trust, Worcester, UK.
  • Giacco D; Herefordshire and Worcestershire Health and Care NHS Trust, Worcester, UK.
  • Barnes NM; Division of Psychology and Mental Health, University of Manchester, Manchester, UK.
  • Walters JTR; Mersey Care NHS Foundation Trust, Merseyside, UK.
  • Barnes TRE; Institute of Mental Health, Division of Mental Health and Neurosciences University of Nottingham, Nottingham, UK.
  • Birchwood M; Nottinghamshire Healthcare National Health Service Foundation Trust, Nottingham, UK.
  • Drake R; Division of Health Sciences, Warwick Medical School, University of Warwick, Warwick, UK.
  • Upthegrove R; Coventry and Warwickshire Partnership NHS Trust, Coventry, UK.
Trials ; 24(1): 646, 2023 Oct 06.
Article en En | MEDLINE | ID: mdl-37803384
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trastornos Psicóticos / Sertralina Tipo de estudio: Clinical_trials / Guideline / Incidence_studies / Prognostic_studies Aspecto: Patient_preference Límite: Adult / Child, preschool / Humans / Infant Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Trastornos Psicóticos / Sertralina Tipo de estudio: Clinical_trials / Guideline / Incidence_studies / Prognostic_studies Aspecto: Patient_preference Límite: Adult / Child, preschool / Humans / Infant Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido