The effects of using the PReDicT Test to guide the antidepressant treatment of depressed patients : study protocol for a randomised controlled trial
Kingslake, Jonathan (P1vital Products Ltd, Howbery Park, Wallingford, Oxfordshire UK)
Dias, Rebecca (P1vital Products Ltd, Howbery Park, Wallingford, Oxfordshire UK)
Dawson, Gerard R. (P1vital Ltd., Howbery Park, Wallingford, Oxfordshire UK)
Simon, Judit (University of Oxford)
Goodwin, Guy M. (Oxford Health NHS Trust, Oxford)
Harmer, Catherine J. (University of Oxford)
Morriss, Richard (University of Nottingham)
Brown, Susan (University of Nottingham)
Guo, Boliang (University of Nottingham)
Dourish, Colin T. (P1vital Ltd., Howbery Park, Wallingford, Oxfordshire UK)
Ruhé, Henricus Gerardus Eric (University of Groningen (Països Baixos))
Lever, Anne G. (VU University Medical Centre and Amsterdam Neuroscience)
Veltman, Dick J. (VU University Medical Centre and Amsterdam Neuroscience)
van Schaik, Anneke (VU University Medical Centre and Amsterdam Neuroscience)
Deckert, Jürgen (University Hospital Würzburg)
Reif, Andreas (University Hospital of Frankfurt (Alemanya))
Stäblein, Michael (University Hospital of Frankfurt (Alemanya))
Menke, Andreas (University Hospital Würzburg)
Gorwood, Philip (Université Paris-Descartes)
Voegeli, Géraldine (Université Paris-Descartes)
Pérez Solà, Víctor (Universitat Autònoma de Barcelona. Departament de Psiquiatria i de Medicina Legal)
Browning, Michael (Oxford Health NHS Trust, Oxford, UK)

Fecha:	2017
Resumen:	Antidepressant medication is commonly used to treat depression. However, many patients do not respond to the first medication prescribed and improvements in symptoms are generally only detectable by clinicians 4-6 weeks after the medication has been initiated. As a result, there is often a long delay between the decision to initiate an antidepressant medication and the identification of an effective treatment regimen. Previous work has demonstrated that antidepressant medications alter subtle measures of affective cognition in depressed patients, such as the appraisal of facial expression. Furthermore, these cognitive effects of antidepressants are apparent early in the course of treatment and can also predict later clinical response. This trial will assess whether an electronic test of affective cognition and symptoms (the Predicting Response to Depression Treatment Test; PReDicT Test) can be used to guide antidepressant treatment in depressed patients and, therefore, hasten treatment response compared to a control group of patients treated as usual. The study is a randomised, two-arm, multi-centre, open-label, clinical investigation of a medical device, the PReDicT Test. It will be conducted in five European countries (UK, France, Spain, Germany and the Netherlands) in depressed patients who are commencing antidepressant medication. Patients will be randomised to treatment guided by the PReDicT Test (PReDicT arm) or to Treatment as Usual (TaU arm). Patients in the TaU arm will be treated as per current standard guidelines in their particular country. Patients in the PReDicT arm will complete the PReDicT Test after 1 (and if necessary, 2) weeks of treatment. If the test indicates non-response to the treatment, physicians will be advised to immediately alter the patient's antidepressant therapy by dose escalation or switching to another compound. The primary outcome of the study is the proportion of patients showing a clinical response (defined as 50% or greater decrease in baseline scores of depression measured using the Quick Inventory of Depressive Symptoms - Self-Rated questionnaire) at week 8. Health economic and acceptability data will also be collected and analysed. This trial will test the clinical efficacy, cost-effectiveness and acceptability of using the novel PReDicT Test to guide antidepressant treatment selection in depressed patients.
Ayudas:	European Commission 696802
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Depression ; Prediction ; Treatment ; Antidepressant ; Primary care
Publicado en:	Trials, Vol. 18 (november 2017) , ISSN 1745-6215

DOI: 10.1186/s13063-017-2247-2
PMID: 29169399

10 p, 855.3 KB

El registro aparece en las colecciones:
Artículos > Artículos de investigación
Artículos > Artículos publicados