The effects of using the PReDicT Test to guide the antidepressant treatment of depressed patients : study protocol for a randomised controlled trial

  • Background: 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. Methods/design: 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. Discussion: 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. Trial registration: ClinicalTrials.gov, ID: NCT02790970. Registered on 30 March 2016.

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Author:Jonathan Kingslake, Rebecca Dias, Gerard R. Dawson, Judit Simon, Guy M. Goodwin, Catherine J. Harmer, Richard Morriss, Susan Brown, Boliang Guo, Colin T. Dourish, Henricus G. Ruhé, Anne G. Lever, Dick J. Veltman, Anneke van Schaik, Jürgen Deckert, Andreas ReifORCiDGND, Michael Stäblein, Andreas Menke, Philip Gorwood, Géraldine Voegeli, Victor Pérez, Michael Browning
URN:urn:nbn:de:hebis:30:3-464731
DOI:https://doi.org/10.1186/s13063-017-2247-2
ISSN:1468-6694
ISSN:1745-6215
ISSN:1468-6708
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/29169399
Parent Title (English):Trials
Publisher:BioMed Central
Place of publication:London
Document Type:Article
Language:English
Year of Completion:2017
Date of first Publication:2017/11/23
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2018/08/21
Tag:Antidepressant; Depression; Prediction; Primary care; Treatment
Volume:18
Issue:1, Art. 558
Page Number:10
First Page:1
Last Page:10
Note:
Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
HeBIS-PPN:446473189
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - Namensnennung 4.0