TY  - JOUR
A1  - Kingslake, Jonathan
A1  - Dias, Rebecca
A1  - Dawson, Gerard R.
A1  - Simon, Judit
A1  - Goodwin, Guy M.
A1  - Harmer, Catherine J.
A1  - Morriss, Richard
A1  - Brown, Susan
A1  - Guo, Boliang
A1  - Dourish, Colin T.
A1  - Ruhé, Henricus G.
A1  - Lever, Anne G.
A1  - Veltman, Dick J.
A1  - Schaik, Anneke van
A1  - Deckert, Jürgen
A1  - Reif, Andreas
A1  - Stäblein, Michael
A1  - Menke, Andreas
A1  - Gorwood, Philip
A1  - Voegeli, Géraldine
A1  - Pérez, Victor
A1  - Browning, Michael
T1  - The effects of using the PReDicT Test to guide the antidepressant treatment of depressed patients : study protocol for a randomised controlled trial
T2  - Trials
N2  - 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.
KW  - Depression
KW  - Prediction
KW  - Treatment
KW  - Antidepressant
KW  - Primary care
Y1  - 2017
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/46473
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-464731
SN  - 1468-6694
SN  - 1745-6215
SN  - 1468-6708
N1  - 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.
VL  - 18
IS  - 1, Art. 558
SP  - 1
EP  - 10
PB  - BioMed Central
CY  - London
ER  -