TY - JOUR
T1 - The clinical effectiveness of using a predictive algorithm to guide antidepressant treatment in primary care (PReDicT)
T2 - an open-label, randomised controlled trial
AU - Browning, Michael
AU - Bilderbeck, Amy C.
AU - Dias, Rebecca
AU - Dourish, Colin T.
AU - Kingslake, Jonathan
AU - Deckert, Jürgen
AU - Goodwin, Guy M.
AU - Gorwood, Philip
AU - Guo, Boliang
AU - Harmer, Catherine J.
AU - Morriss, Richard
AU - Reif, Andreas
AU - Ruhe, Henricus G.
AU - van Schaik, Anneke
AU - Simon, Judit
AU - Sola, Victor Perez
AU - Veltman, Dick J.
AU - Elices, Matilde
AU - Lever, Anne G.
AU - Menke, Andreas
AU - Scanferla, Elisabetta
AU - Stäblein, Michael
AU - Dawson, Gerard R.
N1 - Funding Information:
This project received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 696802. This publication reflects only the authors’ views and neither the Horizon 2020 research and innovation programme nor the European Commission is responsible for any use that may be made of the information it contains. We thank the patients involved in the study and the staff of the participating clinical sites for their help in recruiting patients and running the study. We also thank those that have helped with the running of the study, in particular Lisa Pearce Collins, Sam Campbell, Garima Sharma, Mar Dziedzic and Hannah Alker. GMG is an Emeritus NIHR Senior Investigator. CJH is supported by the Oxford Health NIHR Biomedical Research Centre. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. MB declares grants from the MRC and Wellcome Trust during the conduct of the study. He was employed by the trial CRO, P1vital Ltd, during the study and owns shares in P1vital Products Ltd (which owns the PReDicT algorithm and is the study sponsor). He has worked as a consultant for J&J and CHDR and has accepted travel funds from
Funding Information:
Lundbeck. GD, ACB are employees of P1vital Ltd. RD and JK are employees of P1vital Products Ltd. GD, JK, CTD own shares in P1vtial Ltd. JK, RD, CTD and GD own shares in P1vital Products Ltd. JD reports grants from the DFG, BMBF and Vogel Foundation during the conduct of the study. He is Co-PI with BioVariance in a study financed by the Bavarian Secretary of Commerce. GMG holds shares in P1vital and P1vital Products and has served as consultant, advisor or CME speaker in the last 3 years for Allergan, Angelini, Compass pathways, Evapharm, MSD, Janssen, Lundbeck Otsuka/Takeda, Medscape, Minerva, P1vital, Pfizer, Sage, Servier, Shire and Sun Pharma. PG has received, over the last 5 years, fees for presentations at congresses or participation in scientific boards from Alcediag-Alcen, Angelini, GSK, Janssen, Lundbeck, Otsuka, SAGE and Servier. CJH has received consultancy fees from P1vital Products Ltd as well as Janssen, Lundbeck, Sage Pharmaceuticals, Pfizer, Servier and Zongeixs. AR has received honoraria for lectures or advisory boards from Medice, Shire/Takeda, Janssen, SAGE, Servier and neuraxpharm. HGR has received speaking fees from Lundbeck. BG, RM, AvS, JS, VPS, DJV, ME, AGL, AM, ES and MS declare no conflict of interest.
Publisher Copyright:
© 2021, The Author(s).
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/6
Y1 - 2021/6
N2 - Depressed patients often do not respond to the first antidepressant prescribed, resulting in sequential trials of different medications. Personalised medicine offers a means of reducing this delay; however, the clinical effectiveness of personalised approaches to antidepressant treatment has not previously been tested. We assessed the clinical effectiveness of using a predictive algorithm, based on behavioural tests of affective cognition and subjective symptoms, to guide antidepressant treatment. We conducted a multicentre, open-label, randomised controlled trial in 913 medication-free depressed patients. Patients were randomly assigned to have their antidepressant treatment guided by a predictive algorithm or treatment as usual (TaU). The primary outcome was the response of depression symptoms, defined as a 50% or greater reduction in baseline score of the QIDS-SR-16 scale, at week 8. Additional prespecified outcomes included symptoms of anxiety at week 8, and symptoms of depression and functional outcome at weeks 8, 24 and 48. The response rate of depressive symptoms at week 8 in the PReDicT (55.9%) and TaU (51.8%) arms did not differ significantly (odds ratio: 1.18 (95% CI: 0.89–1.56), P = 0.25). However, there was a significantly greater reduction of anxiety in week 8 and a greater improvement in functional outcome at week 24 in the PReDicT arm. Use of the PReDicT test did not increase the rate of response to antidepressant treatment estimated by depressive symptoms but did improve symptoms of anxiety at week 8 and functional outcome at week 24. Our findings indicate that personalisation of antidepressant treatment may improve outcomes in depressed patients.
AB - Depressed patients often do not respond to the first antidepressant prescribed, resulting in sequential trials of different medications. Personalised medicine offers a means of reducing this delay; however, the clinical effectiveness of personalised approaches to antidepressant treatment has not previously been tested. We assessed the clinical effectiveness of using a predictive algorithm, based on behavioural tests of affective cognition and subjective symptoms, to guide antidepressant treatment. We conducted a multicentre, open-label, randomised controlled trial in 913 medication-free depressed patients. Patients were randomly assigned to have their antidepressant treatment guided by a predictive algorithm or treatment as usual (TaU). The primary outcome was the response of depression symptoms, defined as a 50% or greater reduction in baseline score of the QIDS-SR-16 scale, at week 8. Additional prespecified outcomes included symptoms of anxiety at week 8, and symptoms of depression and functional outcome at weeks 8, 24 and 48. The response rate of depressive symptoms at week 8 in the PReDicT (55.9%) and TaU (51.8%) arms did not differ significantly (odds ratio: 1.18 (95% CI: 0.89–1.56), P = 0.25). However, there was a significantly greater reduction of anxiety in week 8 and a greater improvement in functional outcome at week 24 in the PReDicT arm. Use of the PReDicT test did not increase the rate of response to antidepressant treatment estimated by depressive symptoms but did improve symptoms of anxiety at week 8 and functional outcome at week 24. Our findings indicate that personalisation of antidepressant treatment may improve outcomes in depressed patients.
UR - https://www.scopus.com/pages/publications/85101757145
U2 - 10.1038/s41386-021-00981-z
DO - 10.1038/s41386-021-00981-z
M3 - Article
C2 - 33637837
SN - 0893-133X
VL - 46
SP - 1307
EP - 1314
JO - Neuropsychopharmacology
JF - Neuropsychopharmacology
IS - 7
ER -
SDG 3 Good Health and Well-being