Prospective cohort study of early biosignatures of response to lithium in bipolar-I-disorders: overview of the H2020-funded R-LiNK Initiative

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• dc.contributor.author Scott, Jan
• dc.contributor.author García-Estela, Aitana
• dc.contributor.author Bellivier, Frank
• dc.date.accessioned 2020-01-28T08:29:40Z
• dc.date.available 2020-01-28T08:29:40Z
• dc.date.issued 2019
• dc.description.abstract Background: Lithium is recommended as a first line treatment for bipolar disorders. However, only 30% of patients show an optimal outcome and variability in lithium response and tolerability is poorly understood. It remains difficult for clinicians to reliably predict which patients will benefit without recourse to a lengthy treatment trial. Greater precision in the early identification of individuals who are likely to respond to lithium is a significant unmet clinical need. Structure: The H2020-funded Response to Lithium Network (R-LiNK; http://www.r-link.eu.com/ ) will undertake a prospective cohort study of over 300 individuals with bipolar-I-disorder who have agreed to commence a trial of lithium treatment following a recommendation by their treating clinician. The study aims to examine the early prediction of lithium response, non-response and tolerability by combining systematic clinical syndrome subtyping with examination of multi-modal biomarkers (or biosignatures), including omics, neuroimaging, and actigraphy, etc. Individuals will be followed up for 24 months and an independent panel will assess and classify each participants' response to lithium according to predefined criteria that consider evidence of relapse, recurrence, remission, changes in illness activity or treatment failure (e.g. stopping lithium; new prescriptions of other mood stabilizers) and exposure to lithium. Novel elements of this study include the recruitment of a large, multinational, clinically representative sample specifically for the purpose of studying candidate biomarkers and biosignatures; the application of lithium-7 magnetic resonance imaging to explore the distribution of lithium in the brain; development of a digital phenotype (using actigraphy and ecological momentary assessment) to monitor daily variability in symptoms; and economic modelling of the cost-effectiveness of introducing biomarker tests for the customisation of lithium treatment into clinical practice. Also, study participants with sub-optimal medication adherence will be offered brief interventions (which can be delivered via a clinician or smartphone app) to enhance treatment engagement and to minimize confounding of lithium non-response with non-adherence. Conclusions: The paper outlines the rationale, design and methodology of the first study being undertaken by the newly established R-LiNK collaboration and describes how the project may help to refine the clinical response phenotype and could translate into the personalization of lithium treatment.
• dc.description.sponsorship This project has received funding from the European Union Horizon 2020 research and innovation program ((EU.3.1.1. Understanding health, wellbeing and disease: Grant No 754907).
• dc.format.mimetype application/pdf
• dc.identifier.citation Scott J, Hidalgo-Mazzei D, Strawbridge R, Young A, Resche-Rigon M, Etain B. et al. Prospective cohort study of early biosignatures of response to lithium in bipolar-I-disorders: overview of the H2020-funded R-LiNK Initiative. Int J Bipolar Disord. 2019 Sep 25;7(1):20. DOI 10.1186/s40345-019-0156-x
• dc.identifier.doi http://dx.doi.org/10.1186/s40345-019-0156-x
• dc.identifier.issn 2194-7511
• dc.identifier.uri http://hdl.handle.net/10230/43428
• dc.language.iso eng
• dc.publisher SpringerOpen
• dc.relation.ispartof International Journal of Bipolar Disorders. 2019 Sep 25;7(1):20
• dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/754907
• dc.rights The Author(s) 2019. 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.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Actigraphy
• dc.subject.keyword Bipolar
• dc.subject.keyword Digital
• dc.subject.keyword Lithium
• dc.subject.keyword Neuroimaging
• dc.subject.keyword Omics
• dc.subject.keyword Personalization
• dc.subject.keyword Phenotype
• dc.subject.keyword Precision
• dc.subject.keyword Response
• dc.title Prospective cohort study of early biosignatures of response to lithium in bipolar-I-disorders: overview of the H2020-funded R-LiNK Initiative
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion