Prospective cohort study of early biosignatures of response to lithium in bipolar-I-disorders: overview of the H2020-funded R-LiNK initiative - CEA - Commissariat à l’énergie atomique et aux énergies alternatives Access content directly
Journal Articles International Journal of Bipolar Disorders Year : 2019

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

Ole J Andreassen
  • Function : Author
Michael Bauer
Paolo Brambilla
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Nadia Cattane
  • Function : Author
Annamaria Cattaneo
  • Function : Author
Klara Coello
  • Function : Author
Francesc Colom
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David Cousins
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Adele Ferro
  • Function : Author
Aitana Garcia-Estela
  • Function : Author
Jose Goikolea
  • Function : Author
Margrethe Høegh
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Petter Jakobsen
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Janos Kalman
  • Function : Author
Lars Kessing
  • Function : Author
Farah Klohn-Saghatolislam
  • Function : Author
Trine Lagerberg
  • Function : Author
Mikael Landén
Ute Lewitzka
  • Function : Author
Ashley Lutticke
  • Function : Author
Monica Mazzelli
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Cristina Mora
  • Function : Author
Thorsten Muller
  • Function : Author
Estanislao Mur-Mila
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Ketil Joachim Oedegaard
  • Function : Author
Leif Oltedal
  • Function : Author
Erik Pålsson
  • Function : Author
Sergi Papiol
Victor Perez-Sola
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Andreas Reif
Philipp Ritter
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Roberto Rossi
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Thomas G. Schulze
  • Function : Author
Fanny Senner
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Fiona Smith
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Letizia Squarcina
  • Function : Author
Nils Eiel Steen
  • Function : Author
Pete Thelwall
  • Function : Author
Cristina Varo
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Maj Vinberg
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Michèle Wessa
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Lars Westlye
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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; ) 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.

Dates and versions

cea-02316734 , version 1 (15-10-2019)

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Cite

Jan Scott, Diego Hidalgo-Mazzei, Rebecca Strawbridge, Allan H. Young, Matthieu Resche-Rigon, et al.. Prospective cohort study of early biosignatures of response to lithium in bipolar-I-disorders: overview of the H2020-funded R-LiNK initiative. International Journal of Bipolar Disorders, 2019, 7 (1), pp.20. ⟨10.1186/s40345-019-0156-x⟩. ⟨cea-02316734⟩
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