The European Union’s Horizon 2020 Research and Innovation programme has given R-Link €7.7m for a cohort trial of lithium initiation, the results of which could provide people with bipolar disorder and clinicians better and more accurate information to make appropriate decisions regarding prescription of  lithium.

Professor Allan Young will lead the King’s College London team, supported by Professor Jan Scott, Dr Diego Hidalgo-Mazzei and Dr Becci Strawbridge. The team will manage participant recruitment, non-biological data collection, analysis and documentation.

Professor Allan Young, Director, Centre for Affective Disorders, Department of Psychological Medicine at the Institute of Psychiatry, Psychology & Neuroscience, King’s College London, said, ‘Lithium is the oldest current drug treatment used regularly in psychiatry and one that has shown evidence of many benefits over the decades it has been used.  However, only about one third of patients are  “excellent” responders with a further two thirds showing partial or no response.  This large EU funded study takes place across Europe and aims to find out which “biomarkers” can be used to predict which patients will respond and those for whom lithium will not help.’

‘R-Link uses cutting edge 21st century Personalised Medicine to answer the vitally important clinical question “which patients will respond to lithium?’

Bipolar disorder is a recurrent illness affecting about 2% of the world population. Lithium is considered to be the most effective evidence-based treatments for relapse prevention for bipolar disorder, and several studies have shown that lithium could improve different aspects of the illness.

While a substantial minority of individuals have no bipolar symptoms for years whilst taking lithium, many only partially respond, and up to one third do not respond well. This variability is currently poorly understood and a patient’s response cannot be predicted before treatment is started (and sometimes for many months afterward). Therefore, it is difficult for clinicians to reliably personalise and provide information to people starting lithium about how effective the medication will be beforehand.

Recent advances have been made in identifying new biomarkers capable of predicting response to treatments. However, few studies have evaluated lithium response using these new methodologies, and the majority that have tested  only monitor short durations of treatment, which does not reliably predict long-term outcomes.

The R-LiNK study has therefore been designed using a new multimodal approach which will provide valuable information using these new methodologies alongside a close follow-up of participants taking lithium. This study aims to identify factors linked to a better response, safety and tolerability of lithium treatment. This has the potential to finally enable personalisation of lithium treatment, which would lead to prevention of unnecessary side effects and ineffective treatments while improving long-term management and prognosis for individuals with bipolar disorder.

 The study will run from January 2018 until December 2022 across 15 highly specialised clinical centres in countries including France, Italy, Germany, Spain, Norway, Poland, Sweden and the UK.  The researchers will recruit at least 20 people in each of the 15 sites around Europe participating in the study, who have been diagnosed with type I bipolar disorder and who will be commencing lithium based on his/her clinicians’ assessment and his/her agreement to a personal trial of the treatment.

The Chief Investigator for the five year study, ‘Optimizing response to Li treatment through personalized evaluation of individuals with bipolar I disorder: the R-LiNK initiative’ is Professor Frank Bellivier, French Institute of Health and Medical Research, Paris.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 754907.