R-LINK

  • Research type

    Research Study

  • Full title

    Optimizing response to Li treatment through personalized evaluation of individuals with bipolar I disorder: The R-LiNK initiative

  • IRAS ID

    245166

  • Contact name

    Allan Young

  • Contact email

    allan.young@kcl.ac.uk

  • Sponsor organisation

    ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) and by delegation: Clinical Research and Innovation

  • Clinicaltrials.gov Identifier

    NCT04209140

  • Duration of Study in the UK

    4 years, 0 months, 3 days

  • Research summary

    Bipolar disorder (BD) is a recurrent illness affecting about 2% of the world population. Lithium is one of the most effective evidence-based treatments for relapse prevention for bipolar disorder, and several studies have shown that Lithium could improve different aspects of long-term illness activity. A substantial minority of individuals remain asymptomatic for years on Lithium, but many partially respond and up to one third do not respond well. This variability is currently poorly understood and response cannot be predicted before treatment is started. Therefore, it is still difficult for clinicians to reliably personalize 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. Yet, few studies have evaluated Lithium response using these new methodologies, and most of them only test 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 has the potential to finally enable personalization 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.

    This study aims to identify factors linked to a better response, safety and tolerability of lithium treatment. We are looking for at least 20 people in each of the 16 sites in 8 European countries, who have been diagnosed with type I bipolar disorder and who will be commencing Lithium. The decision to start Lithium treatment will have been decided separately between patients and their doctor.

  • REC name

    London - Camden & Kings Cross Research Ethics Committee

  • REC reference

    18/LO/1890

  • Date of REC Opinion

    9 Jan 2019

  • REC opinion

    Further Information Favourable Opinion