NCT04209140

Optimizing Response to Li Treatment Through Personalized Evaluation of Individuals With Bipolar I Disorder: The R-LiNK Initiative

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 320 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Bipolar disorder (BD), especially BD type I, is a highly prevalent mental disorder and a is a highly prevalent mental disorder and an important factor for suicide. Lithium is the key treatment for prevention of BD relapse and has a proven suicide prevention effect. Whilst many cases become asymptomatic with lithium treatment, the majority show sub-optimal response. The objectives of this project are to: * improve outcomes of bipolar I disorder (BDI) cases prescribed lithium through the application of stratified approaches * optimize the early prediction of lithium response using a set of multi-modal biomarkers ("blood omics", Magnetic Resonance Imaging and Li7-Magnetic Resonance Spectroscopy derived-markers) * develop a multidisciplinary multinational network of experts to undertake this and future projects on personalized diagnostics and therapeutics and * implement new, powerful technologies to characterize brain lithium distribution and the blood molecular signature of lithium in responders and non-responders. This cutting edge approach will identify the eligibility criteria for treatment with lithium in BD in terms of response, safety and tolerability.

Conditions

• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	lithium treatment	Decisions relating to treatment are also considered the clinician's responsibility to be made according to bipolar treatment guidelines and international standards of care (e.g. discontinuation, co-prescriptions, and according to SmPC in force). After the clinician has confirmed the indication of Lithium treatment as well as the absence of contra-indicated concomintant medication (NSAIDs and Diuretics) and after pre- Lithium evaluations confirm the absence of contra-indication, Lithium is initiated following standard of care: progressive titration to reach therapeutic plasma levels. Clinicians will use the therapeutic range provided by the laboratory they use in their usual clinical practice and according to the type of Lithium they prescribe.

Timeline

• Start date: 2020-01-10
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2019-12-23
• Last updated: 2022-07-13

Locations

1 site across 1 country: France