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

NCT ID: NCT04209140

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-10
• Study Completion Date: 2024-06-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

bipolar I disorders who initiate lithium treatment

lithium treatment

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Decision to prescribe Li as a prophylactic treatment based on clinicians' assessment
• Confirmed diagnosis of BD1 according to DSM-5 criteria
• Aged 18-70 years.
• Able and willing to give written informed consent
• consents to blood sample for the purpose of the RLiNK study
• Covered by a Social Security Insurance where applicable
• Patients on Curatorship (consent form signed by the patient and specific consent form for the curator)

Exclusion Criteria

• Trial of Lithium undertaken within the last 6 months
• Lifetime history of mood disorder better explained by a DSM-5 definition for schizoaffective disorder
• Pre-lithium screening suggest that Lithium initiation is contraindicated:
• Incompatible concurrent treatments: long-term use of non- steroidal anti-inflammatory drug or diuretics for a known and established comorbid disorder with no possible alternative treatment (i.e. absolute contra-indication to Li treatment)
• Health issues (risk of worsening of a pre-existing condition) Psoriasis, Brugada syndrome
• Renal dysfunction: Glomerular Filtration rate below 60mL/min/1.73m 2
• On-going Pregnancy or planned pregnancy on the next 2 years
• Lactating and breast feeding women (see SmPc)
• Pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Fernand Widal

Paris, , France

Countries

France

Other Identifiers

2018-002263-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P180101

Identifier Type: -

Identifier Source: org_study_id