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

Assistance Publique - Hôpitaux de Paris

Status: Active, not recruiting

Conditions: Bipolar I Disorder

Treatments: Drug: lithium treatment

Study type: Observational

Funder types: Other

Identifiers

NCT04209140

2018-002263-26 (EudraCT Number)

P180101

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

320 participants in 1 patient group

bipolar I disorders who initiate lithium treatment

Treatment:

Drug: lithium treatment