Clinical trial NCT04209140: Optimizing Response to Li Treatment Through Personalized Evaluation of Individuals With Bipolar I Disorder: The R-LiNK Initiative
Official title: Optimizing Response to Li Treatment Through Personalized Evaluation of Individuals With Bipolar I Disorder: The R-LiNK Initiative
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar I Disorder
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: individuals with bipolar I disorder

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.


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

Primary outcomes:
measure: Responder
timeFrame: month 24
Secondary outcomes:
measure: Adherence
timeFrame: Month 24
measure: Alda Scale
timeFrame: Month 24
measure: Responder - sensitivity
timeFrame: Month 24
measure: Time to new BD
timeFrame: Month 24
measure: Time to BD hospitalization
timeFrame: Month 24
measure: Time to new mood stabilizer
timeFrame: Month 24
measure: Monthly qIDS
timeFrame: monthly from month 1 to month 24
measure: Monthly BRMS
timeFrame: monthly from month 1 to month 24
measure: Monthly BPRS
timeFrame: monthly from month 1 to month 24
measure: Monthly ISS
timeFrame: monthly from month 1 to month 24
measure: Monthly LIFE-II
timeFrame: monthly from month 1 to month 24
measure: WHODAS
timeFrame: Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, month 24
measure: Cost-effectiveness
timeFrame: Month 24
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fernand Widal
Study officials:
References: