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

NCT04209140 | Unknown DMC

• 2 other identifiers: P1801012018-002263-26
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Responder

  Good Responder The individual meets criteria for sustained remission, namely they experience euthymia (defined as a score on the Quick Inventory of Depressive Symptoms (qIDS)\<6 and the Bech Rafaelson Mania Scale (BRMS)\<7) for at least 8 weeks during the two-year follow-up period without evidence of relapse into a syndromal episode of BD at any time after achieving sustained euthymia. AND No addition of a new mood stabilizer with the purpose of promoting mood stabilisation after lithium initiation Non Responder The individual: Fails to meet criteria for sustained remission (euthymia defined as a score on the qIDS\<6 and the BRMS\<7 for a minimum period \>=8 consecutive weeks) during the two-year follow-up. OR Experiences \>=1 relapse into a syndromal episode of BD of any polarity during the two-year follow-up period without any period of sustained remission Definition of a Partial Responder All cases not fulfilling the criteria of Good Responders or Non Responders

  month 24

Secondary Outcomes (13)

• Adherence

  Month 24

• Alda Scale

  Month 24

• Responder - sensitivity

  Month 24

• Time to new BD

  Month 24

• Time to BD hospitalization

  Month 24

Study Arms (1)

bipolar I disorders who initiate lithium treatment

Drug: lithium treatment

Interventions

lithium treatment 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.

bipolar I disorders who initiate lithium treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

individuals with bipolar I disorder

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Fernand Widal

Paris, 75010, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 23, 2019
• Study Start: January 10, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

FR (1)