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Bipolar I DisorderR-LiNKNCT04209140

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

An observational study of Bipolar I Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Bipolar I Disorder
What is being tested?
lithium treatment
How many people
320 participants
Where
1 siteFrance
Study dates
10 Jan 2020to Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: individuals with bipolar I disorder

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • On-going Pregnancy or planned pregnancy on the next 2 years
  • Lactating and breast feeding women (see SmPc)
  • Pregnant women

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Fernand Widal

    Paris, 75010

Other trials in France

About this study

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:

Read more
  • 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.

Being tested
lithium treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lithium treatmentDrug

    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.

Study groups in NCT04209140
Study groupRoleWhat they receive
bipolar I disorders who initiate lithium treatmentNot described
Receives: Drug: lithium treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: month 24

Secondary outcomes (13)

  1. Adherence

    Adequate adherence will be defined as the individual taking at least 70% of the Li prescribed (i.e. either >70% prescribed dose \&/or >70% of the time) based on the monthly assessment of adherence

    Measured: Month 24

  2. Alda Scale

    Alda scale defined in the following article : Grof P, Duffy A, Cavazzoni P, Grof E et al. Is response to prophylactic lithium a familial trait? J Clin Psychiatry. 2002 Oct;63(10):942-7.

    Measured: Month 24

  3. Responder - sensitivity

    Good Responders= Recorded improvement of illness activity is >=70% AND no addition of mood stab after Li initiation Non Responders= Recorded improvement of illness activity is <=30% whatever the treatment has been Partial Responders = Recorded improvement of illness activity is between 70 and 30% whatever the treatment has been OR Recorded improvement of illness activity is >=70% but the addition of mood stab after Li initiation has occurred

    Measured: Month 24

  4. Time to new BD

    Time to a new Bipolar Disorder (BD) episode, defined as the delay between inclusion and the date of the diagnosis of new Bipolar disorder

    Measured: Month 24

  5. Time to BD hospitalization

    Time to a new hospitalization for BD, defined as the delay between inclusion and the date of new hospitalization for Bipolar disorder

    Measured: Month 24

  6. Time to new mood stabilizer

    Time to prescription of a new mood stabilizer, defined as the delay between inclusion and the date of prescription of a new mood stabilizer

    Measured: Month 24

  7. Monthly qIDS

    Quick Inventory of Depressive Symptoms (qIDS)

    Measured: monthly from month 1 to month 24

  8. Monthly BRMS

    Bech Rafaelson Mania Scale (BRMS)

    Measured: monthly from month 1 to month 24

  9. Monthly BPRS

    Brief Psychosis Rating Scale (BPRS)

    Measured: monthly from month 1 to month 24

  10. Monthly ISS

    Internal State Scale (ISS)

    Measured: monthly from month 1 to month 24

  11. Monthly LIFE-II

    Longitudinal Interval Follow-up Evaluation (LIFE-II)

    Measured: monthly from month 1 to month 24

  12. WHODAS

    World Health Organisation Disability Assessment Scale (WHODAS)

    Measured: Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, month 24

  13. Cost-effectiveness

    EuroQOL-5D scale

    Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2019
  2. Study start10 Jan 2020
  3. Primary completionJun 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04209140
Sponsor's protocol ID
P180101
Other IDs
2018-002263-26, 2018
Acronym
R-LiNK
Status last verified
Jul 2022
First submitted
20 Dec 2019
Last updated
13 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Bipolar I Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder (time frame: month 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04209140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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