Adult individuals with bipolar I disorders who initiate lithium treatment based on the decision of themselves and their clinician MedDRA version: 20.0 Level: PT Classification code 10057667 Term: Bipolar disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Lithium
Pharmaceutical Form:
INN or Proposed INN: Lithium
CAS Number: 554-13-2
Other descriptive name: LITHIUM CARBONATE
Concentration unit: mmol millimole(s)
Concentration type: range
Co
Sponsors
DRCI APHP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Decision to prescribe Li as a prophylactic treatment based on clinicians' assessment 2. Confirmed diagnosis of BD1 according to DSM-5 criteria [based on the Mood section of the SCID] 3. Aged 18-70 years. 4. Able and willing to give written informed consent 5. Eligible for, and consents to blood sample for the purpose of the RLiNK study 6. Covered by a Social Security Insurance where applicable Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 320 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Trial of Lithium undertaken within the last 6 months 2 Lifetime history of mood disorder better explained by a DSM-5 definition for schizoaffective disorder [based on the relevant section of the SCID] 3 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/1.73m2 - On-going Pregnancy or planned pregnancy on the next 2 years - Lactating and breast feeding women (see SmPc) - pregnant women - All contra-indications mentionned in the SmPC Lithium of the country Woman of childbearing potential, defined as not meeting at least one of the following criteria, are required to undergo a pregnancy test at least at the beginning and the end of the study: • Post-menopausal (no menses for 12 months without an alternative medical cause or FSH greater than 40 U/ml for 6 months) • Sterilization (hysterectomy, bilateral salpingectomy, bilateral tubal occlusion or bilateral oophorectomy) • Consistent and correct application of contraceptives with a failure less than 1% per year (defined as highly effective birth control method). Contraception should be used for a minimum of 4 days (5 half-lives) after last treatment dose Such methods include: o combined (estrogen an progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal) o progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable) o intrauterine device (IUD) o intrauterine hormone-releasing system (IUS) o sexual abstinence o vasectomy of the partner 4 Participation in another research protocol that interferes with the evaluation of Lithium response (efficacy or tolerance) 5 Severe risk of self-harm at present, based on clinician’s evaluation 6 Patients on Tutorship (France) Protected adult without current capacity to consent (other countries) 7 Persons under the protection of justice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to identify the eligibility criteria for treatment with Li in BDI in terms of response, safety and tolerability Primary Objective: To evaluate the predictive values of the biomarkers collected during the first three months of Lithium treatment on long term Lithium response (2 years) define according the primary outcome measures;Secondary Objective: To evaluate the prognostic values of the biomarkers collected during the first three months of Lithium treatment on long term Lithium response (2 years) define according the secondary outcome measures;Primary end point(s): After all study participants have completed the follow-up period, the expert panel will reach a consensus on the classification of each participant into one of three categories: (i) good responders (GR), (ii) partial responders (PR), (iii) non-responders (NR). If no clinical followup data are available, the participant will be categorized as unclassifiable (UC).;Timepoint(s) of evaluation of this end point: After all study participants have completed the follow-up period, the expert panel will reach a consensus on the classification of each participant into one of three categories: (i) good responders (GR), (ii) partial responders (PR), (iii) non-responders (NR). If no clinical followup data are available, the participant will be categorized as unclassifiable (UC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are several possible definitions of treatment response that employ different levels of precision. a) Response assessed retrospectively by estimating the total score b) Time dependent measures of outcome c) Continuous ratings of BD symptoms;Timepoint(s) of evaluation of this end point: The durations of the clinician-rated and self-questionnaires at each visit are detailed in Table 3 of the protocole - Definition of a Missing face to face visit: Planned appointment + 1month - Definition of a Missing telephone visit: Planned appointment + 1 week - In case of missing visit the information needed to inform the primary outcome (such as relapse, hospitalisation, suicide attempt, comorbidities…) will be collected retrospectively at the next visit. | — |
Countries
Denmark, France, Germany, Italy, Norway, Spain, Sweden, United Kingdom
Contacts
Public ContactProject Manager
DRCI APHP
Outcome results
None listed