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: Lithionit
Pharmaceutical Form: Tablet
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 0
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: 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 Protected adult
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