E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult individuals with bipolar I disorders who initiate lithium treatment based on the decision of themselves and their clinician |
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E.1.1.1 | Medical condition in easily understood language |
Adult individuals with bipolar I disorders who initiate lithium treatment based on the decision of themselves and their clinician |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057667 |
E.1.2 | Term | Bipolar disorder |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 without current capacity to consent 7 Persons under the protection of justice |
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E.5 End points |
E.5.1 | 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). |
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E.5.1.1 | 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). |
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E.5.2 | Secondary end point(s) |
There are several possible definitions of treatment response that employ different levels of precision. a) Response assessed retrospectively at M24 b) Time dependent measures of outcome c) Continuous ratings of BD symptoms |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The timepoints and durations of the clinician-rated and self-questionnaires at each visit are detailed in Table 3 of the protocol.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 48 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 48 |