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 |
Individuos adultos con trastorno bipolar I que han iniciado tratamiento con litio según decisión conjunta del propio paciente y del clínico |
|
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 |
Individuos adultos con trastorno bipolar I que han iniciado tratamiento con litio según decisión conjunta del propio paciente y del clínico |
|
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 | 20.0 |
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 |
|
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 |
Evaluar el valor pronóstico de los biomarcadores recogidos durante los tres primeros meses de tratamiento con litio en la respuesta a largo plazo (2 años). La variable respuesta se define según las variables de medida principales |
|
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 |
Evaluar el valor pronóstico de los biomarcadores recogidos durante los tres primeros meses de tratamiento con litio en la respuesta a largo plazo (2 años). La variable respuesta se define según las variables de medida secundarias |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Substudy of actimetry module |
Subestudio de actimetria |
|
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 |
1. Decisión de prescribir litio como tratamiento profiláctico en base a criterio clínico. 2. Diagnóstico confirmado de TB I en base a los criterios del DSM-5. [basado en la sección de estado de ánimo de la SCID] 3. Edad entre 18 y 70 años. 4. Capaz y dispuesto a dar su consentimiento informado por escrito. 5. Que consienta realizar extracción de sangre para el estudio R-Link. |
|
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 Persons under the protection of justice |
1. Participación en un ensayo clínico con litio en los últimos 6 meses. 2. Historia de enfermedad del estado de ánimo que se ajusta mejor a la definición de trastorno esquizoafectivo de la DSM-5 [basado en la sección relevante de la SCID] 3. Cribado pre-litio que sugiere que el tratamiento con litio está contraindicado 4. Participación en otro protocolo de investigación que interfiera con la evaluación de la respuesta de litio (eficacia o tolerancia). 5. Riesgo grave de autolesión en la actualidad, según la evaluación del médico. 6. Pacientes bajo tutela judicial. |
|
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). |
Una vez que todos los participantes hayan completado el periodo de seguimiento, un equipo de expertos llegará a un consenso en la clasificación de cada participante en una de las tres siguientes categorías: (i) buen respondedor (BR), (ii) respondedor parcial (RP), (iii) no respondedor (NR). Si no se obtiene información de seguimiento será clasificado como inclasificable (IC). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
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 by estimating the total score b) Time dependent measures of outcome c) Continuous ratings of BD symptoms |
Existen múltiples definiciones de respuesta al tratamiento con diferentes niveles de precisión: a) Respuesta evaluada retrospectivamente mediante la estimación de la puntuación total en The Retrospective Longitudinal Evaluation of Lithiu, también conocida como Escala "Alda" Se compara el curso de la enfermedad durante los dos años pre/post inicio del litio. b) Medidas de resultado dependientes del tiempo c) Calificaciones de los síntomas de TB |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | Yes |
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
|
LVLS |
Última visita último paciente |
|
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 | 36 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 36 |