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    Summary
    EudraCT Number:2018-002263-26
    Sponsor's Protocol Code Number:P180101
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-10
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-002263-26
    A.3Full title of the trial
    Optimizing response to Li treatment through personalized evaluation of individuals with bipolar I disorder
    OTTIMIZZAZIONE DELLA RISPOSTA AL TRATTAMENTO CON LITIO MEDIANTE VALUTAZIONE PERSONALIZZATA E MULTIMODALE DI SOGGETTI CON DISTURBO BIPOLARE DI TIPO I
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimizing response to Li treatment through personalized evaluation of individuals with bipolar I disorder
    Ottimizzazione della risposta alla terapia con Litio (Li) tramite la valutazione individualizzata dei pazienti con disturbo bipolare di tipo I
    A.3.2Name or abbreviated title of the trial where available
    R-LiNK
    R-LiNK
    A.4.1Sponsor's protocol code numberP180101
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSITANCE PUBLIQUE DES HOPITAUX DE PARIS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDRCI APHP
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDRCI APHP
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address10 avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number44841793
    B.5.5Fax number44841701
    B.5.6E-maildamien.vanhoye@aphp.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Resilient 83 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAngelini
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameResilient
    D.3.2Product code [044635011]
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLITIO
    D.3.9.2Current sponsor code044635023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number83
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Carbolithium 150 mg
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Italia
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCarbolithium
    D.3.2Product code [024597015]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLITIO CARBONATO
    D.3.9.2Current sponsor code024597015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Litio Carbonato LFM
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorio Farmacologico Milanese S. r. l
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLitio Carbonato
    D.3.2Product code [030226017]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLITIO CARBONATO
    D.3.9.2Current sponsor code030226017
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Carbolithium 300 mg
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Italia
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCarbolithium
    D.3.2Product code [024597039]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLITIO CARBONATO
    D.3.9.2Current sponsor code024597039
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAntipsicotico
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Resilient 83 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAngelini
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameResilient 83 mg
    D.3.2Product code [044635023]
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLITIO
    D.3.9.2Current sponsor code044635011
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number83
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Litio Carbonato
    D.2.1.1.2Name of the Marketing Authorisation holderNova Argentia S. P. A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLitio Carbonato
    D.3.2Product code [030543019]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLITIO CARBONATO
    D.3.9.2Current sponsor code030543019
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult individuals with bipolar I disorders who initiate lithium treatment based on the decision of themselves and their clinician
    Soggetti adulti con diagnosi accertata di disturbo bipolare di tipo I in base ai criteri DSM-5 e decisione di prescrivere il Litio come trattamento profilattico, sulla base di valutazione clinica.
    E.1.1.1Medical condition in easily understood language
    Adult individuals with bipolar I disorders who initiate lithium treatment based on the decision of themselves and their clinician
    Soggetti adulti con diagnosi di disturbo bipolare di tipo I, clinicamente accertata e decisione di prescrivere il Litio come trattamento profilattico, sulla base di valutazione clinica.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10004939
    E.1.2Term Bipolar I disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10004939
    E.1.2Term Bipolar I disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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
    Obiettivo dello studio è l’identificazione dei criteri di ammissibilità al trattamento con Litio dei pazienti con disturbo bipolare di tipo 1 (BD1), in termini risposta, sicurezza e tollerabilità.
    Obiettivo Primario: valutazione del valore prognostico dei biomarkers raccolti nei primi 3 mesi di terapia con Litio rispetto alla efficacia a lungo termine (2 anni) del farmaco, valutata secondo gli indici primari di risposta.
    E.2.2Secondary 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
    Obiettivi Secondari: valutazione del valore prognostico dei biomarkers raccolti durante i primi 3 mesi di terapia con Litio rispetto alla risposta a lungo termine al farmaco (2 anni) definita secondo le misure di outcome secondario
    E.2.3Trial contains a sub-study No
    E.3Principal 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. Decisione di prescrivere il Litio come trattamento profilattico, sulla base di valutazione clinica
    2. Diagnosi di BD1 accertata in base ai criteri DSM-5 (in particolare sulla sezione “Mood” [umore] del SCID)
    3. Età compresa tra i 18 e i 70 anni
    4. Le persone reclutate sono in grado e manifestano precisa volontà di esprimere, per scritto, il loro consenso informato
    5. Idonei e consenzienti ai prelievi di campioni di sangue per lo studio R-Link
    6. Coperti dall’assicurazione sociale, se applicabile
    E.4Principal 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
    1 Trial di terapia con Litio eseguiti entro gli ultimi 6 mesi
    2 Anamnesi positive per alterazioni dell’umore meglio spiegate dalla presenza di disturbi schizo-affettivo (secondo la definizione DSM-5) [sezione SCID]
    3 Lo screening precedente il reclutamento indica che la somministrazione di Litio è controindicata:
    4 Participazione ad altro protocollo di ricerca che possa interferire con la valutazione della risposta al Litio (efficacia e tollerabilità)
    5 Grave rischio attuale di autolesionismo, in base a valutazione del medico
    6 Adulti incapaci (incapaci di autoprotezione)
    E.5 End points
    E.5.1Primary 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).
    Endpoint Primario: alla fine del periodo di follow-up, il panel di esperti coinvolti stileranno un consenso relativo all’ assegnazione di ciascun partecipante a una delle 3 categorie: (i) good responders (GR), (ii) partial responders (PR), non-responders (NR). I partecipanti privi di follow-up clinico, saranno considerati “non classificabili” (UC).
    E.5.1.1Timepoint(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).
    Alla fine del periodo di follow-up, il panel di esperti coinvolti stileranno un consenso relativo all’ assegnazione di ciascun partecipante a una delle 3 categorie: (i) good responders (GR), (ii) partial responders (PR), non-responders (NR). I partecipanti privi di follow-up clinico, saranno considerati “non classificabili” (UC).
    E.5.2Secondary 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
    Le possibili definizioni di risposta al trattamento sono molteplici e comportano differenti livelli di accuratezza.
    a) Valutazione retrospettiva della risposta al trattamento tramite il punteggio totale delle scale di valutazione.
    b) Valutazione della risposta della malattia nel tempo
    c) Valutazione continua dei sintomi di disturbo bipolare di tipo I
    E.5.2.1Timepoint(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.
    I tempi di rilevazione delle scale di valutazione da parte del clinico e dei questionari di autovalutazione effettuati ad ogni visita è riportata nella Tabella 3 del protocollo.
    - Definizione di mancata visita al centro : appuntamento pianificato + 1 mese
    - Definizione di mancata visita telefonica: appuntamento pianificato + 1 mese
    - In caso di mancata visita, le informazioni mancanti necessarie per l'endpoint primario (quali insorgenza di recidive, ospedalizzazione, tentato suicidio, patologie concomitanti...) saranno raccolte retrospettivamente alla visita successiva.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Denmark
    France
    Germany
    Italy
    Norway
    Spain
    Sweden
    United Kingdom
    E.8.7Trial 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
    Participants may exit the study at any time and for any reason. The clinician and the investigator can decide the discontinuation based on the withdrawal of the consent, the compliance to the study (missing visits) and safety issues.
    In case of consent withdrawal, the data already collected will be used for the analyses unless the participant asks for the destruction of these data. These participants will remain in the study (intent to treat analyses) and will be analysed.
    I pazienti possono lasciare lo studio per qualsiasi ragione. I clinici e lo sperimentatore possono interrompere lo studio in base: al ritiro del consenso da parte del paziente, all'aderenza al protocollo e a problemi di sicurezza. In caso di ritiro del consenso, i dati raccolti potranno essere utilizzati per le analisi, a meno che il paziente non richieda la loro distruzione. Le analisi dei pazienti che rimangono nello studio saranno effettuate mediante la valutazione "intent to treat".
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 320
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of the study, all patients will be followed on the basis of normal clinical practice.
    Al termine dello studio, tutti i pazienti saranno seguiti come da normale pratica clinica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-05
    P. End of Trial
    P.End of Trial StatusOngoing
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