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    Summary
    EudraCT Number:2018-002263-26
    Sponsor's Protocol Code Number:P180101
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-06
    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 ConcernedNorway - NOMA
    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
    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
    A.3.2Name or abbreviated title of the trial where available
    RLINK
    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 SponsorDRCI APHP
    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 numberFranc144841793
    B.5.5Fax numberFranc144841701
    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 Lithionit
    D.2.1.1.2Name of the Marketing Authorisation holderBioPhausia
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    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
    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 10057667
    E.1.2Term Bipolar 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
    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
    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
    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
    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).
    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).
    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
    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.
    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 Yes
    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.8.3 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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    Last follow-up visit of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    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)
    None
    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 Decision2019-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-06
    P. End of Trial
    P.End of Trial StatusOngoing
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