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    Summary
    EudraCT Number:2014-002699-98
    Sponsor's Protocol Code Number:CB001-OL
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-15
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2014-002699-98
    A.3Full title of the trial
    OxLith: Exploration of the short-term physical and psychological effects of lithium in mood instability
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oxford Lithium Trial
    A.3.2Name or abbreviated title of the trial where available
    OxLith
    A.4.1Sponsor's protocol code numberCB001-OL
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN91624955
    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 SponsorUniversity of Oxford
    B.1.3.4CountryUnited Kingdom
    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 supportWellcome Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointProfessor John Geddes
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Psychiatry, Warneford Hospital
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX3 7JX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865226481
    B.5.6E-mailjohn.geddes@psych.ox.ac.uk
    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 Priadel
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis or Sanofi
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePriadel
    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 INNLithium carbonate
    D.3.9.1CAS number 554-13-2
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration numbertablet size 200mg
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bipolar disorder with current mood instability
    E.1.1.1Medical condition in easily understood language
    Mood disorder characterised by periods of abnormally high and/or low mood.
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10004908
    E.1.2Term Bipolar affective disorder
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is the evaluation of the effects of lithium on mood variability measured using weekly self-reports of manic and depressive symptoms.

    Weekly self-rating is used routinely by many patients as part of ongoing self-management of mood by people with bipolar disorder and daily ratings have been used successfully in a number of research studies.

    An understanding of the effects of lithium on mood will both inform its use and provide valuable information that will facilitate discovery of more effective and safer treatments.
    E.2.2Secondary objectives of the trial
    The secondary objectives involve the use of a range of paradigms to explore the mechanism of action of lithium treatment on:
    - cognition tasks
    - neural dynamics using magnetoencephalography (MEG) and magnetic resonance imaging (MRI)
    - activity levels during wake and sleep periods using device(s) that can be carried or worn under clothing or on a wrist
    - hormones related to circadian rhythms measured from saliva
    - gene expression from cheek swabs samples for genes known to be associated with circadian rhythms and lithium treatment
    - early markers of adverse effects particularly those associated with renal, thyroid and parathyroid function and inflammatory markers.

    Results of these assessments will provide valuable information about the mechanism of action of lithium.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Willing and able to give informed consent to participate in the trial
    • Male or female
    • Aged 18 or over
    • Meeting criteria for bipolar disorder
    • Clinical complaint of significant mood instability
    • Clinical uncertainty about the prescription of lithium
    • No clear indication for alternative treatment
    • Pre-treatment tests including renal, cardiac, thyroid and parathyroid functions acceptable for initiation of treatment with lithium
    • Willing and able to comply with all trial requirements including mood and behavioural monitoring (True Colours) and MRI and MEG scanning and blood tests (assessed by a psychiatrist).
    • Willing to allow his/ her General Practitioner and consultant, if appropriate, to be notified of his/her participation in the trial.
    E.4Principal exclusion criteria
    • Contraindication(s) to lithium (as documented in the Summary of Product Characteristics for Priadel)
    • Currently taking any psychotropic drug that cannot be withdrawn (i.e. antidepressant, antipsychotic, mood stabiliser, benzodiazepine, non-benzodiazepine sleeping tablets) including as required (prn) medication
    • Clinically significant alcohol or substance use
    • Requiring immediate treatment for an acute mood episode such that placebo would be inappropriate
    • Female and pregnant, lactating or planning a pregnancy during the course of the trial
    • Female of child-bearing potential not willing to use effective contraception
    • Participation in another research trial involving an investigational medicinal product in the past 12 weeks.
    • Judged to be at significant immediate risk of suicide/self-harm

    In addition to the above criteria:
    • Patients who have a pacemaker, non-MR-compatible metal implant, or any other contraindication for MR or MEG brain scanning will be excluded from the corresponding brain scanning element(s) of Theme 2.

    * Patients with a primary diagnosis of bipolar disorder with co-morbid anxiety or borderline personality disorder are not excluded.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be a between group comparison of mood symptoms over the randomised period. This will be measured by the True Colours system for self-rating of mood using mobile phones or online forms and by PANAS (Positive and Negative Affect Scale). The True Colours system collects weekly measures of depressive and manic symptoms on validated self-rating scales (the Quick Inventory of Depressive Symptomatology [QIDS-SR6] and the Altman Self Rating Scale for Mania [ARSM]). The PANAS will be completed daily on an iPad.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Symptoms of depression and mania will be reported weekly by participants using validated scales (Quick Inventory of Depressive Symptomatology [QIDS-SR16] and Altman Self-Rating Scale for Mania [ASRM]) throughout the 6-week randomised phase.
    E.5.2Secondary end point(s)
    Theme 2:
    Cognitive tests: 1. Cognitive assessments and measures of variability in performance across time and Mood Zoom ratings.
    Scans: Blood oxygen level dependent signal during rest and cognitive testing; induced and evoked field activity.

    Theme 3:
    Activity tracking when awake and asleep using activity monitoring device(s) and, for participants with a smartphone who agree to installation of apps, the measurement of relative location and frequency and duration of voicecalls and text messages.

    Theme 4:
    Changes in gene expression and in cortisol and melatonin levels.

    Theme 5: Changes from baseline 6-weeks in blood test results including those relevent to renal, thyroid and parathyroid function and inflammaotory markers.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Theme 2 will include cogntive tests completed at baseline and repeated at the 4-week visit and short daily tests completed on the iPad. Scans (MRI and MEG) will take place during the fourth week.

    Theme 3 activity monitor(s) will be carried throughout the trial.

    Theme 4 will involve two 32-hours periods, one pre-randomisation and the other in week 4 when participants will provide cheek swab and saliva samples every 4 hours.

    Theme 5 will involve blood tests at baseline and week 6 onlhy for all tests except lithium tests which be completed a 4- and 8-days, 4 weeks and 6 weeks after randomisation (in line with routine care for initiation of lithium).
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state40
    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)
    No special arrangements for provision of treatment are needed because the trial IMP, Priadel, and other formulations of lithium salts are available on prescription in the UK.

    For participants who were allocated lithium but want to stop or change treatment post-trial, the investigator will provide advice and a supply of lithium tablets to enable them to taper lithium gradually to reduce the risk of destabilising their mood.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-13
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