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    Summary
    EudraCT Number:2013-000970-31
    Sponsor's Protocol Code Number:TUD-ASLith-057
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-10-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-000970-31
    A.3Full title of the trial
    Randomized, placebo-controlled multicenter trial of lithium plus treatment as
    usual (TAU) for acute suicidal ideation and behaviour in patients with suicidal
    major depressive episode
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, placebo-controlled multicenter trial of lithium plus treatment as
    usual (TAU) for acute suicidal ideation and behaviour in patients with suicidal
    major depressive episode
    A.3.2Name or abbreviated title of the trial where available
    Lithium
    A.4.1Sponsor's protocol code numberTUD-ASLith-057
    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 SponsorTechnische Universität Dresden
    B.1.3.4CountryGermany
    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 supportBundesministerium für Bildung und Forschung
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportAmerican Suicide Foundation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTechnische Universität Dresden
    B.5.2Functional name of contact pointDepartment of Psychiatry and Psycho
    B.5.3 Address:
    B.5.3.1Street AddressFetscherstr. 74
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number00493514582772
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Quilonum retard
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Smith Kline GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule
    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.3.9.1CAS number 554-13-2
    D.3.9.3Other descriptive nameLITHIUM CARBONATE
    D.3.9.4EV Substance CodeSUB14375MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number295
    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 placeboCapsule
    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
    Diagnosis of a major depressive episode; inpatient at screening visit; suicidal
    ideation/behaviour present defined by a clinical rating of ≥ 8 on the Sheehan
    Suicidality Tracking Scale (S-STS) at screening and a rating of ≥20 on the Montgomery
    Asberg Depression Scale (MADRS) at both screening and baseline visits; both
    gender, age ≥18 years.
    E.1.1.1Medical condition in easily understood language
    patients who are severely depressive and have suicidal ideation or behaviour
    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 10012397
    E.1.2Term Depression suicidal
    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 primary hypothesis of this confirmatory study is that lithium therapy will
    acutely decrease suicidal ideation and/or suicidal behaviour in inpatients with a
    major depressive episode (MDE, unipolar and bipolar disorder according to DSM
    IV criteria). The specific aim is to test the hypothesis that lithium plus treatment
    as usual (TAU), compared to placebo plus TAU, results in a significantly greater
    decrease in suicidal ideation and/or behaviour over 5 weeks in inpatients with
    MDE.
    E.2.2Secondary objectives of the trial
    The secondary aim is to observe the influence of the early lithium therapy on other psychometric scales and scores
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of a major depressive episode; inpatient at screening visit; suicidal
    ideation/behaviour present defined by a clinical rating of ≥ 8 on the Sheehan
    Suicidality Tracking Scale (S-STS) at screening visit and a rating of ≥20 on the Montgomery
    Asberg Depression Scale (MADRS) at both screening and baseline visits; both
    gender, age ≥ 18 years.
    E.4Principal exclusion criteria
    Contraindication for and history of lithium treatment within the past 6 months;
    patient unable to tolerate lithium treatment in the past; comorbid
    borderline/antisocial personality disorder, currently active substance
    dependency; patients with acute or unstable severe medical conditions, patients
    unable to understand the informed consent or involuntary inpatients, drug dependence (according to ICD10 or DSMIV and positive Diagnose in MINI), pregnancy and lactation
    E.5 End points
    E.5.1Primary end point(s)
    Change in the clinician administered (S-STS) total score between initial and final
    visit
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 35 after baseline (first intake)
    E.5.2Secondary end point(s)
    Change in the Columbia Suicide Severity Rating Scale (C-SSRS) total score between initial and final visit; MADRS response
    rate (percent with ≥ 50% decrease from initial to final visit); remission rate
    (MADRS of 12 or less) at final visit; change in MADRS, Hamilton Anxiety Scale (HAM-A),
    Clinical Global Impression (CGI) and Barratt Impulsivity Scale (BIS) total score
    between initial and final visit; weekly change in percent days with 0 score on SSTS
    compared to initial visit; weekly change in C-SSRS, MADRS, HAM-A score, YMRS compared to initial visit; association between weekly change in MADRS; HAMA-A
    total score and weekly change in SIS; comparison of the initial SIS, MADRS
    and HAM-A total scores at the six sites; number and dose of concomitant
    psychotropic medication; hours of psychotherapy patients receive.
    E.5.2.1Timepoint(s) of evaluation of this end point
    weekly from week 1 to 5
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 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 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 concerned6
    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 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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 Yes
    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 state254
    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)
    normal treatment
    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 Decision2013-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-04-01
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