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    Summary
    EudraCT Number:2012-000778-46
    Sponsor's Protocol Code Number:LiBiDi-EK314/11
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-07-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-000778-46
    A.3Full title of the trial
    Elucidation of Lithium Working Mechanism in Bipolar Disorder by means of Multi Modal Brain Imaging (LiBiDi)
    Erforschung des Lithiumwirkmechanismus bei bipolaren Störungen mit multi-modaler Bildgebung des Gehirns
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the drug Lithium with Brain Imaging in people with Bipolar Disorder
    Bildgebung des Gehirns zur Erforschung des Medikaments Lithium bei manisch-depressiven Menschen
    A.3.2Name or abbreviated title of the trial where available
    LiBiDi
    LiBiDi
    A.4.1Sponsor's protocol code numberLiBiDi-EK314/11
    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 SponsorForschungszentrum Jülich GmbH
    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 supportForschungszentrum Jülich GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationForschungszentrum Jülich GmbH
    B.5.2Functional name of contact pointProf. Dr. N. J. Shah
    B.5.3 Address:
    B.5.3.1Street AddressWilhelm-Johnen-Straße
    B.5.3.2Town/ cityJülich
    B.5.3.3Post code52428
    B.5.3.4CountryGermany
    B.5.4Telephone number+492461616836
    B.5.5Fax number+492461611919
    B.5.6E-mailn.j.shah@fz-juelich.de
    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 Quilonum retard 450 mg Retard Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Smith Kline GmbH & Co. KG
    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 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.3.9.3Other 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 number450
    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
    Healthy volunteers
    Bipolar patients type 1
    Gesunde Probanden
    Bipolare Patienten Typ 1
    E.1.1.1Medical condition in easily understood language
    Bipolar disorders belong to the category of mood disorders characterized by maniac and depressive episodes
    Bipolare Störungen gehören zu der Kategorie der affektiven Störungen und sind charakterisiert durch manische und depressive Episoden
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10043890
    E.1.2Term Tiredness
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10028821
    E.1.2Term Nausea with vomiting
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10013575
    E.1.2Term Dizziness and giddiness
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10051385
    E.1.2Term Drug-induced headache
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10021689
    E.1.2Term Increased thirst
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036164
    E.1.2Term Poor weight gain
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10044577
    E.1.2Term Tremor of hands
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10027176
    E.1.2Term Memory loss
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    A powerful tool in the treatment of bipolar disorder is lithium. On a molecular level modulation of the protein kinase B and glycogen synthase kinase 3 signalling pathway by various G-protein coupled receptors has been discussed. Dopamine and serotonine receptors play a major role. In humans these two transmitter systems are accessible via PET. Emotional and cognitive functions can non-invasively be explored by fMRI. With MR-spectroscopy at ultra-high field lithium in the brain becomes quantitatively assessable. Imaging at ultra-high fields also opens up avenues for advanced sodium imaging. One hypothesis about the efficacy of lithium states that it balances the intracellular sodium concentration. A multimodal imaging approach is required to elucidate lithium working mechanisms. Our bilateral project aims to elucidate the pathophysiology of lithium in 40 healthy volun-teers (20m/20f) and 40 euthymic bipolar patients type 1 (20m/20f, 2 groups: monotherapy with lithium / lithium naive).
    Eine sehr effiziente Behandlung bipolarer Störungen stellt die Medikation mit Lithium dar. Signale von D2-Rezeptoren, Serotoninrezeptoren und anderen G-Protein-gekoppelten Rezeptoren spielen eine wichtige Rolle im Lithium vermittelten Signalweg. Bei Menschen sind diese Transmittersysteme über PET spezifisch untersuchbar. Emotionale und kognitive Funktionen können nicht-invasiv durch fMRT untersucht werden. Mit dem Beginn der Ultra-Hochfeld-Bildgebung wird es möglich, die Lithium-Konzentration mittels Spektroskopie zu messen. Es eröffnen sich neue Perspektiven für die Natriumbildgebung. Eine Hypothese über die Effektivität von Lithium lautet, dass Lithium die intrazelluläre Sodiumkonzentration steuert. Auf diesen Grundlagen basiert der multimodale Untersuchungsansatz dieses Projektes. Unser bilaterales Projekt untersucht die Wirkweise von Lithium in 40 gesunden Probanden (20m/20w) und euthymen Patienten mit Bipolarer Störung Typ 1 (20m/20w, Monotherapie mit Lithium vs. Lithium naiv).
    E.2.2Secondary objectives of the trial
    not applicable
    nicht zutreffend
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For all volunteers:
    blood examinations (normal level)
    thyroidal parameters (normal level)
    ECG (normal level)
    negative drug screening in urine (Benzodiazepine, Opiate, Amphetamine, Cannabis)
    no nephrological or thyroidal diseases in the medical history
    no metal in the human body
    no tattoos
    no retainer
    Age between 18 and 60 years
    body weight > 50 kg

    For women:
    pregnancy test negative

    For bipolar patients with Lithium rehabilitation:
    Diagnosis bipolar disorder type 1 referred to DSM-IVR criteria
    euthymic condition
    monotherapy with Lithium
    Lithium therapy at least for 12 months (familiar preparation, no change to another preparation)

    For bipolar patients - Lithium naive:
    Diagnosis bipolar disorder type 1 referred to DSM-IVR criteria
    euthymic condition
    no Lithium medication in the past
    no other medication for the mood treatment

    For healthy volunteers:
    no first degree relatives with psychiatric diseases in the past
    no psychiatric or neurological diseases in the past
    Für alle Studienteilnehmer:
    Blutuntersuchung im Normalbereich
    Normalbefund des EKG
    negatives Ergebnis des Drogentests im Urin (auf Benzodiazepine, Opiate, Amphetamine, Cannabis)
    keine Nieren- oder Schilddrüsenerkrankungen in der Anamnese
    kein Metall im Körper
    keine Tätowierungen
    keine Zahnspangen
    Alter zwischen 18 und 60 Jahren
    Körpergewicht > 50 kg

    Bei Frauen:
    negativer Schwangerschaftstest

    Für bipolare Patienten unter Lithium-Therapie:
    Diagnose einer bipolaren Störung Typ 1 gemäß DSM-IVR-Kriterien
    Euthymer Zustand
    Lithium als psychiatrische Monotherapie
    Lithiumtherapie seit mindestens 12 Monaten ( Patienten nehmen ihr gewohntes Präparat weiter, es erfolgt keine Umstellung auf ein anderes Präparat.)

    Für bipolare Paienten - Lithium naiv:
    Diagnose einer bipolaren Störung Typ 1 gemäß DSM-IVR-Kriterien
    Euthymer Zustand
    keine Lithium-Therapie in der Vorgeschichte
    keine anderen Medikamente zur Behandlung der Stimmungslage

    Für gesunde Versuchspersonen:
    keine Verwandten ersten Grades mit psychiatrischen Erkrankungen in der Vorgeschichte
    keine psychiatrischen oder neurologischen Erkrankungen in der Vorgeschichte
    E.4Principal exclusion criteria
    - Volunteers and patients, who are not in the suitable condition for the informed consent
    - pregnancy
    - volunteers and patients before they have reached the majority age
    - persons with an exposure dose to 20 mSv during the last year
    - persons with an exposure dose to 400 mSv during the whole life
    - bipolar patients with psychiatric comorbidity like dependence, personality disorder or psychotic symptoms
    - persons, who were in a static magnetic field of 9,4T longer than 24 hours during the last year
    magnetic metal implants, contraceptive coil, tattoos
    - Versuchspersonen und Patienten, die nicht in einer geeigneten Verfassung für eine informierte Einwilligung sind
    - Schwangerschaft
    - Versuchspersonen und Patienten vor Vollendung des 18. Lebensjahres
    - Personen, die zuvor einer Strahlenbelastung bis 20 mSv im Laufe des letzten Jahres oder bis 400 mSv im Laufe ihres Lebens ausgesetzt waren
    - bei bipolaren Patienten eine psychiatrische Komorbidität wie Sucht, Persönlichkeitsstörungen oder psychotische Symptome
    - Personen, die im Laufe der letzten 12 Monate insgesamt länger als 24 Stundne einem statischen Magnetfeld ausgesetzt waren
    - Magnetische Metallimplantate, intrauterine Spirale, Tätowierungen
    E.5 End points
    E.5.1Primary end point(s)
    Healthy volunteers:
    Multi modal imaging results before and after Lithium

    Patient group 1 bipolar on Lithium:
    Multi modal results during Lithium therapy

    Patient group 2 bipolar without Lithium:
    Multi modal imaging results without Lithium therapy
    multimodale Bildgebung vor und nach Lithiumgabe

    Patientengruppe 1 bipolar unter Lithiumtherapie:
    Multimodale Bildgebung während Lithiumtherapie

    Patientenpruppe 2 bipolar - kein Lithium:
    Multimodale Bildgebung ohne Lithiumgabe
    E.5.1.1Timepoint(s) of evaluation of this end point
    Healthy volunteers:
    before intake of Lithium and after 10 days intake of Lithium

    Patient group1 on medication with lithium:
    at inclusion

    Patient group 2 without Lithium:
    at inclusion
    Gesunde Probanden:
    vor Lithiumgabe und nach 10 Tagen Lithiumgabe

    Patientengruppe 1 unter Lithiumtherapie:
    bei Einschluss

    Patientengruppe 2 ohne Lithiumtherapie:
    bei Einschluss
    E.5.2Secondary end point(s)
    no
    nein
    E.5.2.1Timepoint(s) of evaluation of this end point
    no
    nein
    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 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 Yes
    E.6.13.1Other scope of the trial description
    This proposal will improve our understanding of lithium working mechanisms in healthy subjects and in patients with bipolar disorder:
    PET: information on the molecular level
    high-resolution MRI and DTI: structural brain changes
    sodium MRI and lithium spectroscopy: intra- and extracellular changes, differences in the lithium distribution
    fMRI: task-specific brain activation
    MR-PET: cognitive and emotional processes simultaneously while characterizing associated molecular mechanisms
    Dieser Antrag möchte unser Verständnis des Lithiumwirkmechanismus in gesunden Probanden und Patienten mit bipolaren Störungen verbessern:
    PET: Informationen auf molekularer Ebene
    hochauflösendes MRI und DTI: strukturelle Hirnveränderungen
    Na-MRI und Li-Spektroskopie: intra- und extrazelluläre Veränderungen, Unterschiede in der Lithiumverteilung
    fMRI: Aufgabenabhängige Hirnaktivierung
    MR-PET: kognitive und emotionale Prozesse parallel zur Erfassung der dazu gehörenden molekularen Mechanismen
    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 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 Yes
    E.8.2.3.1Comparator description
    Gesunde Kontrollen vor und nach Lithiumtherape, bipolare Patienten unter vs. ohne Lithiumtherapie
    Healthy controls before and after Lithium therapy, bipolar patients on vs. without Lithium therapy
    E.8.2.4Number of treatment arms in the trial4
    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.8.5The 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
    Teilnahme des letzten Teilnehmers
    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 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: 80
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-07-18. Yes
    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 state80
    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 their studies the bipolar patients continue prior medication with Lithium and stay with their familiar medical doctor.
    The healthy volunteers deduct Lithium after 10 day and don't stay any longer under monitoring.
    Bipolare Patienten unter Lithiumtherapie nehmen nach Abschluss der Untersuchungen ihr gewohntes Lithiumpräparat weiter und bleiben bei ihrem behandelnden Arzt.
    Die gesunden Probanden schleichen das Lithiumpräparat nach 10 Tagen aus und bleiben nicht weiter unter Beobachtung.
    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 Decision2012-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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