Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-003279-41
    Sponsor's Protocol Code Number:PSY-NIL-0013
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-02
    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 ConcernedAustria - BASG
    A.2EudraCT number2022-003279-41
    A.3Full title of the trial
    Investigating N-methyl-d-aspartate (NMDA) receptor alterations in major depressive disorder by brain PET
    Untersuchung von N-methyl-d-aspartat (NMDA) Rezeptor Änderungen in Major Depression (MDD) mittels Positronenemissionstomographie des Gehirns
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigating the neuroreceptor NMDA in the brain of healthy and depressed people
    Untersuchung des Neurorezeptors NMDA im Gehirn gesunder und depressiver Personen
    A.3.2Name or abbreviated title of the trial where available
    NMDA receptor alterations depressed healthy
    A.4.1Sponsor's protocol code numberPSY-NIL-0013
    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 SponsorMedical University of Vienna, University Department of Psychiatry and Psychotherapy
    B.1.3.4CountryAustria
    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 supportMedical University of Vienna, University Department of Psychiatry and Psychotherapy
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Vienna, University Department of Psychiatry and Psychotherapy
    B.5.2Functional name of contact pointNEUROIMAGING LABS
    B.5.3 Address:
    B.5.3.1Street AddressSpitalgass 23
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+4314040035760
    B.5.6E-mailrupert.lanzenberger@meduniwien.ac.at
    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 Cipralex® 10 mg - Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderLundbeck Austria GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEscitalopram
    D.3.9.3Other descriptive nameEscitalopram oxalate
    D.3.9.4EV Substance CodeSUB16426MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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, hard
    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
    Major Depression
    Depressive Episode
    E.1.1.1Medical condition in easily understood language
    Depression, a disease characterized by lowering of mood, reduction of
    energy, and decrease in activity. Capacity for enjoyment, interest, and
    concentration is reduced.
    Depression. Betroffene Patienten unter einer gedrückten Stimmung und
    einer Verminderung von Antrieb und Aktivität. Die Fähigkeit zu Freude,
    das Interesse und die Konzentration sind vermindert.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess alterations in (R)-11C-Me-NB1 NMDA receptor binding in predefined brain regions in unmedicated patients with MDD compared to healthy volunteers
    • To analyze potential treatment effects of an antidepressant (escitalopram) and psychotherapy on GluN2B-containing NMDA receptors in patients with MDD in a longitudinal, double-blind, randomized, placebo-controlled design
    • Die Untersuchung von Änderungen der (R)-11C-Me-NB1 NMDA Rezeptor Bindung in a priori definierten Gehirnregionen in unmedizierten depressiven Patient:innen im Vergleich zu gesunden Proband:innen.
    • Die Untersuchung potentieller Behandlungseffekte eines Antidepressivums (Escitalopram) und Psychotherapie auf die GluN2B-haltigen NMDA Rezeptoren in depressiven Patient:innen in einem longitudinalen, doppel-blinden, randomisierten, Placebo-kontrollierten Design.
    E.2.2Secondary objectives of the trial
    To test associations between treatment changes (as measured by psychiatric tests) and (R)-11C-Me-NB1 NMDA receptor binding
    Die Untersuchung der Assoziation von Behandlungseffekten (gemessen durch psychiatrische Tests) und (R)-11C-Me-NB1 NMDA Rezeporbindung.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General
    • General health based on medical history, physical examination and vital signs at screening.
    • Male and female subjects, age 18 to 55 years
    • Willingness and competence to sign the informed consent form
    • Right‐handedness
    • Non-smoker (less than 5 cigarettes per week)
    • Body weight 50-100 kg (BMI 19-26)
    Depressed Patients
    • DSM-V diagnosis of MDD following SCID I, HDRS29, MADRS and BDI
    Healthy subjects
    • Mental health based on history and initial screening (HDRS ≤ 8, MADRS ≤ 6 and BDI < 13)
    Allgemein:
    • Zufriedenstellende allgemeine Gesundheit, wie durch Anamnese, körperliche Untersuchung und Vitalfunktion beim Screening festgestellt
    • Männliche und weibliche Proband:innen im Alter zwischen 18 und 55 Jahren
    • Die schriftliche Einverständniserklärung wird vor Beginn der Teilnahme eingeholt. Daher ist die Bereitschaft und die Kompetenz zur Unterzeichnung des Einverständniserklärungsformulars erforderlich.
    • Rechtshändigkeit
    • Nicht-Raucher:innen (weniger als 5 Zigaretten pro Woche)
    • Körpergewicht zwischen 50-100 kg (BMI 19-26)
    MDD Patient:innen
    • DSM-IV Diagnose von MDD nach SCID I, HDRS29, MADRS und BDI
    Gesunde Proband:innen
    • Keine psychiatrische Diagnose in der Vergangenheit. HDRS29 ≤ 8, MADRS ≤ 6 and BDI-II < 13
    E.4Principal exclusion criteria
    • Current or history of psychiatric or neurological disease (other than MDD)
    • Current medical illness requiring treatment (other than MDD)
    • Current or former psychopharmacological treatment within the last 6 months
    • Previous escitalopram intake
    • Hypersensitivity to escitalopram
    • Acute suicidality
    • Pregnancy or currently breastfeeding
    • Current or former substance or alcohol abuse
    • Any contraindication for MRI e.g. (implants, stainless steel graft, claustrophobia)
    • Failure to comply with the study protocol or to follow the instruction of the investigating team
    • Summed radiation exposure in this study and the past 10 years exceeds 30 mSv (limit for 10 years acc. to Austrian Radiation Protection Law “Med. Strahlenschutzverordnung 2020, §25 (3)”
    • Depressive Patient:innen: Vorhandensein einer schweren / instabilen neurologischen, somatischen oder psychiatrischen Komorbidität
    • Gesunde Kontrollen: Jede psychische Erkrankung oder jede schwere / instabile neurologische oder somatische Erkrankung
    • Vorhandensein von psychotischen Symptomen
    • Akute Suizidalität
    • Gegenanzeigen für Magnetresonanz- oder PET-Bildgebung (z.B. Vorhandensein von Metallimplantaten im Kopf)
    • Vorgeschichte einer klinisch signifikanten Arzneimittelallergie; Vorgeschichte einer atopischen Allergie (Asthma, Urtikaria, ekzematöse Dermatitis). Eine bekannte Überempfindlichkeit gegen eines der Studienmedikamente (bekannte Überempfindlichkeit gegen Escitalopram)
    • Andere klinisch signifikante Anomalien bei körperlichen, neurologischen oder Laboruntersuchungen oder am Elektrokardiogramm (EKG), das nach Ansicht des:r Prüfärzt:in den:die Patient:in ausschließt
    • Einnahme von Antidepressiva oder anderen Psychopharmaka in den letzten 6 Monaten
    • Frühere Einnahme von Escitalopram
    • Bereits erfolgte Therapieversuche mit DBS, Elektrokrampftherapie (ECT), transkranieller Magnetstimulation (TMS) oder Ketamin
    • Gegenwärtiges Rauchen, ggw. Drogenmissbrauch einschließlich Alkohol, Drogenmissbrauch oder Missbrauch eines Medikaments in einer Weise, die auf substanzbezogene Störungen (z. B. Substanzabhängigkeit) gemäß DSM-V hinweist
    • Nichtbeachtung des Studienprotokolls oder Nicht-Befolgung der Anweisungen der Prüfer:innen
    • Positiver Urin-Schwangerschaftstest
    • Bekannte Schwangerschaft oder Stillzeit
    • MRT-Scan, der Hinweise auf Schlaganfall, Infarkt oder andere raumgreifende Läsionen oder Strukturen zeigt
    • Missbrauch von Drogen oder Alkohol in der Vorgeschichte
    • Teilnahme an einer klinischen Untersuchung innerhalb von 12 Wochen vor Einschluss
    • Auffälliger Allen-Test: Hinweise auf unvollständige Kommunikation zwischen der Arteria radialis und der Arteria ulnaris in der rechten oder der linken Hand
    • Kumulierte Strahlenexposition im Rahmen der Teilnahme an PET, SPECT oder CT-Studien in den letzten 10 Jahren von > 30 mSv.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in GluN2B-containing NMDA receptor binding (PET)
    Änderungen in der GluN2B-haltigen NMDA Rezeptor Bindung (PET)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data analysis will be performed 42 days (+/- 2 days) after study participation
    Die Datenanalyse soll nach 42 Tagen (+/- 2 Tage) der Studienteilnahme begonnen werden.
    E.5.2Secondary end point(s)
    Associated changes in HDRS ≤ 8, MADRS ≤ 6 and BDI < 13 or ≥ 50 % reduction
    Unterschiede in HDRS≤ 8, MADRS ≤ 6 and BDI < 13 oder ≥ 50 % Reduktion
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data analysis will be performed 42 days (+/- 2 days) after study participation
    Die Datenanalyse soll nach 42 Tagen (+/- 2 Tage) der Studienteilnahme begonnen werden.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Längsschnittsstudie
    Longitudinal
    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.8.5The 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
    LVLS
    Letzte Visite der letzten teilnehmenden Person
    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
    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: 60
    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 2023-02-02. 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 state60
    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)
    Persons with MDD who require further treatment by a psychiatrist beyond the participation are referred to appropriate physicians. If inpatient treatment is required, patients will be hospitalized at the Vienna General Hospital (depending on availability) or referred to the responsible hospital
    Personen mit Depressionen, welche über die Teilnahme hinaus eine weiterführende fachärztlich-pschiatrische Betreuung benötigen, werden an entsprechende Fachärzte/innen im niedergelassenen Bereich verwiesen. Sollte eine stationäre Behandlung dieser Personen erforderlich sein, werden Patienten/innen, je nach Verfügbarkeit, stationär aufgenommen oder an das zuständige Versorgungs-Spital überwiesen.
    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 Decision2023-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon May 13 06:21:07 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA