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    Summary
    EudraCT Number:2011-005001-78
    Sponsor's Protocol Code Number:KLI148-B00
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-03
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-005001-78
    A.3Full title of the trial
    Neural Correlates of SSRI Drug Response: Impact of Stress System Genes
    Neuronale Korrelate des Ansprechens auf eine Therapie mit SSRIs: Einflussnahme der im Stress-System involvierten genetischen Varianten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Factors influencing Antidepressant (SSRI) Drug Response: Impact of Stress-related Genes
    Einflussfaktoren des Ansprechens auf eine Therapie mit Antidepressiva (selektive Serotoninwiederaufnahmehemmer): Einflussnahme stressbezogener Gene
    A.3.2Name or abbreviated title of the trial where available
    not available
    A.4.1Sponsor's protocol code numberKLI148-B00
    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 SponsorMedizinische Universität Wien, Universitätsklinik für Psychiatrie u. Psychotherapie, Abteil. für biologische Psychiatrie
    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 supportFWF
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien, Universitätsklinik für Psychiatrie u. Psychotherapie, Abteil. für biologische Psychiatrie
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number00431404003837
    B.5.5Fax number00431404003099
    B.5.6E-maillukas.pezawas@meduniwien.ac.at
    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 CIPRALEX
    D.2.1.1.2Name of the Marketing Authorisation holderLUNDBECK
    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 OXALATE
    D.3.9.1CAS number 219861-08-2
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depressive Disorder
    Depressive Störung
    E.1.1.1Medical condition in easily understood language
    Depression
    Depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    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
    The main objective of this trial is to relate functional and structural MR parameters (e.g. local and system level BOLD signal, gray matter, functional and structural connectivity, surface and parcellation measures) to drug response and remission.
    Das Hauptziel dieser Studie stellt die Untersuchung des Zusammenhangs zwischen funktionellen und strukturellen MR Parametern (BOLD Signal, graue Substanz, funktionelle und strukturelle Konnektivität, Oberflächenmessungen) und Therapieansprechen sowie Remission dar.
    E.2.2Secondary objectives of the trial
    A secondary objective of this trial is to relate genetic variation of SLC6A4, BDNF, HTR1A, NR3C1 and FKBP5 to neural markers of treatment response. An additional objective is to investigate the potential use of peripheral parameters such as mRNA transcription and protein expression levels of these genes as well as 5-HT uptake and cortisol levels as peripheral correlates of neural markers of drug response.
    Ein weiteres Ziel unserer Studie ist es zu untersuchen, ob diese neuronale Veränderungen in einem korrelativen Zusammenhang mit den peripheren Parametern wie RNA-Expression, Serotonin uptake, Serumprotein-basierte Parameter, und dem Cortisollevel stehen, und dass Genotypen, die in pharmakogenetischen Assoziationsstudien mit Therapieansprechen in Verbindung gebracht worden sind, das Antwortverhalten dieser Hirnstrukturen auf Escitalopramtherapie beeinflussen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - willingness and competence to sign the informed consent form voluntarily
    - aged 18 – 45 years
    - right-handedness
    - a DSM-IV diagnosis of a major depressive episode by a structured clinical interview (SCID)
    - a MADRS score ≥20 and ≤ 30
    - ability to be managed as outpatients
    - ability to fulfill the criteria to undergo an MRI scan
    - Caucasian subjects of European ancestry
    - Einverständnis und Kompetenz die Patienteninformation zur freiwilligen Studienteilnahme zu unterzeichnen
    - Alter 18 – 45 Jahre
    - Rechtshändigkeit
    - Diagnose einer ggw. depressiven Episode einer Major Depression nach DSM-IV
    - Einen MADRS Wert ≥20 und ≤ 30
    - ambulante Betreuung möglich
    - Durchführung einer MRT Messung möglich
    - Europäische Herkunft
    E.4Principal exclusion criteria
    - previous or concurrent major medical or neurological illness
    - clinically significant abnormal values in routine laboratory screening or general physical examination
    - DSM-IV diagnosis of substance dependence within the past year, except for caffeine or nicotine or current substance abuse
    - DSM-IV diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or an anxiety disorder as a primary diagnosis
    - the use of any psychotropic drug within the last two months
    - unresponsiveness of a former major depressive episode to an adequate antidepressive drug dosing of at least 6 weeks duration or any kind of therapy resistance
    - a history of severe drug allergy or hypersensitivity or known hypersensitivity to escitalopram
    - being acutely suicidal either indicated by a score ≥ 5 on item 10 (suicidal thoughts) on the MADRS or a score ≥ 4 on the HAM-D 21 (suicidal thoughts) or according to the investigator´s opinion
    - failures to comply with the study protocol or to follow the instructions of the investigating team
    - current pregnancy or breast feeding;
    - metallic implants or other contraindications to MRI
    - Momentane oder frühere schwere somatische, sowie neurologische Erkrankungen
    - Klinisch signifikante abnormale Werte in Routine Blutuntersuchung und/oder physikalischen Untersuchung
    - DSM-IV Diagnose einer Substanzabhängigkeit ausgenommen Koffein oder Nikotin (gegenwärtig oder während des letzten Jahres)
    - DSM-IV Diagnose einer Schizophrenie, einer schizoaffektiven Störung, einer Bipolaren Störung, oder einer Angsterkrankung als Primärdiagnose
    - Psychopharmakologische Behandlung innerhalb der letzten 2 Monate
    - Nicht-Ansprechen auf eine adäquate Dosierung eines Antidepressivum über einen Zeitraum von mind. 6 Wochen oder jegliche Art von Therapieresistenz
    - Schwere Arzneimittelallergie, oder bekannte Hypersensitivität für Escitalopram
    - Akute Suizidalität
    - ggw. Schwangerschaft oder Stillperiode
    - Metallische Implantate oder andere Kontraindikationen für MRI
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome variables are functional and structural MRI parameters dependent on drug response and remission.
    Primären Endzeitpunkt stellt die Abhängigkeit der funktionellen und strukturellen MRT Parameter von Therapieansprechen und Remission dar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This endpoint will be evaluated 8 weeks after escitalopram treatment initiation.
    Dieser Endzeitpunkt wird 8 Wochen nach behandlungsbeginn mit Escitalopram evaluiert.
    E.5.2Secondary end point(s)
    Secondary outcome variables will be genotype-mediated drug response and association between peripheral parameters (such as mRNA expression levels, serotonin uptake, cortisol levels) and drug response.
    Sekundären Endzeitpunkt stellt das von Genotypen beeinflusste Therapiensprechen und der Zusammenhang zwischen peripheren Parametern (mRNA Expression levels, serotonin uptake, cortisol levels) und Therapieansprechen dar.
    E.5.2.1Timepoint(s) of evaluation of this end point
    This endpoint will be evaluated 8 weeks after escitalopram treatment initiation.
    Dieser Endzeitpunkt wird 8 Wochen nach behandlungsbeginn mit Escitalopram evaluiert.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    pharmaco MRI
    Pharmaco MRI assesses the relation of functional and structural MR parameters to drug response and remission.
    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 No
    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 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
    After the last MRT measurement which is planned when maximum response is achieved (after 8 weeks of treatment with escitalopram) patients undergo the end-of-study examination. The investigator must temporarily interrupt or permanently discontinue the study drug if continued administration is believed to be contrary to the best interests of the patient or for administrative reasons, in particular withdrawal of the patient’s consent.
    Die Nachuntersuchung erfolgt eine Woche nach der letzten MRT Messung, die in der 8. Woche nach Behandlungsbeginn geplant ist, da es zu diesem Zeitpunkt mit einem maximalen Therapieansprechen zu rechnen ist. Der behandelnder Arzt kann die Teilnahme an der Studie vorzeitig beenden, wenn er den Eindruck hat, dass eine weitere Teilnahme an der klinischen Prüfung nicht im Interesse der Patienten ist. Patienten haben die wahl ohne Grund zu nennen vorzeitig aus der klinischen Prüfung auszuscheiden.
    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 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: 30
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    The therapeutic options outside of the study will be discussed with the patient individually.
    Die therapeutischen Optionen nach der Beendigung der Studienteilnahme werden mit Patienten individuell besprochen.
    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 Decision2012-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-28
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