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    Summary
    EudraCT Number:2019-004880-33
    Sponsor's Protocol Code Number:18F-FDOPA-BUP-ESC
    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:2023-01-03
    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 number2019-004880-33
    A.3Full title of the trial
    Reward-specific changes of cerebral dopamine synthesis in healthy volunteers and depressed patients
    Aufgabenspezifische Veränderungen der Dopaminsynthese im Gehirn bei gesunden und depressiven Personen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reward-specific changes of the chemical messenger dopamine in the brain of healthy and depressed people
    Veränderungen in der Menge des Botenstoffs Dopamin durch Belohnungsreize bei Aufgaben, gemessen im Gehirn gesunder und depressiver Personen
    A.3.2Name or abbreviated title of the trial where available
    Reward-specific DA changes depressed healthy
    A.4.1Sponsor's protocol code number18F-FDOPA-BUP-ESC
    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 AddressSpitalgasse 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
    D.3.9.4EV Substance CodeSUB16425MIG
    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.IMP: 2
    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 Wellbutrin XR 150 mg - Retardtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Pharma GmbH, Wien
    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 INNBupropion hydrochloride
    D.3.9.1CAS number 31677-93-7
    D.3.9.4EV Substance CodeSUB00432MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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
    - Identifying reward-specific alterations in dopamine synthesis (PET) in the nucleus accumbens (NAcc) in patients with MDD compared to healthy volunteers applying the Monetary Incentive Delay Task
    - To assess the effect of two different antidepressant agents (escitalopram, bupropion) on reward consumption and reward-specific NAcc dopamine synthesis rates in patients with MDD in a longitudinal design
    - To assess the relationship between reward-specific NAcc dopamine synthesis and treatment response in MDD
    - Identifizierung von belohnungsspezifischen Veränderungen der Dopaminsynthese (PET) im Nucleus accumbens (NAcc) bei Patient/innen mit MDD im Vergleich zu gesunden Proband/innen anhand der Monetary Incentive Delay Task
    - Bewertung der Wirkung von zwei verschiedenen Antidepressiva (Escitalopram, Bupropion) auf den Belohnungskonsum und die belohnungsspezifischen Dopaminsyntheseraten im NAcc bei Patient/innen mit MDD in einem Längsschnittdesign
    - Bewertung der Beziehung zwischen der belohnungsspezifischen NAcc-Dopaminsynthese und dem Ansprechen auf die Behandlung von MDD
    E.2.2Secondary objectives of the trial
    - To analyze the relationship between reward-specific dopamine synthesis and fMRI activation across healthy volunteers and patients with MDD
    - To identify remission rates in MDD patients being treated with either escitalopram OR bupropion in a longitudinal design
    - To assess the test-retest reliability of quantifying dopamine synthesis rates applying the same PET protocol across healthy controls

    Magnetic resonance spectroscopy (optional):
    - Relationship between reward-specific dopamine synthesis and GABA/glutamate in the brain
    -Baseline differences in brain GABA/glutamate between depressed and healthy subjects
    - Relationship between clinical outcome after antidepressant therapy with a)escitalopram or b)bupropion and changes in GABA/glutamate in the brain
    - Analyse der Beziehung zwischen belohnungsspezifischer Dopaminsynthese und fMRI-Aktivierung bei gesunden Freiwilligen und Patient/innen mit MDD
    - Ermittlung der Remissionsraten bei MDD-Patient/innen, die entweder mit Escitalopram ODER Bupropion behandelt werden, in einem Längsschnittdesign
    - Bewertung der Test-Retest-Zuverlässigkeit der Quantifizierung der Dopaminsyntheseraten unter Anwendung desselben PET-Protokolls bei gesunden Kontrollpersonen

    Magnetresonanzspektroskopie (optional):
    - Beziehung zwischen belohnungsspezifischer Dopaminsynthese und GABA/Glutamat im Gehirn
    -Unterschiede im GABA/Glutamat-Gehalt des Gehirns zwischen depressiven und gesunden Probanden
    - Zusammenhang zwischen dem klinischen Ergebnis nach einer antidepressiven Therapie mit a) Escitalopram oder b) Bupropion und Veränderungen von GABA/Glutamat im Gehirn
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title:

    Reward-specific changes of cerebral dopamine synthesis in healthy volunteers and depressed patients - Pilot 1

    The aim of the pilot study is to establish a non-invasive protocol for quantification of dopamine synthesis as compared to the gold standard of arterial blood sampling. For this purpose, all subjects participating in the pilot study will undergo a screening visit (day -14 to 0), a single PET/MR scan with acquisition of image-derived and arterial input functions (day 1), and a follow-up visit (day 2-30). The screening visit and the follow-up visit will be performed following the same steps as described for the HC of the main study. The duration of study participation is specified as a minimum of 3 days and a maximum of 30 days.
    Titel:

    Aufgabenspezifische Veränderungen der Dopaminsynthese im Gehirn bei gesunden und depressiven Personen - Pilot 1

    Ziel der Pilotstudie ist es, ein nicht-invasives Protokoll zur Quantifizierung der Dopaminsynthese im Vergleich zum Goldstandard der arteriellen Blutentnahme zu entwickeln. Zu diesem Zweck werden alle an der Pilotstudie teilnehmenden Proband/innen einer Screening-Untersuchung (Tag -14 bis 0), einer einmaligen PET/MR-Untersuchung mit Erfassung der aus dem Bild abgeleiteten und der arteriellen Input-Funktion (Tag 1) und einer Nachuntersuchung (Tag 2-30) unterzogen. Der Screening-Besuch und der Follow-up-Besuch werden nach denselben Schritten durchgeführt, die für die gesunden Kontrollproband/innen der Hauptstudie beschrieben wurden. Die Dauer der Studienteilnahme ist auf mindestens 3 Tage und höchstens 30 Tage festgelegt.
    E.3Principal inclusion criteria
    • Male and female subjects aged between 18-65 years of age
    • Depressive patients: DSM-IV diagnosis of MDD following SCID I, HDRS29, MADRS and BDI-II
    • Satisfactory general health as determined by past medical history, physical examination, vital signs at screening
    • Vital signs measured after 3 minutes resting in the supine position must be within the following ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure 90-140 mmHg, diastolic blood pressure 50-90 mm Hg, pulse rate 40-100 bpm
    • Subjects must weigh 50-100 kg to participate in this study with a BMI within 19-26.
    • Sufficient visual and auditory performance for neuropsychological testing
    • Written informed consent will be obtained prior to the start of any study procedures. Therefore, willingness and competence to sign the informed consent form is needed.
    • Potential patients must be able to communicate well with the investigator and comply with the requirements of the study
    • Only participants who are legally authorized to give informed consent will be included in the present study.
    • Männliche und weibliche Probanden im Alter zwischen 18 und 65 Jahren
    • Depressive Patienten: DSM-IV-Diagnose von MDD nach SCID I, HDRS29, MADRS und BDI-II
    • Zufriedenstellende allgemeine Gesundheit, wie durch Anamnese, körperliche Untersuchung und Vitalfunktionen beim Screening festgestellt
    • Die nach 3 Minuten Ruhe in Rückenlage gemessenen Vitalfunktionen müssen in folgenden Bereichen liegen: Körpertemperatur zwischen 35,0 und 37,5 ° C, systolischer Blutdruck 90
    bis 140 mmHg, diastolischer Blutdruck 50 bis 90 mmHg, Pulsfrequenz 40 bis 100 bpm
    • Die Probanden müssen zwischen 50 und 100 kg wiegen, mit einem BMI zwischen 19 und 26
    • Ausreichende visuelle und auditive Leistung für neuro-psychologische Tests
    • Die schriftliche Einverständniserklärung wird vor Beginn der Teilnahme eingeholt. Daher ist die Bereitschaft und die Kompetenz zur Unterzeichnung des Einverständniserklärungsformulars erforderlich.
    • Potenzielle Patienten/innen müssen in der Lage sein, gut mit dem Prüfer zu kommunizieren und die Anforderungen der Studie zu erfüllen.
    • In die vorliegende Studie werden nur Teilnehmer aufgenommen, die gesetzlich zur Einwilligung nach Aufklärung berechtigt sind.
    E.4Principal exclusion criteria
    • Depressed patients: Presence of any severe / unstable neurological, somatic or psychiatric comorbidity
    • Healthy controls: Any psychiatric disease or any severe / unstable neurological or somatic disease
    • Presence of psychotic symptoms
    • Acute suicidality
    • Any contraindication for magnetic resonance or PET imaging
    • Presence of any metallic implant in the head
    • History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to one of the study drugs or multiple study drugs (known hypersensitivity to bupropion, escitalopram)
    • Other clinically significant abnormality on physical, neurological, or laboratory examination or on electrocardiogram (ECG) that, in the opinion of the investigator precludes the patient from the study
    • Ingestion of antidepressants or other psychotropic agents within the last 6 months
    Previous escitalopram- or bupropion intake
    • Antidepressive trials wit DBS, electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or Ketamine
    • Current smoking, substance abuse including alcohol, drugs of abuse, or any medication in a manner which is indicative of substance-related disorders (e.g. substance dependency) according to DSM-IV
    • Failure to comply with the study protocol or follow the instructions of the investigators
    • Positive urine pregnancy test
    • Known pregnancy or lactation
    • MRI scan that shows evidence of stroke, infarct, or other space occupying lesion or structural abnormality
    • History of any other drug or alcohol abuse or misuse
    • Participation in any clinical investigation within 12 weeks prior to dosing
    • Evidence from an Allen test of incomplete communication between the radial and ulnar artery, in either hand
    • Significant radiation exposure (>5 mSv) in the frame of participation in trials within the past 10 years
    Depressive Patienten: Vorhandensein einer schweren / instabilen neurologischen, somatischen oder psychiatrischen Komorbidität
    • Gesunde Kontrollen: Jede psychiatrische Erkrankung oder jede schwere / instabile neurologische oder somatische Erkrankung
    • Vorhandensein von psychotischen Symptomen
    • Akute Suizidalität
    • Gegenanzeigen für Magnetresonanz- oder PET-Bildgebung
    • 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 oder mehrere Studienmedikamente (bekannte Überempfindlichkeit gegen Bupropion, Escitalopram)
    • Andere klinisch signifikante Anomalien bei körperlichen, neurologischen oder Laboruntersuchungen oder am Elektrokardiogramm (EKG), das nach Ansicht des/der Prüfarztes/ärztin den/die Patienten/in ausschließt
    • Einnahme von Antidepressiva oder anderen Psychopharmaka in den letzten 6 Monaten
    • Frühere Escitalopram- oder Bupropion-Einnahme
    • Antidepressive 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-IV hinweist
    • Nichtbeachtung des Studienprotokolls oder Nicht-Befolgung der Anweisungen der Prüfer
    • Positiver Urin-Schwangerschaftstest
    • Bekannte Schwangerschaft oder Stillzeit
    • MRT-Scan, der Hinweise auf Schlaganfall, Infarkt oder andere raumgreifende Läsionen oder Strukturen zeigt
    • Vorgeschichte eines anderen Missbrauchs oder Missbrauchs von Drogen oder Alkohol
    • Teilnahme an einer klinischen Untersuchung innerhalb von 12 Wochen vor Einschluss
    • Allen-Tests: Hinweise auf unvollständige Kommunikation zwischen der Arteria radialis und der Arteria ulnaris in der rechten oder der linken Hand
    • Signifikante Strahlenexposition (> 5 mSv) im Rahmen der Teilnahme an Studien in den letzten 10 Jahren.
    E.5 End points
    E.5.1Primary end point(s)
    Reward-specific changes of dopamin-synthesis
    Reward-spezifische Veränderungen der Dopamin-Synthese
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data analysis will be performed 42-56 days (+/- 2 days) of study participation.
    Die Datenanalyse soll nach 42-56 Tagen (+/- 2 Tage) der Studienteilnahme begonnen werden.
    E.5.2Secondary end point(s)
    - To analyze the relationship between reward-specific dopamine synthesis and fMRI activation across healthy volunteers and patients with MDD

    - To identify remission rates in MDD patients being treated with either escitalopram OR bupropion in a longitudinal design

    - Test-retest reliability for the quantification of dopamine synthesis rates in healthy volunteers
    - Analyse der Beziehung zwischen belohnungsspezifischer Dopaminsynthese und fMRI-Aktivierung bei gesunden Freiwilligen und Patienten mit MDD

    - Ermittlung der Remissionsraten bei MDD-Patienten, die entweder mit Escitalopram ODER Bupropion behandelt werden, in einem Längsschnittdesign

    - Test-Retest-Zuverlässigkeit für die Quantifizierung der Dopamin-Syntheseraten bei gesunden Probanden
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data analysis on the aforementioned secondary end points should be carried out as of day 42 (+/- 2 days) or (behavioral data of depressive patients) as of day 132 (+/- 7 days).
    Datenanalysen zu den besagten Nebenzielgrößen sollen frühestens ab Tag 42 (+/- 2 Tage) bzw. (Verhaltensdaten depressiver Pat.) ab Tag 132 (+/- 7 Tage) erfolgen.
    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 Yes
    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 Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Längsschnittstudie
    Longitudinal study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Escitalopram (siehe IMP)
    Escitalopram (see IMP)
    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 years4
    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: 100
    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 2023-01-03. 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 state100
    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 Decision2023-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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