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    Summary
    EudraCT Number:2014-005239-15
    Sponsor's Protocol Code Number:MISO
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-005239-15
    A.3Full title of the trial
    Effects of mineralocorticoid receptor stimulation on cognitive bias and social cognition in patients with major depression and healthy controls: what’s the role of NMDA receptors?

    Effekte der Mineralocorticoidrezeptor-Stimulation auf kognitive Verzerrung und soziale Kognition bei depressiven Patienten und gesunden Kontrollprobanden: Was ist die Rolle der NMDA-Rezeptoren?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of mineralocorticoid receptor stimulation on cognitive bias and social cognition in patients with major depression and healthy controls: what’s the role of NMDA receptors?

    Effekte der Mineralocorticoidrezeptor-Stimulation auf kognitive Verzerrung und soziale Kognition bei depressiven Patienten und gesunden Kontrollprobanden: Was ist die Rolle der NMDA-Rezeptoren?
    A.4.1Sponsor's protocol code numberMISO
    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 SponsorCharité - Universitätsmedizin Berlin
    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 supportCharité - Universitätsmedizin Berlin
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointKlinik für Psychiatrie und Psychoth
    B.5.3 Address:
    B.5.3.1Street AddressHindenburgdamm 30
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code12203
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930450 517531
    B.5.5Fax number+4930450 517942
    B.5.6E-mailchristian.otte@charite.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 Astonin H 0.1 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono 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.3.1Product nameFludrocortison
    D.3.4Pharmaceutical form Capsule, hard
    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 INNFLUDROCORTISONE
    D.3.9.1CAS number 127-31-1
    D.3.9.4EV Substance CodeSUB02209MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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 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 Cycloserine
    D.2.1.1.2Name of the Marketing Authorisation holderKing Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameCycloserine
    D.3.4Pharmaceutical form Capsule, hard
    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 INND-CYCLOSERINE
    D.3.9.1CAS number 68-41-7
    D.3.9.4EV Substance CodeSUB06863MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    depressed patients and healthy control subjects
    depressive Patienten und gesunde Kontrollprobanden
    E.1.1.1Medical condition in easily understood language
    depressed patients and healthy control subjects
    depressive Patienten und gesunde Kontrollprobanden
    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
    The primary objective of the study is to investigate the effects of fludrocortisone versus placebo on the attention bias in a pooled group of depressive patients and healthy control subjects (measured by the „Attentional bias index“ in the emotional dot probe paradigm)
    Primäres Ziel der Studie ist es, in der gepoolten Gruppe depressiver Patienten und gesunder Probanden die Effekte von Fludrocortison vs. Placebo zu untersuchen auf die Aufmerksamkeitsverzerrung (gemessen mit dem „Attentional Bias Index“ im emotionalen Dot-Probe-Paradigma; primärer Endpunkt)
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study are to investigate:
    - the effects of fludrocortisone versus placebo on emotion recognition in faces (“Facial recognition task”), empathy (“Multifaceted empathy task”), and spatial memory (“Virtual Water-Maze paradigm”) in a pooled group of depressive patients and healthy control subjects
    - the effects of a combined administration of fludrocortisone and D-cycloserin versus a single administration of fludrocortisone or D-cycloserin on attention bias, emotion recognition in faces, empathy, and spatial memory in a pooled group of depressive patients and healthy control subjects
    Sekundäre Ziele sind zum einen, in der gepoolten Gruppe depressiver Patienten und gesunder Probanden die Effekte von Fludrocortison vs. Placebo zu untersuchen auf:
    - Emotionserkennung in Gesichtern (Facial Recognition Task)
    - Empathie (Multifaceted Empathy Task)
    - räumliches Gedächtnis (Virtual Water-Maze Paradigma)

    und zum anderen in der gepoolten Gruppe depressiver Patienten und gesunder Probanden zu untersuchen, ob die kombinierte Gabe von Fludrocortison und D-Cycloserin einer einmaligen Gabe von Fludrocortison bzw. einer einmaligen Gabe von D-Cycloserin überlegen ist hinsichtlich der vier Zielvariablen
    - Aufmerksamkeitsverzerrung
    - Emotionserkennung in Gesichtern
    - Empathie
    - räumliches Gedächtnis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • healthy adults aged 18 to 65,
    • ability to provide written informed consent
    • Only for patients: Diagnosis major depression according to DSM-5 & 18 points or more in the 17-item Hamilton Depression Rating Scale (Hamilton, 1960),
    • effective contraception in women (defined as Pearl index <1), or reliable abstinence
    from any heterosexual relationships in women of childbearing potential, or postmenopausal status (amenorrhea for at least 12 months without alternative reason).
    •Einwilligungsfähigkeit,
    •durchgeführte Aufklärung und schriftliche Einwilligung,
    •Gesunde Erwachsene im Alter von: 18-65 Jahren,
    •Nur für Patienten: Diagnose Major Depression nach DSM-5 & 18 Punkte oder mehr in der 17-Item-Hamilton Depressionsskala (Hamilton, 1960),
    •effektive Kontrazeption bei Frauen (definiert als Pearl Index < 1) bzw. glaubhafte Abstinenz von heterosexuellen Kontakten oder postmenopausaler Status (Amenorrhoe über mindestens 12 Monate ohne alternativen Grund).
    E.4Principal exclusion criteria
    •taking psychotropic drugs (eg, antidepressants) within the last 5 days,
    • substance abuse or dependence (except nicotine) within the last 6 months,
    • presence of other psychiatric disorders (current or past psychosis, schizoaffective or bipolar disorder)
    • presence of a neurodegenerative disease,
    • existence of a current or past organic brain damage (pervasive developmental disorder, mental retardation, epilepsy, head injury with loss of consciousness)
    • presence of acute suicidality,
    • Treatment with fluoxetine or an injectable antipsychotic within the last 30 days.
    • presence of an endocrine disorder or taking a medication with neuroendocrine effects (eg insulin dependent diabetes mellitus, taking steroids)
    • existence of current pregnancy or lactation,
    • non-agreement to save and transmit pseudonymised study data within the clinical Trial
    • presence of cardiovascular problems (cardiac insufficiency)
    • hypokalemia (potassium deficiency)
    • people who are accommodated in an psychiatric institution based on an official or judicial decision
    • people who are dependent on the investigator, sponsor or study centre
    • known drug intolerance
    • People whose laboratory test results do not meet the following eligibility limits: AST and ALT < 2 x upper limit of normal, Kreatinin < 1,5 x lower limit of normal
    • People whose systolic blood pressure is outside 90 and 140 mmHg, People whose diastolic blood pressure is outside 50 and 90 mmHg, and People whose heart rate is outside 50 and 90 beats per minute
    • dysfunctions of the heart (except : AV block 1st degree)
    • Participation in any drug - interventional clinical trial within the last month or during the study period
    •Einnahme psychotroper Medikation (z.B. Antidepressiva) innerhalb der letzten 5 Tage,
    •Substanzmissbrauch oder -abhängigkeit (außer Nikotin) innerhalb der letzten 6 Monate,
    •Vorliegen einer weiteren psychiatrische Erkrankungen (aktuelle oder vergangene Psychose, schizoaffektive oder bipolare Störung)
    •Vorhandensein einer neurodegenerativen Erkrankung,
    •Vorhandensein einer aktuellen oder vergangenen organischen Hirnschädigung (tiefgreifende Entwicklungsstörung, Entwicklungsverzögerung, Epilepsie, Schädelhirntrauma mit Bewusstlosigkeit),
    •Vorliegen von akuter Suizidalität,
    •Behandlung mit Fluoxetin oder einem injizierbaren Antipsychotikum innerhalb der letzten 30 Tage.
    •Vorhandensein einer endokrinen Störung oder Einnahme einer Medikation mit neuroendokriner Wirkung (z.B. insulinabhängige Diabetes mellitus, Einnahme von Steroiden),
    •Vorliegen aktueller Schwangerschaft oder Stillzeit,
    •fehlende Bereitschaft zur Speicherung und Weitergabe pseudonymisierter Studiendaten im Rahmen der klinischen Prüfung,
    •Vorliegen von Herz-Kreislauf-Problemen (kardiale Insuffizienz)
    •Hypokaliämie (Kaliummangel)
    •Personen, die aufgrund behördlicher oder gerichtlicher Anordnung in einer Anstalt untergebracht sind
    •Personen, die vom Prüfer, Sponsor oder der Prüfstelle abhängig sind
    •Bekannte Unverträglichkeit der Studienmedikation
    •Personen deren Laborwerte die folgenden Zulässigkeitsgrenzen nicht erfüllen (AST und ALT < 2 x obere Normgrenze [ULN], Kreatinin < 1,5 x untere Normgrenze [LLN])
    •Personen deren systolischer Blutdruck außerhalb 90 und 140 mmHg, der diastolische Blutdruck außerhalb 50 und 90 mmHg, und deren Herzfrequenz außerhalb 50 und 90 pro Minute liegt
    •Personen die beim Screening kardiale Funktionseinschränkungen im EKG aufweisen (ausgenommen: AV-Block 1. Grades)
    •Teilnahme an jeglicher medikamentös-interventioneller klinischer Studie innerhalb des letzten Monates oder während der gesamten Studiendauer
    E.5 End points
    E.5.1Primary end point(s)
    Attention bias (measured using an emotional dot-probe paradigm)
    Aufmerksamkeitsverzerrung (gemessen mithilfe eines emotional Dot-Probe-Paradigmas)
    E.5.1.1Timepoint(s) of evaluation of this end point
    three hours after intervention (administration of fludrocortisone, D-cycloserin or placebo)
    drei Stunden nach Intervention (Gabe von Fludrocortison, D-Cycloserin or Placebo)
    E.5.2Secondary end point(s)
    - emotion recognition in faces (measured by the number of right answers in “Facial recognition task”)
    - empathy (measured by the score of “Multifaceted empathy task”)
    - spatial memory (measured by the time spent in the correct quadrant in a test trial of the “Virtual Water-Maze paradigm)
    - Emotionserkennung in Gesichtern (gemessen als Anzahl richtiger Antworten im Facial Recognition Task)
    - Empathie (gemessen als Summenscore im Multifaceted Empathy Task)
    - Räumliches Gedächtnis (gemessen als Zeit im korrekten Quadranten im Probe Trial im Virtual Water-Maze Paradigma)
    E.5.2.1Timepoint(s) of evaluation of this end point
    three hours after intervention (administration of fludrocortisone, D-cycloserin or placebo)
    drei Stunden nach Intervention (Gabe von Fludrocortison, D-Cycloserin or Placebo)
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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
    LVLS
    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: 232
    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 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 state232
    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)
    no plans for treatment
    keine weitere Behandlung geplant
    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 Decision2016-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-11
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