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    Summary
    EudraCT Number:2020-004172-17
    Sponsor's Protocol Code Number:ETES
    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:2021-03-23
    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 number2020-004172-17
    A.3Full title of the trial
    Electroconvulsive therapy vs. esketamine nasal spray in treatment-resistant depression: a longitudinal, randomized efficacy comparison pilot study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of effectiveness of Electroconvulsive Therapy and Esketamine nasal spray in patients with depression
    A.3.2Name or abbreviated title of the trial where available
    ETES
    A.4.1Sponsor's protocol code numberETES
    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 Innsbruck
    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 supportMedizinische Universität Innsbruck
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Innsbruck
    B.5.2Functional name of contact point Kompetenzzentrum klinische Studien
    B.5.3 Address:
    B.5.3.1Street AddressAnichstr. 29
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.6E-mailkks-regulatory@i-med.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 Spravato
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International N.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN esketamine
    D.3.9.3Other descriptive nameESKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB25811
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number28
    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
    treatment resistant depression
    E.1.1.1Medical condition in easily understood language
    treatment resistant depression
    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 compare the effectiveness of electroconvulsive therapy (ECT) vs. esketamine nasal spray using the Montgomery Asberg Depression Rating Scale (MADRS)
    E.2.2Secondary objectives of the trial
    - brain function and structure in patients with TRD (pretreatment)
    - the cognitive effects of ECT and intranasal esketamine
    - the short- and medium-term effects of ECT and intranasal esketamine on functional and structural connectivity in patients with TRD
    - the effects of ECT and intranasal esketamine on working memory and on social cognition on behavioral and functional level in TRD
    - correlations between clinical effects and possible changes in task-related functional activity as well as functional and structural connectivity longitudinally
    - possible imaging biomarkers that predict clinical response to ECT or intranasal esketamine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. DSM-5 diagnosis of Major Depressive Disorder (MDD) without psychotic features (296.22, 296.23, 296.32, 296.33) made through the SCID-5-CV Interview
    2. MADRS score ≥ 25
    3. Pharmacologically treatment-resistant depressive episode [Stage ≥ II, defined by Thase & Rush (1997): failure of at least 2 adequate trials of at least 2 distinctly different classes of antidepressants (< 4 weeks each)]
    4. Age: 18 - 50 years
    5. Written informed consent
    E.4Principal exclusion criteria
    1. Participation in another interventional clinical trial
    2. Relative contraindications to ECT treatment: Neurodegenerative disease e.g. stroke, epilepsy, severe traumatic brain injury, intracranial aneurysm (>7 mm) except small meningioma; acute cardiac disease (<3 months) or chronic heart disease; not organized deep venous thrombosis; autoimmune disease with brain involvement; pheochromocytoma; ablatio retinae; family anamnesis for epilepsy; other clinical contraindications
    3. Patients who meet any exclusion criteria for nasal esketamine treatment: Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation; history of intracerebral hemorrhage; hypersensitivity to esketamine, ketamine, or any of the excipients.
    4. Contraindications to the conduction of MRI: claustrophobia; metal, electric, magnetic, or mechanically driven implants; tattoos on head or neck
    5. History of one or more of the following diagnoses (DSM-5):
    - MDD, single or recurrent episode with psychotic features (296.24; 296.34)
    - past or current substance dependence (except caffeine, nicotine) (303.x, 304.x, 305.x)
    - neurodevelopmental disorders (299.x, 307.x, 314.x, 315.x, 319.x)
    - schizophrenia spectrum and other psychotic disorders (293.x, 295.x, 297.x, 298.x)
    - neurocognitive disorders (290.x, 292.x, 294.x, 331.x).
    6. history of ECT (unsuccessful or successful)
    7. suicidal ideation
    8. pregnancy or lactation period
    9. lack of anesthetic clearance for any other reason
    10. insufficient command of German language.
    E.5 End points
    E.5.1Primary end point(s)
    Effect of treatment (ECT vs. esketamine) on the course of treatment resistant depression measured by the MADRS score
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1, week 1-4, EOF-Visit, FU-Visit
    E.5.2Secondary end point(s)
    -Short- and medium-term changes in the functional (rs-fMRI) and structural (DTI) connectivity after treatment
    - Effects of the two treatment arms on working memory (n-back) and social cognition (eStroop)
    - To find possible imaging biomarkers that predict clinical response to ECT or intranasal esketamine
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of clinical trial
    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 Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Electroconvulsive therapy
    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
    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.1.3.1Number of subjects for this age range: 0
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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)
    Routine treatment according to local standard
    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 Decision2021-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-01
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