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    Clinical Trial Results:
    Electroconvulsive therapy vs. esketamine nasal spray in treatment-resistant depression: a longitudinal, randomized efficacy comparison pilot study

    Summary
    EudraCT number
    		 2020-004172-17
    Trial protocol
    		 AT  
    Global end of trial date
    01 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jan 2023
    First version publication date
    29 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ETES
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Innsbruck
    Sponsor organisation address
    Innrain 52, Innsbruck, Austria, 6020
    Public contact
    Kompetenzzentrum klinische Studien, Medizinische Universität Innsbruck, kks-regulatory@i-med.ac.at
    Scientific contact
    Kompetenzzentrum klinische Studien, Medizinische Universität Innsbruck, kks-regulatory@i-med.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the effectiveness of electroconvulsive therapy (ECT) vs. esketamine nasal spray using the Montgomery Asberg Depression Rating Scale (MADRS)
    Protection of trial subjects
    weekly assesment
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 99999999
    Worldwide total number of subjects
    99999999
    EEA total number of subjects
    99999999
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    99999999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 no patients recruited

    Pre-assignment
    Screening details
    		 no patients recruited

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ketamine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Spravato
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    56 mg (2 devices of SPRAVATO™)

    Arm title
    		 ECT-Arm
    Arm description
    		 -
    Arm type
    		 Electroconvulsive Therapy

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    		Ketamine ECT-Arm
    Started
    99999
    99999
    Completed
    99999
    99999
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: we did not enroll any patients.

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Ketamine
    Reporting group description
    		 -

    Reporting group title
    ECT-Arm
    Reporting group description
    		 -

    Primary: effect of treatment (ECT vs. esketamine) on depression MADRS

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    End point title
    		 effect of treatment (ECT vs. esketamine) on depression MADRS [1]
    End point description
    End point type
    Primary
    End point timeframe
    non, because no patients recruited
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: we did not recruit any patients. Therefor we have no statistical analysis
    End point values
    		 Ketamine ECT-Arm
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: 60
    Notes
    [2] - no patients recruited, study suspended
    [3] - no patients recruited
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    n.a.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 n.a.
    Dictionary version
    n.a.
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: we did not recruit any patients. Therefor we have no non-serious adverse events

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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.

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