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    Clinical Trial Results:
    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?

    Summary
    EudraCT number
    		 2014-005239-15
    Trial protocol
    		 DE  
    Global end of trial date
    11 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2021
    First version publication date
    14 May 2021
    Other versions
    Summary report(s)
    		 MISO_summary

    Trial information

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    Trial identification
    Sponsor protocol code
    MISO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03062150
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - Universitätsmedizin Berlin
    Sponsor organisation address
    Hindenburgdamm 30, Berlin, Germany,
    Public contact
    Christian Otte, Klinik für Psychiatrie und Psychoth, Charité - Universitätsmedizin Berlin, +49 30450 517531, christian.otte@charite.de
    Scientific contact
    Christian Otte, Klinik für Psychiatrie und Psychoth, Charité - Universitätsmedizin Berlin, +49 30450 517531, christian.otte@charite.de
    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
    11 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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)
    Protection of trial subjects
    Safety: Blood pressure, heart rate, measures of subjective well-being (Visual Analogue Mood Scales, VAMS), adverse events (AE), serious adverse events (SAE), serious adverse reactions (SAR)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Sep 2016
    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
    Germany: 232
    Worldwide total number of subjects
    232
    EEA total number of subjects
    232
    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)
    230
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Diagnosis and main criteria for inclusion: - Age 18-65 years - Depressed male and female patients according to DSM-V & minimum of 17-items Hamilton Depression Score of 18 - healthy controls

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fludrocortisone + Placebo
    Arm description
    		 Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fludrocortisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.

    Arm title
    		 Placebo + D-Cycloserine
    Arm description
    		 Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH. D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd
    Arm type
    		 Experimental

    Investigational medicinal product name
    D-Cycloserine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.

    Arm title
    		 Fludrocortisone+D-Cycloserine
    Arm description
    		 Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fludrocortisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.

    Investigational medicinal product name
    D-Cycloserine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd

    Arm title
    		 Placebo + Placebo
    Arm description
    		 Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.

    Number of subjects in period 1
    		Fludrocortisone + Placebo Placebo + D-Cycloserine Fludrocortisone+D-Cycloserine Placebo + Placebo
    Started
    58
    58
    58
    58
    Completed
    58
    58
    58
    58

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fludrocortisone + Placebo
    Reporting group description
    		 Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.

    Reporting group title
    Placebo + D-Cycloserine
    Reporting group description
    		 Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH. D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd

    Reporting group title
    Fludrocortisone+D-Cycloserine
    Reporting group description
    		 Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd

    Reporting group title
    Placebo + Placebo
    Reporting group description
    		 Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.

    Reporting group values
    		 Fludrocortisone + Placebo Placebo + D-Cycloserine Fludrocortisone+D-Cycloserine Placebo + Placebo Total
    Number of subjects
    		 58 58 58 58 232
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 57 58 58 57 230
        From 65-84 years
    		 1 0 0 1 2
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 40 48 54 40 182
        Male
    		 18 10 4 18 50

    End points

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    End points reporting groups
    Reporting group title
    Fludrocortisone + Placebo
    Reporting group description
    		 Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.

    Reporting group title
    Placebo + D-Cycloserine
    Reporting group description
    		 Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH. D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd

    Reporting group title
    Fludrocortisone+D-Cycloserine
    Reporting group description
    		 Fludrocortisone: pill, Astonin H 0,1gm, single dose, Merck Serono GmbH D-Cycloserine: capsule, Cycloserine 250mg, single dose, King Pharmaceuticals Ltd

    Reporting group title
    Placebo + Placebo
    Reporting group description
    		 Placebo: pill, 8mm, single dose, Lichtenstein, Winthrop Arzneimittel GmbH.

    Primary: Emotional dot probe

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    End point title
    		 Emotional dot probe
    End point description
    End point type
    Primary
    End point timeframe
    1 hour
    End point values
    		 Fludrocortisone + Placebo Placebo + D-Cycloserine Fludrocortisone+D-Cycloserine Placebo + Placebo
    Number of subjects analysed
    58
    58
    58
    58
    Units: Effect
    0
    0
    0
    0
    Statistical analysis title
    		 Emotional Dot Probe
    Comparison groups
    Fludrocortisone + Placebo v Placebo + D-Cycloserine v Fludrocortisone+D-Cycloserine v Placebo + Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day of assessment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own system
    Dictionary version
    1
    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: No AE, SEA SAR reported.

    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
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    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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