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    Clinical Trial Results:
    Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

    Summary
    EudraCT number
    		 2011-004860-31
    Trial protocol
    		 AT  
    Global end of trial date
    01 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Mar 2021
    First version publication date
    11 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    v4_20150205
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01477203
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringerguertel 18-20, Vienna, Austria, 1090
    Public contact
    Department of Psychiatry, Medical University of Vienna, +43 1404003825, rupert.lanzenberger@meduniwien.ac.at
    Scientific contact
    Department of Psychiatry, Medical University of Vienna, +43 1404003825, rupert.lanzenberger@meduniwien.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
    01 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    MAN-BIOPSY pursues the concrete research question whether novel biological and psycho-physiological clusters or categories can be defined to improve treatment and minimize side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and endocrinological parameters. One major aspect of our research approach is its focuses on the identification of dysfunctions in fundamental information processing mechanisms and neurocomputational mechanisms, and is not restricted to symptom-oriented tasks. The main objectives of MAN-BIOPSY are therefore • to identify biological and psycho-physiological parameters for major depressive disorders and anxiety disorders, and • to identify predictive markers for treatment response and type/severity of side effects for these disorders.
    Protection of trial subjects
    - Patients were observed by medical staff during the entire experimental procedures. - Regular visits were performed in acute patients between scanning sessions and pharmacotherapy -During MRI measurements respiratory rate was monitored
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 158
    Worldwide total number of subjects
    158
    EEA total number of subjects
    158
    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)
    158
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was performed via advertisement on dedicated mesage boards.

    Pre-assignment
    Screening details
    		 In total 255 subjects were screened, 158 were included in the study

    Period 1
    Period 1 title
    Inclusion (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Acute patients received non-blinded psychopharmacological treatment according to international guidelines.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Healthy controls
    Arm description
    		 -
    Arm type
    		 2 MRI Scans, no study medication

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 acute major depression
    Arm description
    		 aMD
    Arm type
    		 Experimental

    Investigational medicinal product name
    escitalopram
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5mg/d increased to 10mg/d within the first week efficacy was evaluated after 6 weeks: change to second line treatment was performed in case of non-response (Venlafaxin/Mirtazapin)

    Arm title
    		 rMDD
    Arm description
    		 remitted MDD
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    		Healthy controls acute major depression rMDD
    Started
    54
    44
    43
    Completed
    33
    26
    36
    Not completed
    21
    18
    7
         Physician decision
    8
    4
    3
         MRI contraindication: metal
    -
    -
    1
         fMRI technical problems
    9
    1
    -
         manic episode
    -
    1
    -
         claustrophobic reaction
    1
    3
    -
         MRI structural abnormalities
    1
    -
    1
         Lost to follow-up
    2
    3
    2
         Protocol deviation
    -
    6
    -
    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: No systematic analyses of outcomes of anxiety patients has been conducted so far. Thus, data from healthy controls, acute MDD and remitted patients are given.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Healthy controls
    Reporting group description
    		 -

    Reporting group title
    acute major depression
    Reporting group description
    		 aMD

    Reporting group title
    rMDD
    Reporting group description
    		 remitted MDD

    Reporting group values
    		 Healthy controls acute major depression rMDD Total
    Number of subjects
    		 54 44 43 141
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 54 44 43 141
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 26.6 ( 6.8 ) 30.4 ( 9.7 ) 28.5 ( 8.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 33 32 27 92
        Male
    		 21 12 16 49
    Subject analysis sets

    Subject analysis set title
    Healthy controls
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy controls that sucessfully ccompleted the protocol, all data available.

    Subject analysis set title
    acute major depression
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Acute MDD patients that sucessfully ccompleted the protocol, all data available.

    Subject analysis set title
    rMDD
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Remitted MDD patients that sucessfully ccompleted the protocol, all data available.

    Subject analysis sets values
    		 Healthy controls acute major depression rMDD
    Number of subjects
    33
    26
    36
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    33
    26
    36
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    26.6 ( 6.8 )
    30.4 ( 9.7 )
    28.5 ( 8.2 )
    Gender categorical
    Units: Subjects
        Female
    20
    19
    23
        Male
    13
    7
    13

    End points

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    End points reporting groups
    Reporting group title
    Healthy controls
    Reporting group description
    		 -

    Reporting group title
    acute major depression
    Reporting group description
    		 aMD

    Reporting group title
    rMDD
    Reporting group description
    		 remitted MDD

    Subject analysis set title
    Healthy controls
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy controls that sucessfully ccompleted the protocol, all data available.

    Subject analysis set title
    acute major depression
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Acute MDD patients that sucessfully ccompleted the protocol, all data available.

    Subject analysis set title
    rMDD
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Remitted MDD patients that sucessfully ccompleted the protocol, all data available.

    Primary: Task related activity

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    End point title
    		 Task related activity
    End point description
    End point type
    Primary
    End point timeframe
    MRI I - MRI II (~3 months)
    End point values
    		 Healthy controls acute major depression rMDD
    Number of subjects analysed
    33
    26
    36
    Units: BOLD signal
        number (not applicable)
    33
    26
    36
    Statistical analysis title
    		 Linear regression
    Comparison groups
    Healthy controls v rMDD
    Number of subjects included in analysis
    69
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    during entire trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 158 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 158 (0.63%)
    Psychiatric disorders
    Manic episode
         subjects affected / exposed
    1 / 158 (0.63%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Feb 2015
    additional clinical follow-up investigation

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23769917
    http://www.ncbi.nlm.nih.gov/pubmed/28108394
    http://www.ncbi.nlm.nih.gov/pubmed/25324216
    http://www.ncbi.nlm.nih.gov/pubmed/28117844
    http://www.ncbi.nlm.nih.gov/pubmed/29422521
    http://www.ncbi.nlm.nih.gov/pubmed/25541513
    http://www.ncbi.nlm.nih.gov/pubmed/31175273
    http://www.ncbi.nlm.nih.gov/pubmed/31175352
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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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