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    Clinical Trial Results:
    Brain Network Dysfunction as a Model for Schizophrenia: Connectivity Alterations using Ketamine and pharmacological Magnetic Resonance Imaging

    Summary
    EudraCT number
    2010-022772-31
    Trial protocol
    AT  
    Global end of trial date
    27 Aug 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Oct 2019
    First version publication date
    20 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20100812v2
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01394757
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Assoc.-Prof. Rupert Lanzenberger, MD, Medical University of Vienna, +431 4040035760, rupert.lanzenberger@meduniwien.ac.at
    Scientific contact
    Assoc.-Prof. Rupert Lanzenberger, MD, Medical University of Vienna, +431 4040035760, 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
    09 Apr 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Aug 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate time-dependent changes in functional connectivity associated with ketamine.
    Protection of trial subjects
    -Patients were observed by a medical doctor during the entire experimental procedures. -During MRI measurements vital parameters (ECG, heart rate, respiratory rate) were monitored at all times. -In case of termination of the MRI measurement by the participants, debriefing was done with the MD in charge with the possibility of drug application in case of side effects caused by the study drug. -After the MRI measurements participants were observed in the clinical setting for a minimum of 2 hours in order to ensure the lack of side effects.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Jun 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: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    41
    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 in the General Hospital of Vienna

    Pre-assignment
    Screening details
    Approximately 100 potential participants were screened via telephone, 54 were thorougly examined with regards to physical and psychiatric health. After this screening visit 51 participants were included in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo at MRI1/ Ketamine at MRI2
    Arm description
    Using a cross-over design participants were randomized to get either ketamine or placebo during the first MRI-measurement.
    Arm type
    Experimental

    Investigational medicinal product name
    esketamine hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Study drug diluted in 0.9% NaCl. First administration of a bolus of 0.11 mg/kg body weight for 1 minute, followed by a maintenance infusion of 0.12 mg/kg body weight for 19 minutes.

    Arm title
    Ketamine at MRI 1/ Placebo at MRI 2
    Arm description
    Using a cross-over design participants were randomized to get either ketamine or placebo during the first MRI-measurement.
    Arm type
    Placebo

    Investigational medicinal product name
    esketamine hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    55 ml of 0.9 % NaCl was used as placebo.

    Number of subjects in period 1
    Placebo at MRI1/ Ketamine at MRI2 Ketamine at MRI 1/ Placebo at MRI 2
    Started
    21
    20
    MRI measurement completed
    18
    17
    Completed
    18
    17
    Not completed
    3
    3
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    2
    2
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo at MRI1/ Ketamine at MRI2
    Reporting group description
    Using a cross-over design participants were randomized to get either ketamine or placebo during the first MRI-measurement.

    Reporting group title
    Ketamine at MRI 1/ Placebo at MRI 2
    Reporting group description
    Using a cross-over design participants were randomized to get either ketamine or placebo during the first MRI-measurement.

    Reporting group values
    Placebo at MRI1/ Ketamine at MRI2 Ketamine at MRI 1/ Placebo at MRI 2 Total
    Number of subjects
    21 20 41
    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)
    21 20 41
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    24.7 ( 5.2 ) 24.7 ( 4.1 ) -
    Gender categorical
    Units: Subjects
        Female
    10 8 18
        Male
    11 12 23
    Subject analysis sets

    Subject analysis set title
    Main Trial-resting-state measurement
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Only subjects who completed both MRI measurements in the main trial and there was sufficient data quality for the analysis were included in the analysis.

    Subject analysis sets values
    Main Trial-resting-state measurement
    Number of subjects
    35
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    35
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    25.2 ( 4.8 )
    Gender categorical
    Units: Subjects
        Female
    16
        Male
    19

    End points

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    End points reporting groups
    Reporting group title
    Placebo at MRI1/ Ketamine at MRI2
    Reporting group description
    Using a cross-over design participants were randomized to get either ketamine or placebo during the first MRI-measurement.

    Reporting group title
    Ketamine at MRI 1/ Placebo at MRI 2
    Reporting group description
    Using a cross-over design participants were randomized to get either ketamine or placebo during the first MRI-measurement.

    Subject analysis set title
    Main Trial-resting-state measurement
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Only subjects who completed both MRI measurements in the main trial and there was sufficient data quality for the analysis were included in the analysis.

    Primary: Functional connectivity

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    End point title
    Functional connectivity
    End point description
    End point type
    Primary
    End point timeframe
    Ketamine condition vs. Placebo condition, baseline vs. drug condition
    End point values
    Placebo at MRI1/ Ketamine at MRI2 Ketamine at MRI 1/ Placebo at MRI 2 Main Trial-resting-state measurement
    Number of subjects analysed
    18
    17
    35
    Units: BOLD signal
        number (not applicable)
    18
    17
    35
    Statistical analysis title
    repeated-measures ANOVA
    Statistical analysis description
    Interaction effect of time (time blocks of infusion vs. baseline) and drug (ketamine vs. Placebo)
    Comparison groups
    Placebo at MRI1/ Ketamine at MRI2 v Ketamine at MRI 1/ Placebo at MRI 2
    Number of subjects included in analysis
    35
    Analysis specification
    Post-hoc
    Analysis type
    other
    P-value
    ≤ 0.05
    Method
    ANOVA
    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 subjects
    Reporting group description
    -

    Serious adverse events
    All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 41 (12.20%)
    Psychiatric disorders
    claustrophobia, Panic reaction
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 May 2011
    In order to ensure the best possible implementation of the main trial, to optimize the standardized study drug application, to assess start and time-course of ketamine effects and to define the optimal ketamine dosage a pilot trial was performed. In this open trial 11 participants were included, 10 participants completed the pilot-study

    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/25896256
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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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