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    Clinical Trial Results:
    Reconsolidation interference versus retrieval interference as the basis for experimental amnesia in humans – The effect of drug state at memory retrieval

    Summary
    EudraCT number
    		 2016-002392-10
    Trial protocol
    		 BE  
    Global end of trial date
    23 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Nov 2020
    First version publication date
    30 Nov 2020
    Other versions
    Summary report(s)
    		 Academic publication

    Trial information

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    Trial identification
    Sponsor protocol code
    S59302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    KU Leuven
    Sponsor organisation address
    Tiensestraat 102 - box 3712, Leuven, Belgium,
    Public contact
    PI Tom Beckers, KU Leuven, tom.beckers@kuleuven.be
    Scientific contact
    PI Tom Beckers, KU Leuven, tom.beckers@kuleuven.be
    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
    23 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The effect of drug state on memory retrieval after induced experimental amnesia using Propranolol EG 40 mg. Our objective was to test whether the internal drug state induced by a single dose of propranolol (40 mg) was salient/potent enough to make later retrieval of a conditioned fear memory state-dependent.
    Protection of trial subjects
    During all testing days, the experimenter remained in an adjacent room and had one-way visual contact with the subjects at all times. We provided the subjects with the contact details of several support services in case they needed further assistance after completion of the experiment or had the urge to talk to somebody (other than the researchers) about it. These people were prepared to talk to the subjects immediately or get back to them (e.g., contact by e-mail). The counselor in case was Dr. Katleen Bogaerts (therapist and clinical psychologist). Prof. Dr. Lukas Van Oudenhove (MD) could be contacted regarding medical concerns, and for more general issues Marleen Gheldof (student counselor for KU Leuven students) was available.
    Background therapy
    		 None.
    Evidence for comparator
    		 We used a placebo, a commonly used comparator. Placebos were used as they did not contain any active substance that could exert effects upon consumption. Placebo pills were manufactured to be perceptually matched to the active drug (Propranolol). All medication was packaged in the same neutral package that was only labeled with a subject number. Labelling was done by the university hospital pharmacy. These steps were taken as to maintain a double-blind experimental procedure, thus preventing any undue influence on the results from expectations/demands of the subjects or the researcher.
    Actual start date of recruitment
    23 Mar 2017
    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
    Belgium: 85
    Worldwide total number of subjects
    85
    EEA total number of subjects
    85
    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)
    85
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy, adult subjects were recruited from 23/03/2017 until 21/06/2018 through a database of potential research participants, managed by the KU Leuven Faculty of Psychology and Educational Sciences (Experiment Management System, EMS, accessible at psykuleuven.sona-systems.com).

    Pre-assignment
    Screening details
    		 On the first day of the experiment subjects were screened for numerous medical exclusion criteria (exclusion of 1 participant). At the end of the first day, 13 more subjects were excluded based on non-differentiation between CS+ and CS- on EMG. See pre-assignment period.

    Pre-assignment period milestones
    Number of subjects started
    		 85
    Number of subjects completed
    		 71

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Met medical exclusion criterion: 1
    Reason: Number of subjects
    		 Exclusion criterion - non-differentiation CS+/CS-: 13
    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    An external collaborator not involved in the testing randomised subjects into four groups matched on age, gender, trait anxiety (STAI-T), anxiety sensitivity (ASI) and fear of spiders (FSQ).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Propranolol-Propranolol
    Arm description
    		 In this arm, subjects were administered propranolol on the second day of the experiment, following memory reactivation. They were also administered propranolol on the third day of the experiment, prior to testing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Propranolol EG - 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received one oral dose (40 mg) on the second day of the study and one oral dose (40 mg) on the third day of the study.

    Arm title
    		 Propranolol-Placebo
    Arm description
    		 In this arm, subjects were administered propranolol on the second day of the experiment, following memory reactivation. They were administered placebo on the third day of the experiment, prior to testing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Propranolol EG - 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received one oral dose (40 mg) on the second day of the study and one placebo tablet on the third day of the study (orally).

    Arm title
    		 Placebo-Placebo
    Arm description
    		 In this arm, subjects were administered placebo on the second day of the experiment, following memory reactivation. They were also administered placebo on the third day of the experiment, prior to testing.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received one placebo tablet on the second day of the study and one placebo tablet on the third day of the study, orally.

    Arm title
    		 No Reactivation _Propranolol-Placebo
    Arm description
    		 In this arm, subjects were administered propranolol on the second day of the experiment, without prior memory reactivation. They were administered placebo on the third day of the experiment, prior to testing.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Propranolol EG - 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received one oral dose (40 mg) on the second day of the study and one placebo tablet on the third day of the study (orally).

    Number of subjects in period 1 [1]
    		Propranolol-Propranolol Propranolol-Placebo Placebo-Placebo No Reactivation _Propranolol-Placebo
    Started
    19
    16
    19
    17
    Completed
    15
    15
    15
    15
    Not completed
    4
    1
    4
    2
         Subject had low BP and HR - exclusion criterion
    1
    -
    -
    -
         Did not show up on the second/third day
    1
    1
    2
    1
         Subject had a low HR - exclusion criterion
    -
    -
    1
    -
         Pharmacy closed - could not receive medication
    2
    -
    1
    1
    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: The worldwide number enrolled in the trial includes all subjects that were tested for at least one day, thus including those that were excluded at the end of the first day (see pre-assignment period) and were not randomised into one of the arms of the study (see baseline period).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 71 71
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 71 71
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 55 55
        Male
    		 16 16

    End points

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    End points reporting groups
    Reporting group title
    Propranolol-Propranolol
    Reporting group description
    		 In this arm, subjects were administered propranolol on the second day of the experiment, following memory reactivation. They were also administered propranolol on the third day of the experiment, prior to testing.

    Reporting group title
    Propranolol-Placebo
    Reporting group description
    		 In this arm, subjects were administered propranolol on the second day of the experiment, following memory reactivation. They were administered placebo on the third day of the experiment, prior to testing.

    Reporting group title
    Placebo-Placebo
    Reporting group description
    		 In this arm, subjects were administered placebo on the second day of the experiment, following memory reactivation. They were also administered placebo on the third day of the experiment, prior to testing.

    Reporting group title
    No Reactivation _Propranolol-Placebo
    Reporting group description
    		 In this arm, subjects were administered propranolol on the second day of the experiment, without prior memory reactivation. They were administered placebo on the third day of the experiment, prior to testing.

    Primary: Fear-potentiated startle responding

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    End point title
    		 Fear-potentiated startle responding [1]
    End point description
    Values reported have been standardized, as is commonly done in this measure. To standardize the data, means and standard deviations from the first day were used to calculate within-participant z-scores. It is the z-scores that are reported below.
    End point type
    Primary
    End point timeframe
    Fear-potentiated startle responding was measured throughout the experiment, but to assess the end point, we used the average of the first 2 trials during the retention testing phase on day 3 of the experiment.
    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: See attached chart/documents for results.
    End point values
    		 Propranolol-Propranolol Propranolol-Placebo Placebo-Placebo No Reactivation _Propranolol-Placebo
    Number of subjects analysed
    15
    15
    15
    15
    Units: microvolts
    arithmetic mean (standard deviation)
        CS+
    0.480 ± 0.598
    0.746 ± 0.597
    1.063 ± 0.579
    1.035 ± 0.856
        CS-
    0.290 ± 0.850
    0.441 ± 0.637
    0.579 ± 0.527
    0.801 ± 0.836
        NA
    -0.866 ± 0.695
    -0.275 ± 0.570
    -0.746 ± 0.373
    -0.075 ± 0.794
    Attachments
    		 Untitled (Filename: FPS_eudraCT.pdf)
    No statistical analyses for this end point

    Primary: US expectancies

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    End point title
    		 US expectancies [2]
    End point description
    End point type
    Primary
    End point timeframe
    US expectancies were measured throughout the experiment, but to assess the end point, we used the first trial during the retention testing phase on day 3 of the experiment.
    Notes
    [2] - 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: See attached chart/documents for results.
    End point values
    		 Propranolol-Propranolol Propranolol-Placebo Placebo-Placebo No Reactivation _Propranolol-Placebo
    Number of subjects analysed
    15
    15
    15
    15
    Units: Arbitrary units on a scale (-5 to 5)
    arithmetic mean (standard error)
        CS+
    3.733 ± 2.764
    3.200 ± 1.971
    3.800 ± 1.320
    3.933 ± 2.374
        CS-
    -3.533 ± 2.386
    -3.692 ± 1.974
    -2.733 ± 2.404
    -2.467 ± 3.270
    Attachments
    		 Untitled (Filename: USexp_eudraCT.pdf)
    No statistical analyses for this end point

    Secondary: Skin conductance responding

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    End point title
    		 Skin conductance responding
    End point description
    Values reported have been standardized, as is commonly done in this measure. To standardize the data, means and standard deviations from the first day were used to calculate within-participant z-scores. It is the z-scores that are reported below.
    End point type
    Secondary
    End point timeframe
    Skin conductance responding was measured throughout the experiment, but to assess the end point, we used the average of the first 2 trials during the retention testing phase on day 3 of the experiment.
    End point values
    		 Propranolol-Propranolol Propranolol-Placebo Placebo-Placebo No Reactivation _Propranolol-Placebo
    Number of subjects analysed
    11
    13
    13
    14
    Units: microsiemens
    arithmetic mean (standard deviation)
        CS+
    0.321 ± 0.959
    -0.181 ± 0.697
    0.454 ± 0.780
    -0.149 ± 0.650
        CS-
    -0.172 ± 0.635
    -0.169 ± 0.690
    0.045 ± 0.833
    -0.385 ± 0.679
    Attachments
    		 Untitled (Filename: SCR_eudraCT.pdf)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The researcher had to report all serious adverse events immediately to the sponsor except for those that the protocol identifies as not requiring immediate reporting.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Propranolol-Propranolol
    Reporting group description
    		 -

    Reporting group title
    Propranolol-Placebo
    Reporting group description
    		 -

    Reporting group title
    Placebo-Placebo
    Reporting group description
    		 -

    Reporting group title
    No Reactivation_Propranolol-Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Propranolol-Propranolol Propranolol-Placebo Placebo-Placebo No Reactivation_Propranolol-Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Propranolol-Propranolol Propranolol-Placebo Placebo-Placebo No Reactivation_Propranolol-Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    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: There were no non-serious adverse events. Propranolol is a licensed IMP and participants were medically screened before it was administered.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30846933
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