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    Clinical Trial Results:
    Mechanisms of action in exposure therapy: Decoding the neural basis of fear extinction and its pharmacological modulation in patients with panic disorder

    Summary
    EudraCT number
    		 2010-023044-32
    Trial protocol
    		 DE  
    Global end of trial date
    31 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2022
    First version publication date
    01 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DCS-fMRIPanik
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Prof. Dr. Andreas Ströhle Klinik für Psychiatrie und Psychotherapie Campus Charité Mitte, Charité - Universitätsmedizin Berlin, 030 450517034, andreas.stroehle@charite.de
    Scientific contact
    Koordinierungszentrum für klinische Studien der Charité KKS Charité Augustenburger Platz 1 13353 , Charité - Universitätsmedizin Berlin, 030 450 553 875, regulatory-kks@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
    31 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Changes in neuronal activation patterns of the three measurements of time in the "Extinction Circuit" (eg amygdala, hippocampus, medial prefrontal cortex)
    Protection of trial subjects
    Please see subject disposition
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2012
    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
    Germany: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    37
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 advertisemnts in newspapers, internet and the ambulance were used during a recruitment period of 18 months

    Pre-assignment
    Screening details
    		 Height, Weight, Bloodpressure, Pulse, ECG, psychiatric Examination, Blood Examination, Clinical Chemistry, Pregnancy Test, DrugScreening, urinanalysis Clinical Scales: Composite International Diagnostic Interview (CIDI/DIA-X); Hamilton Anxiety Rating (HAMA); SIGH-A Interviewform; Clinical Global Impression Panic Scale (CGIpanic); ....

    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, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DCS-Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Seromycin
    Investigational medicinal product code
    SUB06863MIG
    Other name
    CYCLOSERINE
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received an oral dose of 50 mg of DCS (reformulated from 250 mg capsules, Seromycin®, USA) 1 h before extinction on Day 2.

    Arm title
    		 Placebo-Group
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received an oral dose of 50 mg of Placebo 1 h before extinction on day 2

    Number of subjects in period 1
    		DCS-Group Placebo-Group
    Started
    20
    17
    Completed
    20
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DCS-Group
    Reporting group description
    		 -

    Reporting group title
    Placebo-Group
    Reporting group description
    		 -

    Reporting group values
    		 DCS-Group Placebo-Group Total
    Number of subjects
    		 20 17 37
    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)
    		 20 17 37
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.87 ± 5.67 27.82 ± 5.24 -
    Gender categorical
    Units: Subjects
        Female
    		 9 7 16
        Male
    		 11 10 21
    Smoking status
    Units: Subjects
        smoker
    		 7 5 12
        non-smoker
    		 12 11 23
        no information
    		 1 1 2
    Neuroticism
    Units: Score
        arithmetic mean (standard deviation)
    		 1.58 ± 0.36 1.56 ± 0.26 -
    Anxiety Sensitivity Index
    Units: Score
        arithmetic mean (standard deviation)
    		 8.75 ± 6.33 8.69 ± 5.4 -
    Trail making test TMT A
    Units: Score
        arithmetic mean (standard deviation)
    		 22.80 ± 6.00 23.93 ± 5.71 -
    Trail making test TMT B
    Units: Score
        arithmetic mean (standard deviation)
    		 46.85 ± 11.14 50.47 ± 13.57 -
    Regensburg Verbal Fluency Test - P words
    Units: Score
        arithmetic mean (standard deviation)
    		 11.15 ± 3.80 13.53 ± 3.56 -
    Regensburg Verbal Fluency Test - K words
    Units: Score
        arithmetic mean (standard deviation)
    		 14.95 ± 3.14 15.27 ± 4.74 -
    Range of numbers - forward
    Units: Score
        arithmetic mean (standard deviation)
    		 8.60 ± 1.85 8.80 ± 1.20 -
    Range of numbers - backwards
    Units: Score
        arithmetic mean (standard deviation)
    		 8.25 ± 1.88 8.53 ± 2.32 -

    End points

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    End points reporting groups
    Reporting group title
    DCS-Group
    Reporting group description
    		 -

    Reporting group title
    Placebo-Group
    Reporting group description
    		 -

    Primary: fMRI shows DCS effects on return of Fear in the amygdala Region

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    End point title
    		 fMRI shows DCS effects on return of Fear in the amygdala Region
    End point description
    placebo compared to DCS subjects showed significant increases in differential BOLD (Blood-Oxygen- Level-Dependent) responses in the left amygdala (MNI peak at [x: −24, y: 2) and left posterior hippocampus (MNI peak at [x: −33, y: −34, z: −8]) from extinction learning to recall. For more information see Fig. 3
    End point type
    Primary
    End point timeframe
    2 Days
    End point values
    		 DCS-Group Placebo-Group
    Number of subjects analysed
    20
    17
    Units: Score
    arithmetic mean (standard deviation)
        extinction cs+
    0.3 ± 0.1
    -0.13 ± 0.1
        extinction cs-
    -0.10 ± 0.1
    0.05 ± 0.1
        recall cs+
    -0.3 ± 0.1
    0.18 ± 0.1
        recall cs-
    0.1 ± 0.1
    -0.10 ± 0.1
    Attachments
    		 behavioral and neural measures of ROF
    Statistical analysis title
    		 Behavioral and psychophysiological measures
    Statistical analysis description
    All analyses included study site as a covariate and were performed using R software (v3.4.3; [38]).Conditioning effects in valence and arousal ratings were analyzed in separate repeated measures ANCOVAs (rmANCOVA) with within-subject factors cue (CS+/CS−) and time (pre-/post-acquisition on day 1).
    Comparison groups
    DCS-Group v Placebo-Group
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05 [1]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - Our analyses focused on predefined regions of interest (ROIs) using small volume correction (SVC) at p < 0.05 FWE-corrected, specifically, insula, dACC, amygdala, hippocampus and vmPFC

    Secondary: DCS prevented the return of fear in arousal ratings

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    End point title
    		 DCS prevented the return of fear in arousal ratings
    End point description
    Participants receiving placebo but not DCS experienced a generalized ROF in arousal ratings, mainly driven by increases towards the CS+ from post-extinction to pre-recall.
    End point type
    Secondary
    End point timeframe
    2days
    End point values
    		 DCS-Group Placebo-Group
    Number of subjects analysed
    20
    17
    Units: Score
    arithmetic mean (standard deviation)
        post extinction cs+
    1.9 ± 0.1
    2.2 ± 0.1
        post extinction cs-
    1.7 ± 0.1
    1.9 ± 0.1
        pre recall cs+
    1.8 ± 0.1
    2.8 ± 0.1
        pre recall cs-
    1.7 ± 0.1
    2 ± 0.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    immediately within 24 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Direktive 2001/20 EG
    Dictionary version
    4-Apr-2001
    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 adverse event were 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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28512009
    http://www.ncbi.nlm.nih.gov/pubmed/31634897
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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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