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    Clinical Trial Results:
    Boosting oxytocin after trauma: The effects of intranasal oxytocin administration on emotional and motivational brain processes in PTSD

    Summary
    EudraCT number
    		 2012-001288-58
    Trial protocol
    		 NL  
    Global end of trial date
    19 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2021
    First version publication date
    12 Jul 2021
    Other versions
    Summary report(s)
    		 OXT amygdala
    oxytocin amygdala connectivity
    oxytocin distraction
    oxytocin social reward
    oxytocin monetary reward

    Trial information

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    Trial identification
    Sponsor protocol code
    40122
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amsterdam UMC, location Academic Medical Center
    Sponsor organisation address
    Meibergdreef 9, Amsterdam, Netherlands, 1105 AZ
    Public contact
    prof. dr. Miranda Olff, Amsterdam UMC, location Academic Medical Center, Academic Medical Center, Department of Psychiatru, +31 (0)208913662, m.olff@amc.uva.nl
    Scientific contact
    prof. dr. Miranda Olff, Amsterdam UMC, location Academic Medical Center, Department of Psychiatry, +31 (0)208913662, m.olff@amc.uva.nl
    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
    19 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In this functional Magnetic Resonance Imaging (fMRI) study, the primary objective is to examine the acute effects of intranasal OT administration on emotional- and reward-related brain processes in PTSD patients compared to traumatized healthy controls. Furthermore, we aim to examine gender differences in the effects of intranasal OT administration on functional (task-specific) brain activation and in structural anatomy (i.e. volume and white matter integrity) between PTSD patients and traumatized healthy controls.
    Protection of trial subjects
    All study procedures were carried out in accordance with relevant laws and regulations. All involved reseachers had received GCP training. An independent monitor regularly monitored the RCT.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jun 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
    Netherlands: 83
    Worldwide total number of subjects
    83
    EEA total number of subjects
    83
    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)
    83
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 relevant details in terms of medication use: • Evidence of clinically significant and unstable medical conditions in which OT administration is contra-indicative • Use of: prostaglandins, anti-migraine medications (ergot alkaloids), ß-adrenergic receptor-blocking agents, systemic glucocorticoids and psychopharmacological medication.

    Period 1
    Period 1 title
    Inclusion/baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PTSD women
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    oxytocin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal/oromucosal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    single adminstration of 40 IU

    Arm title
    		 PTSD men
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    oxytocin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal/oromucosal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    single adminstration of 40 IU

    Arm title
    		 Healthy control women
    Arm description
    		 -
    Arm type
    		 healthy control

    Investigational medicinal product name
    oxytocin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal/oromucosal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    single adminstration of 40 IU

    Arm title
    		 healthy control men
    Arm description
    		 -
    Arm type
    		 healthy control group

    Investigational medicinal product name
    oxytocin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal/oromucosal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    single adminstration of 40 IU

    Number of subjects in period 1 [1]
    		PTSD women PTSD men Healthy control women healthy control men
    Started
    20
    21
    20
    20
    Completed
    20
    21
    20
    20
    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: 2 participants dropped out prior to randomization
    Period 2
    Period 2 title
    2 fMRI sessions
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Medication allocation was concealed using a treatment code, only accessed by an independent researched who performed the randomization, made the randomization list and had no role in data collection . The study was conducted in a double-blinded way, in which both the participants and researchers involved in data collection were blind to treatment allocation. The treatment coding key remained concealed until data collection was completed unless in case of SAEs (NA in this trial).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PTSD women
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    oxytocin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal/oromucosal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    single adminstration of 40 IU

    Arm title
    		 PTSD men
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    oxytocin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal/oromucosal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    single adminstration of 40 IU

    Arm title
    		 healthy control women
    Arm description
    		 -
    Arm type
    		 healthy control group

    Investigational medicinal product name
    oxytocin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal/oromucosal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    single adminstration of 40 IU

    Arm title
    		 healthy control men
    Arm description
    		 -
    Arm type
    		 healthy control group

    Investigational medicinal product name
    oxytocin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal/oromucosal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    single adminstration of 40 IU

    Number of subjects in period 2 [2]
    		PTSD women PTSD men healthy control women healthy control men
    Started
    19
    21
    20
    20
    Completed
    17
    21
    20
    20
    Not completed
    2
    0
    0
    0
         Adverse event, non-fatal
    2
    -
    -
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 1 participant dropped out prior to starting the mri sessions because of logistical reasons

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Inclusion/baseline
    Reporting group description
    		 -

    Reporting group values
    		 Inclusion/baseline Total
    Number of subjects
    		 81 81
    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)
    		 81 81
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40 ( 10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 40 40
        Male
    		 41 41

    End points

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    End points reporting groups
    Reporting group title
    PTSD women
    Reporting group description
    		 -

    Reporting group title
    PTSD men
    Reporting group description
    		 -

    Reporting group title
    Healthy control women
    Reporting group description
    		 -

    Reporting group title
    healthy control men
    Reporting group description
    		 -
    Reporting group title
    PTSD women
    Reporting group description
    		 -

    Reporting group title
    PTSD men
    Reporting group description
    		 -

    Reporting group title
    healthy control women
    Reporting group description
    		 -

    Reporting group title
    healthy control men
    Reporting group description
    		 -

    Primary: amygdala connectivity

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    End point title
    		 amygdala connectivity
    End point description
    End point type
    Primary
    End point timeframe
    functional brain connectivity at the level of the right amygdala (CEM) with left vmPFC as measured during resting state during each scanning session, comparing activity during oxytocin to activity during placebo
    End point values
    		 PTSD women PTSD men healthy control women healthy control men
    Number of subjects analysed
    14
    19
    19
    19
    Units: AU contrast oxytocin vs placebo
        arithmetic mean (standard error)
    .0542 ( .1010 )
    -.1355 ( .185 )
    -.0009 ( .108 )
    .0606 ( .155 )
    Statistical analysis title
    		 Difference OTvsPL
    Statistical analysis description
    see Koch et al 2015 NPP second-level repeated measures anovas with contrast estimates of positive correlations of ROIs with amygdala seeds, with between-subject factors PTSD status and SEX, and within subjects factor DRUG (OT vs PL), with drug order and mean framewise displacement added as covariate.
    Comparison groups
    PTSD women v healthy control women v PTSD men v healthy control men
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [1] - FWE corrected

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    within 90 minutes after administration and one week after administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2021AA
    Reporting groups
    Reporting group title
    PTSD patients after oxytocin
    Reporting group description
    		 -

    Reporting group title
    PTSD patients after placebo
    Reporting group description
    		 -

    Reporting group title
    controls after oxytocin
    Reporting group description
    		 -

    Reporting group title
    controls after placebo
    Reporting group description
    		 -

    Serious adverse events
    		 PTSD patients after oxytocin PTSD patients after placebo controls after oxytocin controls after placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (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: 4%
    Non-serious adverse events
    		 PTSD patients after oxytocin PTSD patients after placebo controls after oxytocin controls after placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 37 (40.54%)
    15 / 39 (38.46%)
    16 / 40 (40.00%)
    10 / 40 (25.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 37 (16.22%)
    8 / 39 (20.51%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    6
    8
    2
    1
    concentration impaired
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 39 (5.13%)
    6 / 40 (15.00%)
    5 / 40 (12.50%)
         occurrences all number
    1
    2
    6
    5
    lightheadedness
    Additional description: lightheadedness or dizziness
         subjects affected / exposed
    2 / 37 (5.41%)
    2 / 39 (5.13%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    2
    2
    1
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 37 (18.92%)
    6 / 39 (15.38%)
    10 / 40 (25.00%)
    6 / 40 (15.00%)
         occurrences all number
    7
    6
    10
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 May 2012
    added questionnaire on workrelated traumatic events
    26 Oct 2012
    collection of hair for cortisol assessment

    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
    For support, Contact us.
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    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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