<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03265899</url>
  </required_header>
  <id_info>
    <org_study_id>OXT_OLF_2017</org_study_id>
    <nct_id>NCT03265899</nct_id>
  </id_info>
  <brief_title>Oxytocin and the Processing of Social Stress-Associated Chemosignals</brief_title>
  <official_title>Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Stress-Associated Chemosignals Processing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bonn</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bonn</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether oxytocin modulates the processing of&#xD;
      stress-associated chemosignals and which substrates are involved.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Social transmission of stress and fear is not restricted to visual or auditory cues, but&#xD;
      extends to the olfactory domain, a phylogenetically more ancient sense. Exposure to axillary&#xD;
      sweat from healthy volunteers undergoing an emotional stressor task evokes a strong vicarious&#xD;
      stress response on the behavioral and neural level.Particularly, anxious individuals have&#xD;
      been shown to exhibit a heightened sensitivity to social chemosensory stress cues (axillary&#xD;
      sweat). The neuropeptide oxytocin (OXT) exerts anxiolytic and anti-stress effects in visual&#xD;
      and auditory modalities, however, it still elusive whether OXT also modulates the processing&#xD;
      of stress-associated chemosignals. Axillary sweat were obtained from an unrelated sample of&#xD;
      30 healthy men undergoing the Trier Social Stress Test and ergometer training as&#xD;
      control.Subsequently, subjects completed a forced-choice emotional face recognition task&#xD;
      composed of stimuli with varying intensities (neutral to fearful), while they were exposed to&#xD;
      both sweat stimuli and a non-social control odor (raspberry) after OXT or placebo&#xD;
      administration, respectively. The investigators expect that OXT selectively diminishes&#xD;
      chemosensory-induced behavioral biases and neural responses to stress-related odors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Actual">November 30, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Forced-choice ratings of morphed emotional faces with varying intensities (neutral to fearful).</measure>
    <time_frame>30 min after nasal spray administration</time_frame>
    <description>After each trial, subjects were asked to use a button response grip to indicate whether they perceived the depicted face as neutral or fearful.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response time for facial stimuli ratings.</measure>
    <time_frame>30 min after nasal spray administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood-oxygen-level dependent signal in response to chemosensory cues.</measure>
    <time_frame>30 minutes after nasal spray administration</time_frame>
    <description>The modulatory effect of oxytocin on neural correlates Using functional magnetic resonance imaging, signal changes in the amygdala, hippocampus and the anterior cingulate cortex in response to olfactory cues of stress and sport (axillary sweat obtained from an unrelated sample of 30 healthy men undergoing the Trier Social Stress Test and ergometer training as control).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire measurement of mood (PANAS).</measure>
    <time_frame>15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva oxytocin concentrations</measure>
    <time_frame>immediately before the nasal spray administration and (on average) 10 minutes after the fMRI experiment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire measurement of anxiety (STAI).</measure>
    <time_frame>15 minutes after nasal spray administration and (on average) 10 minutes after the fMRI experiment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 IU Oxytocin, intranasal application 30 min prior to the experiment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>sodium chloride solution, intranasal application 30 min prior to the experiment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>40 IU; 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>Syntocinon-Spray, Novartis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo nasal spray, 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo-Spray, Novartis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or past psychiatric disease&#xD;
&#xD;
          -  Current or past physical illness&#xD;
&#xD;
          -  Psychoactive medication&#xD;
&#xD;
          -  Tobacco smokers&#xD;
&#xD;
          -  MRI contraindications (e.g. metal in body, claustrophobia)&#xD;
&#xD;
          -  Anosmia&#xD;
&#xD;
          -  Medication known to interfere with olfactory processing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rene Hurlemann, MSc MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry, University of Bonn, Germany</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Bonn</investigator_affiliation>
    <investigator_full_name>Rene Hurlemann</investigator_full_name>
    <investigator_title>Prof. Dr. Dr.</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lactitol</mesh_term>
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03265899
org study id: OXT_OLF_2017
nct id: NCT03265899
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to determine whether oxytocin modulates the processing of
      stress-associated chemosignals and which substrates are involved.
Social transmission of stress and fear is not restricted to visual or auditory cues, but
      extends to the olfactory domain, a phylogenetically more ancient sense. Exposure to axillary
      sweat from healthy volunteers undergoing an emotional stressor task evokes a strong vicarious
      stress response on the behavioral and neural level.Particularly, anxious individuals have
      been shown to exhibit a heightened sensitivity to social chemosensory stress cues (axillary
      sweat). The neuropeptide oxytocin (OXT) exerts anxiolytic and anti-stress effects in visual
      and auditory modalities, however, it still elusive whether OXT also modulates the processing
      of stress-associated chemosignals. Axillary sweat were obtained from an unrelated sample of
      30 healthy men undergoing the Trier Social Stress Test and ergometer training as
      control.Subsequently, subjects completed a forced-choice emotional face recognition task
      composed of stimuli with varying intensities (neutral to fearful), while they were exposed to
      both sweat stimuli and a non-social control odor (raspberry) after OXT or placebo
      administration, respectively. The investigators expect that OXT selectively diminishes
      chemosensory-induced behavioral biases and neural responses to stress-related odors.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Forced-choice ratings of morphed emotional faces with varying intensities (neutral to fearful).
time frame: 30 min after nasal spray administration
description: After each trial, subjects were asked to use a button response grip to indicate whether they perceived the depicted face as neutral or fearful.
measure: Response time for facial stimuli ratings.
time frame: 30 min after nasal spray administration
measure: Blood-oxygen-level dependent signal in response to chemosensory cues.
time frame: 30 minutes after nasal spray administration
description: The modulatory effect of oxytocin on neural correlates Using functional magnetic resonance imaging, signal changes in the amygdala, hippocampus and the anterior cingulate cortex in response to olfactory cues of stress and sport (axillary sweat obtained from an unrelated sample of 30 healthy men undergoing the Trier Social Stress Test and ergometer training as control).
measure: Questionnaire measurement of mood (PANAS).
time frame: 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
measure: Saliva oxytocin concentrations
time frame: immediately before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
measure: Questionnaire measurement of anxiety (STAI).
time frame: 15 minutes after nasal spray administration and (on average) 10 minutes after the fMRI experiment
arm group label: Oxytocin
arm group type: Experimental
description: 40 IU Oxytocin, intranasal application 30 min prior to the experiment
arm group label: Placebo
arm group type: Placebo Comparator
description: sodium chloride solution, intranasal application 30 min prior to the experiment
intervention type: Drug
intervention name: Oxytocin
description: 40 IU; 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds
arm group label: Oxytocin
other name: Syntocinon-Spray, Novartis
intervention type: Drug
intervention name: Placebo
description: Placebo nasal spray, 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds
arm group label: Placebo
other name: Placebo-Spray, Novartis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rene Hurlemann, MSc MD PhD
role: Principal Investigator
affiliation: Department of Psychiatry, University of Bonn, Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Bonn
investigator full name: Rene Hurlemann
investigator title: Prof. Dr. Dr.
mesh term: Lactitol
mesh term: Oxytocin
sharing ipd: No