<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/NCT01701180</url>
  </required_header>
  <id_info>
    <org_study_id>OXT-151/12</org_study_id>
    <secondary_id>OXT-151/12</secondary_id>
    <nct_id>NCT01701180</nct_id>
  </id_info>
  <brief_title>Neural Correlates of Empathogenic and Affiliative Actions of Oxytocin</brief_title>
  <acronym>ODIS</acronym>
  <official_title>Neural Correlates of the Empathogenic and Affiliative Actions of Oxytocin</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin&#xD;
      has prosocial effects. However, the neural substrates of these effects are still unclear. The&#xD;
      investigators hypothesized that a single dose administration of oxytocin should increase&#xD;
      empathogenic and affiliative responses and that these effects are mediated by an increased&#xD;
      insula activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>Early 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Empathy ratings and their neural correlates</measure>
    <time_frame>About one hour after the intranasal administration of oxytocin</time_frame>
    <description>All subjects are scanned while they view emotional and neutral faces and rate their empathy for these stimuli.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neural correlates of pair-bonding</measure>
    <time_frame>About one hour after the intranasal administration of oxytocin</time_frame>
    <description>All subjects are scanned while they view a picture of their mate and and an unknown female.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 IU Oxytocin, intranasal application 45 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>Intranasal application, sodium chloride solution, 3 puffs per nostril</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>24 IU; 3 puffs per nostril, each with 4 IU OXT</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>Oxytocin: Syntocinon-Spray, Novartis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male volunteers&#xD;
&#xD;
          -  In a heterosexual relationship&#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;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>René Hurlemann, MD PhD M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry University of Bonn</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Psychiatry, University of Bonn</name>
      <address>
        <city>Bonn</city>
        <state>North Rhine-Westphalia</state>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://renehurlemann.squarespace.com/welcome/</url>
    <description>NEMO research group</description>
  </link>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>December 2, 2014</last_update_submitted>
  <last_update_submitted_qc>December 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</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>MSc MD PhD</investigator_title>
  </responsible_party>
  <keyword>Male Volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01701180
org study id: OXT-151/12
secondary id: OXT-151/12
nct id: NCT01701180
lead sponsor: 
has dmc: No
Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin
      has prosocial effects. However, the neural substrates of these effects are still unclear. The
      investigators hypothesized that a single dose administration of oxytocin should increase
      empathogenic and affiliative responses and that these effects are mediated by an increased
      insula activity.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Empathy ratings and their neural correlates
time frame: About one hour after the intranasal administration of oxytocin
description: All subjects are scanned while they view emotional and neutral faces and rate their empathy for these stimuli.
measure: Neural correlates of pair-bonding
time frame: About one hour after the intranasal administration of oxytocin
description: All subjects are scanned while they view a picture of their mate and and an unknown female.
arm group label: Oxytocin
arm group type: Experimental
description: 24 IU Oxytocin, intranasal application 45 min prior to the experiment
arm group label: Placebo
arm group type: Placebo Comparator
description: Intranasal application, sodium chloride solution, 3 puffs per nostril
intervention type: Drug
intervention name: Oxytocin
description: 24 IU; 3 puffs per nostril, each with 4 IU OXT
arm group label: Oxytocin
other name: Oxytocin: Syntocinon-Spray, Novartis
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: René Hurlemann, MD PhD M.Sc.
role: Principal Investigator
affiliation: Department of Psychiatry University of Bonn
facility: 
country: Germany
url: http://renehurlemann.squarespace.com/welcome/
description: NEMO research group
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Bonn
investigator full name: Rene Hurlemann
investigator title: MSc MD PhD
mesh term: Oxytocin