<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/NCT02183948</url>
  </required_header>
  <id_info>
    <org_study_id>UESTC-SCAN-01</org_study_id>
    <secondary_id>UESTC-SCAN-01</secondary_id>
    <nct_id>NCT02183948</nct_id>
  </id_info>
  <brief_title>Effect of Oxytocin on Masked Facial Expressions: an fMRI Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Electronic Science and Technology of China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Electronic Science and Technology of China</source>
  <brief_summary>
    <textblock>
      The purpose is to test whether oxytocin has an effect on masked facial expressions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The neuropeptide oxytocin (OXT) has been shown to modulate several aspects of human social&#xD;
      cognition. Although the exact mechanisms behind these effects remain unclear, recent research&#xD;
      suggests that OXT modulates the perception of cues that are important for interpersonal&#xD;
      processing, particularly emotional facial expressions. Using a backward masking procedure and&#xD;
      functional magnetic resonance imaging, we investigated the modulatory effects of intranasal&#xD;
      OXT on the processing of sub-liminally presented emotional faces. In a double-blind&#xD;
      placebo-controlled between-subject pharmaco-fMRI experiment healthy volunteers received&#xD;
      either 24IU of intranasal oxytocin or placebo 45mins before they were presented emotional&#xD;
      (happy, angry, fearful, sad, disgusting) faces and mirror-reversed neutral faces masked by&#xD;
      neutral faces of the same individual. To ensure attentional processing of the faces subjects&#xD;
      were required to perform a simple gender decision task in the scanner and a recognition&#xD;
      memory task afterwards. All subjects were additionally assessed for their state and trait&#xD;
      anxiety and depression as well as empathy. For the analysis, we will use matlab, SPM and SPSS&#xD;
      to conduct structural ROI analysis and two Sample t test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with neuro activity to facial expressions</measure>
    <time_frame>one week</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Facial Expressions</condition>
  <arm_group>
    <arm_group_label>oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nasal spray</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>nasal spray</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <arm_group_label>oxytocin</arm_group_label>
  </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 subjects, no smoke or drink alcohol, coffee or other stimulants during the day&#xD;
             before Experiment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of head injury; pregnancy; uterine cavity operations were took within one&#xD;
             year; medical or psychiatric illness; rhinitis in case they may not fully absorb the&#xD;
             spray.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>March 4, 2017</last_update_submitted>
  <last_update_submitted_qc>March 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Electronic Science and Technology of China</investigator_affiliation>
    <investigator_full_name>Keith Kendrick</investigator_full_name>
    <investigator_title>Professor / Research group leader</investigator_title>
  </responsible_party>
  <keyword>treatment</keyword>
  <keyword>mask face exoressions</keyword>
  <keyword>genier</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Facies</mesh_term>
  </condition_browse>
  <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/NCT02183948
org study id: UESTC-SCAN-01
secondary id: UESTC-SCAN-01
nct id: NCT02183948
lead sponsor: 
The purpose is to test whether oxytocin has an effect on masked facial expressions
The neuropeptide oxytocin (OXT) has been shown to modulate several aspects of human social
      cognition. Although the exact mechanisms behind these effects remain unclear, recent research
      suggests that OXT modulates the perception of cues that are important for interpersonal
      processing, particularly emotional facial expressions. Using a backward masking procedure and
      functional magnetic resonance imaging, we investigated the modulatory effects of intranasal
      OXT on the processing of sub-liminally presented emotional faces. In a double-blind
      placebo-controlled between-subject pharmaco-fMRI experiment healthy volunteers received
      either 24IU of intranasal oxytocin or placebo 45mins before they were presented emotional
      (happy, angry, fearful, sad, disgusting) faces and mirror-reversed neutral faces masked by
      neutral faces of the same individual. To ensure attentional processing of the faces subjects
      were required to perform a simple gender decision task in the scanner and a recognition
      memory task afterwards. All subjects were additionally assessed for their state and trait
      anxiety and depression as well as empathy. For the analysis, we will use matlab, SPM and SPSS
      to conduct structural ROI analysis and two Sample t test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Number of participants with neuro activity to facial expressions
time frame: one week
arm group label: oxytocin
arm group type: Experimental
description: nasal spray
arm group label: Placebo
arm group type: Placebo Comparator
description: nasal spray
intervention type: Drug
intervention name: Oxytocin
arm group label: oxytocin
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Electronic Science and Technology of China
investigator full name: Keith Kendrick
investigator title: Professor / Research group leader
mesh term: Facies
mesh term: Oxytocin