<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/NCT04413786</url>
  </required_header>
  <id_info>
    <org_study_id>UESTC-neuSCAN-71</org_study_id>
    <nct_id>NCT04413786</nct_id>
  </id_info>
  <brief_title>Oxytocin's Effects on Face Attentional Processing</brief_title>
  <official_title>The Modulatory Effect of Oxytocin on Attentional Processing of Emotional Faces</official_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>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate whether intranasal oxytocin (24IU) treatment has a regulatory effect on&#xD;
      attentional processing of emotional faces.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a placebo-controlled double-blind between-subject design experiment, investigators plan to&#xD;
      investigate the effect of oxytocin treatment on attentional processing of emotional faces.&#xD;
      Subjects complete questionnaires in Chinese versions before treatment administration,&#xD;
      including the Beck Depression Inventory, Autism Spectrum Quotient , Trait Anxiety Inventory,&#xD;
      Toronto Alexithymia Scale, Multidimentional Assessment of Interoceptive Awareness. This&#xD;
      experiment consists of two tasks including Emotional Face Cue-target Task and Visual Search&#xD;
      Task. In the first task, subjects need to make a response to judge the position of target&#xD;
      after a cue-target is presented. In the second task, subjects are asked to search the target&#xD;
      &quot;U&quot; or inverted &quot;U&quot; placed on the nose of emotional/neutral faces and make an choices based&#xD;
      on their oorientation. During these phases, subjects' response accuracy, response time and&#xD;
      electrophysiological activity (ERP) are recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 14, 2019</start_date>
  <completion_date type="Actual">December 26, 2021</completion_date>
  <primary_completion_date type="Actual">December 16, 2021</primary_completion_date>
  <phase>N/A</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>Response time in reponse to different emotional face targets.</measure>
    <time_frame>1 hour</time_frame>
    <description>Response time in discriminating which side (left or right) the emotional face target appear.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>N2pc</measure>
    <time_frame>1 hour</time_frame>
    <description>N2pc is an enhanced negative event-related potential typically elicited at posterior electrodes (e.g., PO7 and PO8) contralateral to the target presented among distractors between 180 and 300 ms after the onset of stimuli.&#xD;
display.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response accuracy in response to different emotional face targets.</measure>
    <time_frame>1 hour</time_frame>
    <description>Response accuracy is caculated by the precentage of correct responses among the total responses in discriminating the position (left or right side) of different face conditions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>oxytocin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>male subjects with oxytocin treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>male subjects with placebo treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oxytocin treatment</intervention_name>
    <description>intranasal administration of oxytocin (24IU)</description>
    <arm_group_label>oxytocin group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo treatment</intervention_name>
    <description>intranasal administration of placebo (24IU)</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects without past or current psychiatric or neurological disorders.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of head injury&#xD;
&#xD;
          -  medical or psychiatric illness&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shuxia Yao, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>University of Electronic Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of life science and technology, University of Electronic Science and Technology of China</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>611731</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 8, 2022</last_update_submitted>
  <last_update_submitted_qc>February 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</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>Shuxia Yao</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>oxytocin</keyword>
  <keyword>emotional faces</keyword>
  <keyword>attention</keyword>
  <keyword>N2pc</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/NCT04413786
org study id: UESTC-neuSCAN-71
nct id: NCT04413786
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate whether intranasal oxytocin (24IU) treatment has a regulatory effect on
      attentional processing of emotional faces.
In a placebo-controlled double-blind between-subject design experiment, investigators plan to
      investigate the effect of oxytocin treatment on attentional processing of emotional faces.
      Subjects complete questionnaires in Chinese versions before treatment administration,
      including the Beck Depression Inventory, Autism Spectrum Quotient , Trait Anxiety Inventory,
      Toronto Alexithymia Scale, Multidimentional Assessment of Interoceptive Awareness. This
      experiment consists of two tasks including Emotional Face Cue-target Task and Visual Search
      Task. In the first task, subjects need to make a response to judge the position of target
      after a cue-target is presented. In the second task, subjects are asked to search the target
      "U" or inverted "U" placed on the nose of emotional/neutral faces and make an choices based
      on their oorientation. During these phases, subjects' response accuracy, response time and
      electrophysiological activity (ERP) are recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Response time in reponse to different emotional face targets.
time frame: 1 hour
description: Response time in discriminating which side (left or right) the emotional face target appear.
measure: N2pc
time frame: 1 hour
description: N2pc is an enhanced negative event-related potential typically elicited at posterior electrodes (e.g., PO7 and PO8) contralateral to the target presented among distractors between 180 and 300 ms after the onset of stimuli.
display.
measure: Response accuracy in response to different emotional face targets.
time frame: 1 hour
description: Response accuracy is caculated by the precentage of correct responses among the total responses in discriminating the position (left or right side) of different face conditions.
arm group label: oxytocin group
arm group type: Experimental
description: male subjects with oxytocin treatment
arm group label: placebo group
arm group type: Placebo Comparator
description: male subjects with placebo treatment
intervention type: Drug
intervention name: oxytocin treatment
description: intranasal administration of oxytocin (24IU)
arm group label: oxytocin group
intervention type: Drug
intervention name: placebo treatment
description: intranasal administration of placebo (24IU)
arm group label: placebo group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shuxia Yao, Doctor
role: Study Director
affiliation: University of Electronic Science and Technology
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: University of Electronic Science and Technology of China
investigator full name: Shuxia Yao
investigator title: Associate Professor
mesh term: Oxytocin