<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/NCT03293511</url>
  </required_header>
  <id_info>
    <org_study_id>UESCT_neuSCAN_42</org_study_id>
    <nct_id>NCT03293511</nct_id>
  </id_info>
  <brief_title>Oxytocin Modulates Eye Gaze Behavior During Social Processing</brief_title>
  <official_title>Oxytocin Modulates Eye Gaze Behavior During Social Processing and Associations With Trait Autism</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>
      The main aim of the study is to examine whether the effects of intranasal oxytocin on&#xD;
      eye-gaze behavior towards social stimuli are modulated via individual differences in trait&#xD;
      autism&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this double-blind, within subject, placebo controlled design a total of n = 40 healthy&#xD;
      male subjects will receive either 24 IU of oxytocin or placebo (interval between&#xD;
      administration &gt; two weeks). 45 minutes after treatment subjects will undergo a total of 7&#xD;
      eye-tracking paradigms examining eye-gaze behavior during social processing: (1) dynamic&#xD;
      social-nonsocial visual preference task during which movies of dynamic geometric images (DGI)&#xD;
      and dynamic social images (DSI) will be presented; (2) non-biological versus biological&#xD;
      motion task; (3) social attention and motivation of sharing enjoyment; (4) preference for&#xD;
      emotional faces versus schematic faces (emoticons); (5) shared social attention - shared gaze&#xD;
      direction with an actor shifting his attention to different objects; (6) preferred visual&#xD;
      scanning of face regions in emotional faces; and, (7) eye gaze in response to empathy&#xD;
      eliciting visual stimuli. Autistic and associated traits will be assessed using the Autism&#xD;
      Spectrum Quotient (ASQ), Social Responsibilities Scale (SRS) and the Interpersonal Reactivity&#xD;
      Index (IRI). Within-subject differences in the effects of oxytocin on social eye gazing&#xD;
      behaviour will be related to individual differences in autistic traits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 9, 2017</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized placebo-controlled double-blind within-subject design</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global eye gaze characteristic: differences between oxytocin and placebo treatment</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>Global eye-gaze patterns will be compared between the administration of oxytocin and placebo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feature-specific eye gaze characteristics: differences between oxytocin and placebo treatment</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>Localized feature-specific eye gaze patterns will be compared between oxytocin and placebo treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global eye gaze characteristic - associations with autism traits</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>Within-subject differences in global eye gaze characteristics between the oxytocin and placebo administration will be examined for associations with individual differences in autism traits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feature-specific eye gaze characteristics - associations with trait autism</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>Within-subject differences in localized feature-specific eye gaze characteristics between the oxytocin and placebo administration will be examined for associations with individual differences in autism traits</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Order of administration: oxytocin - placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo nasal spray</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Order of administration: placebo - oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants first received placebo nasal spray. After a washout period of 2 weeks, they then receive oxytocin (24 IU).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intranasal oxytocin</intervention_name>
    <description>24 IU of oxytocin nasal spray will be applied to each subject.</description>
    <arm_group_label>Order of administration: oxytocin - placebo</arm_group_label>
    <arm_group_label>Order of administration: placebo - oxytocin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intranasal placebo</intervention_name>
    <description>24 IU of of placebo nasal spray will be applied to each subject.</description>
    <arm_group_label>Order of administration: oxytocin - placebo</arm_group_label>
    <arm_group_label>Order of administration: placebo - oxytocin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects without any past or present psychiatric or neurological disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of brain injury&#xD;
&#xD;
          -  Visual impairments&#xD;
&#xD;
          -  Use of medication&#xD;
&#xD;
          -  Contraindications for oxytocin administration&#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>Juan Kou, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>University of Electronic Science and Technology of China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Keith M Kendrick, PhD</last_name>
    <phone>86-28-61830811</phone>
    <email>k.kendrick.uestc@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Benjamin Becker, PhD</last_name>
    <phone>86-28-61830988</phone>
    <email>ben_becker@gmx.de</email>
  </overall_contact_backup>
  <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>610054</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Kou, Master</last_name>
      <email>Joykou.uestc@outlook.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Electronic Science and Technology of China</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>611731</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>October 26, 2018</last_update_submitted>
  <last_update_submitted_qc>October 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2018</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</investigator_title>
  </responsible_party>
  <keyword>Oxytocin</keyword>
  <keyword>Eye tracking</keyword>
  <keyword>Autistic trait</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/NCT03293511
org study id: UESCT_neuSCAN_42
nct id: NCT03293511
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The main aim of the study is to examine whether the effects of intranasal oxytocin on
      eye-gaze behavior towards social stimuli are modulated via individual differences in trait
      autism
In this double-blind, within subject, placebo controlled design a total of n = 40 healthy
      male subjects will receive either 24 IU of oxytocin or placebo (interval between
      administration > two weeks). 45 minutes after treatment subjects will undergo a total of 7
      eye-tracking paradigms examining eye-gaze behavior during social processing: (1) dynamic
      social-nonsocial visual preference task during which movies of dynamic geometric images (DGI)
      and dynamic social images (DSI) will be presented; (2) non-biological versus biological
      motion task; (3) social attention and motivation of sharing enjoyment; (4) preference for
      emotional faces versus schematic faces (emoticons); (5) shared social attention - shared gaze
      direction with an actor shifting his attention to different objects; (6) preferred visual
      scanning of face regions in emotional faces; and, (7) eye gaze in response to empathy
      eliciting visual stimuli. Autistic and associated traits will be assessed using the Autism
      Spectrum Quotient (ASQ), Social Responsibilities Scale (SRS) and the Interpersonal Reactivity
      Index (IRI). Within-subject differences in the effects of oxytocin on social eye gazing
      behaviour will be related to individual differences in autistic traits.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized placebo-controlled double-blind within-subject design
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Global eye gaze characteristic: differences between oxytocin and placebo treatment
time frame: 45-90 minutes after treatment administration
description: Global eye-gaze patterns will be compared between the administration of oxytocin and placebo
measure: Feature-specific eye gaze characteristics: differences between oxytocin and placebo treatment
time frame: 45-90 minutes after treatment administration
description: Localized feature-specific eye gaze patterns will be compared between oxytocin and placebo treatment
measure: Global eye gaze characteristic - associations with autism traits
time frame: 45-90 minutes after treatment administration
description: Within-subject differences in global eye gaze characteristics between the oxytocin and placebo administration will be examined for associations with individual differences in autism traits
measure: Feature-specific eye gaze characteristics - associations with trait autism
time frame: 45-90 minutes after treatment administration
description: Within-subject differences in localized feature-specific eye gaze characteristics between the oxytocin and placebo administration will be examined for associations with individual differences in autism traits
arm group label: Order of administration: oxytocin - placebo
arm group type: Experimental
description: Participants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo nasal spray
arm group label: Order of administration: placebo - oxytocin
arm group type: Experimental
description: Participants first received placebo nasal spray. After a washout period of 2 weeks, they then receive oxytocin (24 IU).
intervention type: Drug
intervention name: intranasal oxytocin
description: 24 IU of oxytocin nasal spray will be applied to each subject.
arm group label: Order of administration: oxytocin - placebo
arm group label: Order of administration: placebo - oxytocin
intervention type: Drug
intervention name: intranasal placebo
description: 24 IU of of placebo nasal spray will be applied to each subject.
arm group label: Order of administration: oxytocin - placebo
arm group label: Order of administration: placebo - oxytocin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Juan Kou, MSc
role: Study Chair
affiliation: University of Electronic Science and Technology of China
last name: Keith M Kendrick, PhD
phone: 86-28-61830811
email: k.kendrick.uestc@gmail.com
last name: Benjamin Becker, PhD
phone: 86-28-61830988
email: ben_becker@gmx.de
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
country: China
responsible party type: Principal Investigator
investigator affiliation: University of Electronic Science and Technology of China
investigator full name: Keith Kendrick
investigator title: Professor
mesh term: Oxytocin