<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/NCT04493515</url>
  </required_header>
  <id_info>
    <org_study_id>UESTC-neuSCAN-69</org_study_id>
    <nct_id>NCT04493515</nct_id>
  </id_info>
  <brief_title>Oral Oxytocin's Effects on Attention Control</brief_title>
  <official_title>Oral Oxytocin's Effects on Attention Control: An Eye-tracking Study</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>
    <has_dmc>No</has_dmc>
    <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 investigate whether orally administered oxytocin (24IU) could&#xD;
      modulate attention control using a social-emotional saccade/antisaccade eye-tracking&#xD;
      paradigm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Numerous studies have reported the effect of intranasally administered oxytocin on&#xD;
      attentional processing including stimulus-driven bottom-up processing and top-down&#xD;
      goal-directed inhibitory control. However, it is unclear whether the functional effects are&#xD;
      mediated by the peptide directly entering the brain or indirectly via raising peripheral&#xD;
      concentrations. One possible method of producing a similar pattern of increased peripheral&#xD;
      oxytocin concentrations but without the possibility of direct entry into the brain would be&#xD;
      to administer the peptide lingually. In the present double-blind, between-subject,&#xD;
      placebo-controlled study, 80 healthy male subjects will be recruited and receive either&#xD;
      oxytocin (24IU) or placebo control administered orally (lingual). 45 minutes after treatment&#xD;
      subjects are required to complete a social-emotional saccade/antisaccade eye-tracking&#xD;
      paradigm. This paradigm uses social (happy, sad, angry, fear, and neutral faces) as well as&#xD;
      non-social (oval shapes) stimuli to explore social- and emotion-specific effects of orally&#xD;
      administered oxytocin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>
    <intervention_model_description>Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of oral oxytocin administration on saccade/antisaccade latencies towards social (facial) versus non-social (shape) stimuli</measure>
    <time_frame>45 minutes - 100 minutes after treatment</time_frame>
    <description>Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the oxytocin and placebo treatment conditions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of oral oxytocin administration on error rates of saccade/antisaccade for social (facial) versus non-social (shape) stimuli</measure>
    <time_frame>45 minutes - 100 minutes after treatment</time_frame>
    <description>Comparison between social-specific error rates of saccade/antisaccade between the oxytocin and placebo treatment conditions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emotion-specific effects of oral oxytocin administration on saccade/antisaccade latencies towards the separate facial emotions</measure>
    <time_frame>45 minutes - 100 minutes after treatment</time_frame>
    <description>Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the oxytocin and placebo treatment conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotion-specific effects of oral oxytocin administration on saccade/antisaccade error rates for the separate facial emotions</measure>
    <time_frame>45 minutes - 100 minutes after treatment</time_frame>
    <description>Comparison between emotion-specific saccade/antisaccade error rates between the oxytocin and placebo treatment conditions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Oral Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxytocin orally (24 IU)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo orally (24 IU, identical ingredients, except the active agent)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral Oxytocin</intervention_name>
    <description>Administration of oxytocin orally (24 IU)</description>
    <arm_group_label>Oral Oxytocin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral Placebo</intervention_name>
    <description>Administration of placebo orally (24 IU)</description>
    <arm_group_label>Oral Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male, healthy participants&#xD;
&#xD;
          -  Non smokers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous or current medical, psychiatric, neurological disorder&#xD;
&#xD;
          -  Regular medication&#xD;
&#xD;
          -  Use of any psychoactive substances in the 24 hours before experiment&#xD;
&#xD;
          -  Contra-indications for oxytocin&#xD;
&#xD;
          -  Contra-indications for eye-tracking data acquisition&#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>Keith Kendrick, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Electronic Science and Technology of China (UESTC)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhuang Qian, MD</last_name>
    <phone>13086663679</phone>
    <email>zq19910362@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xu Xiaolei, PhD</last_name>
    <phone>18780140034</phone>
    <email>rabby_uestc@outlook.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Electronic Science and Technology of China(UESTC)</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>611731</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhao Weihua, PhD</last_name>
      <phone>+86 2861 830 811</phone>
      <email>zarazhao.uestc@outlook.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04493515
org study id: UESTC-neuSCAN-69
nct id: NCT04493515
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main aim of the study is to investigate whether orally administered oxytocin (24IU) could
      modulate attention control using a social-emotional saccade/antisaccade eye-tracking
      paradigm.
Numerous studies have reported the effect of intranasally administered oxytocin on
      attentional processing including stimulus-driven bottom-up processing and top-down
      goal-directed inhibitory control. However, it is unclear whether the functional effects are
      mediated by the peptide directly entering the brain or indirectly via raising peripheral
      concentrations. One possible method of producing a similar pattern of increased peripheral
      oxytocin concentrations but without the possibility of direct entry into the brain would be
      to administer the peptide lingually. In the present double-blind, between-subject,
      placebo-controlled study, 80 healthy male subjects will be recruited and receive either
      oxytocin (24IU) or placebo control administered orally (lingual). 45 minutes after treatment
      subjects are required to complete a social-emotional saccade/antisaccade eye-tracking
      paradigm. This paradigm uses social (happy, sad, angry, fear, and neutral faces) as well as
      non-social (oval shapes) stimuli to explore social- and emotion-specific effects of orally
      administered oxytocin.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Effect of oral oxytocin administration on saccade/antisaccade latencies towards social (facial) versus non-social (shape) stimuli
time frame: 45 minutes - 100 minutes after treatment
description: Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the oxytocin and placebo treatment conditions
measure: Effect of oral oxytocin administration on error rates of saccade/antisaccade for social (facial) versus non-social (shape) stimuli
time frame: 45 minutes - 100 minutes after treatment
description: Comparison between social-specific error rates of saccade/antisaccade between the oxytocin and placebo treatment conditions.
measure: Emotion-specific effects of oral oxytocin administration on saccade/antisaccade latencies towards the separate facial emotions
time frame: 45 minutes - 100 minutes after treatment
description: Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the oxytocin and placebo treatment conditions
measure: Emotion-specific effects of oral oxytocin administration on saccade/antisaccade error rates for the separate facial emotions
time frame: 45 minutes - 100 minutes after treatment
description: Comparison between emotion-specific saccade/antisaccade error rates between the oxytocin and placebo treatment conditions
arm group label: Oral Oxytocin
arm group type: Experimental
description: Oxytocin orally (24 IU)
arm group label: Oral Placebo
arm group type: Placebo Comparator
description: Placebo orally (24 IU, identical ingredients, except the active agent)
intervention type: Drug
intervention name: Oral Oxytocin
description: Administration of oxytocin orally (24 IU)
arm group label: Oral Oxytocin
intervention type: Drug
intervention name: Oral Placebo
description: Administration of placebo orally (24 IU)
arm group label: Oral Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Keith Kendrick, PhD
role: Principal Investigator
affiliation: University of Electronic Science and Technology of China (UESTC)
last name: Zhuang Qian, MD
phone: 13086663679
email: zq19910362@126.com
last name: Xu Xiaolei, PhD
phone: 18780140034
email: rabby_uestc@outlook.com
facility: 
status: Recruiting
contact: 
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
sharing ipd: No