<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/NCT04493554</url>
  </required_header>
  <id_info>
    <org_study_id>UESTC-neuSCAN-70</org_study_id>
    <nct_id>NCT04493554</nct_id>
  </id_info>
  <brief_title>The Effects of Vasopressin on Attention Control</brief_title>
  <official_title>The Effects of Vasopressin 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 present study is to investigate whether intranasal vasopressin (20IU)&#xD;
      could influence attention control in a social-emotional saccade/antisaccade eye-tracking&#xD;
      paradigm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A number of previous studies have reported vasopressin's effect on human social behavior and&#xD;
      social cognition, although it remains unclear whether vasopressin could modulate attention&#xD;
      allocation including stimulus-driven bottom-up control and goal-directed top-down control. In&#xD;
      the current randomized, between-subject, placebo controlled study, 89 healthy male subjects&#xD;
      will be recruited and receive either vasopressin (20 IU) or placebo control administered&#xD;
      intranasally. 45 minutes after treatment subjects will be required to complete a&#xD;
      social-emotional saccade /antisaccade eye-tracking paradigm. The paradigm uses social (happy,&#xD;
      sad, angry, fear, and neutral faces) as well as non-social (oval shapes) stimuli to explore&#xD;
      social- and emotion-specific effects of vasopressin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 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 vasopressin 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 vasopressin and placebo treatment conditions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of vasopressin 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 vasopressin and placebo treatment conditions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emotion-specific effects of vasopressin 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 vasopressin and placebo treatment conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotion-specific effects of vasopressin 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 vasopressin and placebo treatment conditions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Vasopressin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vasopressin (20 IU) intranasally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo intranasally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vasopressin</intervention_name>
    <description>Administration of vasopressin (20 IU) intranasally</description>
    <arm_group_label>Vasopressin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administration of placebo intranasally</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  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 vasopressin&#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>
  <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>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</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>January 5, 2021</last_update_submitted>
  <last_update_submitted_qc>January 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2021</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>Vasopressins</mesh_term>
    <mesh_term>Arginine Vasopressin</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/NCT04493554
org study id: UESTC-neuSCAN-70
nct id: NCT04493554
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main aim of the present study is to investigate whether intranasal vasopressin (20IU)
      could influence attention control in a social-emotional saccade/antisaccade eye-tracking
      paradigm.
A number of previous studies have reported vasopressin's effect on human social behavior and
      social cognition, although it remains unclear whether vasopressin could modulate attention
      allocation including stimulus-driven bottom-up control and goal-directed top-down control. In
      the current randomized, between-subject, placebo controlled study, 89 healthy male subjects
      will be recruited and receive either vasopressin (20 IU) or placebo control administered
      intranasally. 45 minutes after treatment subjects will be required to complete a
      social-emotional saccade /antisaccade eye-tracking paradigm. The 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 vasopressin.
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 vasopressin 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 vasopressin and placebo treatment conditions
measure: Effect of vasopressin 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 vasopressin and placebo treatment conditions
measure: Emotion-specific effects of vasopressin 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 vasopressin and placebo treatment conditions
measure: Emotion-specific effects of vasopressin 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 vasopressin and placebo treatment conditions
arm group label: Vasopressin
arm group type: Experimental
description: Vasopressin (20 IU) intranasally
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo intranasally
intervention type: Drug
intervention name: Vasopressin
description: Administration of vasopressin (20 IU) intranasally
arm group label: Vasopressin
intervention type: Drug
intervention name: Placebo
description: Administration of placebo intranasally
arm group label: 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)
facility: 
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: Vasopressins
mesh term: Arginine Vasopressin
sharing ipd: No