<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/NCT02228031</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00059904</org_study_id>
    <nct_id>NCT02228031</nct_id>
  </id_info>
  <brief_title>Oxytocin, Emotions and Mirror Neurons</brief_title>
  <official_title>The Influence of Oxytocin on the Mirror Neuron System: Developing Brain Imaging Paradigms for Future Therapeutic Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Maryland, College Park</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to investigate the possible effect of intranasally&#xD;
      administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron&#xD;
      system (MNS) is thought to be involved in action perception and understanding, and may also&#xD;
      underlie more complex cognitive processes such as imitation. We will use&#xD;
      electroencephalographic (EEG) investigations to examine brain activity while participants&#xD;
      complete two different tasks, consisting of the observation and imitation of emotional facial&#xD;
      expressions (video presented) and the observation and execution of simple grasping actions&#xD;
      (live presented), respectively. In addition, before the beginning of the EEG recording&#xD;
      session, subjects will be randomly assigned to two different groups (Oxytocin or Placebo&#xD;
      group) and will receive a dose of either intranasal Oxytocin or Placebo solution. Oxytocin is&#xD;
      a polypeptide hormone that plays a critical role in social behavior. We will identify mu and&#xD;
      beta rhythm from the ongoing EEG and examine suppression as a function of emotion and goal&#xD;
      directed action perception and imitation/execution.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EEG mu rhythm suppression</measure>
    <time_frame>Before oxytocin/placebo administration and 45 minutes after</time_frame>
    <description>The EEG mu rhythm suppression is an index of the human mirror neuron system (alpha and lower beta band activity (8-13 and ~20Hz) recorded over the sensorimotor cortex. EEG will be recorded during the performance of an emotion imitation task (Carr et al., 2003) in which participants will be asked to imitate and internally generate facial emotions seen on a computer screen, or to simply observe, as well as performing a simple grasping action task. Changes in the mu suppression while the performance of these tasks, before and after oxytocin/placebo administration, will be the primary outcome measure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Social Cognition</condition>
  <condition>Expressed Emotion</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>Syntocinon nasal spray</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Right-hand dominant&#xD;
&#xD;
          -  Sufficient spoken English so as to be able to complete testing validly and give&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently taking any psychotropic or cognition enhancing medication&#xD;
&#xD;
          -  History of schizophrenia or any other psychotic disorder, including Bipolar Disorder&#xD;
&#xD;
          -  Family history of psychosis&#xD;
&#xD;
          -  Neurological disease or clinically significant head injury&#xD;
&#xD;
          -  Physical disability that substantially impairs motor function&#xD;
&#xD;
          -  Current diagnosis of polydypsic-induced hyponatremia&#xD;
&#xD;
          -  Substance dependence or abuse in the past 6 months&#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>Robert W Buchanan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland, College Park</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nathan Fox, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Maryland, College Park</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Child Development Lab, University of Maryland</name>
      <address>
        <city>College Park</city>
        <state>Maryland</state>
        <zip>20742</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Carr L, Iacoboni M, Dubeau MC, Mazziotta JC, Lenzi GL. Neural mechanisms of empathy in humans: a relay from neural systems for imitation to limbic areas. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5497-502. doi: 10.1073/pnas.0935845100. Epub 2003 Apr 7.</citation>
    <PMID>12682281</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>August 15, 2019</last_update_submitted>
  <last_update_submitted_qc>August 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Robert Buchanan</investigator_full_name>
    <investigator_title>Interim Director, Maryland Psychiatric Research Center</investigator_title>
  </responsible_party>
  <keyword>Mirror neurons</keyword>
  <keyword>Imitation</keyword>
  <keyword>Oxytocin</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/NCT02228031
org study id: HP-00059904
nct id: NCT02228031
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this project is to investigate the possible effect of intranasally
      administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron
      system (MNS) is thought to be involved in action perception and understanding, and may also
      underlie more complex cognitive processes such as imitation. We will use
      electroencephalographic (EEG) investigations to examine brain activity while participants
      complete two different tasks, consisting of the observation and imitation of emotional facial
      expressions (video presented) and the observation and execution of simple grasping actions
      (live presented), respectively. In addition, before the beginning of the EEG recording
      session, subjects will be randomly assigned to two different groups (Oxytocin or Placebo
      group) and will receive a dose of either intranasal Oxytocin or Placebo solution. Oxytocin is
      a polypeptide hormone that plays a critical role in social behavior. We will identify mu and
      beta rhythm from the ongoing EEG and examine suppression as a function of emotion and goal
      directed action perception and imitation/execution.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: EEG mu rhythm suppression
time frame: Before oxytocin/placebo administration and 45 minutes after
description: The EEG mu rhythm suppression is an index of the human mirror neuron system (alpha and lower beta band activity (8-13 and ~20Hz) recorded over the sensorimotor cortex. EEG will be recorded during the performance of an emotion imitation task (Carr et al., 2003) in which participants will be asked to imitate and internally generate facial emotions seen on a computer screen, or to simply observe, as well as performing a simple grasping action task. Changes in the mu suppression while the performance of these tasks, before and after oxytocin/placebo administration, will be the primary outcome measure.
arm group label: Oxytocin
arm group type: Experimental
description: The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session.
arm group label: Placebo
arm group type: Placebo Comparator
description: The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.
intervention type: Drug
intervention name: Oxytocin
description: The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session
arm group label: Oxytocin
other name: Syntocinon nasal spray
intervention type: Other
intervention name: Placebo
description: The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert W Buchanan, MD
role: Principal Investigator
affiliation: University of Maryland, College Park
last name: Nathan Fox, PhD
role: Study Director
affiliation: University of Maryland, College Park
facility: 
country: United States
citation: Carr L, Iacoboni M, Dubeau MC, Mazziotta JC, Lenzi GL. Neural mechanisms of empathy in humans: a relay from neural systems for imitation to limbic areas. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5497-502. doi: 10.1073/pnas.0935845100. Epub 2003 Apr 7.
PMID: 12682281
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Robert Buchanan
investigator title: Interim Director, Maryland Psychiatric Research Center
mesh term: Oxytocin