<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/NCT02238379</url>
  </required_header>
  <id_info>
    <org_study_id>1309012677</org_study_id>
    <nct_id>NCT02238379</nct_id>
  </id_info>
  <brief_title>Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception</brief_title>
  <official_title>Oxytocin Pilot: Oxytocin and Face Perception</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Anna Freud Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the effects of oxytocin on social behavior and&#xD;
      brain activity using EEG and the event-related potential (ERP) technique. The value of EEG is&#xD;
      its high temporal specificity, enabling precision in the timing of social behavior to be&#xD;
      addressed. In order to elicit social responses in the human brain, a variety of social and&#xD;
      emotional visual stimuli will be presented during EEG recording, namely infant and adult&#xD;
      faces and houses. Brain responses after intranasal oxytocin will then be compared with&#xD;
      placebo, to examine the effect of intranasal oxytocin on central nervous system activity. We&#xD;
      hypothesize that intranasal oxytocin will enhance the neural response to social stimuli&#xD;
      (infant and adult faces) but not to non-social stimuli (houses).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amplitude Social</measure>
    <time_frame>Duration of 30 minutes</time_frame>
    <description>The investigators will analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that the intervention will modulate the amplitude of the neural response to social stimuli given its previously identified role in social interactions, most likely increasing the size of the ERPs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amplitude Non-Social</measure>
    <time_frame>Duration of 30 minutes</time_frame>
    <description>The investigators analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo during the non-social condition on the amplitude of the ERPs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Latency Social</measure>
    <time_frame>Duration of 30 minutes</time_frame>
    <description>The investigators analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be more efficient processing (i.e., earlier latency) of ERPs during the social condition following administration of the intervention relative to the placebo condition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Latency Non-Social</measure>
    <time_frame>Duration of 30 minutes</time_frame>
    <description>The investigators will analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo on ERP latency measures in the non-social condition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Within 20 minutes of study visit commencing</time_frame>
    <description>The investigators will assess depression by employing the Beck Depression Inventory (Beck et al., 1961). Specifically addressing whether the level of depression symptomatology in participants and whether this is associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in depression symptoms are associated with this methodology, although prior research has suggested depression modulates the neural response to social cues. This measure includes a question regarding suicidal ideation and therefore it is acknowledged there may be a safety issue in response to the questionnaire. Scores range from 0-63, with higher scores indicating greater levels of depression (scores 29+ indicates severe depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking</measure>
    <time_frame>Within 30 minutes of study visit commencing</time_frame>
    <description>Participants will complete a CO breathalyzer and the Fagerstrom Test for Nicotine Dependence (Heatherton, Kozlowski, Frecker, &amp; Fagerstrom, 1991) to assess smoking behavior. These measures are included to characterize the sample in respect of substance use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Within 20 minutes of study visit commencing</time_frame>
    <description>The investigators will assess anxiety using the State-Trait Anxiety Inventory (Spielberger et al., 1970). Specifically, it will be explored whether participant anxiety symptoms are associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in anxiety symptoms are associated with this methodology, although prior research has suggested anxiety modulates the neural response to social cues. Scores range from 20-80 and a higher score on both state and trait measures indicate higher levels of anxiety. A potential clinical cut off has been proposed for participants scoring over 39-40 as being high anxious.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>Within 20 minutes of study visit commencing</time_frame>
    <description>The investigators will measure current levels of stress by using the Perceived Stress Scale (Cohen et al., 1983). It is not yet known the extent to which variation in perceived stress is associated with this methodology, but it is anticipated stress will be associated with levels of depression and anxiety in the sample. The PSS consists of 14 items, with scores ranging from 0 to 42, with higher scores indicating higher levels of perceived stress. A score of 21+ is considered to indicate that participants have higher than average stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early Experience</measure>
    <time_frame>Within 20 minutes of study visit commencing</time_frame>
    <description>The investigators will employ the Parental Bonding Instrument (Parker, Tupling, &amp; Brown, 1979) to assess the early relationship experiences participants have with their caregivers. Existing research employing intranasal oxytocin suggests that the quality of early relationships may impact the strength of any modulation of brain or behavior by oxytocin administration and therefore this variable will be included in the analyses in support of this hypothesis. There are 12 items that capture parental care and 13 items that capture parental overprotection. Items are scored on a 4-point likert scale from &quot;very like&quot; to &quot;very unlike&quot;. The PBI is typically scored by identifying optimal (High Care Scores, Low Protection Scores) and less optimal (Low Care Scores, Low Protection Scores) scores on the mother and father subscales (NB: protection refers to overprotection). For the care items, scores can range from 0 to 36; for overprotection items, scores can range from 0 to 39.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Endorsing Substance Use</measure>
    <time_frame>Within 30 minutes of study visit commencing</time_frame>
    <description>The investigators will employ the ASI Lite (McLellan, Luborsky, Woody, &amp; O'Brien, 1980) to assess for current substance use. This measure is included to characterize the sample in respect of substance use; however the ASI Lite did not provide a measure of substance dependance and therefore we report the data from the Mini International Neuropsychiatric Interview substance dependance module (Sheehan et al., 1998) to provide a specific indication of the presence of absence of substance dependance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer</measure>
    <time_frame>Within 30 minutes of study visit commencing</time_frame>
    <description>Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Social Perception</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>24 International Units of Oxytocin in a Nasal Spray</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>Pitocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults ages 18-64&#xD;
&#xD;
          -  Good medical health&#xD;
&#xD;
          -  Ability to understand and speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Medical Illnesses: Moderate or severe acute or chronic medical illnesses (e.g. cardiac&#xD;
             disease, diabetes, epilepsy, influenza).&#xD;
&#xD;
          -  Cardiovascular risk factors: History of hypertension with baseline blood pressure&#xD;
             above 140 mm Hg (systolic) over 90 mm Hg (diastolic). Also any history of syncope&#xD;
             and/or baseline blood pressure below 100 mm Hg (systolic).&#xD;
&#xD;
          -  CNS disease: Known history of brain abnormalities (e.g., neoplasms, subarachnoid&#xD;
             cysts), cerebrovascular disease, infectious disease (e.g., abscess), other central&#xD;
             nervous system disease, or history of head trauma which resulted in a persistent&#xD;
             neurologic deficit or loss of consciousness &gt; 3 minutes.&#xD;
&#xD;
          -  Medication status: Individuals on stable doses of a neuroleptic and/or an&#xD;
             antidepressant medication for at least the past 6 weeks will be allowed to participate&#xD;
             in this study. The use of other psychotropic medications will not be allowed. Females&#xD;
             taking contraceptive hormones will not be able to participate in the study.&#xD;
&#xD;
          -  A history of seizures or current use of anticonvulsants; history of head injury with&#xD;
             loss of consciousness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda C Mayes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Helena JV Rutherford, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Child Study Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>November 28, 2016</results_first_submitted>
  <results_first_submitted_qc>May 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 25, 2017</results_first_posted>
  <last_update_submitted>January 12, 2018</last_update_submitted>
  <last_update_submitted_qc>January 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intranasal oxytocin</keyword>
  <keyword>Social perception</keyword>
  <keyword>EEG/ERP</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Oxytocin First, Then Placebo</title>
          <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
        </group>
        <group group_id="P2">
          <title>Placebo First, Then Oxytocin</title>
          <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>1 participant was lost to follow up for their placebo visit (determined after blind was broken).</population>
      <group_list>
        <group group_id="B1">
          <title>Oxytocin</title>
          <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24" spread="3"/>
                    <measurement group_id="B2" value="23" spread="3"/>
                    <measurement group_id="B3" value="24" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Amplitude Social</title>
        <description>The investigators will analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that the intervention will modulate the amplitude of the neural response to social stimuli given its previously identified role in social interactions, most likely increasing the size of the ERPs.</description>
        <time_frame>Duration of 30 minutes</time_frame>
        <population>1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participant was a statistical outlier and removed from oxytocin and placebo arms</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
          </group>
        </group_list>
        <measure>
          <title>Amplitude Social</title>
          <description>The investigators will analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that the intervention will modulate the amplitude of the neural response to social stimuli given its previously identified role in social interactions, most likely increasing the size of the ERPs.</description>
          <population>1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participant was a statistical outlier and removed from oxytocin and placebo arms</population>
          <units>microvolts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>N170 Infant Distress Faces</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.72" spread="2.81"/>
                    <measurement group_id="O2" value="-3.55" spread="2.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N170 Infant Neutral</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.28" spread="2.55"/>
                    <measurement group_id="O2" value="-3.30" spread="2.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N170 Adult Distress</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.70" spread="2.72"/>
                    <measurement group_id="O2" value="-3.27" spread="2.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N170 Adult Neutral</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.23" spread="2.48"/>
                    <measurement group_id="O2" value="-2.87" spread="2.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>P300 Infant Distress Face</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="1.26"/>
                    <measurement group_id="O2" value="0.50" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>P300 Infant Neutral Face</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="1.47"/>
                    <measurement group_id="O2" value="0.55" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>P300 Adult Distress Face</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.65" spread="1.22"/>
                    <measurement group_id="O2" value="0.39" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>P300 Adult Neutral Face</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" spread="1.38"/>
                    <measurement group_id="O2" value="0.61" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPP Infant Distress Face</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="1.53"/>
                    <measurement group_id="O2" value="-0.50" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPP Infant Neutral Face</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="1.40"/>
                    <measurement group_id="O2" value="-0.54" spread="1.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPP Adult Distress Face</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.38" spread="1.33"/>
                    <measurement group_id="O2" value="-0.57" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPP Adult Neutral Face</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.71" spread="1.49"/>
                    <measurement group_id="O2" value="-0.40" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>N170 Analysis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.003</p_value>
            <p_value_desc>Main Effect of Emotion</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>N170 Analysis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.034</p_value>
            <p_value_desc>Main Effect of Face Type</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P300 Analysis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.03</p_value>
            <p_value_desc>Main Effect of Face Type</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P300 Analysis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.03</p_value>
            <p_value_desc>Spray Type by Face Type Interaction</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>LPP Analysis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&gt;.22</p_value>
            <p_value_desc>No Main Effects or Interactions</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Amplitude Non-Social</title>
        <description>The investigators analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo during the non-social condition on the amplitude of the ERPs.</description>
        <time_frame>Duration of 30 minutes</time_frame>
        <population>1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms)</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
          </group>
        </group_list>
        <measure>
          <title>Amplitude Non-Social</title>
          <description>The investigators analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo during the non-social condition on the amplitude of the ERPs.</description>
          <population>1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms)</population>
          <units>microvolts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>N170 House</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.15" spread="1.71"/>
                    <measurement group_id="O2" value="-1.15" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>P300 House</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" spread="1.47"/>
                    <measurement group_id="O2" value="0.86" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPP House</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.58" spread="1.12"/>
                    <measurement group_id="O2" value="-0.32" spread="1.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>N170 Analysis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&gt;.14</p_value>
            <p_value_desc>No Main Effects or Interactions</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Spray Type (Oxytocin, Placebo) and Hemisphere (left, right) ANOVA</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P300 Analysis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&gt;.17</p_value>
            <p_value_desc>No difference between Spray Types</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>LPP Analysis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&gt;.27</p_value>
            <p_value_desc>No difference between Spray Types</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Latency Social</title>
        <description>The investigators analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be more efficient processing (i.e., earlier latency) of ERPs during the social condition following administration of the intervention relative to the placebo condition.</description>
        <time_frame>Duration of 30 minutes</time_frame>
        <population>1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
          </group>
        </group_list>
        <measure>
          <title>Latency Social</title>
          <description>The investigators analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be more efficient processing (i.e., earlier latency) of ERPs during the social condition following administration of the intervention relative to the placebo condition.</description>
          <population>1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>N170 Infant Distress</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164" spread="8"/>
                    <measurement group_id="O2" value="164" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N170 Infant Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163" spread="9"/>
                    <measurement group_id="O2" value="161" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N170 Adult Distress</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164" spread="10"/>
                    <measurement group_id="O2" value="163" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N170 Adult Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161" spread="9"/>
                    <measurement group_id="O2" value="161" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left N170 Infant Distress</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165" spread="9"/>
                    <measurement group_id="O2" value="166" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right N170 Infant Distress</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164" spread="8"/>
                    <measurement group_id="O2" value="162" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left N170 Infant Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165" spread="11"/>
                    <measurement group_id="O2" value="163" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right N170 Infant Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161" spread="7"/>
                    <measurement group_id="O2" value="160" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left N170 Adult Distress</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166" spread="11"/>
                    <measurement group_id="O2" value="165" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right N170 Adult Distress</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162" spread="9"/>
                    <measurement group_id="O2" value="161" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left N170 Adult Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163" spread="10"/>
                    <measurement group_id="O2" value="162" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right N170 Adult Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159" spread="8"/>
                    <measurement group_id="O2" value="160" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Only relevant for N170</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.006</p_value>
            <p_value_desc>Main Effect of Emotion</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Only relevant for N170</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.01</p_value>
            <p_value_desc>Main Effect of Hemisphere</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Latency Non-Social</title>
        <description>The investigators will analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo on ERP latency measures in the non-social condition.</description>
        <time_frame>Duration of 30 minutes</time_frame>
        <population>1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); 2 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
          </group>
        </group_list>
        <measure>
          <title>Latency Non-Social</title>
          <description>The investigators will analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo on ERP latency measures in the non-social condition.</description>
          <population>1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); 2 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Left N170 House</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="171" spread="13"/>
                    <measurement group_id="O2" value="174" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right N170 House</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166" spread="9"/>
                    <measurement group_id="O2" value="169" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Only relevant for N170</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.03</p_value>
            <p_value_desc>Main Effect of Spray</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Only relevant for N170</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.008</p_value>
            <p_value_desc>Main Effect of Hemisphere</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression</title>
        <description>The investigators will assess depression by employing the Beck Depression Inventory (Beck et al., 1961). Specifically addressing whether the level of depression symptomatology in participants and whether this is associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in depression symptoms are associated with this methodology, although prior research has suggested depression modulates the neural response to social cues. This measure includes a question regarding suicidal ideation and therefore it is acknowledged there may be a safety issue in response to the questionnaire. Scores range from 0-63, with higher scores indicating greater levels of depression (scores 29+ indicates severe depression).</description>
        <time_frame>Within 20 minutes of study visit commencing</time_frame>
        <population>Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
          </group>
        </group_list>
        <measure>
          <title>Depression</title>
          <description>The investigators will assess depression by employing the Beck Depression Inventory (Beck et al., 1961). Specifically addressing whether the level of depression symptomatology in participants and whether this is associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in depression symptoms are associated with this methodology, although prior research has suggested depression modulates the neural response to social cues. This measure includes a question regarding suicidal ideation and therefore it is acknowledged there may be a safety issue in response to the questionnaire. Scores range from 0-63, with higher scores indicating greater levels of depression (scores 29+ indicates severe depression).</description>
          <population>Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" spread="6.06"/>
                    <measurement group_id="O2" value="4.33" spread="5.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.05</p_value>
            <method>correlation</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Smoking</title>
        <description>Participants will complete a CO breathalyzer and the Fagerstrom Test for Nicotine Dependence (Heatherton, Kozlowski, Frecker, &amp; Fagerstrom, 1991) to assess smoking behavior. These measures are included to characterize the sample in respect of substance use.</description>
        <time_frame>Within 30 minutes of study visit commencing</time_frame>
        <population>1 participant was lost to follow-up</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
          </group>
        </group_list>
        <measure>
          <title>Smoking</title>
          <description>Participants will complete a CO breathalyzer and the Fagerstrom Test for Nicotine Dependence (Heatherton, Kozlowski, Frecker, &amp; Fagerstrom, 1991) to assess smoking behavior. These measures are included to characterize the sample in respect of substance use.</description>
          <population>1 participant was lost to follow-up</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FTND indicated smoking status</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO indicated smoking status</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anxiety</title>
        <description>The investigators will assess anxiety using the State-Trait Anxiety Inventory (Spielberger et al., 1970). Specifically, it will be explored whether participant anxiety symptoms are associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in anxiety symptoms are associated with this methodology, although prior research has suggested anxiety modulates the neural response to social cues. Scores range from 20-80 and a higher score on both state and trait measures indicate higher levels of anxiety. A potential clinical cut off has been proposed for participants scoring over 39-40 as being high anxious.</description>
        <time_frame>Within 20 minutes of study visit commencing</time_frame>
        <population>Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety</title>
          <description>The investigators will assess anxiety using the State-Trait Anxiety Inventory (Spielberger et al., 1970). Specifically, it will be explored whether participant anxiety symptoms are associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in anxiety symptoms are associated with this methodology, although prior research has suggested anxiety modulates the neural response to social cues. Scores range from 20-80 and a higher score on both state and trait measures indicate higher levels of anxiety. A potential clinical cut off has been proposed for participants scoring over 39-40 as being high anxious.</description>
          <population>Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>State Anxiety</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.54" spread="10.67"/>
                    <measurement group_id="O2" value="35.50" spread="11.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trait Anxiety</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.58" spread="10.11"/>
                    <measurement group_id="O2" value="30.79" spread="7.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.05</p_value>
            <method>correlation</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stress</title>
        <description>The investigators will measure current levels of stress by using the Perceived Stress Scale (Cohen et al., 1983). It is not yet known the extent to which variation in perceived stress is associated with this methodology, but it is anticipated stress will be associated with levels of depression and anxiety in the sample. The PSS consists of 14 items, with scores ranging from 0 to 42, with higher scores indicating higher levels of perceived stress. A score of 21+ is considered to indicate that participants have higher than average stress.</description>
        <time_frame>Within 20 minutes of study visit commencing</time_frame>
        <population>Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
          </group>
        </group_list>
        <measure>
          <title>Stress</title>
          <description>The investigators will measure current levels of stress by using the Perceived Stress Scale (Cohen et al., 1983). It is not yet known the extent to which variation in perceived stress is associated with this methodology, but it is anticipated stress will be associated with levels of depression and anxiety in the sample. The PSS consists of 14 items, with scores ranging from 0 to 42, with higher scores indicating higher levels of perceived stress. A score of 21+ is considered to indicate that participants have higher than average stress.</description>
          <population>Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.54" spread="8.28"/>
                    <measurement group_id="O2" value="18.13" spread="8.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.05</p_value>
            <method>correlation</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Early Experience</title>
        <description>The investigators will employ the Parental Bonding Instrument (Parker, Tupling, &amp; Brown, 1979) to assess the early relationship experiences participants have with their caregivers. Existing research employing intranasal oxytocin suggests that the quality of early relationships may impact the strength of any modulation of brain or behavior by oxytocin administration and therefore this variable will be included in the analyses in support of this hypothesis. There are 12 items that capture parental care and 13 items that capture parental overprotection. Items are scored on a 4-point likert scale from &quot;very like&quot; to &quot;very unlike&quot;. The PBI is typically scored by identifying optimal (High Care Scores, Low Protection Scores) and less optimal (Low Care Scores, Low Protection Scores) scores on the mother and father subscales (NB: protection refers to overprotection). For the care items, scores can range from 0 to 36; for overprotection items, scores can range from 0 to 39.</description>
        <time_frame>Within 20 minutes of study visit commencing</time_frame>
        <population>Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss); 1 participant did not know their father and did not complete the measure for paternal assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
          </group>
        </group_list>
        <measure>
          <title>Early Experience</title>
          <description>The investigators will employ the Parental Bonding Instrument (Parker, Tupling, &amp; Brown, 1979) to assess the early relationship experiences participants have with their caregivers. Existing research employing intranasal oxytocin suggests that the quality of early relationships may impact the strength of any modulation of brain or behavior by oxytocin administration and therefore this variable will be included in the analyses in support of this hypothesis. There are 12 items that capture parental care and 13 items that capture parental overprotection. Items are scored on a 4-point likert scale from &quot;very like&quot; to &quot;very unlike&quot;. The PBI is typically scored by identifying optimal (High Care Scores, Low Protection Scores) and less optimal (Low Care Scores, Low Protection Scores) scores on the mother and father subscales (NB: protection refers to overprotection). For the care items, scores can range from 0 to 36; for overprotection items, scores can range from 0 to 39.</description>
          <population>Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss); 1 participant did not know their father and did not complete the measure for paternal assessment</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Maternal Care Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.13" spread="6.69"/>
                    <measurement group_id="O2" value="29.50" spread="6.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paternal Care Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.74" spread="8.67"/>
                    <measurement group_id="O2" value="28.13" spread="8.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maternal Protectiveness Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.71" spread="8.01"/>
                    <measurement group_id="O2" value="13.75" spread="8.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paternal Protectiveness Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.91" spread="8.30"/>
                    <measurement group_id="O2" value="10.91" spread="9.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>.05</p_value>
            <method>correlation</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Endorsing Substance Use</title>
        <description>The investigators will employ the ASI Lite (McLellan, Luborsky, Woody, &amp; O'Brien, 1980) to assess for current substance use. This measure is included to characterize the sample in respect of substance use; however the ASI Lite did not provide a measure of substance dependance and therefore we report the data from the Mini International Neuropsychiatric Interview substance dependance module (Sheehan et al., 1998) to provide a specific indication of the presence of absence of substance dependance.</description>
        <time_frame>Within 30 minutes of study visit commencing</time_frame>
        <population>1 participant lost to follow-up; count of participants where substance dependence indicated</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Endorsing Substance Use</title>
          <description>The investigators will employ the ASI Lite (McLellan, Luborsky, Woody, &amp; O'Brien, 1980) to assess for current substance use. This measure is included to characterize the sample in respect of substance use; however the ASI Lite did not provide a measure of substance dependance and therefore we report the data from the Mini International Neuropsychiatric Interview substance dependance module (Sheehan et al., 1998) to provide a specific indication of the presence of absence of substance dependance.</description>
          <population>1 participant lost to follow-up; count of participants where substance dependence indicated</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer</title>
        <description>Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.</description>
        <time_frame>Within 30 minutes of study visit commencing</time_frame>
        <population>1 participant lost to follow-up; data indicates number of participants with alcohol in their system</population>
        <group_list>
          <group group_id="O1">
            <title>Oxytocin</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer</title>
          <description>Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.</description>
          <population>1 participant lost to follow-up; data indicates number of participants with alcohol in their system</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Oxytocin</title>
          <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Oxytocin: 24 International Units of Oxytocin in a Nasal Spray</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.&#xD;
Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Small sample size limiting the interpretations of ERP differences between oxytocin and placebo conditions and individual difference measures.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Helena Rutherford</name_or_title>
      <organization>Yale University</organization>
      <phone>203-737-3408</phone>
      <email>helena.rutherford@yale.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02238379
org study id: 1309012677
nct id: NCT02238379
lead sponsor: 
collaborator: 
The objective of this study is to investigate the effects of oxytocin on social behavior and
      brain activity using EEG and the event-related potential (ERP) technique. The value of EEG is
      its high temporal specificity, enabling precision in the timing of social behavior to be
      addressed. In order to elicit social responses in the human brain, a variety of social and
      emotional visual stimuli will be presented during EEG recording, namely infant and adult
      faces and houses. Brain responses after intranasal oxytocin will then be compared with
      placebo, to examine the effect of intranasal oxytocin on central nervous system activity. We
      hypothesize that intranasal oxytocin will enhance the neural response to social stimuli
      (infant and adult faces) but not to non-social stimuli (houses).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Amplitude Social
time frame: Duration of 30 minutes
description: The investigators will analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that the intervention will modulate the amplitude of the neural response to social stimuli given its previously identified role in social interactions, most likely increasing the size of the ERPs.
measure: Amplitude Non-Social
time frame: Duration of 30 minutes
description: The investigators analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo during the non-social condition on the amplitude of the ERPs.
measure: Latency Social
time frame: Duration of 30 minutes
description: The investigators analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be more efficient processing (i.e., earlier latency) of ERPs during the social condition following administration of the intervention relative to the placebo condition.
measure: Latency Non-Social
time frame: Duration of 30 minutes
description: The investigators will analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo on ERP latency measures in the non-social condition.
measure: Depression
time frame: Within 20 minutes of study visit commencing
description: The investigators will assess depression by employing the Beck Depression Inventory (Beck et al., 1961). Specifically addressing whether the level of depression symptomatology in participants and whether this is associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in depression symptoms are associated with this methodology, although prior research has suggested depression modulates the neural response to social cues. This measure includes a question regarding suicidal ideation and therefore it is acknowledged there may be a safety issue in response to the questionnaire. Scores range from 0-63, with higher scores indicating greater levels of depression (scores 29+ indicates severe depression).
measure: Smoking
time frame: Within 30 minutes of study visit commencing
description: Participants will complete a CO breathalyzer and the Fagerstrom Test for Nicotine Dependence (Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991) to assess smoking behavior. These measures are included to characterize the sample in respect of substance use.
measure: Anxiety
time frame: Within 20 minutes of study visit commencing
description: The investigators will assess anxiety using the State-Trait Anxiety Inventory (Spielberger et al., 1970). Specifically, it will be explored whether participant anxiety symptoms are associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in anxiety symptoms are associated with this methodology, although prior research has suggested anxiety modulates the neural response to social cues. Scores range from 20-80 and a higher score on both state and trait measures indicate higher levels of anxiety. A potential clinical cut off has been proposed for participants scoring over 39-40 as being high anxious.
measure: Stress
time frame: Within 20 minutes of study visit commencing
description: The investigators will measure current levels of stress by using the Perceived Stress Scale (Cohen et al., 1983). It is not yet known the extent to which variation in perceived stress is associated with this methodology, but it is anticipated stress will be associated with levels of depression and anxiety in the sample. The PSS consists of 14 items, with scores ranging from 0 to 42, with higher scores indicating higher levels of perceived stress. A score of 21+ is considered to indicate that participants have higher than average stress.
measure: Early Experience
time frame: Within 20 minutes of study visit commencing
description: The investigators will employ the Parental Bonding Instrument (Parker, Tupling, & Brown, 1979) to assess the early relationship experiences participants have with their caregivers. Existing research employing intranasal oxytocin suggests that the quality of early relationships may impact the strength of any modulation of brain or behavior by oxytocin administration and therefore this variable will be included in the analyses in support of this hypothesis. There are 12 items that capture parental care and 13 items that capture parental overprotection. Items are scored on a 4-point likert scale from "very like" to "very unlike". The PBI is typically scored by identifying optimal (High Care Scores, Low Protection Scores) and less optimal (Low Care Scores, Low Protection Scores) scores on the mother and father subscales (NB: protection refers to overprotection). For the care items, scores can range from 0 to 36; for overprotection items, scores can range from 0 to 39.
measure: Number of Participants Endorsing Substance Use
time frame: Within 30 minutes of study visit commencing
description: The investigators will employ the ASI Lite (McLellan, Luborsky, Woody, & O'Brien, 1980) to assess for current substance use. This measure is included to characterize the sample in respect of substance use; however the ASI Lite did not provide a measure of substance dependance and therefore we report the data from the Mini International Neuropsychiatric Interview substance dependance module (Sheehan et al., 1998) to provide a specific indication of the presence of absence of substance dependance.
measure: Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer
time frame: Within 30 minutes of study visit commencing
description: Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.
arm group label: Oxytocin
arm group type: Experimental
description: Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
arm group label: Placebo
arm group type: Placebo Comparator
description: Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
intervention type: Drug
intervention name: Oxytocin
description: 24 International Units of Oxytocin in a Nasal Spray
arm group label: Oxytocin
other name: Pitocin
intervention type: Other
intervention name: Placebo
description: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Linda C Mayes, MD
role: Principal Investigator
affiliation: Yale University
last name: Helena JV Rutherford, PhD
role: Study Director
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Oxytocin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample size limiting the interpretations of ERP differences between oxytocin and placebo conditions and individual difference measures.
point of contact: 