<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/NCT03033784</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00093455</org_study_id>
    <secondary_id>P50MH100023</secondary_id>
    <nct_id>NCT03033784</nct_id>
  </id_info>
  <brief_title>Autism Oxytocin Brain Project</brief_title>
  <official_title>Target Engagement for Intranasal Oxytocin in Autism Spectrum Disorders, an fMRI Dose Response Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main goal of the study is to look at the effects of intranasal oxytocin on the brain in&#xD;
      Autism Spectrum Disorder (ASD). Oxytocin is a hormone that exists naturally in the body and&#xD;
      the brain, affecting a wide range of social behaviors and emotions. The investigators will&#xD;
      study the effects of different treatments (3 doses of oxytocin and one dose of placebo) on&#xD;
      brain functional connectivity at rest in patients with ASD, using functional magnetic&#xD;
      resonance imaging (fMRI). Investigators also seek to study how the effects of oxytocin&#xD;
      treatment can be affected by genetic, immune and environmental factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consists of investigating the effects of several doses of acute administration of&#xD;
      intranasal oxytocin on brain activity in adults with Autism Spectrum Disorder (ASD). There is&#xD;
      increasing evidence for the role of intranasal oxytocin (IN-OT) in enhancing social skills in&#xD;
      ASD. Nevertheless, there is still a need of determining target engagement for oxytocin's&#xD;
      action on brain and behavior. Here, investigators are studying the effects of different doses&#xD;
      of IN-OT on the modulation of behavioral outcomes and neural responses in a double blind&#xD;
      crossover study in individuals with ASD.&#xD;
&#xD;
      The aims of the research are to:&#xD;
&#xD;
        1. Study the effects of IN-OT doses on the modulation of brain functional connectivity&#xD;
           between key socio-emotional brain regions during resting state in ASD&#xD;
&#xD;
        2. Study the effects of IN-OT doses on the blood-oxygen-level dependent (BOLD) activity of&#xD;
           key emotional and perceptual brain networks in response to social cues (such as faces)&#xD;
&#xD;
        3. Study the effects of IN-OT on the BOLD activity of brain regions during an interactive&#xD;
           social environment (ball game) in ASD&#xD;
&#xD;
      Investigators will compare the neuroimaging and behavioral results of individuals with ASD to&#xD;
      control healthy males who will receive intranasal placebo. Investigators are also&#xD;
      investigating the role of genetic factors, behavioral or clinical sub-groups of ASD, immune&#xD;
      and environmental factors in modulating the effect of IN-OT on brain and behavior.&#xD;
&#xD;
      Participants with ASD will undergo 4 clinical visits during which they receive various&#xD;
      randomly assigned doses of intranasal oxytocin and placebo. Both participants and the&#xD;
      experimenter will be blind to the type of the treatment administered.&#xD;
&#xD;
      There will be only one visit for healthy controls who will all receive placebo spray. The&#xD;
      visit for healthy controls will be conducted in a single-blind design. The experimenter will&#xD;
      be aware that the subject is receiving placebo. However, the participant will be told that he&#xD;
      might receive oxytocin or placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Actual">October 3, 2018</completion_date>
  <primary_completion_date type="Actual">October 3, 2018</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resting State Functional Connectivity (rsFC) Salience Network (Anterior Cingulate Cortex (ACC) and Insula Versus Visual Cortex)</measure>
    <time_frame>Post Intervention (Up to 40 minutes after receiving spray) at Study Visits 1, 2, 3 and 4</time_frame>
    <description>Investigators will study the effects of intranasal oxytocin (IN-OT) on the resting state functional connectivity between key socio-emotional and social salience brain regions using functional magnetic resonance imaging (fMRI). Resting state functional connectivity is a task-independent metric of brain activity that is based on correlations between low-frequency fluctuations of the blood oxygen level-dependent signal between several brain regions. It reflects the strength of a functional connection that is in good agreement with the underlying neuroanatomy and provides a system-level understanding of brain function. Z-scores represent the number of standard deviations from the mean of 0 and range from -3 to +3, and z-scores greater than 0 indicate greater than average resting state functional connectivity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues</measure>
    <time_frame>Post Intervention (Up to 70 minutes) at Study Visits 1, 2, 3, and 4</time_frame>
    <description>BOLD activity level was assessed via fMRI during completion of the face perception task (FPT) of emotional and neutral faces. BOLD scores are reported on a z-scale, with the mean, standard deviation and the minimum and the maximum. This refers to the non-thresholded z-scores that are obtained for each dose before conducting small volume correction analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task</measure>
    <time_frame>Post Intervention (up to 70 minutes) at Study Visits 1, 2, 3, and 4</time_frame>
    <description>BOLD activity in social-emotional brain regions during the perception of emotional facial videos were measured during the ball-game task. Mean percent change in contrast of parameter estimates in anatomical regions of interest are presented here. A positive value indicates increased BOLD activity while a negative value indicates decreased BOLD activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxytocin Plasma Concentration</measure>
    <time_frame>Visits 1, 2, 3 and 4 (before spray and 5 minutes after spray)</time_frame>
    <description>Plasma concentration of oxytocin prior to administration of study intervention and after administration of study intervention will be compared between the different dose levels and placebo. Plasma concentration of oxytocin is expected to increase following administration of intranasal oxytocin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Smiling During Global Clinical Interview</measure>
    <time_frame>Post Intervention (Up to 180 minutes after receiving spray) at Study Visits 1, 2, 3 and 4</time_frame>
    <description>Clinical improvements will be rated by a clinician as based on a videotaped interview conducted after the MRI scanning session. Values between the different treatment conditions will be assessed to study the effect of intranasal oxytocin on ASD at the clinical level. The improvement will be assessed based on the quality of social interaction between the experimenter and the participant, specifically as the amount of smiling behavior displayed by participants. Larger values indicate that participants are smiling more frequently.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Milliseconds of Visual Fixation</measure>
    <time_frame>Post Intervention (Up to 50 minutes) at Study Visits 1, 2, 3 and 4</time_frame>
    <description>Eye gaze will be recorded via an eye tracker inside the MRI scanner during the face perception task (FPT). Visual fixation between different treatment conditions will be assessed in ASD participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Learning Test (SLT) Reaction Time</measure>
    <time_frame>Post Intervention (Up to 130 minutes) at Study Visits 1, 2, 3 and 4</time_frame>
    <description>During the SLT, participants complete an implicit association test using faces and words. The faces that are presented in this task are partners' faces with whom participants played during the ball-game inside the MRI scanner. In this task, there are congruent blocks where neutral faces of &quot;positive&quot; partners are presented with friendly words and neutral faces of &quot;negative&quot; partners are presented with unfriendly words. During incongruent blocks, neutral faces of &quot;positive&quot; partners are presented with unfriendly words and neutral faces of &quot;negative&quot; partners are presented with friendly words. Participants match the face or the word to one of two categories. Longer reaction time indicates difficulty with selecting a category. Longer reaction time in incongruent trials signifies implicit biases were formed for the positive and negative players such that &quot;positive&quot; partners from the ball-game are now perceived as friendly and &quot;negative&quot; partners are now perceived as unfriendly.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Autism</condition>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Autism Spectrum Disorder (ASD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Male participants diagnosed with ASD will receive 12 puffs (6 in each nostril) of intranasal oxytocin (syntocinon) and placebo (assigned randomly) during 4 study visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Age matched healthy controls will receive placebo intranasal spray (12 puffs, 6 per nostril) during one study visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>8 International Units (IU) of Oxytocin</intervention_name>
    <description>Participants will receive one dose of intranasal oxytocin at a dose of 8IU.</description>
    <arm_group_label>Autism Spectrum Disorder (ASD)</arm_group_label>
    <other_name>syntocinon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>24IU of Oxytocin</intervention_name>
    <description>Participants will receive one dose of intranasal oxytocin at a dose of 24IU.</description>
    <arm_group_label>Autism Spectrum Disorder (ASD)</arm_group_label>
    <other_name>syntocinon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>48IU of Oxytocin</intervention_name>
    <description>Participants will receive one dose of intranasal oxytocin at a dose of 48IU.</description>
    <arm_group_label>Autism Spectrum Disorder (ASD)</arm_group_label>
    <other_name>syntocinon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive an intranasal placebo to match the oxytocin doses.</description>
    <arm_group_label>Autism Spectrum Disorder (ASD)</arm_group_label>
    <arm_group_label>Healthy Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for ASD Participants:&#xD;
&#xD;
          -  Have an ASD diagnosis based on the Autism Diagnostic Observation Schedule (ADOS) and&#xD;
             Autism Diagnostic Interview (ADI) criteria, gold standards of research-based autism&#xD;
             diagnosis&#xD;
&#xD;
          -  Intelligence quotient (IQ) &gt; 70&#xD;
&#xD;
          -  Normal or corrected-to-normal vision&#xD;
&#xD;
        Exclusion Criteria for ASD Participants:&#xD;
&#xD;
          -  Recent occurrence of seizures (past 5 years)&#xD;
&#xD;
          -  Brain damage or head trauma (can be included at discretion of PI and sponsor)&#xD;
&#xD;
          -  Color blind&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Presence of a severe medical problem&#xD;
&#xD;
          -  Severe mental retardation&#xD;
&#xD;
          -  Alcoholism or substance abuse&#xD;
&#xD;
          -  Asthma (can be included at the discretion of study physician/nurse practitioner if&#xD;
             episodes are infrequent and no active problems at time of the study)&#xD;
&#xD;
          -  Migraine headaches (at the discretion of the nurse practitioner or the study&#xD;
             physician)&#xD;
&#xD;
          -  Claustrophobia (at discretion of study physician/designee/PI)&#xD;
&#xD;
          -  Pacemakers, cochlear implants, surgical clips or metal fragments&#xD;
&#xD;
        Inclusion Criteria for Healthy Age-Matched Controls:&#xD;
&#xD;
          -  IQ &gt; 70&#xD;
&#xD;
          -  Normal or corrected-to-normal vision&#xD;
&#xD;
        Exclusion Criteria for Healthy Age-Matched Controls:&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Neurological disorder&#xD;
&#xD;
          -  Current psychiatric disorder&#xD;
&#xD;
          -  Previous psychiatric disorder (can be included at discretion of PI)&#xD;
&#xD;
          -  Current use of psychoactive drugs&#xD;
&#xD;
          -  Previous use of psychoactive drugs (can be included at discretion of PI)&#xD;
&#xD;
          -  Head trauma (can be included at discretion of PI)&#xD;
&#xD;
          -  Alcoholism or substance abuse&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Color blind&#xD;
&#xD;
          -  Asthma (can be included at the discretion of study physician/nurse practitioner if&#xD;
             episodes are infrequent and no active problems at time of the study)&#xD;
&#xD;
          -  Migraine headaches (at the discretion of the nurse practitioner or the study&#xD;
             physician)&#xD;
&#xD;
          -  Claustrophobia (at discretion of study physician/designee/PI)&#xD;
&#xD;
          -  Presence of a severe medical problem&#xD;
&#xD;
          -  Severe mental retardation&#xD;
&#xD;
          -  Pacemakers, cochlear implants, surgical clips or metal fragments&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elissar Andari, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>October 30, 2020</results_first_submitted>
  <results_first_submitted_qc>December 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 12, 2021</results_first_posted>
  <disposition_first_submitted>November 20, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>December 18, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">January 12, 2021</disposition_first_posted>
  <last_update_submitted>December 18, 2020</last_update_submitted>
  <last_update_submitted_qc>December 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Elissar Andari</investigator_full_name>
    <investigator_title>Adjunct Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Neuroscience</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 10, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03033784/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03033784/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study participants were recruited from a list of participants in a prior study who agreed to be contacted for future studies. Study procedures were conducted at Emory University Hospital in Atlanta, Georgia. Participant enrollment began May 10, 2017 and all study activities were completed on October 3, 2018.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Dose Order: Placebo, 8 International Units (IU), 24IU, 48IU</title>
          <description>Participants with ASD randomized to receive the placebo first, followed by an 8IU of oxytocin, then 24IU dose of oxytocin, and a 48IU dose of oxytocin last.</description>
        </group>
        <group group_id="P2">
          <title>Dose Order: 24IU, 8IU, Placebo, 48IU</title>
          <description>Participants with ASD randomized to receive a 24IU dose of oxytocin, followed by an 8IU of oxytocin, then the placebo, and a 48IU dose of oxytocin last.</description>
        </group>
        <group group_id="P3">
          <title>Dose Order: 24IU, Placebo, 8IU, 48IU</title>
          <description>Participants with ASD randomized to receive a 24IU dose of oxytocin first, followed by the placebo, then 8IU dose of oxytocin, and a 48IU dose of oxytocin last.</description>
        </group>
        <group group_id="P4">
          <title>Dose Order: 48IU, Placebo, 8IU, 24IU</title>
          <description>Participants with ASD randomized to receive a 48IU dose of oxytocin first, followed by the placebo, then an 8IU dose of oxytocin, and a 24IU dose of oxytocin last.</description>
        </group>
        <group group_id="P5">
          <title>Dose Order: 8IU, 24IU, Placebo, 48IU</title>
          <description>Participants with ASD randomized to receive an 8IU dose of oxytocin first, followed by a 24IU dose of oxytocin, then the placebo, and a 48IU dose of oxytocin last.</description>
        </group>
        <group group_id="P6">
          <title>Dose Order: 48IU, 24IU, 8IU, Placebo</title>
          <description>Participants with ASD randomized to receive a 48IU dose of oxytocin first, followed by a 24IU of oxytocin, then an 8IU dose of oxytocin, and the placebo last.</description>
        </group>
        <group group_id="P7">
          <title>Dose Order: Placebo, 48IU, 24IU, 8IU</title>
          <description>Participants with ASD randomized to receive the placebo first, followed by a 48IU of oxytocin, then 24IU dose of oxytocin, and an 8IU dose of oxytocin last.</description>
        </group>
        <group group_id="P8">
          <title>Dose Order: Placebo, 24IU, 48IU, 8IU</title>
          <description>Participants with ASD randomized to receive the placebo first, followed by a 24IU of oxytocin, then a 48IU dose of oxytocin, and an 8IU dose of oxytocin last.</description>
        </group>
        <group group_id="P9">
          <title>Dose Order: 48IU, 24IU, Placebo, 8IU</title>
          <description>Participants with ASD randomized to receive a dose of 48IU of oxytocin first, followed by a 24IU of oxytocin, then the placebo, and an 8IU dose of oxytocin last.</description>
        </group>
        <group group_id="P10">
          <title>Dose Order: 8IU, 24IU, 48IU, Placebo</title>
          <description>Participants with ASD randomized to receive an 8IU of oxytocin first, followed by an 24IU of oxytocin, then 48IU dose of oxytocin, the placebo last.</description>
        </group>
        <group group_id="P11">
          <title>Dose Order: 24IU, 48IU, 8IU, Placebo</title>
          <description>Participants with ASD randomized to receive a 24IU dose of oxytocin first, followed by a 48IU of oxytocin, then an 8IU dose of oxytocin, and the placebo last.</description>
        </group>
        <group group_id="P12">
          <title>Dose Order: 48IU, 8IU, Placebo, 24IU</title>
          <description>Participants with ASD randomized to receive a 48IU dose of oxytocin first, followed by an 8IU of oxytocin, then the placebo, and a 24IU dose of oxytocin last.</description>
        </group>
        <group group_id="P13">
          <title>Healthy Controls Receiving the Placebo</title>
          <description>Healthy controls (persons without ASD) received the placebo rather than any oxytocin. The healthy controls only attended one clinical visit, per the study protocol.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Clinical Visit 2</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Clinical Visit 3</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Clinical Visit 4</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Anxiety related to MRI scanner</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Autism Spectrum Disorder (ASD)</title>
          <description>Male participants diagnosed with ASD received 12 puffs (6 in each nostril) of intranasal oxytocin (syntocinon) or a placebo during 4 study visits. The order in which the participant received the placebo and three different doses of oxytocin (8, 24, or 48IU) was randomly assigned.</description>
        </group>
        <group group_id="B2">
          <title>Healthy Control</title>
          <description>Age matched healthy males received a placebo intranasal spray (12 puffs, 6 per nostril) during one study visit</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="32"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="51"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="28.97" spread="5.83"/>
                    <measurement group_id="B2" value="30.84" spread="6.50"/>
                    <measurement group_id="B3" value="29.67" spread="6.09"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>Not Hispanic or Latino</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>Asian</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>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Resting State Functional Connectivity (rsFC) Salience Network (Anterior Cingulate Cortex (ACC) and Insula Versus Visual Cortex)</title>
        <description>Investigators will study the effects of intranasal oxytocin (IN-OT) on the resting state functional connectivity between key socio-emotional and social salience brain regions using functional magnetic resonance imaging (fMRI). Resting state functional connectivity is a task-independent metric of brain activity that is based on correlations between low-frequency fluctuations of the blood oxygen level-dependent signal between several brain regions. It reflects the strength of a functional connection that is in good agreement with the underlying neuroanatomy and provides a system-level understanding of brain function. Z-scores represent the number of standard deviations from the mean of 0 and range from -3 to +3, and z-scores greater than 0 indicate greater than average resting state functional connectivity.</description>
        <time_frame>Post Intervention (Up to 40 minutes after receiving spray) at Study Visits 1, 2, 3 and 4</time_frame>
        <population>This analysis includes participants with complete data for all visits. Two participants withdrew and data from another participant were not able to be analyzed due to technical problems during the MRI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo in ASD Participants</title>
            <description>Participants receiving the placebo</description>
          </group>
          <group group_id="O2">
            <title>8IU of Oxytocin Spray</title>
            <description>Participants receiving 8IU of oxytocin</description>
          </group>
          <group group_id="O3">
            <title>24IU of Oxytocin Spray</title>
            <description>Participants receiving 24IU of oxytocin</description>
          </group>
          <group group_id="O4">
            <title>48IU of Oxytocin Spray</title>
            <description>Participants receiving 48IU of oxytocin</description>
          </group>
          <group group_id="O5">
            <title>Healthy Controls Receiving Placebo</title>
            <description>Healthy controls received the placebo spray only</description>
          </group>
        </group_list>
        <measure>
          <title>Resting State Functional Connectivity (rsFC) Salience Network (Anterior Cingulate Cortex (ACC) and Insula Versus Visual Cortex)</title>
          <description>Investigators will study the effects of intranasal oxytocin (IN-OT) on the resting state functional connectivity between key socio-emotional and social salience brain regions using functional magnetic resonance imaging (fMRI). Resting state functional connectivity is a task-independent metric of brain activity that is based on correlations between low-frequency fluctuations of the blood oxygen level-dependent signal between several brain regions. It reflects the strength of a functional connection that is in good agreement with the underlying neuroanatomy and provides a system-level understanding of brain function. Z-scores represent the number of standard deviations from the mean of 0 and range from -3 to +3, and z-scores greater than 0 indicate greater than average resting state functional connectivity.</description>
          <population>This analysis includes participants with complete data for all visits. Two participants withdrew and data from another participant were not able to be analyzed due to technical problems during the MRI.</population>
          <units>z-scores rsFC salience-visual</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.338" spread="0.331"/>
                    <measurement group_id="O2" value="0.400" spread="0.261"/>
                    <measurement group_id="O3" value="0.428" spread="0.248"/>
                    <measurement group_id="O4" value="0.522" spread="0.216"/>
                    <measurement group_id="O5" value="0.591" spread="0.214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues</title>
        <description>BOLD activity level was assessed via fMRI during completion of the face perception task (FPT) of emotional and neutral faces. BOLD scores are reported on a z-scale, with the mean, standard deviation and the minimum and the maximum. This refers to the non-thresholded z-scores that are obtained for each dose before conducting small volume correction analysis.</description>
        <time_frame>Post Intervention (Up to 70 minutes) at Study Visits 1, 2, 3, and 4</time_frame>
        <population>This analysis includes participants with high quality images that were able to be examined. Some participants moved during the MRI resulting in distorted images.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo in ASD Participants</title>
            <description>Participants receiving the placebo</description>
          </group>
          <group group_id="O2">
            <title>8IU of Oxytocin Spray</title>
            <description>Participants receiving 8IU of oxytocin</description>
          </group>
          <group group_id="O3">
            <title>24IU of Oxytocin Spray</title>
            <description>Participants receiving 24IU of oxytocin</description>
          </group>
          <group group_id="O4">
            <title>48IU of Oxytocin Spray</title>
            <description>Participants receiving 48IU of oxytocin</description>
          </group>
          <group group_id="O5">
            <title>Healthy Controls Receiving Placebo</title>
            <description>Healthy controls received the placebo spray only</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues</title>
          <description>BOLD activity level was assessed via fMRI during completion of the face perception task (FPT) of emotional and neutral faces. BOLD scores are reported on a z-scale, with the mean, standard deviation and the minimum and the maximum. This refers to the non-thresholded z-scores that are obtained for each dose before conducting small volume correction analysis.</description>
          <population>This analysis includes participants with high quality images that were able to be examined. Some participants moved during the MRI resulting in distorted images.</population>
          <units>z-scores</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="25"/>
                <count group_id="O5" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Face versus Fixation, Insular Cortex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.347824" lower_limit="-3.086408" upper_limit="2.294047"/>
                    <measurement group_id="O2" value="-0.758427" lower_limit="-2.614224" upper_limit="0.614738"/>
                    <measurement group_id="O3" value="-0.602304" lower_limit="-2.746292" upper_limit="1.613434"/>
                    <measurement group_id="O4" value="0.33747" lower_limit="-2.70115" upper_limit="2.94780"/>
                    <measurement group_id="O5" value="-0.540874" lower_limit="-3.423316" upper_limit="2.087243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face versus Fixation, Cingulate Gyrus, Anterior Division</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.313911" lower_limit="-2.50618" upper_limit="2.058421"/>
                    <measurement group_id="O2" value="-0.59443" lower_limit="-2.122833" upper_limit="1.013119"/>
                    <measurement group_id="O3" value="-0.922999" lower_limit="-2.996872" upper_limit="2.020612"/>
                    <measurement group_id="O4" value="0.03105" lower_limit="-2.13638" upper_limit="2.62367"/>
                    <measurement group_id="O5" value="-0.573381" lower_limit="-3.103699" upper_limit="2.334144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face versus Fixation, Frontal Orbital Cortex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.517829" lower_limit="-2.3038" upper_limit="3.234023"/>
                    <measurement group_id="O2" value="-0.339727" lower_limit="-2.099626" upper_limit="2.850896"/>
                    <measurement group_id="O3" value="0.133334" lower_limit="-2.105783" upper_limit="2.2979"/>
                    <measurement group_id="O4" value="0.51544" lower_limit="-2.51943" upper_limit="3.32401"/>
                    <measurement group_id="O5" value="0.504016" lower_limit="-2.080812" upper_limit="3.234903"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face versus Fixation, Occipital Fusiform Gyrus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.427291" lower_limit="-0.812082" upper_limit="5.631112"/>
                    <measurement group_id="O2" value="3.556448" lower_limit="-1.039342" upper_limit="6.120963"/>
                    <measurement group_id="O3" value="3.403614" lower_limit="-1.445628" upper_limit="5.572412"/>
                    <measurement group_id="O4" value="3.39230" lower_limit="-1.00470" upper_limit="5.80665"/>
                    <measurement group_id="O5" value="3.322934" lower_limit="-0.978423" upper_limit="6.224413"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face versus Fixation, Left Laterobasal Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.003581" lower_limit="-1.595989" upper_limit="2.935086"/>
                    <measurement group_id="O2" value="-0.46194" lower_limit="-1.821512" upper_limit="0.953573"/>
                    <measurement group_id="O3" value="0.347864" lower_limit="-1.570765" upper_limit="1.521856"/>
                    <measurement group_id="O4" value="1.06647" lower_limit="-1.74681" upper_limit="2.66841"/>
                    <measurement group_id="O5" value="1.341538" lower_limit="-1.84355" upper_limit="3.69492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face versus Fixation, Right Laterobasal Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.817701" lower_limit="-0.488433" upper_limit="1.900966"/>
                    <measurement group_id="O2" value="-0.80763" lower_limit="-1.895006" upper_limit="2.793559"/>
                    <measurement group_id="O3" value="0.57701" lower_limit="-0.796838" upper_limit="2.303261"/>
                    <measurement group_id="O4" value="0.989042" lower_limit="-2.810703" upper_limit="3.013389"/>
                    <measurement group_id="O5" value="1.03517" lower_limit="-2.307756" upper_limit="3.598735"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face versus Fixation, Left Accumbens</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.324295" lower_limit="-1.939803" upper_limit="1.759384"/>
                    <measurement group_id="O2" value="-0.358148" lower_limit="-1.451141" upper_limit="0.765259"/>
                    <measurement group_id="O3" value="-0.76235" lower_limit="-1.917312" upper_limit="0.928076"/>
                    <measurement group_id="O4" value="-0.364131" lower_limit="-1.405679" upper_limit="1.852745"/>
                    <measurement group_id="O5" value="-0.859178" lower_limit="-2.026179" upper_limit="1.316851"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face versus Fixation, Right Caudate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.086391" lower_limit="-1.634846" upper_limit="1.335388"/>
                    <measurement group_id="O2" value="-0.820473" lower_limit="-2.670037" upper_limit="0.688685"/>
                    <measurement group_id="O3" value="0.536007" lower_limit="-0.75045" upper_limit="2.122765"/>
                    <measurement group_id="O4" value="-0.602492" lower_limit="-2.543713" upper_limit="2.199534"/>
                    <measurement group_id="O5" value="0.232223" lower_limit="-2.707574" upper_limit="2.410349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face versus Fixation, Right Hippocampus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.86138" lower_limit="-1.352965" upper_limit="4.348929"/>
                    <measurement group_id="O2" value="-0.391579" lower_limit="-1.868284" upper_limit="3.961795"/>
                    <measurement group_id="O3" value="0.194145" lower_limit="-1.941021" upper_limit="4.12766"/>
                    <measurement group_id="O4" value="0.485382" lower_limit="-2.754611" upper_limit="3.198802"/>
                    <measurement group_id="O5" value="0.613169" lower_limit="-2.431345" upper_limit="5.088185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face versus Fixation, Right Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.047957" lower_limit="-0.621127" upper_limit="3.190074"/>
                    <measurement group_id="O2" value="-0.638315" lower_limit="-1.963881" upper_limit="1.061985"/>
                    <measurement group_id="O3" value="0.175908" lower_limit="-1.389825" upper_limit="1.977887"/>
                    <measurement group_id="O4" value="1.302074" lower_limit="-1.287299" upper_limit="2.737782"/>
                    <measurement group_id="O5" value="1.701371" lower_limit="-0.697901" upper_limit="4.212626"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face versus Fixation, Right Accumbens</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.316604" lower_limit="-1.951857" upper_limit="0.911325"/>
                    <measurement group_id="O2" value="-0.567634" lower_limit="-1.789596" upper_limit="0.482181"/>
                    <measurement group_id="O3" value="-0.418176" lower_limit="-1.775193" upper_limit="1.027106"/>
                    <measurement group_id="O4" value="-0.556553" lower_limit="-1.956654" upper_limit="2.058268"/>
                    <measurement group_id="O5" value="-1.532579" lower_limit="-2.425838" upper_limit="-0.526067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Face versus Fixation, Left Caudate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.241254" lower_limit="-1.046636" upper_limit="1.514177"/>
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              <title>Happy versus Neutral, Right Caudate</title>
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                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.050791" lower_limit="-1.771317" upper_limit="2.670673"/>
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              <title>Happy versus Neutral, Right Amygdala</title>
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                <category>
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            </class>
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              <title>Happy versus Neutral, Right Accumbens</title>
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                <category>
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            <class>
              <title>Happy versus Neutral, Left Caudate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.377711" lower_limit="-1.217217" upper_limit="2.477899"/>
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            <class>
              <title>Happy versus Neutral, Left Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
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            </class>
            <class>
              <title>Emotion versus Neutral, Insular Cortex</title>
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                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3329" lower_limit="-2.675982" upper_limit="2.832457"/>
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                    <measurement group_id="O5" value="0.779819" lower_limit="-2.346668" upper_limit="3.176402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion versus Neutral, Cingulate Gyrus, Anterior Division</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13682" lower_limit="-2.575577" upper_limit="2.913227"/>
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                    <measurement group_id="O5" value="1.267345" lower_limit="-1.801961" upper_limit="3.327014"/>
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                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion versus Neutral, Frontal Orbital Cortex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.444076" lower_limit="-3.980701" upper_limit="4.066222"/>
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                    <measurement group_id="O5" value="1.116102" lower_limit="-1.707134" upper_limit="3.869851"/>
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              </category_list>
            </class>
            <class>
              <title>Emotion versus Neutral, Occipital Fusiform Gyrus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.547858" lower_limit="-1.359913" upper_limit="3.171797"/>
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              </category_list>
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            <class>
              <title>Emotion versus Neutral, Left Laterobasal Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.477913" lower_limit="-2.687634" upper_limit="1.870421"/>
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                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion versus Neutral, Right Laterobasal Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.203773" lower_limit="-2.527037" upper_limit="1.933879"/>
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              </category_list>
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            <class>
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                <category>
                  <measurement_list>
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                </category>
              </category_list>
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            <class>
              <title>Emotion versus Neutral, Right Caudate</title>
              <category_list>
                <category>
                  <measurement_list>
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            <class>
              <title>Emotion versus Neutral, Right Hippocampus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.015598" lower_limit="-2.428018" upper_limit="3.698757"/>
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                    <measurement group_id="O5" value="1.203561" lower_limit="-0.834364" upper_limit="3.154893"/>
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                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion versus Neutral, Right Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.147144" lower_limit="-1.452559" upper_limit="2.200656"/>
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                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion versus Neutral, Right Accumbens</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.893013" lower_limit="-0.681809" upper_limit="1.831226"/>
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                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion versus Neutral, Left Caudate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.188575" lower_limit="-2.121857" upper_limit="2.886153"/>
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                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion versus Neutral, Left Hippocampus</title>
              <category_list>
                <category>
                  <measurement_list>
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                </category>
              </category_list>
            </class>
            <class>
              <title>Emotion versus Neutral, Left Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.148364" lower_limit="-2.244867" upper_limit="1.857259"/>
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                </category>
              </category_list>
            </class>
            <class>
              <title>Negative Emotions versus Neutral, Insular Cortex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.078993" lower_limit="-2.741794" upper_limit="2.651302"/>
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                </category>
              </category_list>
            </class>
            <class>
              <title>Negative Emotions versus Neutral, Cingulate Gyrus, Anterior Division</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.189082" lower_limit="-2.496925" upper_limit="2.594132"/>
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                </category>
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              <title>Negative Emotions versus Neutral, Occipital Fusiform Gyrus</title>
              <category_list>
                <category>
                  <measurement_list>
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                </category>
              </category_list>
            </class>
            <class>
              <title>Negative Emotions versus Neutral, Left Laterobasal Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50816" lower_limit="-2.706088" upper_limit="2.065712"/>
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                </category>
              </category_list>
            </class>
            <class>
              <title>Negative Emotions versus Neutral, Right Laterobasal Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.516251" lower_limit="-2.699315" upper_limit="1.637606"/>
                    <measurement group_id="O2" value="0.143468" lower_limit="-1.877897" upper_limit="2.858212"/>
                    <measurement group_id="O3" value="0.6247" lower_limit="-2.617959" upper_limit="3.03048"/>
                    <measurement group_id="O4" value="0.230971" lower_limit="-1.722826" upper_limit="2.324656"/>
                    <measurement group_id="O5" value="1.905216" lower_limit="-0.464664" upper_limit="3.187876"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative Emotions versus Neutral, Right Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.119579" lower_limit="-1.766533" upper_limit="2.24458"/>
                    <measurement group_id="O2" value="0.735094" lower_limit="-1.151499" upper_limit="3.192013"/>
                    <measurement group_id="O3" value="1.018509" lower_limit="-2.083258" upper_limit="3.03048"/>
                    <measurement group_id="O4" value="0.554755" lower_limit="-1.860525" upper_limit="2.394795"/>
                    <measurement group_id="O5" value="1.683817" lower_limit="-0.853004" upper_limit="3.205723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative Emotions versus Neutral, Left Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.192095" lower_limit="-2.406393" upper_limit="1.693166"/>
                    <measurement group_id="O2" value="0.512198" lower_limit="-1.087271" upper_limit="3.282288"/>
                    <measurement group_id="O3" value="0.368682" lower_limit="-1.412992" upper_limit="2.378465"/>
                    <measurement group_id="O4" value="1.091867" lower_limit="-1.250699" upper_limit="2.76721"/>
                    <measurement group_id="O5" value="2.214728" lower_limit="0.952909" upper_limit="3.208958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task</title>
        <description>BOLD activity in social-emotional brain regions during the perception of emotional facial videos were measured during the ball-game task. Mean percent change in contrast of parameter estimates in anatomical regions of interest are presented here. A positive value indicates increased BOLD activity while a negative value indicates decreased BOLD activity.</description>
        <time_frame>Post Intervention (up to 70 minutes) at Study Visits 1, 2, 3, and 4</time_frame>
        <population>This analysis includes participants with high quality images that were able to be examined. Some participants moved during the MRI resulting in distorted images.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo in ASD Participants</title>
            <description>Participants receiving the placebo</description>
          </group>
          <group group_id="O2">
            <title>8IU of Oxytocin Spray</title>
            <description>Participants receiving 8IU of oxytocin</description>
          </group>
          <group group_id="O3">
            <title>24IU of Oxytocin Spray</title>
            <description>Participants receiving 24IU of oxytocin</description>
          </group>
          <group group_id="O4">
            <title>48IU of Oxytocin Spray</title>
            <description>Participants receiving 48IU of oxytocin</description>
          </group>
          <group group_id="O5">
            <title>Healthy Controls Receiving Placebo</title>
            <description>Healthy controls received the placebo spray only</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task</title>
          <description>BOLD activity in social-emotional brain regions during the perception of emotional facial videos were measured during the ball-game task. Mean percent change in contrast of parameter estimates in anatomical regions of interest are presented here. A positive value indicates increased BOLD activity while a negative value indicates decreased BOLD activity.</description>
          <population>This analysis includes participants with high quality images that were able to be examined. Some participants moved during the MRI resulting in distorted images.</population>
          <units>percent change in contrast</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Human Minus Computer, Negative Feedback, Left Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2568" spread="0.0563"/>
                    <measurement group_id="O2" value="0.1379" spread="0.0494"/>
                    <measurement group_id="O3" value="0.1631" spread="0.0430"/>
                    <measurement group_id="O4" value="0.3304" spread="0.0658"/>
                    <measurement group_id="O5" value="0.3502" spread="0.0738"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Negative Feedback, Right Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3141" spread="0.0621"/>
                    <measurement group_id="O2" value="0.1118" spread="0.0452"/>
                    <measurement group_id="O3" value="0.1979" spread="0.0490"/>
                    <measurement group_id="O4" value="0.3576" spread="0.0641"/>
                    <measurement group_id="O5" value="0.3823" spread="0.0796"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Negative Feedback, Right Laterobasal Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1724" spread="0.0476"/>
                    <measurement group_id="O2" value="0.0921" spread="0.0379"/>
                    <measurement group_id="O3" value="0.0984" spread="0.0362"/>
                    <measurement group_id="O4" value="0.2569" spread="0.0666"/>
                    <measurement group_id="O5" value="0.2258" spread="0.0479"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Negative Feedback, Left Laterobasal Amygdala</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1512" spread="0.0493"/>
                    <measurement group_id="O2" value="0.0739" spread="0.0472"/>
                    <measurement group_id="O3" value="0.1094" spread="0.0417"/>
                    <measurement group_id="O4" value="0.2014" spread="0.0715"/>
                    <measurement group_id="O5" value="0.2717" spread="0.0555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Negative Feedback, Ventral Anterior Insula (Sphere)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1830" spread="0.0801"/>
                    <measurement group_id="O2" value="0.0311" spread="0.0574"/>
                    <measurement group_id="O3" value="-0.0575" spread="0.0661"/>
                    <measurement group_id="O4" value="0.1866" spread="0.0872"/>
                    <measurement group_id="O5" value="0.0815" spread="0.0651"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Negative Feedback, Anterior Cingulate (Sphere)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2604" spread="0.1109"/>
                    <measurement group_id="O2" value="0.0953" spread="0.0630"/>
                    <measurement group_id="O3" value="0.0419" spread="0.0497"/>
                    <measurement group_id="O4" value="0.3214" spread="0.0780"/>
                    <measurement group_id="O5" value="0.1406" spread="0.0525"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Positive Feedback, Anterior Cingulate (Sphere)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2774" spread="0.0854"/>
                    <measurement group_id="O2" value="0.0996" spread="0.0564"/>
                    <measurement group_id="O3" value="0.1526" spread="0.0711"/>
                    <measurement group_id="O4" value="0.2343" spread="0.0696"/>
                    <measurement group_id="O5" value="0.1218" spread="0.0594"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Positive Feedback, Frontal Orbital Cortex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2263" spread="0.0760"/>
                    <measurement group_id="O2" value="0.1338" spread="0.0360"/>
                    <measurement group_id="O3" value="0.1826" spread="0.0509"/>
                    <measurement group_id="O4" value="0.1859" spread="0.0575"/>
                    <measurement group_id="O5" value="0.2301" spread="0.0388"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Positive Feedback, Ventral Tegmental Area</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2412" spread="0.0738"/>
                    <measurement group_id="O2" value="0.1010" spread="0.0528"/>
                    <measurement group_id="O3" value="0.1889" spread="0.0769"/>
                    <measurement group_id="O4" value="0.1770" spread="0.0879"/>
                    <measurement group_id="O5" value="0.0848" spread="0.0607"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Positive Feedback, Right Caudate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2540" spread="0.0823"/>
                    <measurement group_id="O2" value="0.1114" spread="0.0512"/>
                    <measurement group_id="O3" value="0.2605" spread="0.0753"/>
                    <measurement group_id="O4" value="0.2824" spread="0.0728"/>
                    <measurement group_id="O5" value="0.3004" spread="0.0602"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Positive Feedback, Right Nucleus Accumbens</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1139" spread="0.0675"/>
                    <measurement group_id="O2" value="0.1017" spread="0.0557"/>
                    <measurement group_id="O3" value="0.1779" spread="0.0575"/>
                    <measurement group_id="O4" value="0.1341" spread="0.0642"/>
                    <measurement group_id="O5" value="0.2092" spread="0.0669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Positive - Negative Feedback, Anterior Cingulate (Sphere)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0175" spread="0.0501"/>
                    <measurement group_id="O2" value="0.0084" spread="0.0431"/>
                    <measurement group_id="O3" value="0.1156" spread="0.0592"/>
                    <measurement group_id="O4" value="-0.0996" spread="0.0443"/>
                    <measurement group_id="O5" value="-0.0320" spread="0.0439"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Positive - Negative Feedback, Frontal Orbital Cortex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0142" spread="0.0428"/>
                    <measurement group_id="O2" value="0.081" spread="0.0481"/>
                    <measurement group_id="O3" value="0.0826" spread="0.0412"/>
                    <measurement group_id="O4" value="-0.0957" spread="0.0443"/>
                    <measurement group_id="O5" value="0.0286" spread="0.0359"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Positive - Negative Feedback, Ventral Tegmental Area</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1417" spread="0.0448"/>
                    <measurement group_id="O2" value="-0.0175" spread="0.0391"/>
                    <measurement group_id="O3" value="0.0302" spread="0.0416"/>
                    <measurement group_id="O4" value="-0.0940" spread="0.0810"/>
                    <measurement group_id="O5" value="-0.0457" spread="0.0555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Positive - Negative Feedback, Right Caudate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0072" spread="0.0376"/>
                    <measurement group_id="O2" value="0.0205" spread="0.0278"/>
                    <measurement group_id="O3" value="0.1188" spread="0.0440"/>
                    <measurement group_id="O4" value="-0.0452" spread="0.0527"/>
                    <measurement group_id="O5" value="-0.0057" spread="0.0576"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Human Minus Computer, Positive - Negative Feedback, Right Nucleus Accumbens</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0277" spread="0.0354"/>
                    <measurement group_id="O2" value="0.0528" spread="0.0354"/>
                    <measurement group_id="O3" value="0.1174" spread="0.0352"/>
                    <measurement group_id="O4" value="-0.0615" spread="0.0417"/>
                    <measurement group_id="O5" value="-0.0737" spread="0.0666"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Oxytocin Plasma Concentration</title>
        <description>Plasma concentration of oxytocin prior to administration of study intervention and after administration of study intervention will be compared between the different dose levels and placebo. Plasma concentration of oxytocin is expected to increase following administration of intranasal oxytocin.</description>
        <time_frame>Visits 1, 2, 3 and 4 (before spray and 5 minutes after spray)</time_frame>
        <population>Only participants with ASD had blood drawn for plasma oxytocin concentrations. This analysis includes participants who provided a blood sample (one refused to give a sample).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo in ASD Participants</title>
            <description>Participants receiving the placebo</description>
          </group>
          <group group_id="O2">
            <title>8IU of Oxytocin Spray</title>
            <description>Participants receiving 8IU of oxytocin</description>
          </group>
          <group group_id="O3">
            <title>24IU of Oxytocin Spray</title>
            <description>Participants receiving 24IU of oxytocin</description>
          </group>
          <group group_id="O4">
            <title>48IU of Oxytocin Spray</title>
            <description>Participants receiving 48IU of oxytocin</description>
          </group>
        </group_list>
        <measure>
          <title>Oxytocin Plasma Concentration</title>
          <description>Plasma concentration of oxytocin prior to administration of study intervention and after administration of study intervention will be compared between the different dose levels and placebo. Plasma concentration of oxytocin is expected to increase following administration of intranasal oxytocin.</description>
          <population>Only participants with ASD had blood drawn for plasma oxytocin concentrations. This analysis includes participants who provided a blood sample (one refused to give a sample).</population>
          <units>picogram/milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Prior to spray</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.09" spread="3.97"/>
                    <measurement group_id="O2" value="11.17" spread="6.99"/>
                    <measurement group_id="O3" value="9.06" spread="3.45"/>
                    <measurement group_id="O4" value="9.72" spread="9.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After spray</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.75" spread="3.67"/>
                    <measurement group_id="O2" value="14.36" spread="9.28"/>
                    <measurement group_id="O3" value="17.52" spread="8.41"/>
                    <measurement group_id="O4" value="20.86" spread="12.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Smiling During Global Clinical Interview</title>
        <description>Clinical improvements will be rated by a clinician as based on a videotaped interview conducted after the MRI scanning session. Values between the different treatment conditions will be assessed to study the effect of intranasal oxytocin on ASD at the clinical level. The improvement will be assessed based on the quality of social interaction between the experimenter and the participant, specifically as the amount of smiling behavior displayed by participants. Larger values indicate that participants are smiling more frequently.</description>
        <time_frame>Post Intervention (Up to 180 minutes after receiving spray) at Study Visits 1, 2, 3 and 4</time_frame>
        <population>This analysis includes participants with ASD who completed the videotaped interview. One participant declined to be videotaped and is not included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo in ASD Participants</title>
            <description>Participants receiving the placebo</description>
          </group>
          <group group_id="O2">
            <title>8IU of Oxytocin Spray</title>
            <description>Participants receiving 8IU of oxytocin</description>
          </group>
          <group group_id="O3">
            <title>24IU of Oxytocin Spray</title>
            <description>Participants receiving 24IU of oxytocin</description>
          </group>
          <group group_id="O4">
            <title>48IU of Oxytocin Spray</title>
            <description>Participants receiving 48IU of oxytocin</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Smiling During Global Clinical Interview</title>
          <description>Clinical improvements will be rated by a clinician as based on a videotaped interview conducted after the MRI scanning session. Values between the different treatment conditions will be assessed to study the effect of intranasal oxytocin on ASD at the clinical level. The improvement will be assessed based on the quality of social interaction between the experimenter and the participant, specifically as the amount of smiling behavior displayed by participants. Larger values indicate that participants are smiling more frequently.</description>
          <population>This analysis includes participants with ASD who completed the videotaped interview. One participant declined to be videotaped and is not included in this analysis.</population>
          <units>Smiles per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.954" spread="0.724"/>
                    <measurement group_id="O2" value="0.954" spread="0.801"/>
                    <measurement group_id="O3" value="1.013" spread="0.810"/>
                    <measurement group_id="O4" value="1.015" spread="0.744"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Milliseconds of Visual Fixation</title>
        <description>Eye gaze will be recorded via an eye tracker inside the MRI scanner during the face perception task (FPT). Visual fixation between different treatment conditions will be assessed in ASD participants.</description>
        <time_frame>Post Intervention (Up to 50 minutes) at Study Visits 1, 2, 3 and 4</time_frame>
        <population>This analysis includes participants with ASD who had usable data for this outcome. There were difficulties with the eye tracking technology inside the MRI scanner and tracking of the pupil was not successful at all times. Healthy controls did not participate in the eye tracker portion of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo in ASD Participants</title>
            <description>Participants receiving the placebo</description>
          </group>
          <group group_id="O2">
            <title>8IU of Oxytocin Spray</title>
            <description>Participants receiving 8IU of oxytocin</description>
          </group>
          <group group_id="O3">
            <title>24IU of Oxytocin Spray</title>
            <description>Participants receiving 24IU of oxytocin</description>
          </group>
          <group group_id="O4">
            <title>48IU of Oxytocin Spray</title>
            <description>Participants receiving 48IU of oxytocin</description>
          </group>
        </group_list>
        <measure>
          <title>Milliseconds of Visual Fixation</title>
          <description>Eye gaze will be recorded via an eye tracker inside the MRI scanner during the face perception task (FPT). Visual fixation between different treatment conditions will be assessed in ASD participants.</description>
          <population>This analysis includes participants with ASD who had usable data for this outcome. There were difficulties with the eye tracking technology inside the MRI scanner and tracking of the pupil was not successful at all times. Healthy controls did not participate in the eye tracker portion of the study.</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="14"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91786.05" spread="65288.71"/>
                    <measurement group_id="O2" value="82503.23" spread="48615.57"/>
                    <measurement group_id="O3" value="134913.00" spread="55067.12"/>
                    <measurement group_id="O4" value="130600.90" spread="66305.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Social Learning Test (SLT) Reaction Time</title>
        <description>During the SLT, participants complete an implicit association test using faces and words. The faces that are presented in this task are partners' faces with whom participants played during the ball-game inside the MRI scanner. In this task, there are congruent blocks where neutral faces of &quot;positive&quot; partners are presented with friendly words and neutral faces of &quot;negative&quot; partners are presented with unfriendly words. During incongruent blocks, neutral faces of &quot;positive&quot; partners are presented with unfriendly words and neutral faces of &quot;negative&quot; partners are presented with friendly words. Participants match the face or the word to one of two categories. Longer reaction time indicates difficulty with selecting a category. Longer reaction time in incongruent trials signifies implicit biases were formed for the positive and negative players such that &quot;positive&quot; partners from the ball-game are now perceived as friendly and &quot;negative&quot; partners are now perceived as unfriendly.</description>
        <time_frame>Post Intervention (Up to 130 minutes) at Study Visits 1, 2, 3 and 4</time_frame>
        <population>Among participants with autism who completed the study, two participants had outlying data and were removed from this analysis.Two healthy controls did not complete the SLT due to time constraints.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo in ASD Participants</title>
            <description>Participants receiving the placebo</description>
          </group>
          <group group_id="O2">
            <title>8IU of Oxytocin Spray</title>
            <description>Participants receiving 8IU of oxytocin</description>
          </group>
          <group group_id="O3">
            <title>24IU of Oxytocin Spray</title>
            <description>Participants receiving 24IU of oxytocin</description>
          </group>
          <group group_id="O4">
            <title>48IU of Oxytocin Spray</title>
            <description>Participants receiving 48IU of oxytocin</description>
          </group>
          <group group_id="O5">
            <title>Healthy Controls Receiving Placebo</title>
            <description>Healthy controls received the placebo spray only</description>
          </group>
        </group_list>
        <measure>
          <title>Social Learning Test (SLT) Reaction Time</title>
          <description>During the SLT, participants complete an implicit association test using faces and words. The faces that are presented in this task are partners' faces with whom participants played during the ball-game inside the MRI scanner. In this task, there are congruent blocks where neutral faces of &quot;positive&quot; partners are presented with friendly words and neutral faces of &quot;negative&quot; partners are presented with unfriendly words. During incongruent blocks, neutral faces of &quot;positive&quot; partners are presented with unfriendly words and neutral faces of &quot;negative&quot; partners are presented with friendly words. Participants match the face or the word to one of two categories. Longer reaction time indicates difficulty with selecting a category. Longer reaction time in incongruent trials signifies implicit biases were formed for the positive and negative players such that &quot;positive&quot; partners from the ball-game are now perceived as friendly and &quot;negative&quot; partners are now perceived as unfriendly.</description>
          <population>Among participants with autism who completed the study, two participants had outlying data and were removed from this analysis.Two healthy controls did not complete the SLT due to time constraints.</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="29"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Congruent Blocks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="939.43" spread="605.79"/>
                    <measurement group_id="O2" value="972.08" spread="950.41"/>
                    <measurement group_id="O3" value="905.99" spread="741.22"/>
                    <measurement group_id="O4" value="896.63" spread="679.50"/>
                    <measurement group_id="O5" value="762.72" spread="335.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Incongruent Blocks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="969.17" spread="730.30"/>
                    <measurement group_id="O2" value="960.41" spread="745.84"/>
                    <measurement group_id="O3" value="920.23" spread="622.83"/>
                    <measurement group_id="O4" value="921.90" spread="650.23"/>
                    <measurement group_id="O5" value="791.65" spread="410.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Training Blocks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="790.49" spread="757.66"/>
                    <measurement group_id="O2" value="800.25" spread="922.21"/>
                    <measurement group_id="O3" value="765.53" spread="754.48"/>
                    <measurement group_id="O4" value="761.89" spread="782.89"/>
                    <measurement group_id="O5" value="655.27" spread="499.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events that were potentially related to the study intervention were collected from the time of consent to participate in the study through all study visits (up to Week 5).</time_frame>
      <desc>Only treatment related adverse events were monitored. The total number of participants in each intervention is the number who were administered that treatment; one participant withdrew before being administered the 48IU dose or placebo. Healthy controls were only administered the placebo.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants receiving the placebo</description>
        </group>
        <group group_id="E2">
          <title>8IU of Oxytocin Spray</title>
          <description>Participants receiving 8IU of oxytocin</description>
        </group>
        <group group_id="E3">
          <title>24IU of Oxytocin Spray</title>
          <description>Participants receiving 24IU of oxytocin</description>
        </group>
        <group group_id="E4">
          <title>48IU of Oxytocin Spray</title>
          <description>Participants receiving 48IU of oxytocin</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Lightheaded after spray</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Dizziness after spray and blood draw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Temperature increase</sub_title>
                <description>Body temperature increased by 2 degrees for a few minutes</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Frustration during MRI</sub_title>
                <description>Frustration with game errors while in MRI, 40 minutes after the spray</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nostril tingling after spray</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Light coughing after spray</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increase</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Numb left hand</sub_title>
                <description>Numbing of hand while inside MRI, more than 40 minutes after spray intake</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <point_of_contact>
      <name_or_title>Elissar Andari, PhD</name_or_title>
      <organization>The University of Toledo</organization>
      <phone>419-383-5227</phone>
      <email>elissar.andari@Utoledo.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/NCT03033784
org study id: IRB00093455
secondary id: P50MH100023
nct id: NCT03033784
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The main goal of the study is to look at the effects of intranasal oxytocin on the brain in
      Autism Spectrum Disorder (ASD). Oxytocin is a hormone that exists naturally in the body and
      the brain, affecting a wide range of social behaviors and emotions. The investigators will
      study the effects of different treatments (3 doses of oxytocin and one dose of placebo) on
      brain functional connectivity at rest in patients with ASD, using functional magnetic
      resonance imaging (fMRI). Investigators also seek to study how the effects of oxytocin
      treatment can be affected by genetic, immune and environmental factors.
This study consists of investigating the effects of several doses of acute administration of
      intranasal oxytocin on brain activity in adults with Autism Spectrum Disorder (ASD). There is
      increasing evidence for the role of intranasal oxytocin (IN-OT) in enhancing social skills in
      ASD. Nevertheless, there is still a need of determining target engagement for oxytocin's
      action on brain and behavior. Here, investigators are studying the effects of different doses
      of IN-OT on the modulation of behavioral outcomes and neural responses in a double blind
      crossover study in individuals with ASD.

      The aims of the research are to:

        1. Study the effects of IN-OT doses on the modulation of brain functional connectivity
           between key socio-emotional brain regions during resting state in ASD

        2. Study the effects of IN-OT doses on the blood-oxygen-level dependent (BOLD) activity of
           key emotional and perceptual brain networks in response to social cues (such as faces)

        3. Study the effects of IN-OT on the BOLD activity of brain regions during an interactive
           social environment (ball game) in ASD

      Investigators will compare the neuroimaging and behavioral results of individuals with ASD to
      control healthy males who will receive intranasal placebo. Investigators are also
      investigating the role of genetic factors, behavioral or clinical sub-groups of ASD, immune
      and environmental factors in modulating the effect of IN-OT on brain and behavior.

      Participants with ASD will undergo 4 clinical visits during which they receive various
      randomly assigned doses of intranasal oxytocin and placebo. Both participants and the
      experimenter will be blind to the type of the treatment administered.

      There will be only one visit for healthy controls who will all receive placebo spray. The
      visit for healthy controls will be conducted in a single-blind design. The experimenter will
      be aware that the subject is receiving placebo. However, the participant will be told that he
      might receive oxytocin or placebo.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Resting State Functional Connectivity (rsFC) Salience Network (Anterior Cingulate Cortex (ACC) and Insula Versus Visual Cortex)
time frame: Post Intervention (Up to 40 minutes after receiving spray) at Study Visits 1, 2, 3 and 4
description: Investigators will study the effects of intranasal oxytocin (IN-OT) on the resting state functional connectivity between key socio-emotional and social salience brain regions using functional magnetic resonance imaging (fMRI). Resting state functional connectivity is a task-independent metric of brain activity that is based on correlations between low-frequency fluctuations of the blood oxygen level-dependent signal between several brain regions. It reflects the strength of a functional connection that is in good agreement with the underlying neuroanatomy and provides a system-level understanding of brain function. Z-scores represent the number of standard deviations from the mean of 0 and range from -3 to +3, and z-scores greater than 0 indicate greater than average resting state functional connectivity.
measure: Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues
time frame: Post Intervention (Up to 70 minutes) at Study Visits 1, 2, 3, and 4
description: BOLD activity level was assessed via fMRI during completion of the face perception task (FPT) of emotional and neutral faces. BOLD scores are reported on a z-scale, with the mean, standard deviation and the minimum and the maximum. This refers to the non-thresholded z-scores that are obtained for each dose before conducting small volume correction analysis.
measure: Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task
time frame: Post Intervention (up to 70 minutes) at Study Visits 1, 2, 3, and 4
description: BOLD activity in social-emotional brain regions during the perception of emotional facial videos were measured during the ball-game task. Mean percent change in contrast of parameter estimates in anatomical regions of interest are presented here. A positive value indicates increased BOLD activity while a negative value indicates decreased BOLD activity.
measure: Oxytocin Plasma Concentration
time frame: Visits 1, 2, 3 and 4 (before spray and 5 minutes after spray)
description: Plasma concentration of oxytocin prior to administration of study intervention and after administration of study intervention will be compared between the different dose levels and placebo. Plasma concentration of oxytocin is expected to increase following administration of intranasal oxytocin.
measure: Rate of Smiling During Global Clinical Interview
time frame: Post Intervention (Up to 180 minutes after receiving spray) at Study Visits 1, 2, 3 and 4
description: Clinical improvements will be rated by a clinician as based on a videotaped interview conducted after the MRI scanning session. Values between the different treatment conditions will be assessed to study the effect of intranasal oxytocin on ASD at the clinical level. The improvement will be assessed based on the quality of social interaction between the experimenter and the participant, specifically as the amount of smiling behavior displayed by participants. Larger values indicate that participants are smiling more frequently.
measure: Milliseconds of Visual Fixation
time frame: Post Intervention (Up to 50 minutes) at Study Visits 1, 2, 3 and 4
description: Eye gaze will be recorded via an eye tracker inside the MRI scanner during the face perception task (FPT). Visual fixation between different treatment conditions will be assessed in ASD participants.
measure: Social Learning Test (SLT) Reaction Time
time frame: Post Intervention (Up to 130 minutes) at Study Visits 1, 2, 3 and 4
description: During the SLT, participants complete an implicit association test using faces and words. The faces that are presented in this task are partners' faces with whom participants played during the ball-game inside the MRI scanner. In this task, there are congruent blocks where neutral faces of "positive" partners are presented with friendly words and neutral faces of "negative" partners are presented with unfriendly words. During incongruent blocks, neutral faces of "positive" partners are presented with unfriendly words and neutral faces of "negative" partners are presented with friendly words. Participants match the face or the word to one of two categories. Longer reaction time indicates difficulty with selecting a category. Longer reaction time in incongruent trials signifies implicit biases were formed for the positive and negative players such that "positive" partners from the ball-game are now perceived as friendly and "negative" partners are now perceived as unfriendly.
arm group label: Autism Spectrum Disorder (ASD)
arm group type: Experimental
description: Male participants diagnosed with ASD will receive 12 puffs (6 in each nostril) of intranasal oxytocin (syntocinon) and placebo (assigned randomly) during 4 study visits.
arm group label: Healthy Control
arm group type: Placebo Comparator
description: Age matched healthy controls will receive placebo intranasal spray (12 puffs, 6 per nostril) during one study visit.
intervention type: Drug
intervention name: 8 International Units (IU) of Oxytocin
description: Participants will receive one dose of intranasal oxytocin at a dose of 8IU.
arm group label: Autism Spectrum Disorder (ASD)
other name: syntocinon
intervention type: Drug
intervention name: 24IU of Oxytocin
description: Participants will receive one dose of intranasal oxytocin at a dose of 24IU.
arm group label: Autism Spectrum Disorder (ASD)
other name: syntocinon
intervention type: Drug
intervention name: 48IU of Oxytocin
description: Participants will receive one dose of intranasal oxytocin at a dose of 48IU.
arm group label: Autism Spectrum Disorder (ASD)
other name: syntocinon
intervention type: Drug
intervention name: Placebo
description: Participants will receive an intranasal placebo to match the oxytocin doses.
arm group label: Autism Spectrum Disorder (ASD)
arm group label: Healthy Control
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elissar Andari, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Elissar Andari
investigator title: Adjunct Assistant Professor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Oxytocin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 