<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/NCT03245437</url>
  </required_header>
  <id_info>
    <org_study_id>OT R33</org_study_id>
    <secondary_id>R33MH107564</secondary_id>
    <nct_id>NCT03245437</nct_id>
  </id_info>
  <brief_title>Target Engagement and Response to Oxytocin</brief_title>
  <official_title>Effects of Oxytocin on Social Cognition Training: Relationship to Target Engagement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</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>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will measure whether the engagement of intranasal oxytocin with a brain target is&#xD;
      related to effects on learning during a social cognition training program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will determine whether oxytocin (OT) administration 30 min before a training&#xD;
      session enhances the learning of social information in the context of a social cognitive&#xD;
      skills training (SCST) program, and it will test a possible mediator of this effect. Subjects&#xD;
      with psychotic disorders will be randomized to one of four groups in a 2 by 2 factorial&#xD;
      design: OT with SCST; Placebo with SCST; OT with training control condition; placebo with&#xD;
      training control condition. Target engagement will be measured in an OT challenge (placebo&#xD;
      versus OT one week apart) prior to baseline assessment. The measure of target engagement will&#xD;
      be EEG mu suppression while observing biological motion. A social cognition battery will be&#xD;
      administered at baseline, at midpoint after 6 weeks of SCST, and at completion of training at&#xD;
      12 weeks. The battery will include measures of social cue identification and mentalizing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 4, 2018</start_date>
  <completion_date type="Anticipated">December 4, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 4, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-Blind Placebo controlled</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Social Cognition Composite Score</measure>
    <time_frame>16 weeks</time_frame>
    <description>We will assess social cognition in two subdomains: (1) social cue identification (Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) branch 1, Ekman, Profile of Nonverbal Sensitivity (PONS); and (2) mentalizing (The Awareness of Social Inference Test (TASIT). and Empathic accuracy) (see below). The primary summary measure for each test will be mean-centered and standardized to create a Z-score. These Z-scores will be averaged to create a single composite score for social cognition that will serve as the primary outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery</measure>
    <time_frame>16 weeks</time_frame>
    <description>Standardized z-score</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Oxytocin with SCST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxytocin with SCST (active condition)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxytocin with Health Management</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Administration of OT with control psychosocial treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo with SCST</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administration of Placebo with active psychosocial treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo with HM</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administration of Placebo with control psychosocial treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin nasal spray</intervention_name>
    <description>nasal spray</description>
    <arm_group_label>Oxytocin with Health Management</arm_group_label>
    <arm_group_label>Oxytocin with SCST</arm_group_label>
    <other_name>OT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social Cognition Skills Training</intervention_name>
    <description>Group based training in social cognition skills</description>
    <arm_group_label>Oxytocin with SCST</arm_group_label>
    <arm_group_label>Placebo with SCST</arm_group_label>
    <other_name>SCST</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Management</intervention_name>
    <description>Group-based training in mental health management</description>
    <arm_group_label>Oxytocin with Health Management</arm_group_label>
    <arm_group_label>Placebo with HM</arm_group_label>
    <other_name>HM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo nasal spray</intervention_name>
    <description>placebo condition</description>
    <arm_group_label>Placebo with HM</arm_group_label>
    <arm_group_label>Placebo with SCST</arm_group_label>
    <other_name>PBO</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Schizophrenia or schizoaffective disorder&#xD;
&#xD;
          -  stable on an antipsychotic medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  positive pregnancy test history of head injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Marder, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Stephen R. Marder</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Social Cognition</keyword>
  <keyword>Oxytocin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03245437
org study id: OT R33
secondary id: R33MH107564
nct id: NCT03245437
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will measure whether the engagement of intranasal oxytocin with a brain target is
      related to effects on learning during a social cognition training program.
The study will determine whether oxytocin (OT) administration 30 min before a training
      session enhances the learning of social information in the context of a social cognitive
      skills training (SCST) program, and it will test a possible mediator of this effect. Subjects
      with psychotic disorders will be randomized to one of four groups in a 2 by 2 factorial
      design: OT with SCST; Placebo with SCST; OT with training control condition; placebo with
      training control condition. Target engagement will be measured in an OT challenge (placebo
      versus OT one week apart) prior to baseline assessment. The measure of target engagement will
      be EEG mu suppression while observing biological motion. A social cognition battery will be
      administered at baseline, at midpoint after 6 weeks of SCST, and at completion of training at
      12 weeks. The battery will include measures of social cue identification and mentalizing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-Blind Placebo controlled
measure: Social Cognition Composite Score
time frame: 16 weeks
description: We will assess social cognition in two subdomains: (1) social cue identification (Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) branch 1, Ekman, Profile of Nonverbal Sensitivity (PONS); and (2) mentalizing (The Awareness of Social Inference Test (TASIT). and Empathic accuracy) (see below). The primary summary measure for each test will be mean-centered and standardized to create a Z-score. These Z-scores will be averaged to create a single composite score for social cognition that will serve as the primary outcome measure.
measure: Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery
time frame: 16 weeks
description: Standardized z-score
arm group label: Oxytocin with SCST
arm group type: Experimental
description: Oxytocin with SCST (active condition)
arm group label: Oxytocin with Health Management
arm group type: Sham Comparator
description: Administration of OT with control psychosocial treatment
arm group label: Placebo with SCST
arm group type: Placebo Comparator
description: Administration of Placebo with active psychosocial treatment
arm group label: Placebo with HM
arm group type: Placebo Comparator
description: Administration of Placebo with control psychosocial treatment
intervention type: Drug
intervention name: Oxytocin nasal spray
description: nasal spray
arm group label: Oxytocin with Health Management
arm group label: Oxytocin with SCST
other name: OT
intervention type: Behavioral
intervention name: Social Cognition Skills Training
description: Group based training in social cognition skills
arm group label: Oxytocin with SCST
arm group label: Placebo with SCST
other name: SCST
intervention type: Behavioral
intervention name: Health Management
description: Group-based training in mental health management
arm group label: Oxytocin with Health Management
arm group label: Placebo with HM
other name: HM
intervention type: Drug
intervention name: Placebo nasal spray
description: placebo condition
arm group label: Placebo with HM
arm group label: Placebo with SCST
other name: PBO
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Stephen Marder, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Stephen R. Marder
investigator title: Professor
mesh term: Schizophrenia
mesh term: Oxytocin