<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/NCT02225600</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 13-0744</org_study_id>
    <nct_id>NCT02225600</nct_id>
  </id_info>
  <brief_title>The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults</brief_title>
  <official_title>The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults: A Pilot Behavioral Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will examine behavioral patterns and underlying neural correlates which distinguish&#xD;
      patients with borderline personality disorder (BPD) from healthy subjects as they participate&#xD;
      in a two-person trust game and will determine whether administration of intranasal oxytocin&#xD;
      (OT) will normalize trust game performance and concomitant neural processing in the BPD&#xD;
      group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study to support submission of a larger-scale federally funded study. The&#xD;
      study is designed to develop new strategies for treating the severe interpersonal dysfunction&#xD;
      in borderline personality disorder (BPD) by modeling the interpersonal disturbance in BPD in&#xD;
      the laboratory, identifying its neural correlates and determining whether the social&#xD;
      neuropeptide, oxytocin, can ameliorate the interpersonal dysfunction. The study will examine&#xD;
      behavioral patterns and underlying neural correlates which distinguish patients with&#xD;
      borderline personality disorder (BPD) from healthy subjects as they participate in a&#xD;
      two-person trust game and will determine whether administration of intranasal oxytocin (OT)&#xD;
      will normalize trust game performance and concomitant neural processing in the BPD group.&#xD;
&#xD;
      The specific aims of the study are: 1) to determine whether BPD patients and healthy controls&#xD;
      (HC) differ in their pattern of investing in a trustee when the trustee behaves benevolently&#xD;
      or malevolently towards them or suddenly becomes malevolent after a period of benevolence (or&#xD;
      vice-versa) in a multi-round economic exchange game (&quot;The Trust Game&quot;), and 2) to determine&#xD;
      the effect upon behavior of the administration of 40 IU intranasal oxytocin relative to&#xD;
      placebo in BPD subjects and HC's engaged in the Trust Game.&#xD;
&#xD;
      Subjects are being recruited and may participate in the Trust Game task, but intranasal&#xD;
      administration of oxytocin has temporarily been held because of the COVID-19 pandemic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 26, 2014</start_date>
  <completion_date type="Anticipated">March 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Trust Game Affect Ratings</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>Behavioral differences between groups based on Scale with 1= most negative to 5=most positive</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Borderline Personality Disorder</condition>
  <arm_group>
    <arm_group_label>patients with BPD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>cross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cross-over of 40 IU oxytocin, 24 IU oxytocin and placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>40 IU Intranasal Oxytocin</intervention_name>
    <description>40 IU intranasal oxytocin</description>
    <arm_group_label>healthy patients</arm_group_label>
    <arm_group_label>patients with BPD</arm_group_label>
    <other_name>OT</other_name>
    <other_name>Syntocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intranasal Placebo</description>
    <arm_group_label>healthy patients</arm_group_label>
    <arm_group_label>patients with BPD</arm_group_label>
    <other_name>Intranasal Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>24 IU intranasal Oxytocin</intervention_name>
    <arm_group_label>healthy patients</arm_group_label>
    <arm_group_label>patients with BPD</arm_group_label>
    <other_name>syntocin</other_name>
    <other_name>OT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BPD subjects meets criteria for DSM-IV Borderline Personality Disorder.&#xD;
&#xD;
          -  18 to 55 years old&#xD;
&#xD;
          -  Healthy controls are free of any lifetime DSM-IV Axis I or Axis II diagnosis. However,&#xD;
             to avoid a group of HC's too highly groomed and unrepresentative of the general&#xD;
             population subjects meeting criteria for a past Axis I diagnosis of adjustment,&#xD;
             dysthymic, or depressive NOS disorders, specific phobias, and sleep disorders will not&#xD;
             be excluded. Subjects will not be excluded for a non-IV substance abuse disorder more&#xD;
             than 6 months prior to enrollment.&#xD;
&#xD;
          -  All subjects will be free of psychotropic medications for 2 weeks (6 weeks for&#xD;
             fluoxetine).&#xD;
&#xD;
          -  Subjects may be enrolled in psychotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BPD subjects not meeting DSM-IV criteria for past or present bipolar I disorder,&#xD;
             schizophrenia, schizoaffective disorder, substance dependence, head trauma, CNS&#xD;
             neurological disease, seizure disorder or current major depression. Since depression&#xD;
             is commonly associated with BPD, too stringent a depression exclusion criterion would&#xD;
             yield a clinically atypical BPD sample. For this reason, BPD patients with Axis I&#xD;
             depressive disorders other than major depression and those with a past history of&#xD;
             major depression will not be excluded.&#xD;
&#xD;
          -  Substance abuse disorder in the prior 6 months&#xD;
&#xD;
          -  Significant medical illness&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Metallic foreign-bodies that contraindicate MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harold Koenigsberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Harold Koenigsberg, MD</last_name>
    <phone>212-241-0441</phone>
    <email>harold.w.koenigsberg@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Harold Koenigsberg, MD</last_name>
      <email>harold.w.koenigsberg@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Harold W Koenigsberg</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Borderline Personality Disorder</keyword>
  <keyword>BPD</keyword>
  <keyword>Intranasal oxytocin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Personality Disorders</mesh_term>
    <mesh_term>Borderline Personality 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>
  <!-- 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/NCT02225600
org study id: GCO 13-0744
nct id: NCT02225600
lead sponsor: 
has dmc: Yes
The study will examine behavioral patterns and underlying neural correlates which distinguish
      patients with borderline personality disorder (BPD) from healthy subjects as they participate
      in a two-person trust game and will determine whether administration of intranasal oxytocin
      (OT) will normalize trust game performance and concomitant neural processing in the BPD
      group.
This is a pilot study to support submission of a larger-scale federally funded study. The
      study is designed to develop new strategies for treating the severe interpersonal dysfunction
      in borderline personality disorder (BPD) by modeling the interpersonal disturbance in BPD in
      the laboratory, identifying its neural correlates and determining whether the social
      neuropeptide, oxytocin, can ameliorate the interpersonal dysfunction. The study will examine
      behavioral patterns and underlying neural correlates which distinguish patients with
      borderline personality disorder (BPD) from healthy subjects as they participate in a
      two-person trust game and will determine whether administration of intranasal oxytocin (OT)
      will normalize trust game performance and concomitant neural processing in the BPD group.

      The specific aims of the study are: 1) to determine whether BPD patients and healthy controls
      (HC) differ in their pattern of investing in a trustee when the trustee behaves benevolently
      or malevolently towards them or suddenly becomes malevolent after a period of benevolence (or
      vice-versa) in a multi-round economic exchange game ("The Trust Game"), and 2) to determine
      the effect upon behavior of the administration of 40 IU intranasal oxytocin relative to
      placebo in BPD subjects and HC's engaged in the Trust Game.

      Subjects are being recruited and may participate in the Trust Game task, but intranasal
      administration of oxytocin has temporarily been held because of the COVID-19 pandemic.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Trust Game Affect Ratings
time frame: up to 4 weeks
description: Behavioral differences between groups based on Scale with 1= most negative to 5=most positive
arm group label: patients with BPD
arm group type: Other
description: cross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo
arm group label: healthy patients
arm group type: Active Comparator
description: Cross-over of 40 IU oxytocin, 24 IU oxytocin and placebo
intervention type: Drug
intervention name: 40 IU Intranasal Oxytocin
description: 40 IU intranasal oxytocin
arm group label: healthy patients
arm group label: patients with BPD
other name: OT
other name: Syntocin
intervention type: Drug
intervention name: Placebo
description: Intranasal Placebo
arm group label: healthy patients
arm group label: patients with BPD
other name: Intranasal Placebo
intervention type: Drug
intervention name: 24 IU intranasal Oxytocin
arm group label: healthy patients
arm group label: patients with BPD
other name: syntocin
other name: OT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harold Koenigsberg, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Harold Koenigsberg, MD
phone: 212-241-0441
email: harold.w.koenigsberg@gmail.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Harold W Koenigsberg
investigator title: Professor
mesh term: Personality Disorders
mesh term: Borderline Personality Disorder
mesh term: Oxytocin