<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/NCT02236702</url>
  </required_header>
  <id_info>
    <org_study_id>S14-00643</org_study_id>
    <nct_id>NCT02236702</nct_id>
  </id_info>
  <brief_title>Kappa Opioid Receptor Imaging in Depression (KOR Depression)</brief_title>
  <official_title>Kappa Opioid Receptor Imaging in Depression (KOR Depression)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to use positron emission tomography (PET) imaging to measure the&#xD;
      activity of the kappa opioid receptor (KOR) in the brains of depressed and non-depressed&#xD;
      individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The kappa opioid receptor (KOR) has been implicated in the etiology of fear, threat, and&#xD;
      anhedonia in animal models of human depression psychopathology. Herein, we propose to study&#xD;
      the KOR in vivo using positron emission tomography, and we will also measure the activity of&#xD;
      the hypothalamic-pituitary-adrenal (HPA)-axis in all study participants. We propose to&#xD;
      recruit up to N=50 medication-free individuals using a transdiagnostic approach, measure&#xD;
      their KOR-selective radioligand [11C]LY2795050 volumes of distribution (VT), an equivalent of&#xD;
      KOR availability using positron emission tomography (PET) and study the role of the KOR in&#xD;
      mediating the quality and severity of the depressive phenotype.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>[11C]LY2795050 volume of distribution (VT) values in specific brain regions of asymptomatic vs mildly symptomatic vs moderately symptomatic vs severely symptomatic individuals</measure>
    <time_frame>one month</time_frame>
    <description>To use the KOR radioligand [11C]LY2795050 and PET to examine the relation between KOR availability in the ventral striatum and amygdala, and the full dimensional spectrum of threat and loss symptomatology, and reward responsiveness.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Major Depressive Disorder</condition>
  <condition>Anhedonia</condition>
  <arm_group>
    <arm_group_label>Asymptomatic control</arm_group_label>
    <description>Asymptomatic control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mildly symptomatic with depressive symptoms</arm_group_label>
    <description>Mildly symptomatic with depressive symptoms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderately symptomatic with depressive symptoms</arm_group_label>
    <description>Moderately symptomatic with depressive symptoms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severely symptomatic with depressive symptoms</arm_group_label>
    <description>Severely symptomatic with depressive symptoms</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Positron Emission Tomography (PET) imaging</intervention_name>
    <description>Positron Emission Tomography (PET) imaging</description>
    <arm_group_label>Asymptomatic control</arm_group_label>
    <arm_group_label>Mildly symptomatic with depressive symptoms</arm_group_label>
    <arm_group_label>Moderately symptomatic with depressive symptoms</arm_group_label>
    <arm_group_label>Severely symptomatic with depressive symptoms</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects are between the ages of 18-55, are medically healthy and not currently taking any&#xD;
        medications to treat any medical illness, have been diagnosed with major depressive&#xD;
        disorder (MDD) or will be as a result of this study, or are healthy control.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Inclusion criteria for all subjects include a willingness to participate in a&#xD;
             psychiatric evaluation, collection of behavioral ratings and neuroendocrine&#xD;
             assessments, and imaging studies including 1 positron emission tomography (PET) scan&#xD;
             and 1 mantic resonance imaging (MRI) scan.&#xD;
&#xD;
          2. We propose to use a transdiagnostic approach where participants will be stratified&#xD;
             according to their symptom severity to have a full representation of different&#xD;
             depressive severities and components of the depressive phenotype in the cohort. To&#xD;
             ensure recruitment of participants from each level of this phenotype, we will employ a&#xD;
             stratified sampling approach to recruit 12 participants who are asymptomatic (i.e.,&#xD;
             Montgomery-Asberg Depression Rating Scale (MADRS) score=0-6); 12 who are mildly&#xD;
             symptomatic (i.e., MADRS score=7-19; 12 who are moderately symptomatic (i.e., MADRS&#xD;
             sore=20-34); and 12 who are severely symptomatic (i.e., MADRS score&gt;34).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. any major medical (including HIV due to possible neuropsychiatric affects; and asthma&#xD;
             or heart disease which may limit the interpretation of the imaging results, for&#xD;
             example due to changes in tracer delivery in hypertensive patients or significant&#xD;
             weight change in prior 12 weeks prior to the study) and neurological illness or injury&#xD;
             (i.e. head trauma with loss of consciousness);&#xD;
&#xD;
          2. any current or prior clinically significant substance use disorder (abuse and&#xD;
             dependence within a year from imaging studies) as determined by Structured Clinical&#xD;
             Interview for Diagnostic and Statistical Manual Disorders (SCID) interview;&#xD;
&#xD;
          3. acute or chronic suicidality as determined by the SCID interview;&#xD;
&#xD;
          4. presence of any legal or illegal psychoactive substances determined with urine&#xD;
             toxicology, urine cotinine, carbon monoxide (CO) monitoring, and breathalyzer;&#xD;
&#xD;
          5. intelligence quotient (IQ) &lt;70 based on past intelligence testing;&#xD;
&#xD;
          6. any metal in body that would pose a risk with MRI;&#xD;
&#xD;
          7. claustrophobia that would interfere with MRI or PET imaging;&#xD;
&#xD;
          8. pregnancy or nursing for women;&#xD;
&#xD;
          9. women with estrogen and/or progesterone levels outside the normal range, on birth&#xD;
             control pills, peri- and post- menopausal women, and those with ovarectomies;&#xD;
&#xD;
         10. obesity as defined by a body mass index (BMI) of &gt; 35;&#xD;
&#xD;
         11. use of psychoactive medications including regular use of benzodiazepines;&#xD;
&#xD;
         12. having an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of&#xD;
             the investigator, increases the risks associated with participation in the study;&#xD;
&#xD;
         13. life-time history of use and abuse of opioids; and&#xD;
&#xD;
         14. presence of psychotic symptoms in patients with mood and anxiety disorders,&#xD;
             schizophrenia or schizoaffective disorders; and&#xD;
&#xD;
         15. blood donation within 8 weeks prior to the study.&#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>Charles Marmar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>August 15, 2016</last_update_submitted>
  <last_update_submitted_qc>August 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Major Depressive Disorder</keyword>
  <keyword>Anhedonia</keyword>
  <keyword>Positron Emission Tomography (PET)</keyword>
  <keyword>Kappa Opioid Receptor (KOR)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anhedonia</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_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/NCT02236702
org study id: S14-00643
nct id: NCT02236702
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to use positron emission tomography (PET) imaging to measure the
      activity of the kappa opioid receptor (KOR) in the brains of depressed and non-depressed
      individuals.
The kappa opioid receptor (KOR) has been implicated in the etiology of fear, threat, and
      anhedonia in animal models of human depression psychopathology. Herein, we propose to study
      the KOR in vivo using positron emission tomography, and we will also measure the activity of
      the hypothalamic-pituitary-adrenal (HPA)-axis in all study participants. We propose to
      recruit up to N=50 medication-free individuals using a transdiagnostic approach, measure
      their KOR-selective radioligand [11C]LY2795050 volumes of distribution (VT), an equivalent of
      KOR availability using positron emission tomography (PET) and study the role of the KOR in
      mediating the quality and severity of the depressive phenotype.
observational model: Case-Control
time perspective: Cross-Sectional
measure: [11C]LY2795050 volume of distribution (VT) values in specific brain regions of asymptomatic vs mildly symptomatic vs moderately symptomatic vs severely symptomatic individuals
time frame: one month
description: To use the KOR radioligand [11C]LY2795050 and PET to examine the relation between KOR availability in the ventral striatum and amygdala, and the full dimensional spectrum of threat and loss symptomatology, and reward responsiveness.
arm group label: Asymptomatic control
description: Asymptomatic control
arm group label: Mildly symptomatic with depressive symptoms
description: Mildly symptomatic with depressive symptoms
arm group label: Moderately symptomatic with depressive symptoms
description: Moderately symptomatic with depressive symptoms
arm group label: Severely symptomatic with depressive symptoms
description: Severely symptomatic with depressive symptoms
intervention type: Other
intervention name: Positron Emission Tomography (PET) imaging
description: Positron Emission Tomography (PET) imaging
arm group label: Asymptomatic control
arm group label: Mildly symptomatic with depressive symptoms
arm group label: Moderately symptomatic with depressive symptoms
arm group label: Severely symptomatic with depressive symptoms
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Marmar, MD
role: Principal Investigator
affiliation: NYU School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anhedonia
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major