<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/NCT02221518</url>
  </required_header>
  <id_info>
    <org_study_id>#7000/R01MH104648-01</org_study_id>
    <nct_id>NCT02221518</nct_id>
  </id_info>
  <brief_title>Control and Reward Circuits in Obsessive Compulsive Disorder</brief_title>
  <official_title>Control &amp; Reward Circuits as Targets for Repetitive Thoughts and Behaviors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York State Psychiatric Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the brain functioning of OCD patients and healthy&#xD;
      controls before and after treatment with Exposure and Response Prevention (EXRP) therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The capacity to coordinate thoughts and actions to execute goal-directed behaviors (cognitive&#xD;
      control) and the capacity to anticipate, respond to, and learn from reward (reward&#xD;
      processing) are key processes for human behavior. Dysfunction in these processes has been&#xD;
      hypothesized to contribute to repetitive thoughts and behaviors in many disorders, including&#xD;
      obsessive-compulsive disorder (OCD), Tourette Syndrome (TS), and eating disorders. We will&#xD;
      use multimodal imaging to investigate neural circuits that support cognitive control and&#xD;
      reward processing, using OCD as a model system. The short-term goal is to clarify how&#xD;
      circuit-based abnormalities contribute to repetitive thoughts/behaviors; these data will&#xD;
      inform future transdiagnostic studies. The long-term goal is to identify control and reward&#xD;
      circuit-abnormalities as targets for new transdiagnostic treatments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in brain activation (fMRI) and fractional anisotropy (Diffusion tensor imaging) after therapy</measure>
    <time_frame>Baseline &amp; approximately 10 weeks later</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in reaction times and correct responses on Stop signal reaction time task</measure>
    <time_frame>Baseline and approximately 10 weeks later, at second scan</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Patients with OCD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioral: Exposure &amp; Response Prevention (EX/RP)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exposure &amp; Response Prevention (EX/RP)</intervention_name>
    <description>Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD.</description>
    <arm_group_label>Patients with OCD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Patients:&#xD;
&#xD;
          -  Male and females with OCD aged 18-55&#xD;
&#xD;
          -  Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD&#xD;
&#xD;
          -  Not on psychotropic medication&#xD;
&#xD;
        Exclusion Criteria for Patients:&#xD;
&#xD;
          -  Presence of metallic devices or dental braces in the body that are contraindicators&#xD;
             for MR imaging&#xD;
&#xD;
          -  Comorbid psychiatric conditions that significantly elevate the risk of study&#xD;
             participation (e.g. psychotic disorders, bipolar disorder, evidence of dementia or&#xD;
             other cognitive disorder, suicidality)&#xD;
&#xD;
          -  Unstable medical conditions that need attention and would make participation in the&#xD;
             study unsafe (e.g. very high blood pressure)&#xD;
&#xD;
          -  Use of psychotropic medication&#xD;
&#xD;
          -  Females who are pregnant or post-menopausal&#xD;
&#xD;
        Inclusion Criteria for Healthy Volunteers&#xD;
&#xD;
        - Male and females aged 18-55&#xD;
&#xD;
        Exclusion Criteria for Healthy Volunteers&#xD;
&#xD;
          -  Presence of metallic devices or dental braces in the body that are contraindicators&#xD;
             for MR imaging&#xD;
&#xD;
          -  Any psychiatric diagnosis&#xD;
&#xD;
          -  Use of psychotropic medication&#xD;
&#xD;
          -  Diagnosis of OCD in a first degree relative&#xD;
&#xD;
          -  Females who are pregnant or post-menopausal&#xD;
&#xD;
          -  Unstable medical conditions that need attention and would make participation in the&#xD;
             study unsafe (e.g. very high blood pressure)&#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>Blair Simpson, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York State Psychiatric Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NY State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
    <investigator_full_name>Helen Blair Simpson</investigator_full_name>
    <investigator_title>Professor of Psychiatry-Columbia University Medical Center, Columbia University; Director of Anxiety Disorders Clinic &amp; Center for OCD and Related Disorders</investigator_title>
  </responsible_party>
  <keyword>OCD</keyword>
  <keyword>Functional Magnetic Resonance Imaging (fMRI)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</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/NCT02221518
org study id: #7000/R01MH104648-01
nct id: NCT02221518
lead sponsor: 
has dmc: No
The purpose of this study is to examine the brain functioning of OCD patients and healthy
      controls before and after treatment with Exposure and Response Prevention (EXRP) therapy.
The capacity to coordinate thoughts and actions to execute goal-directed behaviors (cognitive
      control) and the capacity to anticipate, respond to, and learn from reward (reward
      processing) are key processes for human behavior. Dysfunction in these processes has been
      hypothesized to contribute to repetitive thoughts and behaviors in many disorders, including
      obsessive-compulsive disorder (OCD), Tourette Syndrome (TS), and eating disorders. We will
      use multimodal imaging to investigate neural circuits that support cognitive control and
      reward processing, using OCD as a model system. The short-term goal is to clarify how
      circuit-based abnormalities contribute to repetitive thoughts/behaviors; these data will
      inform future transdiagnostic studies. The long-term goal is to identify control and reward
      circuit-abnormalities as targets for new transdiagnostic treatments.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change from baseline in brain activation (fMRI) and fractional anisotropy (Diffusion tensor imaging) after therapy
time frame: Baseline & approximately 10 weeks later
measure: Change in reaction times and correct responses on Stop signal reaction time task
time frame: Baseline and approximately 10 weeks later, at second scan
arm group label: Patients with OCD
arm group type: Experimental
description: Behavioral: Exposure & Response Prevention (EX/RP)
intervention type: Behavioral
intervention name: Exposure & Response Prevention (EX/RP)
description: Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD.
arm group label: Patients with OCD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Blair Simpson, MD, Ph.D
role: Principal Investigator
affiliation: New York State Psychiatric Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: Helen Blair Simpson
investigator title: Professor of Psychiatry-Columbia University Medical Center, Columbia University; Director of Anxiety Disorders Clinic & Center for OCD and Related Disorders
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder