<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/NCT03257592</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00037683</org_study_id>
    <nct_id>NCT03257592</nct_id>
  </id_info>
  <brief_title>Positron Emission Tomography (PET) Imaging of Glial Activation in Psychotic Disease States</brief_title>
  <official_title>PET Imaging of Glial Activation in Psychotic Disease States</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many neurological diseases, including AIDS dementia, Alzheimer's disease and schizophrenia,&#xD;
      involve an inflammatory component thought to specifically involve glial cell activation. The&#xD;
      Investigators has been concerned with the development of tools for noninvasive imaging of&#xD;
      inflammatory processes in psychotic disease. Here, the investigators aim to use PET-based&#xD;
      neuroimaging with carbon-11&#xD;
      N,N-diethyl-2-(4-methoxyphenyl)-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide,&#xD;
      ([11C]DPA)-713 to quantify regional distribution of translocator protein (TSPO), a putative&#xD;
      marker of inflammation, in the brains of patients with schizophrenia and bipolar disorder,&#xD;
      type I. The investigators will focus on patients in the early stages of disease (within first&#xD;
      five years of onset of schizophrenia diagnosis and within first five years of first manis,&#xD;
      respectively) to minimize the confounds of age-, chronic illness-, and medication- effects on&#xD;
      our results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and Specificity of ([11C]DPA)-713 PET brain imaging in patients with recent onset schizophrenia and in patients with recent onset of mania</measure>
    <time_frame>within five years of onset of schizophrenia or within five years of first manic episode</time_frame>
    <description>To determine regional brain uptake of this radioligand in patients with recent onset schizophrenia and in patients with recent onset of mania</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PET Imaging of microglial activation</measure>
    <time_frame>5 years</time_frame>
    <description>To evaluate changes in activation of microglia in patients with acute schizophrenia and bipolar disorder relative to controls</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Patients with Schizophrenia Disorder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Schizophrenia Disorder will be imaged with [11C] DPA-713</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with Bipolar Disorder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Bipolar Disorder will be imaged with [11C] DPA-713</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Normal volunteers will be imaged with [11C] DPA-713</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[11C]DPA-713</intervention_name>
    <description>[11C]DPA-713 PET imaging</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Patients with Bipolar Disorder</arm_group_label>
    <arm_group_label>Patients with Schizophrenia Disorder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers 18-65 years of age&#xD;
&#xD;
          -  Patients diagnosed with recent onset schizophrenia (within 5 years of onset), 18-65&#xD;
             years of age&#xD;
&#xD;
          -  Patients diagnosed with recent onset bipolar disorder (within 5 years of onset of&#xD;
             first mania), 18-65 years of age&#xD;
&#xD;
          -  screening laboratory tests will be obtained for subjects within a 10 day period prior&#xD;
             to the PET study and the results must be within normal limits for gender and age.&#xD;
             These tests will be repeated with a 7-day window following the PET study&#xD;
&#xD;
          -  EKG conducted within 10 day period prior to the PET study. The EKG will be repeated&#xD;
             within 7 days following the study.&#xD;
&#xD;
          -  Subject agrees to return to the Hospital for a follow-up EKG and laboratory testing of&#xD;
             blood and urine.&#xD;
&#xD;
          -  For females of childbearing potential, negative serum pregnancy test within a 10 day&#xD;
             period prior to PET study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of recent nosocomial infection,&#xD;
&#xD;
          -  history of chronic neurological disorder, such as multiple sclerosis or epilepsy, or&#xD;
             structural,central nervous system (CNS) abnormality such as stroke or arteriovenous&#xD;
             malformation,&#xD;
&#xD;
          -  history of head injury with loss of consciousness &gt; 1 hour,&#xD;
&#xD;
          -  history of active substance abuse as defined by substance abuse including alcohol&#xD;
             abuse over the 6 months prior to the study,&#xD;
&#xD;
          -  dependence on benzodiazepine medication&#xD;
&#xD;
          -  contraindications to MRI scanning to include pacemakers, metallic implants/prosthesis&#xD;
             or prohibitive claustrophobia, etc.&#xD;
&#xD;
          -  contraindications to PET scanning to include pregnancy, etc. For females of&#xD;
             childbearing potential, negative serum pregnancy test less than 10 days prior to PET&#xD;
             study&#xD;
&#xD;
          -  ECG demonstrating the patient is not in a sinus rhythm or is having acute ischemia.&#xD;
&#xD;
          -  any medical condition that in the opinion of the study investigators would constitute&#xD;
             a safety risk to the subject.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Pomper, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar 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/NCT03257592
org study id: NA_00037683
nct id: NCT03257592
lead sponsor: 
has dmc: No
Many neurological diseases, including AIDS dementia, Alzheimer's disease and schizophrenia,
      involve an inflammatory component thought to specifically involve glial cell activation. The
      Investigators has been concerned with the development of tools for noninvasive imaging of
      inflammatory processes in psychotic disease. Here, the investigators aim to use PET-based
      neuroimaging with carbon-11
      N,N-diethyl-2-(4-methoxyphenyl)-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide,
      ([11C]DPA)-713 to quantify regional distribution of translocator protein (TSPO), a putative
      marker of inflammation, in the brains of patients with schizophrenia and bipolar disorder,
      type I. The investigators will focus on patients in the early stages of disease (within first
      five years of onset of schizophrenia diagnosis and within first five years of first manis,
      respectively) to minimize the confounds of age-, chronic illness-, and medication- effects on
      our results.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity and Specificity of ([11C]DPA)-713 PET brain imaging in patients with recent onset schizophrenia and in patients with recent onset of mania
time frame: within five years of onset of schizophrenia or within five years of first manic episode
description: To determine regional brain uptake of this radioligand in patients with recent onset schizophrenia and in patients with recent onset of mania
measure: PET Imaging of microglial activation
time frame: 5 years
description: To evaluate changes in activation of microglia in patients with acute schizophrenia and bipolar disorder relative to controls
arm group label: Patients with Schizophrenia Disorder
arm group type: Experimental
description: Patients with Schizophrenia Disorder will be imaged with [11C] DPA-713
arm group label: Patients with Bipolar Disorder
arm group type: Experimental
description: Patients with Bipolar Disorder will be imaged with [11C] DPA-713
arm group label: Control
arm group type: Experimental
description: Normal volunteers will be imaged with [11C] DPA-713
intervention type: Drug
intervention name: [11C]DPA-713
description: [11C]DPA-713 PET imaging
arm group label: Control
arm group label: Patients with Bipolar Disorder
arm group label: Patients with Schizophrenia Disorder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Martin Pomper, MD,PhD
role: Principal Investigator
affiliation: Professor
facility: 
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Bipolar Disorder