<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/NCT01688765</url>
  </required_header>
  <id_info>
    <org_study_id>2012P001796</org_study_id>
    <nct_id>NCT01688765</nct_id>
  </id_info>
  <brief_title>Longitudinal Multimodal Neuroimaging Studies in Patients With First Episode Psychosis</brief_title>
  <official_title>Longitudinal Multimodal Neuroimaging Studies in Patients With First Episode Psychosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mclean Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mclean Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the structural, functional and chemical brain&#xD;
      abnormalities in patients with first episode psychosis and assess the evolution of these&#xD;
      abnormalities during the course of the disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to investigate the structural, functional and chemical brain&#xD;
      abnormalities in patients with first episode psychosis and assess the evolution of these&#xD;
      abnormalities during the course of the disease.&#xD;
&#xD;
      The study design is case-control, there are no interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2012</start_date>
  <completion_date type="Actual">September 23, 2022</completion_date>
  <primary_completion_date type="Actual">September 23, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">187</enrollment>
  <condition>Psychotic Disorders</condition>
  <arm_group>
    <arm_group_label>First Episode Psychosis Patients</arm_group_label>
    <description>Individuals experiencing a first episode of psychosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Psychiatrically healthy individuals</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <arm_group_label>First Episode Psychosis Patients</arm_group_label>
    <arm_group_label>Healthy Controls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        First episode psychosis patients Healthy controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of first episode of a psychotic disorder&#xD;
&#xD;
          -  Healthy controls with no psychiatric disorder history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant neurological or medical illness history&#xD;
&#xD;
          -  Ages &lt;18 or &gt;45&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dost Ongur, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mclean Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McLean Hospital</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>September 24, 2022</last_update_submitted>
  <last_update_submitted_qc>September 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mclean Hospital</investigator_affiliation>
    <investigator_full_name>Dost Ongur</investigator_full_name>
    <investigator_title>M.D, PhD, Clinical Director</investigator_title>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Schizoaffective disorder</keyword>
  <keyword>Bipolar disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic Disorders</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/NCT01688765
org study id: 2012P001796
nct id: NCT01688765
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the structural, functional and chemical brain
      abnormalities in patients with first episode psychosis and assess the evolution of these
      abnormalities during the course of the disease.
The purpose of this study is to investigate the structural, functional and chemical brain
      abnormalities in patients with first episode psychosis and assess the evolution of these
      abnormalities during the course of the disease.

      The study design is case-control, there are no interventions.
observational model: Case-Control
time perspective: Prospective
arm group label: First Episode Psychosis Patients
description: Individuals experiencing a first episode of psychosis
arm group label: Healthy Controls
description: Psychiatrically healthy individuals
intervention type: Other
intervention name: Observational
arm group label: First Episode Psychosis Patients
arm group label: Healthy Controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dost Ongur, MD PhD
role: Principal Investigator
affiliation: Mclean Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mclean Hospital
investigator full name: Dost Ongur
investigator title: M.D, PhD, Clinical Director
mesh term: Psychotic Disorders