<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/NCT01683214</url>
  </required_header>
  <id_info>
    <org_study_id>11122902</org_study_id>
    <nct_id>NCT01683214</nct_id>
  </id_info>
  <brief_title>Brain Network Activation Analysis to Diagnose/Assess Treatment of Unipolar Major Depression and Bipolar I Depression</brief_title>
  <acronym>BNA-Mood</acronym>
  <official_title>Potential Use of Brain Network Activation (BNA) Analysis Using Evoked Response Potentials to Diagnose Unipolar Major Depression and Bipolar I Depression and Assess Response to Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are conducting this study to test the usefulness of a new type of analysis&#xD;
      of electroencephalographic (EEG) recordings called brain network activation or BNA. BNA&#xD;
      allows to identify patterns of activation in brain networks and to track their changes over&#xD;
      time. The investigators want to examine the possible role of brain network activation (BNA)&#xD;
      in the diagnosis of mood disorders and predicting improvement over time. The procedure&#xD;
      conducted with patients diagnosed with a mood disorder will be compared to people who do not&#xD;
      have a mood disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Novel approach to ascertain use of BNA strategy and technology for the use in confirming&#xD;
      diagnosis and predicting effect of specific treatment(s)in the various stages of&#xD;
      affective/mood disorders. The goal is to develop non-invasive technology to confirm diagnosis&#xD;
      via biological outcomes, and to study the preliminary data of predicting&#xD;
      response/non-response to specific interventions before clinical effects are shown.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">August 21, 2015</completion_date>
  <primary_completion_date type="Actual">August 21, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of changes in BNA with changes in mood symptoms</measure>
    <time_frame>Beginning of study to end of study</time_frame>
    <description>This is an observational study, so no other outcomes are measured</description>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Depression</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study will only enroll subjects who are participating in another specified clinical&#xD;
        trial.The inclusion/exclusion criteria will depend on the criteria for each of the studies&#xD;
        utilizing subjects with depression or bipolar type I disorder&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Only subjects participating in another specific clinical trial will be invited to&#xD;
        participate in this study.&#xD;
&#xD;
        The inclusion/exclusion criteria for this observational study are based on the individual&#xD;
        inclusion/exclusion criteria for each of the studies and can be found for each of the&#xD;
        studies on this website.&#xD;
&#xD;
        The specific studies and their numbers are found on their individual ClinicalTrials.gov&#xD;
        site.&#xD;
&#xD;
        INCLUSION CRITERIA:&#xD;
&#xD;
        Bipolar I, depressed Major depression Meeting all criteria to sign the informed consent for&#xD;
        each study included in this study who currently have a major depression (unipolar or&#xD;
        bipolarI)&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        Medically unstable (based on opinion of sponsor and PI Unable to meet the criteria to&#xD;
        conform to the Rush University informed consent process&#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>John M Zajecka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RushUMC ; Rush University Medical center</affiliation>
  </overall_official>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rush University Medical Center</investigator_affiliation>
    <investigator_full_name>John Zajecka</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive 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/NCT01683214
org study id: 11122902
nct id: NCT01683214
lead sponsor: 
has dmc: No
The investigators are conducting this study to test the usefulness of a new type of analysis
      of electroencephalographic (EEG) recordings called brain network activation or BNA. BNA
      allows to identify patterns of activation in brain networks and to track their changes over
      time. The investigators want to examine the possible role of brain network activation (BNA)
      in the diagnosis of mood disorders and predicting improvement over time. The procedure
      conducted with patients diagnosed with a mood disorder will be compared to people who do not
      have a mood disorder.
Novel approach to ascertain use of BNA strategy and technology for the use in confirming
      diagnosis and predicting effect of specific treatment(s)in the various stages of
      affective/mood disorders. The goal is to develop non-invasive technology to confirm diagnosis
      via biological outcomes, and to study the preliminary data of predicting
      response/non-response to specific interventions before clinical effects are shown.
observational model: Case-Control
time perspective: Prospective
measure: Correlation of changes in BNA with changes in mood symptoms
time frame: Beginning of study to end of study
description: This is an observational study, so no other outcomes are measured
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John M Zajecka, MD
role: Principal Investigator
affiliation: RushUMC ; Rush University Medical center
responsible party type: Principal Investigator
investigator affiliation: Rush University Medical Center
investigator full name: John Zajecka
investigator title: Associate Professor of Psychiatry
mesh term: Depression
mesh term: Depressive Disorder