<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/NCT02253225</url>
  </required_header>
  <id_info>
    <org_study_id>2012P000714</org_study_id>
    <secondary_id>19531</secondary_id>
    <nct_id>NCT02253225</nct_id>
  </id_info>
  <brief_title>Self Focus in Bipolar Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study</brief_title>
  <official_title>An fMRI Study of Self Processing and Self Focus in Major Depression and Bipolar Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brain &amp; Behavior Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to examine both resting state activity and functional activity&#xD;
      during rumination and during self-processing to study the relationship between neural&#xD;
      correlates of rumination/self-focus and self-processing in major depression and bipolar&#xD;
      disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Negative rumination, a specific form of self-focus, characterized by repetitively focusing on&#xD;
      one's symptoms of distress, and the possible causes and consequences of these symptoms, is a&#xD;
      hallmark of depression. Nearly a decade of research has culminated in evidence that the&#xD;
      tendency to engage in negative rumination is highly correlated with depressive symptoms.&#xD;
      Rumination also plays a critical role in the etiology and maintenance of depressed states and&#xD;
      predicts risk for mania in bipolar disorder. Despite the central role of rumination in major&#xD;
      depression and bipolar disorder, there have been few studies to date investigating the&#xD;
      functional neuroanatomy of negative rumination, and no studies of positive rumination. The&#xD;
      few neuroimaging studies that have utilized measures of the tendency to engage in negative&#xD;
      rumination have focused on brain functioning when performing tasks that involve processing&#xD;
      emotional or self-referential stimuli, but they have not studied resting state activity or&#xD;
      functional activity during negative and positive rumination. We are examining both resting&#xD;
      state activity and functional activity during negative and positive rumination and during&#xD;
      self-processing to study the relationship between the neural correlates of&#xD;
      rumination/self-focus and self-processing in major depression and bipolar disorder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2020</completion_date>
  <primary_completion_date type="Actual">January 2020</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>Functional Magnetic Resonance Imaging (fMRI) to examine self processing and self focus</measure>
    <time_frame>Participants will be analyzed as quickly as possible after a screening visit, an expected average of 2 weeks</time_frame>
    <description>Functional Magnetic Resonance Imaging (fMRI) will be used to look at the neuroanatomy of self processing and self focus.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Bipolar Disorder</condition>
  <condition>Major Depression</condition>
  <condition>Rumination</condition>
  <arm_group>
    <arm_group_label>Bipolar Disorder</arm_group_label>
    <description>Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 patients with bipolar disorder (BPAD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Major Depressive Disorder</arm_group_label>
    <description>Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 patients with major depression (MDD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control</arm_group_label>
    <description>Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 normal, healthy volunteers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional Magnetic Resonance Imaging (fMRI)</intervention_name>
    <description>Imaging will be performed on a 3T Siemens Trio scanner. Each MRI scanning session will last no more than 90 minutes.</description>
    <arm_group_label>Bipolar Disorder</arm_group_label>
    <arm_group_label>Healthy Control</arm_group_label>
    <arm_group_label>Major Depressive Disorder</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy controls will be recruited through email announcements at MGH, internet website at&#xD;
        Harvard, and flyers posted at the Massachusetts General Hospital and in the community&#xD;
        (e.g., community centers, public libraries, coffee shops, restaurants, and laundromats).&#xD;
        Subjects with major depression will be recruited through the Depression Clinic and Research&#xD;
        Program at MGH and flyers posted at MGH. Subjects with bipolar disorder will be recruited&#xD;
        through the Bipolar Clinic and Research Program at MGH and flyers posted at MGH.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria Healthy Controls:&#xD;
&#xD;
          -  Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)&#xD;
&#xD;
          -  Normal or corrected-to normal vision and hearing&#xD;
&#xD;
        Exclusion Criteria for Healthy Controls:&#xD;
&#xD;
          -  Any current or past psychiatric history&#xD;
&#xD;
          -  Significant medical, psychiatric or neurological illness&#xD;
&#xD;
          -  Currently taking antidepressants, mood stabilizers, or benzodiazepines&#xD;
&#xD;
          -  Positive MR screen (e.g., metal implant, claustrophobia, etc)&#xD;
&#xD;
        Inclusion Criteria for Patients with Major Depression:&#xD;
&#xD;
          -  Current diagnosis of MDD&#xD;
&#xD;
          -  Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)&#xD;
&#xD;
          -  Normal or corrected-to normal vision and hearing&#xD;
&#xD;
        Exclusion Criteria for MDD Patients:&#xD;
&#xD;
          -  If a history of substance abuse, at least 6 months in remission&#xD;
&#xD;
          -  Current suicidal ideation or history of suicide attempts&#xD;
&#xD;
          -  Positive MR screen (e.g., metal implant, claustrophobia, etc)&#xD;
&#xD;
        Inclusion Criteria for patients with BPAD:&#xD;
&#xD;
          -  Current diagnosis of BPAD&#xD;
&#xD;
          -  Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)&#xD;
&#xD;
          -  Normal or corrected-to normal vision and hearing&#xD;
&#xD;
        Exclusion Criteria for BPAD Patients:&#xD;
&#xD;
          -  If a history of substance abuse, at least 6 months in remission&#xD;
&#xD;
          -  Current suicidal ideation or history of suicide attempts&#xD;
&#xD;
          -  Positive MR screen (e.g., metal implant, claustrophobia, etc)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharmin Ghaznavi, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Sharmin Ghaznavi</investigator_full_name>
    <investigator_title>Staff Psychiatrist</investigator_title>
  </responsible_party>
  <keyword>Bipolar Disorder</keyword>
  <keyword>Major Depression</keyword>
  <keyword>Rumination</keyword>
  <keyword>Self Processing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rumination Syndrome</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Bipolar 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/NCT02253225
org study id: 2012P000714
secondary id: 19531
nct id: NCT02253225
lead sponsor: 
collaborator: 
has dmc: No
The investigators propose to examine both resting state activity and functional activity
      during rumination and during self-processing to study the relationship between neural
      correlates of rumination/self-focus and self-processing in major depression and bipolar
      disorder.
Negative rumination, a specific form of self-focus, characterized by repetitively focusing on
      one's symptoms of distress, and the possible causes and consequences of these symptoms, is a
      hallmark of depression. Nearly a decade of research has culminated in evidence that the
      tendency to engage in negative rumination is highly correlated with depressive symptoms.
      Rumination also plays a critical role in the etiology and maintenance of depressed states and
      predicts risk for mania in bipolar disorder. Despite the central role of rumination in major
      depression and bipolar disorder, there have been few studies to date investigating the
      functional neuroanatomy of negative rumination, and no studies of positive rumination. The
      few neuroimaging studies that have utilized measures of the tendency to engage in negative
      rumination have focused on brain functioning when performing tasks that involve processing
      emotional or self-referential stimuli, but they have not studied resting state activity or
      functional activity during negative and positive rumination. We are examining both resting
      state activity and functional activity during negative and positive rumination and during
      self-processing to study the relationship between the neural correlates of
      rumination/self-focus and self-processing in major depression and bipolar disorder.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Functional Magnetic Resonance Imaging (fMRI) to examine self processing and self focus
time frame: Participants will be analyzed as quickly as possible after a screening visit, an expected average of 2 weeks
description: Functional Magnetic Resonance Imaging (fMRI) will be used to look at the neuroanatomy of self processing and self focus.
arm group label: Bipolar Disorder
description: Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 patients with bipolar disorder (BPAD).
arm group label: Major Depressive Disorder
description: Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 patients with major depression (MDD).
arm group label: Healthy Control
description: Clinical status will be determined using the Mini International Neuropsychiatric Interview (M.I.N.I) for 20 normal, healthy volunteers.
intervention type: Other
intervention name: Functional Magnetic Resonance Imaging (fMRI)
description: Imaging will be performed on a 3T Siemens Trio scanner. Each MRI scanning session will last no more than 90 minutes.
arm group label: Bipolar Disorder
arm group label: Healthy Control
arm group label: Major Depressive Disorder
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sharmin Ghaznavi, M.D., Ph.D.
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Sharmin Ghaznavi
investigator title: Staff Psychiatrist
mesh term: Rumination Syndrome
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Bipolar Disorder
mesh term: Depressive Disorder, Major