<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/NCT02983838</url>
  </required_header>
  <id_info>
    <org_study_id>2015-12-009</org_study_id>
    <nct_id>NCT02983838</nct_id>
  </id_info>
  <brief_title>Research on Pathophysiology and Treatment in Depression Using Brain Derived Neurotrophic Factor and Amyloid Neuroimaging</brief_title>
  <official_title>Development of Biomarker With Neuroimaging : Research on Pathophysiology and Treatment in Depression Using Brain Derived Neurotrophic Factor (BDNF) and Amyloid Neuroimaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sungkyunkwan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Korea University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Target of the research Based on change of Brain-derived neurotrophic factor and other&#xD;
      pro-inflammatory cytokine along with symptom improvement following treatment, the&#xD;
      investigators are trying to find the new treatment target molecule. The investigators will&#xD;
      follow up the subjective and objective cognitive dysfunction with psychiatric symptom&#xD;
      profiles and compare the neuroimaging related to these change.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently the investigators reported the association between childhood trauma and refractory&#xD;
      depression, which related to Brain Derived Neurotrophic Factor (BDNF). Even though level of&#xD;
      peripheral BDNF is closely related to depression treatment, the investigators still have&#xD;
      little idea on role of BDNF. In this research, the investigators are going to find the&#xD;
      genetic variation affecting treatment response and process, figure out specific role of BDNF&#xD;
      in depressive patient correlated with Neuroimaging. Along with BDNF, many kinds of&#xD;
      proinflammatory cytokine showed increased amount related to depressive patient. Leptin,&#xD;
      adiponectin, and plasma tryptohphan are also seen to be related to response of depression.&#xD;
      Here, the investigators are trying to see specific difference on neuroimaging shown in&#xD;
      depressive patient related to peripheral marker. The investigators will evaluate the 36&#xD;
      depressive patients compared to 24 normal control. For depressive patients, after excluding&#xD;
      other bipolar spectrum disorder, psychotic disorder, other neurocognitive disorder, subjects&#xD;
      who have organic brain lesion, tested as HAM D score above 16, will be included in this&#xD;
      research. As a psychiatric evaluation, the investigators will do the MINI International&#xD;
      Psychiatric Interview Plus (MINI Plus), Suicidal ideation evaluation, Hamilton Depression&#xD;
      Inventory 17 (HAM D 17), Hamilton Anxiety Inventory (HAM A) to get the information of their&#xD;
      clinical severity. As a neuroimaging evaluation, the investigators will do the magnetic&#xD;
      resonance imaging (MRI) with diffusion tensor imaging and amyloid Positron Emission&#xD;
      Tomography(PET) to see the specific deposition. For peripheral marker for inflammation and&#xD;
      other neurotrophic factor, the investigators will do the platelet BDNF level,and other&#xD;
      pre-inflammatory factors. The investigators will also check for genotyping for BDNF. For&#xD;
      follow up evaluation, the investigators will keep up the psychiatric evaluation with HAM D,&#xD;
      HAM A and peripheral proteinomic evaluation with platelet BDNF level, and other&#xD;
      pro-inflammatory cytokines.&#xD;
&#xD;
      This research will figure out the correlation between neurotrophic factor as BDNF, and&#xD;
      inflammatory factor seen in peripheral blood assay with treatment response in depression.&#xD;
      Also the investigators are trying to integrate the peripheral change along with BDNF&#xD;
      genotyping and specific change seen in neuroimaging. Replicating this research with high&#xD;
      statistical power would be promising to find 'reliable peripheral marker for prognosis of&#xD;
      depression'.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>The change of Psychiatric symptom profile scores</measure>
    <time_frame>baseline, 1month, 3months</time_frame>
    <description>Hamilton depression inventory 17 (HAM-D), Hamilton anxiety inventory (HAM-A) and peripheral proteinomic evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of subjective Cognitive decline assessment profiles</measure>
    <time_frame>baseline, 1month follow up, 3 months follow up, cognitive function assessment with subjective one and objective one</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>depression with cognitive impairment</arm_group_label>
    <description>depression onset after 60 years old with subjective cognitive impairment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>depression without cognitive impairment</arm_group_label>
    <description>depression onset after 60 years old without subjective cognitive impairment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal control</arm_group_label>
    <description>older than 65 years, free from other neurocognitive disorder</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood specimen for pro-inflammatory cytokine and BDNF BDNF genotyping&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        older than 65 years free from other main psychiatric diagnosis except major depressive&#xD;
        disorder free from neurocognitive disorder&#xD;
&#xD;
        normal control: older than 65 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed as major depressive disorder with MINI and DSM-5 criteria whose age is more&#xD;
             than 65 years&#xD;
&#xD;
          -  Whose score of Hamilton Depression Scale is more than 16&#xD;
&#xD;
          -  Whose first depressive episode onset was later than one's age of 60&#xD;
&#xD;
          -  Who is free from antidepressants for 2 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with past history of Psychotic disorder or with present symptoms related to&#xD;
             psychotic disorders&#xD;
&#xD;
          -  Bipolar Spectrum Disorder&#xD;
&#xD;
          -  With Neurocognitive disorder such as Parkinson's disease, Huntington's chorea, Mild&#xD;
             Cognitive Disorder, or Dementia&#xD;
&#xD;
          -  Who ever diagnosed as a Cognitive disability&#xD;
&#xD;
          -  Who have serious medical condition which needs to be cared (e.g, cancer)&#xD;
&#xD;
          -  Who have past history of epileptic disorder or present with epileptic disorder in&#xD;
             treatment&#xD;
&#xD;
          -  Who have recent history of alcohol or other substance use disorder within 6 months and&#xD;
             suspicious for this condition&#xD;
&#xD;
          -  Who is suspicious for the clinically implicable personality disorder&#xD;
&#xD;
          -  Who is suspicious for the brain injury&#xD;
&#xD;
          -  Who is having trouble with uncontrolled claustrophobia, hard to go through&#xD;
             neuroimaging&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Jin Jeon, M.D.,Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center, Sungkyunkwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hong Jin Jeon, M.D.,Ph.D.</last_name>
    <phone>+82-2-3410-3586</phone>
    <email>jhj001001@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Irwon-dong, Gangnam-gu</state>
        <zip>135710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Jin Jeon, MD, PhD</last_name>
      <phone>82-10-3198-3586</phone>
      <email>jhj001001@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>April 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Amyloid</keyword>
  <keyword>BDNF</keyword>
  <keyword>major depressive disorder</keyword>
  <keyword>cognitive decline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02983838
org study id: 2015-12-009
nct id: NCT02983838
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Target of the research Based on change of Brain-derived neurotrophic factor and other
      pro-inflammatory cytokine along with symptom improvement following treatment, the
      investigators are trying to find the new treatment target molecule. The investigators will
      follow up the subjective and objective cognitive dysfunction with psychiatric symptom
      profiles and compare the neuroimaging related to these change.
Recently the investigators reported the association between childhood trauma and refractory
      depression, which related to Brain Derived Neurotrophic Factor (BDNF). Even though level of
      peripheral BDNF is closely related to depression treatment, the investigators still have
      little idea on role of BDNF. In this research, the investigators are going to find the
      genetic variation affecting treatment response and process, figure out specific role of BDNF
      in depressive patient correlated with Neuroimaging. Along with BDNF, many kinds of
      proinflammatory cytokine showed increased amount related to depressive patient. Leptin,
      adiponectin, and plasma tryptohphan are also seen to be related to response of depression.
      Here, the investigators are trying to see specific difference on neuroimaging shown in
      depressive patient related to peripheral marker. The investigators will evaluate the 36
      depressive patients compared to 24 normal control. For depressive patients, after excluding
      other bipolar spectrum disorder, psychotic disorder, other neurocognitive disorder, subjects
      who have organic brain lesion, tested as HAM D score above 16, will be included in this
      research. As a psychiatric evaluation, the investigators will do the MINI International
      Psychiatric Interview Plus (MINI Plus), Suicidal ideation evaluation, Hamilton Depression
      Inventory 17 (HAM D 17), Hamilton Anxiety Inventory (HAM A) to get the information of their
      clinical severity. As a neuroimaging evaluation, the investigators will do the magnetic
      resonance imaging (MRI) with diffusion tensor imaging and amyloid Positron Emission
      Tomography(PET) to see the specific deposition. For peripheral marker for inflammation and
      other neurotrophic factor, the investigators will do the platelet BDNF level,and other
      pre-inflammatory factors. The investigators will also check for genotyping for BDNF. For
      follow up evaluation, the investigators will keep up the psychiatric evaluation with HAM D,
      HAM A and peripheral proteinomic evaluation with platelet BDNF level, and other
      pro-inflammatory cytokines.

      This research will figure out the correlation between neurotrophic factor as BDNF, and
      inflammatory factor seen in peripheral blood assay with treatment response in depression.
      Also the investigators are trying to integrate the peripheral change along with BDNF
      genotyping and specific change seen in neuroimaging. Replicating this research with high
      statistical power would be promising to find 'reliable peripheral marker for prognosis of
      depression'.
observational model: Case-Control
time perspective: Prospective
measure: The change of Psychiatric symptom profile scores
time frame: baseline, 1month, 3months
description: Hamilton depression inventory 17 (HAM-D), Hamilton anxiety inventory (HAM-A) and peripheral proteinomic evaluation
measure: The change of subjective Cognitive decline assessment profiles
time frame: baseline, 1month follow up, 3 months follow up, cognitive function assessment with subjective one and objective one
arm group label: depression with cognitive impairment
description: depression onset after 60 years old with subjective cognitive impairment
arm group label: depression without cognitive impairment
description: depression onset after 60 years old without subjective cognitive impairment
arm group label: normal control
description: older than 65 years, free from other neurocognitive disorder
blood specimen for pro-inflammatory cytokine and BDNF BDNF genotyping
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hong Jin Jeon, M.D.,Ph.D.
role: Principal Investigator
affiliation: Samsung Medical Center, Sungkyunkwan University
last name: Hong Jin Jeon, M.D.,Ph.D.
phone: +82-2-3410-3586
email: jhj001001@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
sharing ipd: No