<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/NCT04430556</url>
  </required_header>
  <id_info>
    <org_study_id>PS18-00016</org_study_id>
    <nct_id>NCT04430556</nct_id>
  </id_info>
  <brief_title>Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients</brief_title>
  <official_title>Study on the Brain Hippocampal Volume, Cortisol and C-reactive Protein Levels Relationship With Anxious Symptoms in Major Depressive Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario Dr. Jose E. Gonzalez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Información e Investigación en Salud Mental A. C.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitario Dr. Jose E. Gonzalez</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this transversal study is to determine if there is a difference in the&#xD;
      volume of the hippocampus with the degree of anxiety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response on Hamilton Anxiety Rating Scale</measure>
    <time_frame>Change from baseline to week 8</time_frame>
    <description>The Hamilton Anxiety Rating Scale and its correlation with hippocampal size</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response on Clinical Global Impression-Improvement</measure>
    <time_frame>Change from baseline to week 8</time_frame>
    <description>Difference between baseline and final score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response on Hamilton Depression Rating Scale</measure>
    <time_frame>Change from baseline to week 8</time_frame>
    <description>Difference between baseline and final score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response on Montgomery-Asberg Scale for Depression</measure>
    <time_frame>Change from baseline to week 8</time_frame>
    <description>Difference between baseline and final score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response on Columbia Scale for Suicidality</measure>
    <time_frame>Change from baseline to week 8</time_frame>
    <description>Difference between baseline and final score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response on State-Trait Depression Inventory</measure>
    <time_frame>Change from baseline to week 8</time_frame>
    <description>Difference between baseline and final score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response on Beck Anxiety Inventory</measure>
    <time_frame>Change from baseline to week 8</time_frame>
    <description>Difference between baseline and final score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response on EQ-5D</measure>
    <time_frame>Change from baseline to week 8</time_frame>
    <description>Difference between baseline and final score</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Major Depressive Disorder</condition>
  <condition>Anxiety Disorders</condition>
  <arm_group>
    <arm_group_label>Volumetric changes in response to sertraline or escitalopram</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sertraline</intervention_name>
    <description>Sertraline will be started in all patients, unless it is contraindicated, in this case, Escitalopram will be indicated.</description>
    <arm_group_label>Volumetric changes in response to sertraline or escitalopram</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First-time patients, without prior antidepressant treatment that meet the diagnostic&#xD;
             criteria of DSM 5 for major depressive disorder.&#xD;
&#xD;
          -  Patients who meet the current major depressive disorder criteria in the MINI&#xD;
             interview.&#xD;
&#xD;
          -  Patients who signed the informed consent for the investigation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients presenting insufficient data in the MINI interview for current major&#xD;
             depression.&#xD;
&#xD;
          -  Patients diagnosed with intellectual development disorder, by clinic.&#xD;
&#xD;
          -  Patients with diagnosis of the schizophrenic spectrum, bipolar disorder, autism&#xD;
             spectrum disorder, post-traumatic stress disorder and obsessive-compulsive disorder by&#xD;
             clinic and / or by the MINI interview.&#xD;
&#xD;
          -  Patients with contraindications for MRI.&#xD;
&#xD;
          -  Patients with serious or unstable medical problems.&#xD;
&#xD;
          -  Patients undergoing some legal procedure.&#xD;
&#xD;
          -  Patients with difficulties in understanding the interview or completing the assessment&#xD;
             instruments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose A Ontiveros Sanchez de la Barquera, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Universitario Dr. Jose E. Gonzalez</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Dr. Jose E. Gonzalez</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario Dr. Jose E. Gonzalez</investigator_affiliation>
    <investigator_full_name>José Alfonso Ontiveros Sánchez De la Barquera</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>major depressive disorder</keyword>
  <keyword>hippocampal volume</keyword>
  <keyword>cortisol</keyword>
  <keyword>c-reactive protein</keyword>
  <keyword>brain metabolites</keyword>
  <keyword>MRI</keyword>
  <keyword>anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sertraline</mesh_term>
  </intervention_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/NCT04430556
org study id: PS18-00016
nct id: NCT04430556
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The objective of this transversal study is to determine if there is a difference in the
      volume of the hippocampus with the degree of anxiety.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Response on Hamilton Anxiety Rating Scale
time frame: Change from baseline to week 8
description: The Hamilton Anxiety Rating Scale and its correlation with hippocampal size
measure: Response on Clinical Global Impression-Improvement
time frame: Change from baseline to week 8
description: Difference between baseline and final score
measure: Response on Hamilton Depression Rating Scale
time frame: Change from baseline to week 8
description: Difference between baseline and final score
measure: Response on Montgomery-Asberg Scale for Depression
time frame: Change from baseline to week 8
description: Difference between baseline and final score
measure: Response on Columbia Scale for Suicidality
time frame: Change from baseline to week 8
description: Difference between baseline and final score
measure: Response on State-Trait Depression Inventory
time frame: Change from baseline to week 8
description: Difference between baseline and final score
measure: Response on Beck Anxiety Inventory
time frame: Change from baseline to week 8
description: Difference between baseline and final score
measure: Response on EQ-5D
time frame: Change from baseline to week 8
description: Difference between baseline and final score
arm group label: Volumetric changes in response to sertraline or escitalopram
arm group type: Other
intervention type: Drug
intervention name: Sertraline
description: Sertraline will be started in all patients, unless it is contraindicated, in this case, Escitalopram will be indicated.
arm group label: Volumetric changes in response to sertraline or escitalopram
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jose A Ontiveros Sanchez de la Barquera, MD, PhD
role: Study Chair
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario Dr. Jose E. Gonzalez
investigator full name: José Alfonso Ontiveros Sánchez De la Barquera
investigator title: Associate Professor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Anxiety Disorders
mesh term: Sertraline