<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/NCT01728194</url>
  </required_header>
  <id_info>
    <org_study_id>1205012392</org_study_id>
    <secondary_id>1R01MH097735-01</secondary_id>
    <nct_id>NCT01728194</nct_id>
  </id_info>
  <brief_title>Emotional and Cognitive Control in Late-Onset Depression</brief_title>
  <official_title>White Matter and Emotional and Cognitive Control in Late-Onset Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study may help identify how abnormalities in brain systems that control the ability to&#xD;
      ignore irrelevant information may contribute to the development of depression in older&#xD;
      adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately half of those who develop depression in late life never had depression before.&#xD;
      The classic view is that changes taking place in our brains as we age contribute to the&#xD;
      development of late-onset depression. This view is supported by the relative absence of&#xD;
      family history for those with late onset depression. This research study will recruit 70&#xD;
      older adults with late life depression and 70 older adults without depression. All&#xD;
      participants will receive a sub-clinical, non-contrast (magnetic resonance imaging (MRI) scan&#xD;
      at the beginning of the study and then again 12 weeks later at the completion of the study.&#xD;
      The depressed older participants will also receive a Food and Drug Administration&#xD;
      (FDA)-approved antidepressant, escitalopram (Lexapro), as treatment for their depressive&#xD;
      symptoms over 12 weeks. This MRI study may help the researchers identify how abnormalities in&#xD;
      brain systems that control our ability to ignore distractions, control our emotions, and&#xD;
      anticipate reward may contribute to the development of depression in older adults. The&#xD;
      investigators hope that the findings promote the development of tests that may improve the&#xD;
      detection of older adults at risk for poor treatment outcomes and eventually guide the&#xD;
      development of novel treatments for depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)</measure>
    <time_frame>Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)</time_frame>
    <description>Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Montgomery Asberg Depression Rating Scale (MADRS). This measure is a clinical rating of mood with a score range from 0 to 60. Higher scores indicate greater depression severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Depression Severity (Measured by Hamilton Depression Rating Scale)</measure>
    <time_frame>Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)</time_frame>
    <description>Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Hamilton Depression Rating Scale (HAM-D). This measure is a clinical rating of mood with a score range from 0 to 76. Higher scores indicate greater depression severity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Escitalopram</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Target dose 20mg for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Non-psychiatric comparison participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Escitalopram</intervention_name>
    <description>20 mg target dose for 12 weeks</description>
    <arm_group_label>Escitalopram</arm_group_label>
    <other_name>Lexapro</other_name>
    <other_name>76184942</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic Resonance Imaging</intervention_name>
    <description>Structural and functional MRI of the brain for research purposes.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Escitalopram</arm_group_label>
    <other_name>MRI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 60-85 years, right-handed;&#xD;
&#xD;
          -  Diagnosis: Major depression, unipolar (by Structured Clinical Interview for Diagnostic&#xD;
             and Statistical Manual (DSM)IV (SCID-R) and DSM-IV criteria);&#xD;
&#xD;
          -  Age of onset of first episode ≥ 50 years with up to three depressive episodes;&#xD;
&#xD;
          -  Severity of depression: A 24-Item Hamilton Depression Rating Scale (HDRS) ≥ 20.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychotic depression by DSM-IV, i.e., presence of delusions with a SCID-R score higher&#xD;
             than 2;&#xD;
&#xD;
          -  High suicide risk, i.e. intent or plan to attempt suicide in near future;&#xD;
&#xD;
          -  Presence of any Axis I psychiatric disorder (other than unipolar major depression) or&#xD;
             substance abuse;&#xD;
&#xD;
          -  History of psychiatric disorders other than unipolar major depression or generalized&#xD;
             anxiety disorder (bipolar disorder, hypomania, and dysthymia are exclusion criteria);&#xD;
&#xD;
          -  Dementia: Diagnosis of dementia by DSM-IV;&#xD;
&#xD;
          -  Mild Cognitive Impairment (MCI);&#xD;
&#xD;
          -  Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated&#xD;
             cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction&#xD;
             during the three months prior to entry; or use of drugs known to cause depression,&#xD;
             e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal;&#xD;
&#xD;
          -  Neurological brain disease and/or history of electroconvulsive therapy;&#xD;
&#xD;
          -  History of any use of citalopram or escitalopram during the current episode or need&#xD;
             for drugs that may interact with these agents, i.e. drug metabolized by the 2D6 P450&#xD;
             isoenzyme system;&#xD;
&#xD;
          -  Current involvement in psychotherapy;&#xD;
&#xD;
          -  Contraindications to MRI scanning including cardiac pacemaker, metallic objects and&#xD;
             metallic implants contraindicating MRI, cardiac stent, claustrophobia;&#xD;
&#xD;
          -  Inability to speak English;&#xD;
&#xD;
          -  Corrected visual acuity &lt; 20/70; Color blindness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faith Gunning, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College - Westchester Division</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Victoria LW, Alexopoulos GS, Ilieva I, Stein AT, Hoptman MJ, Chowdhury N, Respino M, Morimoto SS, Kanellopoulos D, Avari JN, Gunning FM. White matter abnormalities predict residual negative self-referential thinking following treatment of late-life depression with escitalopram: A preliminary study. J Affect Disord. 2019 Jan 15;243:62-69. doi: 10.1016/j.jad.2018.09.013. Epub 2018 Sep 11.</citation>
    <PMID>30236759</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <results_first_submitted>September 11, 2020</results_first_submitted>
  <results_first_submitted_qc>September 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 6, 2020</results_first_posted>
  <disposition_first_submitted>June 15, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>June 15, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 17, 2020</disposition_first_posted>
  <last_update_submitted>September 11, 2020</last_update_submitted>
  <last_update_submitted_qc>September 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Depressive Disorder</keyword>
  <keyword>Behavioral Symptoms</keyword>
  <keyword>Mood Disorders</keyword>
  <keyword>Mental Disorders</keyword>
  <keyword>Escitalopram</keyword>
  <keyword>Central Nervous System Agents</keyword>
  <keyword>Therapeutic Uses</keyword>
  <keyword>Pharmacologic Actions</keyword>
  <keyword>Physiological Effects of Drugs</keyword>
  <keyword>Muscarinic Antagonists</keyword>
  <keyword>Antidepressive Agents</keyword>
  <keyword>Psychotropic Drugs</keyword>
  <keyword>Serotonin Uptake Inhibitors</keyword>
  <keyword>Neurotransmitter Uptake Inhibitors</keyword>
  <keyword>Serotonin Agents</keyword>
  <keyword>Magnetic Resonance Imaging, Functional</keyword>
  <keyword>fMRI</keyword>
  <keyword>Magnetic Resonance Imaging</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Escitalopram</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT01728194/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 24, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT01728194/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MDD (Escitalopram Tx)</title>
          <description>Target dose 20mg for 12 weeks&#xD;
Escitalopram: 20 mg target dose for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>No treatment (healthy comparison participants with no history or presence of psychiatric disorder)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Perceived Medication Side Effects</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Family Member Request</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MDD (Escitalopram Tx)</title>
          <description>Target dose 20mg for 12 weeks&#xD;
Escitalopram: 20 mg target dose for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>No treatment (healthy comparison participants with no history or presence of psychiatric disorder)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="54"/>
            <count group_id="B2" value="67"/>
            <count group_id="B3" value="121"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.76" spread="6.77"/>
                    <measurement group_id="B2" value="72.36" spread="6.17"/>
                    <measurement group_id="B3" value="72.09" spread="6.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diagnostic Status</title>
          <description>Diagnostic status based on structured clinical interview (binary outcome of &quot;depressed&quot; (MDD group) or &quot;not depressed&quot; (control group) by DSM-IV / SCID criteria)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)</title>
        <description>Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Montgomery Asberg Depression Rating Scale (MADRS). This measure is a clinical rating of mood with a score range from 0 to 60. Higher scores indicate greater depression severity.</description>
        <time_frame>Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)</time_frame>
        <population>4 participants in the Escitalopram group and 4 participants in the Control group do not have follow-up MADRS data and have therefore been excluded from Week 12 analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Escitalopram</title>
            <description>Patients diagnosed with MDD receiving 12-week Escitalopram intervention</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No Intervention / Non-psychiatric comparison participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)</title>
          <description>Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Montgomery Asberg Depression Rating Scale (MADRS). This measure is a clinical rating of mood with a score range from 0 to 60. Higher scores indicate greater depression severity.</description>
          <population>4 participants in the Escitalopram group and 4 participants in the Control group do not have follow-up MADRS data and have therefore been excluded from Week 12 analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Depression Severity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.26" spread="4.65"/>
                    <measurement group_id="O2" value="1.03" spread="1.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 Depression Severity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.78" spread="9.07"/>
                    <measurement group_id="O2" value="1.08" spread="1.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.025</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Depression Severity (Measured by Hamilton Depression Rating Scale)</title>
        <description>Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Hamilton Depression Rating Scale (HAM-D). This measure is a clinical rating of mood with a score range from 0 to 76. Higher scores indicate greater depression severity.</description>
        <time_frame>Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)</time_frame>
        <population>4 participants in the Escitalopram group and 3 participants in the Control group do not have follow-up MADRS data and have therefore been excluded from Week 12 analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Escitalopram</title>
            <description>Patients diagnosed with MDD receiving 12-week Escitalopram intervention</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No Intervention / Non-psychiatric comparison participants</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Depression Severity (Measured by Hamilton Depression Rating Scale)</title>
          <description>Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Hamilton Depression Rating Scale (HAM-D). This measure is a clinical rating of mood with a score range from 0 to 76. Higher scores indicate greater depression severity.</description>
          <population>4 participants in the Escitalopram group and 3 participants in the Control group do not have follow-up MADRS data and have therefore been excluded from Week 12 analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Depression Severity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.48" spread="4.45"/>
                    <measurement group_id="O2" value="1.24" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 Depression Severity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.44" spread="8.49"/>
                    <measurement group_id="O2" value="1.52" spread="1.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.025</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline (Study Entry) through 12 Weeks of Treatment/Participation</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MDD (Escitalopram Tx)</title>
          <description>Target dose 20mg for 12 weeks&#xD;
Escitalopram: 20 mg target dose for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>No treatment (healthy comparison participants with no history or presence of psychiatric disorder)</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Acute CVA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Gallbladder removal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="54"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="54"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue + poor appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Low libido + low mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin - Hives/Itchiness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Elevated BP</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Faith M. Gunning, PhD, Vice Chair for Research, Dept of Psychiatry</name_or_title>
      <organization>Well Cornell Medicine</organization>
      <phone>212-746-5832</phone>
      <email>fgd2002@med.cornell.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01728194
org study id: 1205012392
secondary id: 1R01MH097735-01
nct id: NCT01728194
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study may help identify how abnormalities in brain systems that control the ability to
      ignore irrelevant information may contribute to the development of depression in older
      adults.
Approximately half of those who develop depression in late life never had depression before.
      The classic view is that changes taking place in our brains as we age contribute to the
      development of late-onset depression. This view is supported by the relative absence of
      family history for those with late onset depression. This research study will recruit 70
      older adults with late life depression and 70 older adults without depression. All
      participants will receive a sub-clinical, non-contrast (magnetic resonance imaging (MRI) scan
      at the beginning of the study and then again 12 weeks later at the completion of the study.
      The depressed older participants will also receive a Food and Drug Administration
      (FDA)-approved antidepressant, escitalopram (Lexapro), as treatment for their depressive
      symptoms over 12 weeks. This MRI study may help the researchers identify how abnormalities in
      brain systems that control our ability to ignore distractions, control our emotions, and
      anticipate reward may contribute to the development of depression in older adults. The
      investigators hope that the findings promote the development of tests that may improve the
      detection of older adults at risk for poor treatment outcomes and eventually guide the
      development of novel treatments for depression.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)
time frame: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)
description: Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Montgomery Asberg Depression Rating Scale (MADRS). This measure is a clinical rating of mood with a score range from 0 to 60. Higher scores indicate greater depression severity.
measure: Change in Depression Severity (Measured by Hamilton Depression Rating Scale)
time frame: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)
description: Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Hamilton Depression Rating Scale (HAM-D). This measure is a clinical rating of mood with a score range from 0 to 76. Higher scores indicate greater depression severity.
arm group label: Escitalopram
arm group type: Experimental
description: Target dose 20mg for 12 weeks
arm group label: Control
arm group type: Other
description: Non-psychiatric comparison participants.
intervention type: Drug
intervention name: Escitalopram
description: 20 mg target dose for 12 weeks
arm group label: Escitalopram
other name: Lexapro
other name: 76184942
intervention type: Other
intervention name: Magnetic Resonance Imaging
description: Structural and functional MRI of the brain for research purposes.
arm group label: Control
arm group label: Escitalopram
other name: MRI
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Faith Gunning, Ph.D.
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
facility: 
country: United States
citation: Victoria LW, Alexopoulos GS, Ilieva I, Stein AT, Hoptman MJ, Chowdhury N, Respino M, Morimoto SS, Kanellopoulos D, Avari JN, Gunning FM. White matter abnormalities predict residual negative self-referential thinking following treatment of late-life depression with escitalopram: A preliminary study. J Affect Disord. 2019 Jan 15;243:62-69. doi: 10.1016/j.jad.2018.09.013. Epub 2018 Sep 11.
PMID: 30236759
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Escitalopram
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 