<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/NCT02969876</url>
  </required_header>
  <id_info>
    <org_study_id>2016P001243</org_study_id>
    <nct_id>NCT02969876</nct_id>
  </id_info>
  <brief_title>Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine</brief_title>
  <acronym>VOR-IISR</acronym>
  <official_title>Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with&#xD;
      major depressive disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The U.S. Food and Drug Administration approved vortioxetine to treat major depressive&#xD;
      disorder in 2013. Researchers believe vortioxetine may improve pattern separation and pattern&#xD;
      completion (i.e., a neurological function) in people with major depressive disorder; thus,&#xD;
      this research study aims to determine how vortioxetine increases a person's ability to think.&#xD;
      The current study is an open label trial, therefore, all participants will receive&#xD;
      vortioxetine. Furthermore, participants receive the vortioxetine at no cost. It will take&#xD;
      participants 6 weeks to complete this study. Participants are asked to come to the Mass&#xD;
      General Hospital campus for 1 screening visit which includes a full psychiatric evaluation,&#xD;
      and 5 additional study visits. During study visits, participants will meet with a clinician&#xD;
      and then complete computer based cognitive tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Site was unable to reach Sponsor recruitment goals.&#xD;
  </why_stopped>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Actual">August 6, 2018</completion_date>
  <primary_completion_date type="Actual">August 6, 2018</primary_completion_date>
  <phase>Phase 4</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)</measure>
    <time_frame>6 weeks</time_frame>
    <description>This scale is designed to assess the severity of depressive symptoms. The minimum score is a 0 (zero) and the maximum score is a 27, and a higher score means a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Digital Symbol Substitution Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>A cognitive measure sensitive to learning and memory. Participants are given 90 seconds to match as many symbols to numbers according to a key located on the top of the page. A higher score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rey Auditory Verbal Learning Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>A cognitive measure sensitive to learning and memory. Minimum score is a zero. Maximum score is a 75. A higher score means a better outcome</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Depressive Disorder</condition>
  <condition>Major Depression</condition>
  <condition>Depression</condition>
  <condition>Depression, Unipolar</condition>
  <arm_group>
    <arm_group_label>Study Phase</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>During this phase participants receive open label vortioxetine for 6 weeks. Participants come to the Depression Clinical &amp; Research Program at the Massachusetts General Hospital for visits once a week. During these visits the participants meet with clinicians and complete cognitive tasks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vortioxetine</intervention_name>
    <description>Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.</description>
    <arm_group_label>Study Phase</arm_group_label>
    <other_name>Trintellix</other_name>
    <other_name>Brintellix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meets Diagnostic and Statistical Manual of Mental Disorders (Versions 4 and 5)&#xD;
             criteria for and Major Depressive Disorder.&#xD;
&#xD;
          2. Hamilton Depression Rating Scale-17 score greater than 18.&#xD;
&#xD;
          3. Men and women between ages &gt;=18 and 65.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5)&#xD;
             criteria for schizophrenia, schizoaffective disorder, obsessive compulsive disorder.&#xD;
&#xD;
          2. Unable to follow instructions or otherwise unable to participate in the trial.&#xD;
&#xD;
          3. Pregnant women or women of child bearing potential who are not using a medically&#xD;
             accepted means of contraception (defined as oral contraceptive pill or implant,&#xD;
             condom, diaphragm, spermicide, intrauterine device, tubal ligation, partner with&#xD;
             vasectomy)&#xD;
&#xD;
          4. Patients who, in the investigator's judgment, pose a current, serious suicidal or&#xD;
             homicidal risk.&#xD;
&#xD;
          5. Serious or unstable medical illness including cardiovascular, hepatic, renal,&#xD;
             respiratory, endocrine, neurologic, or hematologic disease.&#xD;
&#xD;
          6. History of seizure disorder.&#xD;
&#xD;
          7. The following Diagnostic and Statistical Manual of Mental Disorders (Version 4)&#xD;
             diagnoses (any current or past history, except substance abuse disorders):&#xD;
&#xD;
             Organic mental disorders, schizoaffective disorder, delusional disorder, psychotic&#xD;
             disorders not elsewhere classified.&#xD;
&#xD;
          8. History of multiple adverse drug reactions or allergy to the study drugs.&#xD;
&#xD;
          9. Patients with mood congruent or mood incongruent psychotic features&#xD;
&#xD;
         10. Current use of other psychotropic drugs.&#xD;
&#xD;
         11. Clinical or laboratory evidence of hypothyroidism.&#xD;
&#xD;
         12. Patients who have failed to respond during the course of their current major&#xD;
             depressive episode to at least one adequate antidepressant trial, defined as six weeks&#xD;
             or more of treatment with citalopram 40 mg/day (or its antidepressant equivalent)&#xD;
&#xD;
         13. Patients who have had electroconvulsive therapy within the 6 months preceding&#xD;
             baseline.&#xD;
&#xD;
         14. Concomitant use of serotonergic agents&#xD;
&#xD;
         15. Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5)&#xD;
             criteria for bipolar disorder&#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>Andrew Nierenberg, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Depression Clinical and Research Program/ Bipolar Clinical and Research Program</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the 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>September 2019</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>September 23, 2019</results_first_submitted>
  <results_first_submitted_qc>September 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 14, 2019</results_first_posted>
  <last_update_submitted>September 23, 2019</last_update_submitted>
  <last_update_submitted_qc>September 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Andrew A. Nierenberg, MD</investigator_full_name>
    <investigator_title>Director, Bipolar Clinic and Research Program; Associate Director, Depression Clinical and Research Program; Director, Clinical Research Support Office, Clinical Research Program</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vortioxetine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT02969876/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Open Trial Vortioxetine</title>
          <description>All enrolled participants received open trial of Vortioxetine for 6 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study Phase</title>
          <description>During this phase participants receive open label vortioxetine for 6 weeks. Participants come to the Depression Clinical &amp; Research Program at the Massachusetts General Hospital for visits once a week. During these visits the participants meet with clinicians and complete cognitive tasks.&#xD;
Vortioxetine: Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="20.5" spread="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)</title>
        <description>This scale is designed to assess the severity of depressive symptoms. The minimum score is a 0 (zero) and the maximum score is a 27, and a higher score means a worse outcome.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Phase</title>
            <description>During this phase participants receive open label vortioxetine for 6 weeks. Participants come to the Depression Clinical &amp; Research Program at the Massachusetts General Hospital for visits once a week. During these visits the participants meet with clinicians and complete cognitive tasks.&#xD;
Vortioxetine: Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.</description>
          </group>
        </group_list>
        <measure>
          <title>Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)</title>
          <description>This scale is designed to assess the severity of depressive symptoms. The minimum score is a 0 (zero) and the maximum score is a 27, and a higher score means a worse outcome.</description>
          <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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="10.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Digital Symbol Substitution Test</title>
        <description>A cognitive measure sensitive to learning and memory. Participants are given 90 seconds to match as many symbols to numbers according to a key located on the top of the page. A higher score means a better outcome.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Open Trial Vortioxetine</title>
            <description>All enrolled participants received open trial of Vortioxetine for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Digital Symbol Substitution Test</title>
          <description>A cognitive measure sensitive to learning and memory. Participants are given 90 seconds to match as many symbols to numbers according to a key located on the top of the page. A higher score means a better outcome.</description>
          <units>number of substitutions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.5" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rey Auditory Verbal Learning Test</title>
        <description>A cognitive measure sensitive to learning and memory. Minimum score is a zero. Maximum score is a 75. A higher score means a better outcome</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Open Trial Vortioxetine</title>
            <description>All enrolled participants received open trial of Vortioxetine for 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Rey Auditory Verbal Learning Test</title>
          <description>A cognitive measure sensitive to learning and memory. Minimum score is a zero. Maximum score is a 75. A higher score means a better outcome</description>
          <units>number of words recalled</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Open Trial Vortioxetine</title>
          <description>All enrolled participants received open trial of Vortioxetine for 6 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <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="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Migraines</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Headaches</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Tripped, hit knee, went to ER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Andrew Nierenberg</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>6175122641</phone>
      <email>anierenberg@mgh.harvard.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/NCT02969876
org study id: 2016P001243
nct id: NCT02969876
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with
      major depressive disorder.
The U.S. Food and Drug Administration approved vortioxetine to treat major depressive
      disorder in 2013. Researchers believe vortioxetine may improve pattern separation and pattern
      completion (i.e., a neurological function) in people with major depressive disorder; thus,
      this research study aims to determine how vortioxetine increases a person's ability to think.
      The current study is an open label trial, therefore, all participants will receive
      vortioxetine. Furthermore, participants receive the vortioxetine at no cost. It will take
      participants 6 weeks to complete this study. Participants are asked to come to the Mass
      General Hospital campus for 1 screening visit which includes a full psychiatric evaluation,
      and 5 additional study visits. During study visits, participants will meet with a clinician
      and then complete computer based cognitive tests.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)
time frame: 6 weeks
description: This scale is designed to assess the severity of depressive symptoms. The minimum score is a 0 (zero) and the maximum score is a 27, and a higher score means a worse outcome.
measure: Digital Symbol Substitution Test
time frame: 6 weeks
description: A cognitive measure sensitive to learning and memory. Participants are given 90 seconds to match as many symbols to numbers according to a key located on the top of the page. A higher score means a better outcome.
measure: Rey Auditory Verbal Learning Test
time frame: 6 weeks
description: A cognitive measure sensitive to learning and memory. Minimum score is a zero. Maximum score is a 75. A higher score means a better outcome
arm group label: Study Phase
arm group type: Other
description: During this phase participants receive open label vortioxetine for 6 weeks. Participants come to the Depression Clinical & Research Program at the Massachusetts General Hospital for visits once a week. During these visits the participants meet with clinicians and complete cognitive tasks.
intervention type: Drug
intervention name: Vortioxetine
description: Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.
arm group label: Study Phase
other name: Trintellix
other name: Brintellix
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Andrew Nierenberg, M.D.
role: Principal Investigator
affiliation: Depression Clinical and Research Program/ Bipolar Clinical and Research Program
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Andrew A. Nierenberg, MD
investigator title: Director, Bipolar Clinic and Research Program; Associate Director, Depression Clinical and Research Program; Director, Clinical Research Support Office, Clinical Research Program
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Vortioxetine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 