<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/NCT04504175</url>
  </required_header>
  <id_info>
    <org_study_id>202007085</org_study_id>
    <nct_id>NCT04504175</nct_id>
  </id_info>
  <brief_title>Ketamine for Older Adults Pilot</brief_title>
  <official_title>Precision Medicine With Ketamine for Older Adults With Treatment-resistant Depression: Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study will assess the safety and feasibility of intravenous (IV) ketamine in older&#xD;
      adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and&#xD;
      utilize innovative methodological approaches to demonstrate the feasibility of precision&#xD;
      medicine and mobile health approaches in depression treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants in this study will receive ketamine infusions twice a week for 4 weeks (acute&#xD;
      phase). Participants who respond or remit will continue with an additional 4 weeks of weekly&#xD;
      ketamine infusions (continuation phase). Participants will be assessed at baseline, end of&#xD;
      acute phase, and end of continuation phase for effectiveness, safety, and executive&#xD;
      functioning. Participants will be asked to complete daily surveys of their depression&#xD;
      symptoms during their participation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 22, 2020</start_date>
  <completion_date type="Actual">March 15, 2022</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Remission From Depression</measure>
    <time_frame>4 weeks for acute phase, 8 weeks for continuation phase</time_frame>
    <description>Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depression severity.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Treatment Resistant Depression</condition>
  <condition>Refractory Depression</condition>
  <condition>Therapy-Resistant Depression</condition>
  <condition>Late Life Depression</condition>
  <condition>Geriatric Depression</condition>
  <arm_group>
    <arm_group_label>Acute infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acute phase: ketamine infusions twice a week for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes</description>
    <arm_group_label>Acute infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Community-living men and women age 65 years and older;&#xD;
&#xD;
          2. Treatment-resistant depression: defined as unipolar major depressive disorder,&#xD;
             non-delusional (diagnosed by SCID-5) that persists despite ≥ 2 adequate antidepressant&#xD;
             trials of different classes in the current episode; including at least one&#xD;
             evidence-based second-line treatment in the current episode (including serotonin&#xD;
             norepinephrine reuptake inhibitors, bupropion, tricyclics, monoamine oxidase&#xD;
             inhibitors, or augmentation with an atypical antipsychotic, stimulant, bupropion,&#xD;
             lithium, or triiodothyronine&#xD;
&#xD;
          3. Persistent moderate to severe depressive symptoms determined by Patient Health&#xD;
             Questionnaire 9-item (PHQ-9)26 score ≥15 at baseline&#xD;
&#xD;
          4. Able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Dementia per history, score &lt; 24 on the Montreal Cognitive Assessment (MoCA), or&#xD;
             determined by clinical interview with geriatric psychiatrist to have high likelihood&#xD;
             of dementia;&#xD;
&#xD;
          2. Psychotic spectrum or bipolar disorder or severe personality disorder that at the PIs&#xD;
             discretion would interfere with safe participation. Anxiety disorders are not an&#xD;
             exclusion.&#xD;
&#xD;
          3. Unstable medical conditions such that IV ketamine is not safe or tolerated or that&#xD;
             would interfere with participation in a long-term study (i.e., poorly controlled&#xD;
             hypertension, life expectancy &lt; 1 year because of terminal illness, unstable angina).&#xD;
&#xD;
          4. Baseline systolic BP &gt; 165 systolic or 100 diastolic at evaluation.&#xD;
&#xD;
          5. Current alcohol or substance use disorder or lifetime recreational ketamine use or&#xD;
             other dissociative agent (e.g., PCP).&#xD;
&#xD;
          6. Use of naltrexone, memantine, or any medication that could be considered&#xD;
             contraindicated with ketamine.&#xD;
&#xD;
          7. Taking more than 2 adequately-dosed oral antidepressants.&#xD;
&#xD;
          8. High acute risk for suicide and unable to be managed safely in the clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Lenze, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Late-Life Mood, Stress, and Wellness Research Program</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine Healthy Mind Lab</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Adult and Late Life Depression Clinic</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6J-1H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <results_first_submitted>October 5, 2022</results_first_submitted>
  <results_first_submitted_qc>January 11, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2023</results_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Eric Lenze</investigator_full_name>
    <investigator_title>Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>ketamine</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, Treatment-Resistant</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>October 12, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT04504175/Prot_000.pdf</document_url>
    </provided_document>
    <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>May 28, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT04504175/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Acute</title>
          <description>Acute phase: ketamine infusions twice a week for 4 weeks&#xD;
Ketamine: ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Acute Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Continuation Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </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>Acute Infusion</title>
          <description>Acute phase: ketamine infusions twice a week for 4 weeks&#xD;
Ketamine: ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
          </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="71.5" spread="4.9"/>
                  </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="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </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>CIRS-G Total</title>
          <description>The Cumulative Illness Rating Scale for Geriatrics (CIRS-G) is a 14-item scale that assesses overall health. A total score is reported with a range of 0 to 56, where a higher score represents worse overall health.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.1" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MADRS Total</title>
          <description>Montgomery Asberg Depression Rating Scale (MADRS) score. Scale ranges from 0-60 with higher scores indicating higher depressive symptoms.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.4" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years of education</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.2" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>DCCS</title>
          <description>The Dimensional Change Card Sort (DCCS) is a test for executive functioning. Raw scores are converted to standardized scores where the average is 100 and the standard deviation is 15. Higher scores indicate higher levels of executive functioning.</description>
          <units>Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98.2" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Flanker</title>
          <description>The Flanker Inhibitory Control and Attention Test (Flanker) is a test for participant's attention and inhibitory control. Raw scores are converted to standardized scores where the average is 100 and the standard deviation is 15. Higher scores indicate higher levels of attention and inhibitory control in participants.</description>
          <units>Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82.7" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>List Sorting</title>
          <description>The List Sorting Working Memory Test is a test for working memory. Raw scores are converted to standardized scores where the average is 100 and the standard deviation is 15. Higher scores indicate higher levels of working memory in participants.</description>
          <units>Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101.0" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Picture Sequence Memory</title>
          <description>The Toolbox Picture Sequence Memory Test (TPSMT) is a test for episodic memory. Raw scores are converted to standardized scores where the average is 100 and the standard deviation is 15. Higher scores indicate higher levels of episodic memory.</description>
          <units>Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102.5" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pattern Processing Speed</title>
          <description>This test measures speed of processing by asking participants to identify whether two side by side pictures are the same or not. The items are presented one pair at a time on the computer screen, and the participant is given 85 seconds to respond to as many items as possible.&#xD;
The participant's raw score is the number of items answered correctly during the 85 seconds of response time, with a range of 0-130. The higher the number, the more items were answered correctly.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87.7" spread="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fluid Cognition Composite</title>
          <description>This score is found from averaging the standard scores of the Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison tasks, and then deriving standard scores based on this new distribution. An uncorrected standard score at or near 100 indicates ability that is average compared with others nationally. A standard score of around 85 suggests significantly below-average fluid cognitive ability. The population mean is 100 with a standard deviation of 15. This scale does not have a full scale range.</description>
          <units>t-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92.4" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Remission From Depression</title>
        <description>Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depression severity.</description>
        <time_frame>4 weeks for acute phase, 8 weeks for continuation phase</time_frame>
        <population>25 adults ages 60 years or over with Treatment-Resistant Depression (TRD) received IV ketamine infusion twice a week for 4 weeks (the &quot;acute phase&quot;); people who responded to the infusion at the end of the acute phase went to receive weekly infusions for 4 more weeks in a &quot;continuation phase.&quot;</population>
        <group_list>
          <group group_id="O1">
            <title>Acute Infusion</title>
            <description>Acute phase: ketamine infusions twice a week for 4 weeks&#xD;
Ketamine: ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Remission From Depression</title>
          <description>Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depression severity.</description>
          <population>25 adults ages 60 years or over with Treatment-Resistant Depression (TRD) received IV ketamine infusion twice a week for 4 weeks (the &quot;acute phase&quot;); people who responded to the infusion at the end of the acute phase went to receive weekly infusions for 4 more weeks in a &quot;continuation phase.&quot;</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Acute phase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Continuation phase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4-8 weeks: The first period (Acute Phase) lasted 4 weeks, those who went to the Continuation Phase continued for an additional 4 weeks to total 8 weeks</time_frame>
      <desc>As far as adverse events (AE's) for this pilot study, all events were recorded during the Acute Phase. No AE's were reported in the Continuation Phase.</desc>
      <group_list>
        <group group_id="E1">
          <title>Acute</title>
          <description>Acute phase: ketamine infusions twice a week for 4 weeks&#xD;
Ketamine: ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes</description>
        </group>
        <group group_id="E2">
          <title>Continuation</title>
          <description>Continuation phase: those who completed the acute phase and continued for an additional 4 weeks to total 8 weeks&#xD;
Ketamine: ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes</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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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="4" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Nausea with vomitting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Swelling in feet and ankles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper respitory symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </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. Eric Lenze</name_or_title>
      <organization>Washington University in St. Louis</organization>
      <phone>314-362-5154</phone>
      <email>lenzee@wustl.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/NCT04504175
org study id: 202007085
nct id: NCT04504175
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This pilot study will assess the safety and feasibility of intravenous (IV) ketamine in older
      adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and
      utilize innovative methodological approaches to demonstrate the feasibility of precision
      medicine and mobile health approaches in depression treatment.
Participants in this study will receive ketamine infusions twice a week for 4 weeks (acute
      phase). Participants who respond or remit will continue with an additional 4 weeks of weekly
      ketamine infusions (continuation phase). Participants will be assessed at baseline, end of
      acute phase, and end of continuation phase for effectiveness, safety, and executive
      functioning. Participants will be asked to complete daily surveys of their depression
      symptoms during their participation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Remission From Depression
time frame: 4 weeks for acute phase, 8 weeks for continuation phase
description: Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depression severity.
arm group label: Acute infusion
arm group type: Experimental
description: Acute phase: ketamine infusions twice a week for 4 weeks
intervention type: Drug
intervention name: Ketamine
description: ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes
arm group label: Acute infusion
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Lenze, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Eric Lenze
investigator title: Professor of Psychiatry
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Treatment-Resistant
mesh term: Ketamine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 