<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/NCT01667926</url>
  </required_header>
  <id_info>
    <org_study_id>2012-P-001042</org_study_id>
    <nct_id>NCT01667926</nct_id>
  </id_info>
  <brief_title>Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder</brief_title>
  <official_title>Randomized, Double-blind Ketamine Augmentation in Chronically Suicidal, Treatment-resistant Major Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ketamine infusions resulted in an acute reduction in global depression scores and in severity&#xD;
      of suicidal ideation. The investigators therefore plan to investigate the feasibility and&#xD;
      efficacy of repeated intravenous administration of ketamine in severely depressed, treatment&#xD;
      resistant patients. The results of the study could lead to development of new strategies for&#xD;
      treating depression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)</measure>
    <time_frame>up to 4 months</time_frame>
    <description>The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HDRS-28 Total</measure>
    <time_frame>up to 5 months</time_frame>
    <description>Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will receive 6 infusions of ketamine over three weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive 6 infusions of normal saline over 3 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.</description>
    <arm_group_label>Ketamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatient with sever treatment resistant depression&#xD;
&#xD;
          -  Currently depressed&#xD;
&#xD;
          -  Currently under regular psychiatric care&#xD;
&#xD;
          -  On an aggressive antidepressant regimen, stable for 4 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No history of other major psychiatric illness, including bipolar&#xD;
&#xD;
          -  No history of psychosis&#xD;
&#xD;
          -  No history of drug abuse&#xD;
&#xD;
          -  No major medical illness or unstable medical problem&#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>Cristina Cusin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>MGH Department of Psychiatry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Depression Clinical and Reseach Program - MGH</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>April 2017</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <results_first_submitted>March 2, 2017</results_first_submitted>
  <results_first_submitted_qc>April 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 20, 2017</results_first_posted>
  <last_update_submitted>April 18, 2017</last_update_submitted>
  <last_update_submitted_qc>April 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Cristina Cusin, MD</investigator_full_name>
    <investigator_title>Instructor HSM</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Outpatients were recruited primarily through referrals.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Ketamine</title>
          <description>Subject will receive 6 infusions of ketamine over three weeks.&#xD;
Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Subjects will receive 6 infusions of normal saline over 3 weeks.&#xD;
Placebo</description>
        </group>
        <group group_id="P3">
          <title>Screen Fail/No Baseline</title>
          <description>Participants who signed informed consent and were screened but did not meet study inclusion/exclusion criteria.&#xD;
Participants in the screen fail group were not randomized to either Ketamine nor placebo and did not receive any infusions.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="0">Participants in the screen fail group were not randomized in the study.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Time committment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inclusion/Exclusion Criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Side effects</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ketamine</title>
          <description>Subject will receive 6 infusions of ketamine over three weeks.&#xD;
Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Subjects will receive 6 infusions of normal saline over 3 weeks.&#xD;
Placebo</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="13"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="26"/>
          </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="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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_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="45.5" spread="13.6"/>
                    <measurement group_id="B2" value="45.3" spread="11.7"/>
                    <measurement group_id="B3" value="45.4" spread="12.4"/>
                  </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="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)</title>
        <description>The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.</description>
        <time_frame>up to 4 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ketamine</title>
            <description>Subject will receive 6 infusions of ketamine over three weeks.&#xD;
Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects will receive 6 infusions of normal saline over 3 weeks.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)</title>
          <description>The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.</description>
          <units>units 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="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="1.4"/>
                    <measurement group_id="O2" value="1.6" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HDRS-28 Total</title>
        <description>Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.</description>
        <time_frame>up to 5 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ketamine</title>
            <description>Subject will receive 6 infusions of ketamine over three weeks.&#xD;
Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects will receive 6 infusions of normal saline over 3 weeks.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>HDRS-28 Total</title>
          <description>Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.</description>
          <units>units 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="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" spread="11.1"/>
                    <measurement group_id="O2" value="20.0" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 3 months</time_frame>
      <desc>Adverse events were tracked from Baseline to three months after final infusion in a naturalistic &quot;follow-up&quot; phase.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ketamine</title>
          <description>Subject will receive 6 infusions of ketamine over three weeks.&#xD;
Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Subjects will receive 6 infusions of normal saline over 3 weeks.&#xD;
Placebo</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, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Unrelated hospitalization</sub_title>
                <description>The subject was hospitalized due to syncope. This event very unlikely related to the study medication, due to the significant time delay between the final infusion and the episodes of syncope. The most probable explanation is a viral infection.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Worsening Depression</sub_title>
                <description>Participant was hospitalized due to worsening depression and suicidal ideation. Study team was notified by the participant via phone call or email.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </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="3" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Ketamine side effects</sub_title>
                <description>Including dizziness, fever, fainting, and detachment from reality</description>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Blood Pressure elevated</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric Hospitalization</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </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. Cristina Cusin</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>6177263855</phone>
      <email>ccusin@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/NCT01667926
org study id: 2012-P-001042
nct id: NCT01667926
lead sponsor: 
has dmc: Yes
Ketamine infusions resulted in an acute reduction in global depression scores and in severity
      of suicidal ideation. The investigators therefore plan to investigate the feasibility and
      efficacy of repeated intravenous administration of ketamine in severely depressed, treatment
      resistant patients. The results of the study could lead to development of new strategies for
      treating depression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)
time frame: up to 4 months
description: The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.
measure: HDRS-28 Total
time frame: up to 5 months
description: Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.
arm group label: Ketamine
arm group type: Experimental
description: Subject will receive 6 infusions of ketamine over three weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive 6 infusions of normal saline over 3 weeks.
intervention type: Drug
intervention name: Ketamine
description: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.
arm group label: Ketamine
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Cristina Cusin, M.D.
role: Principal Investigator
affiliation: MGH Department of Psychiatry
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Cristina Cusin, MD
investigator title: Instructor HSM
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Ketamine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 