<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/NCT02997722</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0107</org_study_id>
    <nct_id>NCT02997722</nct_id>
  </id_info>
  <brief_title>The Effect of Ketamine on the Length of Hospital Stay of Patients Hospitalized With Suicidal Ideation.</brief_title>
  <official_title>Ketamine: Its Effects on Suicidal Ideations and Inpatient Hospital Length of Stay</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allen Richert</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Mississippi Medical Center</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>
      This study will evaluate the effect of ketamine on the treatment of patients hospitalized&#xD;
      with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein.&#xD;
      The other half will receive a placebo. Because we think that ketamine will improve depression&#xD;
      and suicidal thoughts, we expect that patients who receive ketamine will require less time in&#xD;
      the hospital than patients who receive placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients admitted to UMMC's psychiatry inpatient unit with suicidal thoughts will be given&#xD;
      the opportunity to participate in the study. Those patients who consent to participate, after&#xD;
      being informed about the study and its risks, will be randomized to receive an IV infusion of&#xD;
      either saline or ketamine 0.5 mg/kg. The infusion will be given within 24 hours of arriving&#xD;
      on the psychiatry inpatient unit. We will record the dates and times that the patient was&#xD;
      admitted to and discharged from the psychiatric inpatient unit. At completion of the study,&#xD;
      we will compare the average length of stay, defined as date and time of discharge minus date&#xD;
      of time of admission, of the group that received ketamine to the average length of stay of&#xD;
      the group that received placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Staffing and space deficiencies prevented completion of the study.&#xD;
  </why_stopped>
  <start_date type="Actual">March 2, 2017</start_date>
  <completion_date type="Actual">May 19, 2017</completion_date>
  <primary_completion_date type="Actual">May 19, 2017</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inpatient Hospital Length of Stay</measure>
    <time_frame>The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study.</time_frame>
    <description>We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Suicidal Ideation</condition>
  <arm_group>
    <arm_group_label>Ketamine infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Saline infusion</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.</description>
    <arm_group_label>Ketamine infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>IV infusion of 100 ml of normal saline over 45 minutes.</description>
    <arm_group_label>Normal Saline infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women between the ages of 18 and 64&#xD;
&#xD;
          2. Patients admitted to the University of Mississippi Medical Center inpatient psychiatry&#xD;
             service with suicidal ideations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lifetime history of schizophrenia or other primary psychotic disorder&#xD;
&#xD;
          2. Current psychotic or manic symptoms&#xD;
&#xD;
          3. Substance use disorder within one month of admission&#xD;
&#xD;
          4. Positive urine toxicology at admission&#xD;
&#xD;
          5. Any lifetime abuse of ketamine or phencyclidine&#xD;
&#xD;
          6. Systolic BP &gt;180 mmHg or diastolic BP &gt;110 mmHg&#xD;
&#xD;
          7. Any patient who has eaten food within 8 hours prior to receiving the ketamine infusion&#xD;
             or who has drank clear liquids within 2 hours prior to receiving the infusion&#xD;
&#xD;
          8. Known central nervous system (CNS) mass&#xD;
&#xD;
          9. CNS abnormalities&#xD;
&#xD;
         10. Hydrocephalus&#xD;
&#xD;
         11. Glaucoma&#xD;
&#xD;
         12. Acute globe injury&#xD;
&#xD;
         13. Porphyria&#xD;
&#xD;
         14. Untreated thyroid disease&#xD;
&#xD;
         15. Known coronary artery disease with poor functional capacity&#xD;
&#xD;
         16. Pregnancy&#xD;
&#xD;
         17. Currently breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allen C Richert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mississippi Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <results_first_submitted>April 16, 2020</results_first_submitted>
  <results_first_submitted_qc>April 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 29, 2020</results_first_posted>
  <last_update_submitted>May 18, 2020</last_update_submitted>
  <last_update_submitted_qc>May 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Mississippi Medical Center</investigator_affiliation>
    <investigator_full_name>Allen Richert</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry and Human Behavior</investigator_title>
  </responsible_party>
  <keyword>ketamine</keyword>
  <keyword>suicidal ideation</keyword>
  <keyword>length of stay</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicidal Ideation</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>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02997722/ICF_000.pdf</document_url>
    </provided_document>
    <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>November 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02997722/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ketamine Infusion</title>
          <description>Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.&#xD;
Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.</description>
        </group>
        <group group_id="P2">
          <title>Normal Saline Infusion</title>
          <description>Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.&#xD;
Normal Saline: IV infusion of 100 ml of normal saline over 45 minutes.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ketamine Infusion</title>
          <description>Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.&#xD;
Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.</description>
        </group>
        <group group_id="B2">
          <title>Normal Saline Infusion</title>
          <description>Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.&#xD;
Normal Saline: IV infusion of 100 ml of normal saline over 45 minutes.</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="3"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                    <count group_id="B2" value="1"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </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>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                    <count group_id="B2" value="1"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.67" lower_limit="38" upper_limit="59"/>
                    <measurement group_id="B2" value="36" lower_limit="36" upper_limit="36"/>
                    <measurement group_id="B3" value="44.75" lower_limit="36" upper_limit="59"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                    <count group_id="B2" value="1"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                    <count group_id="B2" value="1"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Inpatient Hospital Length of Stay</title>
        <description>We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.</description>
        <time_frame>The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ketamine Infusion</title>
            <description>Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.&#xD;
Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Normal Saline Infusion</title>
            <description>Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.&#xD;
Normal Saline: IV infusion of 100 ml of normal saline over 45 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Inpatient Hospital Length of Stay</title>
          <description>We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130.75" lower_limit="62.47" upper_limit="227.23"/>
                    <measurement group_id="O2" value="81.97" lower_limit="81.97" upper_limit="81.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>We recorded adverse events that occurred during the infusion and for 30 minutes after the infusion.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ketamine Infusion</title>
          <description>Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.&#xD;
Ketamine: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.</description>
        </group>
        <group group_id="E2">
          <title>Normal Saline Infusion</title>
          <description>Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.&#xD;
Normal Saline: IV infusion of 100 ml of normal saline over 45 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="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </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="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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>
    <limitations_and_caveats>The small number of subjects (i.e., only 4) recruited prior to the premature termination of this study prevents one from drawing meaningful conclusions from this data.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Allen Richert, MD</name_or_title>
      <organization>University of Mississippi Medical Center</organization>
      <phone>(601) 984-4820</phone>
      <email>arichert@umc.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/NCT02997722
org study id: 2016-0107
nct id: NCT02997722
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the effect of ketamine on the treatment of patients hospitalized
      with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein.
      The other half will receive a placebo. Because we think that ketamine will improve depression
      and suicidal thoughts, we expect that patients who receive ketamine will require less time in
      the hospital than patients who receive placebo.
Patients admitted to UMMC's psychiatry inpatient unit with suicidal thoughts will be given
      the opportunity to participate in the study. Those patients who consent to participate, after
      being informed about the study and its risks, will be randomized to receive an IV infusion of
      either saline or ketamine 0.5 mg/kg. The infusion will be given within 24 hours of arriving
      on the psychiatry inpatient unit. We will record the dates and times that the patient was
      admitted to and discharged from the psychiatric inpatient unit. At completion of the study,
      we will compare the average length of stay, defined as date and time of discharge minus date
      of time of admission, of the group that received ketamine to the average length of stay of
      the group that received placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Inpatient Hospital Length of Stay
time frame: The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study.
description: We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.
arm group label: Ketamine infusion
arm group type: Experimental
description: Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.
arm group label: Normal Saline infusion
arm group type: Placebo Comparator
description: Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.
intervention type: Drug
intervention name: Ketamine
description: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.
arm group label: Ketamine infusion
intervention type: Drug
intervention name: Normal Saline
description: IV infusion of 100 ml of normal saline over 45 minutes.
arm group label: Normal Saline infusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Allen C Richert, MD
role: Principal Investigator
affiliation: University of Mississippi Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Mississippi Medical Center
investigator full name: Allen Richert
investigator title: Associate Professor of Psychiatry and Human Behavior
mesh term: Suicidal Ideation
mesh term: Ketamine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The small number of subjects (i.e., only 4) recruited prior to the premature termination of this study prevents one from drawing meaningful conclusions from this data.
point of contact: 