<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/NCT01680172</url>
  </required_header>
  <id_info>
    <org_study_id>12-001156</org_study_id>
    <nct_id>NCT01680172</nct_id>
  </id_info>
  <brief_title>Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer</brief_title>
  <official_title>Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depression is common in patients with cancer. Current medications for depression, while&#xD;
      effective, take several weeks to take effect. Ketamine has emerged as a drug with promise for&#xD;
      cancer patients. In two reported cases, a single dose of ketamine induced rapid and&#xD;
      moderately sustained symptom reduction in depression and anxiety with no adverse side&#xD;
      effects. Benefit was seen in as little as 1 hour and sustained up to 30 days. This study is a&#xD;
      randomized, double-blind, placebo-controlled investigation testing whether a single dose of&#xD;
      ketamine improves depression and anxiety relative to placebo in patients with cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is common in patients with cancer. Current antidepressants, while effective, have&#xD;
      an onset of action of at least several weeks. Ketamine has emerged as a drug with promise for&#xD;
      cancer patients. It has been shown to potentiate opiate analgesic effects. Single dose&#xD;
      parenteral and enteral administration studies in medically healthy treatment-resistant&#xD;
      depressed patients have shown rapid relief of symptoms. A recent two patient case series&#xD;
      reported a rapid and moderately sustained symptom reduction in depression and anxiety in&#xD;
      palliative care patients following a single dose of oral ketamine 0.5 mg/kg, with no adverse&#xD;
      effects. Benefit was seen as little as 1 hour after the administration and sustained up to 30&#xD;
      days. These case reports generate hypotheses of efficacy for ketamine in the treatment of&#xD;
      depression and anxiety in patients with cancer. This study is a randomized, double-blind,&#xD;
      placebo-controlled investigation of these hypotheses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow enrollment&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 2</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)</measure>
    <time_frame>Baseline, 120 minutes</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be &gt;10 for anxiety and &gt;8 for depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety Depression Scale- Depression Score (HADS-D)</measure>
    <time_frame>Baseline, 120 minutes</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be &gt;10 for anxiety and &gt;8 for depression.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Cancer</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of ketamine (0.5 mg/kg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose of placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>Single dose (0.5 mg/kg) of liquid ketamine 10mg/mL solution taken by mouth</description>
    <arm_group_label>Ketamine</arm_group_label>
    <other_name>Ketalar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Single dose of liquid placebo solution taken by mouth</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with cancer&#xD;
&#xD;
          -  Outpatient status at the time of study entry&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Life expectancy of at least 1 month&#xD;
&#xD;
          -  Regular access to a telephone (for safety reasons)&#xD;
&#xD;
          -  Reliable transportation to follow-up visits&#xD;
&#xD;
          -  Caregiver observation available for 24 hours after the dose&#xD;
&#xD;
          -  Histologically-proven malignancy&#xD;
&#xD;
          -  Depression score of &gt;11 on the Hospital Anxiety and Depression Scale (HADS)&#xD;
&#xD;
          -  Provision of informed consent&#xD;
&#xD;
          -  Able to complete the patient questionnaires alone or with assistance&#xD;
&#xD;
          -  Able to speak and read English&#xD;
&#xD;
          -  May receive other psycho-active medications while on the study i.e. opiates, except as&#xD;
             defined within the exclusion criteria&#xD;
&#xD;
          -  May receive psychotherapy from an outside provider at the beginning and/or during the&#xD;
             course of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obvious cognitive dysfunction or Mini Mental Status Exam score &lt;20&#xD;
&#xD;
          -  Antidepressants started or dose changed within 8 weeks of the beginning of the study&#xD;
             or during the study&#xD;
&#xD;
          -  Benzodiazepines prescribed for psychiatric indications that have been started or dose&#xD;
             change within 2 weeks of the beginning of study enrollment&#xD;
&#xD;
          -  Suicidal ideation or a suicide attempt within the last year&#xD;
&#xD;
          -  Patients with current or past psychosis not from delirium&#xD;
&#xD;
          -  Females who are pregnant or nursing&#xD;
&#xD;
          -  Unable to take oral medications&#xD;
&#xD;
          -  Primary or metastatic brain malignancy&#xD;
&#xD;
          -  Gastrointestinal tract obstruction&#xD;
&#xD;
          -  Prior adverse reaction to or other contraindication to ketamine&#xD;
&#xD;
          -  Substance abuse or dependence, as defined by Diagnostic and Statistical Manual of&#xD;
             Mental Disorders-IV (DSM-IV) criteria, within the last 90 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert P. Bright, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yuma Regional Medical Center</name>
      <address>
        <city>Yuma</city>
        <state>Arizona</state>
        <zip>85364</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <results_first_submitted>January 29, 2016</results_first_submitted>
  <results_first_submitted_qc>January 29, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 29, 2016</results_first_posted>
  <last_update_submitted>January 29, 2016</last_update_submitted>
  <last_update_submitted_qc>January 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Robert P. Bright</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>depression</keyword>
  <keyword>anxiety</keyword>
  <keyword>palliative care</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>Anxiety Disorders</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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited at Mayo Clinic in Scottsdale, Arizona from 2012 to 2014.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Ketamine</title>
          <description>Single dose of ketamine (0.5 mg/kg)&#xD;
Ketamine: Single dose of ketamine (0.5 mg/kg)</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Single dose of placebo&#xD;
Placebo: Single dose of placebo</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="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </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</title>
          <description>Single dose of ketamine (0.5 mg/kg)&#xD;
Ketamine: Single dose of ketamine (0.5 mg/kg)</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Single dose of placebo&#xD;
Placebo: Single dose of 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="3"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="5"/>
          </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="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)</title>
        <description>Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be &gt;10 for anxiety and &gt;8 for depression.</description>
        <time_frame>Baseline, 120 minutes</time_frame>
        <population>Study was terminated early due to slow accrual.</population>
        <group_list>
          <group group_id="O1">
            <title>Ketamine</title>
            <description>Single dose of ketamine (0.5 mg/kg)&#xD;
Ketamine: Single dose of ketamine (0.5 mg/kg)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single dose of placebo&#xD;
Placebo: Single dose of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)</title>
          <description>Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be &gt;10 for anxiety and &gt;8 for depression.</description>
          <population>Study was terminated early due to slow accrual.</population>
          <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="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HADS-A score at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" spread="2.5"/>
                    <measurement group_id="O2" value="16.5" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HADS-A Score at 120 minutes post dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="3.8"/>
                    <measurement group_id="O2" value="11.0" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hospital Anxiety Depression Scale- Depression Score (HADS-D)</title>
        <description>Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be &gt;10 for anxiety and &gt;8 for depression.</description>
        <time_frame>Baseline, 120 minutes</time_frame>
        <population>Study was terminated early due to slow accrual.</population>
        <group_list>
          <group group_id="O1">
            <title>Ketamine</title>
            <description>Single dose of ketamine (0.5 mg/kg)&#xD;
Ketamine: Single dose of ketamine (0.5 mg/kg)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single dose of placebo&#xD;
Placebo: Single dose of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety Depression Scale- Depression Score (HADS-D)</title>
          <description>Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be &gt;10 for anxiety and &gt;8 for depression.</description>
          <population>Study was terminated early due to slow accrual.</population>
          <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="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HADS-D Score at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" spread="1.5"/>
                    <measurement group_id="O2" value="14.5" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HADS-D Score 120 minutes post dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" spread="2.3"/>
                    <measurement group_id="O2" value="10.5" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were evaluated at baseline, 60 minutes and 120 minutes after study drug administration and Days 2, 7, 14 and 28 after study drug administration.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ketamine</title>
          <description>Single dose of ketamine (0.5 mg/kg)&#xD;
Ketamine: Single dose of ketamine (0.5 mg/kg)</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Single dose of placebo&#xD;
Placebo: Single dose of placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <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="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Rapid Heart Rate</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Chest Pain</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="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Impaired Concentration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lightheaded</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Feeling high</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="2"/>
              </event>
              <event>
                <sub_title>Feeling of floating</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="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Tingling sensation on skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Impaired judgement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Shortness of breath</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated due to slow accrual rate. Data analysis limited to 5 participants.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Robert Bright, MD</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>480-301-4853</phone>
      <email>bright.robert@mayo.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/NCT01680172
org study id: 12-001156
nct id: NCT01680172
lead sponsor: 
has dmc: No
Depression is common in patients with cancer. Current medications for depression, while
      effective, take several weeks to take effect. Ketamine has emerged as a drug with promise for
      cancer patients. In two reported cases, a single dose of ketamine induced rapid and
      moderately sustained symptom reduction in depression and anxiety with no adverse side
      effects. Benefit was seen in as little as 1 hour and sustained up to 30 days. This study is a
      randomized, double-blind, placebo-controlled investigation testing whether a single dose of
      ketamine improves depression and anxiety relative to placebo in patients with cancer.
Depression is common in patients with cancer. Current antidepressants, while effective, have
      an onset of action of at least several weeks. Ketamine has emerged as a drug with promise for
      cancer patients. It has been shown to potentiate opiate analgesic effects. Single dose
      parenteral and enteral administration studies in medically healthy treatment-resistant
      depressed patients have shown rapid relief of symptoms. A recent two patient case series
      reported a rapid and moderately sustained symptom reduction in depression and anxiety in
      palliative care patients following a single dose of oral ketamine 0.5 mg/kg, with no adverse
      effects. Benefit was seen as little as 1 hour after the administration and sustained up to 30
      days. These case reports generate hypotheses of efficacy for ketamine in the treatment of
      depression and anxiety in patients with cancer. This study is a randomized, double-blind,
      placebo-controlled investigation of these hypotheses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)
time frame: Baseline, 120 minutes
description: Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.
measure: Hospital Anxiety Depression Scale- Depression Score (HADS-D)
time frame: Baseline, 120 minutes
description: Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.
arm group label: Ketamine
arm group type: Experimental
description: Single dose of ketamine (0.5 mg/kg)
arm group label: Placebo
arm group type: Placebo Comparator
description: Single dose of placebo
intervention type: Drug
intervention name: Ketamine
description: Single dose (0.5 mg/kg) of liquid ketamine 10mg/mL solution taken by mouth
arm group label: Ketamine
other name: Ketalar
intervention type: Drug
intervention name: Placebo
description: Single dose of liquid placebo solution taken by mouth
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert P. Bright, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Robert P. Bright
investigator title: Principal Investigator
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
mesh term: Ketamine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated due to slow accrual rate. Data analysis limited to 5 participants.
point of contact: 