<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/NCT04471818</url>
  </required_header>
  <id_info>
    <org_study_id>(019/024/CPI) /CEI/1332/18)</org_study_id>
    <nct_id>NCT04471818</nct_id>
  </id_info>
  <brief_title>Ketamine or Placebo in Patients With Major Depression and Advanced Cancer</brief_title>
  <acronym>KODIAC</acronym>
  <official_title>Ketamine Versus Placebo as Adjuvant Treatment for Major Depressive Disorder and Wish to Hasten Death in Advanced Cancer Patients Undergoing Palliative Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Cancerologia de Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Cancerologia de Mexico</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Major depression (MD) is a psychiatric disorder characterized by a persistent feeling of&#xD;
      sadness, anhedonia or a decreased perception of pleasurable experiences, as well as appetite&#xD;
      alterations and weight variations, sleep disorders, altered psychomotor skills, fatigue,&#xD;
      guilt, decreased self-worth, suicidal thoughts and difficulty concentrating in a task (1).&#xD;
&#xD;
      MD is a frequent complication in patients who are diagnosed with advanced cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 19, 2019</start_date>
  <completion_date type="Anticipated">July 19, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 19, 2023</primary_completion_date>
  <phase>Phase 1/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>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brief Edinburg Depression Scale (BEDS) score</measure>
    <time_frame>3 weeks</time_frame>
    <description>Scale to assess depression validated in cancer patients. For the BEDS scale, 6 items are included and scored, maximum score is 18 and minimum score is 0. Patients screened for depression are considered cases when scoring ≥7 in this scale.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Major Depressive Disorder</condition>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study</description>
    <arm_group_label>Ketamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: 18 to 65 years of age&#xD;
&#xD;
          2. Sex: Male or female&#xD;
&#xD;
          3. Major depressive disorder (MDD) diagnosis as per Diagnostic and Statistical Manual of&#xD;
             Mental Disorders (DSM-5).&#xD;
&#xD;
          4. Palliative stage cancer diagnosis (advanced-disease stage)&#xD;
&#xD;
          5. Who can read and write in spanish&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group (ECOG) 0-2&#xD;
&#xD;
          7. Karnofsky ≥ 50&#xD;
&#xD;
          8. Palliative prognostic index A&#xD;
&#xD;
          9. Not currently undergoing systemic oncologic treatment&#xD;
&#xD;
         10. Patients who agree to participate in the study by signing an informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Comorbidities including other psychiatric diseases (additional to MDD, generalized&#xD;
             anxiety or panic disorder).&#xD;
&#xD;
          2. Magnetic resonance or computerized tomography with major structural alterations.&#xD;
&#xD;
          3. Pregnant or breastfeeding women.&#xD;
&#xD;
          4. Patients with hypersensitivity to ketamine&#xD;
&#xD;
          5. Cardiac insufficiency&#xD;
&#xD;
          6. Patients with a history of psychosis&#xD;
&#xD;
          7. Patients with first-degree relatives with a history of psychosis&#xD;
&#xD;
          8. Patients with uncontrolled glaucoma&#xD;
&#xD;
          9. Current neurological illness&#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_contact>
    <last_name>Oscar Rodríguez, MD</last_name>
    <phone>55 5628 0400</phone>
    <email>oscroma@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Instituto Nacional de Cancerología (INCan)</name>
      <address>
        <city>Mexico City</city>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oscar Rodríguez Mayoral, MD</last_name>
      <phone>55 5628 0400</phone>
      <email>oscroma@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Cancerologia de Mexico</investigator_affiliation>
    <investigator_full_name>Oscar Raúl Rodríguez Mayoral</investigator_full_name>
    <investigator_title>Head psychiatrist at the Palliative Care Unit of the National Cancer Institute (INCan, Mexico)</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04471818
org study id: (019/024/CPI) /CEI/1332/18)
nct id: NCT04471818
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Major depression (MD) is a psychiatric disorder characterized by a persistent feeling of
      sadness, anhedonia or a decreased perception of pleasurable experiences, as well as appetite
      alterations and weight variations, sleep disorders, altered psychomotor skills, fatigue,
      guilt, decreased self-worth, suicidal thoughts and difficulty concentrating in a task (1).

      MD is a frequent complication in patients who are diagnosed with advanced cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Brief Edinburg Depression Scale (BEDS) score
time frame: 3 weeks
description: Scale to assess depression validated in cancer patients. For the BEDS scale, 6 items are included and scored, maximum score is 18 and minimum score is 0. Patients screened for depression are considered cases when scoring ≥7 in this scale.
arm group label: Ketamine
arm group type: Experimental
description: Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.
intervention type: Drug
intervention name: Ketamine
description: Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
arm group label: Ketamine
intervention type: Other
intervention name: Placebo
description: Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Oscar Rodríguez, MD
phone: 55 5628 0400
email: oscroma@gmail.com
facility: 
status: Recruiting
contact: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Cancerologia de Mexico
investigator full name: Oscar Raúl Rodríguez Mayoral
investigator title: Head psychiatrist at the Palliative Care Unit of the National Cancer Institute (INCan, Mexico)
mesh term: Neoplasms
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Ketamine