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Ketamine or Placebo in Patients With Major Depression and Advanced Cancer (KODIAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04471818
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : March 16, 2022
Sponsor:
Information provided by (Responsible Party):
Oscar Raúl Rodríguez Mayoral, Instituto Nacional de Cancerologia de Mexico

Tracking Information
First Submitted Date  ICMJE June 16, 2020
First Posted Date  ICMJE July 15, 2020
Last Update Posted Date March 16, 2022
Actual Study Start Date  ICMJE November 19, 2019
Estimated Primary Completion Date June 19, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2022)
Brief Edinburg Depression Scale (BEDS) score [ Time Frame: 3 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
Brief Edinburg Depression Scale (BEDS) score [ Time Frame: 6 weeks ]
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine or Placebo in Patients With Major Depression and Advanced Cancer
Official Title  ICMJE Ketamine Versus Placebo as Adjuvant Treatment for Major Depressive Disorder and Wish to Hasten Death in Advanced Cancer Patients Undergoing Palliative Care
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Advanced Cancer
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
  • Other: Placebo
    Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
Study Arms  ICMJE
  • Experimental: Ketamine
    Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 19, 2022
Estimated Primary Completion Date June 19, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age: 18 to 65 years of age
  2. Sex: Male or female
  3. Major depressive disorder (MDD) diagnosis as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
  4. Palliative stage cancer diagnosis (advanced-disease stage)
  5. Who can read and write in spanish
  6. Eastern Cooperative Oncology Group (ECOG) 0-2
  7. Karnofsky ≥ 50
  8. Palliative prognostic index A
  9. Not currently undergoing systemic oncologic treatment
  10. Patients who agree to participate in the study by signing an informed consent.

Exclusion Criteria:

  1. Comorbidities including other psychiatric diseases (additional to MDD, generalized anxiety or panic disorder).
  2. Magnetic resonance or computerized tomography with major structural alterations.
  3. Pregnant or breastfeeding women.
  4. Patients with hypersensitivity to ketamine
  5. Cardiac insufficiency
  6. Patients with a history of psychosis
  7. Patients with first-degree relatives with a history of psychosis
  8. Patients with uncontrolled glaucoma
  9. Current neurological illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Oscar Rodríguez, MD 55 5628 0400 oscroma@gmail.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04471818
Other Study ID Numbers  ICMJE (019/024/CPI) /CEI/1332/18)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oscar Raúl Rodríguez Mayoral, Instituto Nacional de Cancerologia de Mexico
Study Sponsor  ICMJE Instituto Nacional de Cancerologia de Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Instituto Nacional de Cancerologia de Mexico
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP