Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
  • Placebo (OTHER)
    Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study

Condition or Disease

  • Major Depressive Disorder
  • Advanced Cancer

Phase

  • Phase 1
  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 19 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Sep 19, 2019 ACTUAL
    Primary Completion: Jun 01, 2023 ACTUAL
    Completion Date: Jul 30, 2023 ACTUAL
    Study First Posted: Jul 15, 2020 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 26, 2023

    Sponsors / Collaborators

    Lead Sponsor: Instituto Nacional de Cancerologia de Mexico
    Responsible Party: N/A

    Location

    Mexico City, Mexico

    Participant Groups

    • Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.

    • Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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.

    More Details

    NCT Number: NCT04471818
    Acronym: KODIAC
    Other IDs: (019/024/CPI) /CEI/1332/18)
    Study URL: https://clinicaltrials.gov/study/NCT04471818
    Last updated: Sep 29, 2023