Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboCompleted

Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

Randomised, double-blind, parallel-group Phase I/II study (n=19 actual) comparing IV ketamine 0.5 mg/kg weekly ×4 versus placebo in patients with major depressive disorder and advanced cancer receiving palliative care.

Target Enrollment
19 participants
Study Type
Phase I/II interventional
Design
Randomized, double Blind

Detailed Description

This randomised, double-blind, parallel-group Phase I/II trial tests intravenous ketamine 0.5 mg/kg given once weekly for four weeks versus placebo in patients with major depressive disorder in the context of advanced cancer and palliative care.

Primary aim is to assess antidepressant efficacy and tolerability as an adjuvant treatment; outcomes include depressive symptom change, safety, and palliative-relevant measures.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

IV ketamine 0.5 mg/kg weekly for 4 weeks.

Interventions

  • Ketamine0.5 mg/kg
    via IV• weekly• 4 doses total

    IV infusion once weekly for 4 weeks

Placebo

inactive

IV placebo infusions matching ketamine schedule.

Interventions

  • Placebo0.5 mg/kg
    via IV• weekly• 4 doses total

    Placebo infusion weekly for 4 weeks

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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

Study Details

Locations

Instituto Nacional de Cancerología (INCan) — Mexico City, Mexico

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