Clinical TrialMajor Depressive Disorder (MDD)KetamineCompleted

Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care

Single-group Phase II study (n=22) of intranasal ketamine (three doses on Days 1, 4, 7; 50 mg → 50–100 mg → 50–150 mg) for treatment of moderate–severe major depressive disorder in cancer patients receiving palliative care.

Target Enrollment
22 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open single-group Phase II trial testing intranasal ketamine in patients receiving palliative cancer care who meet DSM-5 criteria for major depressive disorder and have a MADRS score ≥ 20.

Participants receive three intranasal ketamine dosing sessions on Days 1, 4 and 7 with dose escalation (Day 1 50 mg; Day 4 50–100 mg; Day 7 50–150 mg). Primary purpose is treatment effect on depressive symptom severity; safety and tolerability assessed during follow-up.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Three intranasal ketamine doses given on Days 1, 4 and 7 (dose escalation).

Interventions

  • Ketamine50 - 150 mg
    via Other• three sessions• 3 doses total

    Intranasal: Day 1 50 mg; Day 4 50–100 mg; Day 7 50–150 mg.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Provide written, voluntary informed consent prior to study enrollment. Participants must be capable of consenting to treatment as substitute decision makers will not be allowed to consent to the study on their behalf
  • Males and females ≥ 18 years of age
  • Patient is receiving palliative care at Princess Margaret Cancer Centre (PM) including all in-patient units and outpatients
  • Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder (MDD), with a current Major Depressive Episode (MDE)
  • Depression severity must be in the moderate to severe range, as determined by a Montgomery-Åsberg Depression Rating Scale (MADRS) score greater than or equal to 20
  • Participants must have a confirmed diagnosis of cancer and an estimated life expectancy of less than twelve months, as determined by the palliative care physician

Exclusion Criteria

  • Exclusion Criteria:
  • Presence of delirium or suspected delirium
  • Severe hypertension or severe cardiac decompensation
  • Previous stroke history
  • History of intolerability, hypersensitivity or allergy to ketamine
  • Patients with bipolar disorder, psychotic disorders, substance use disorders or active suicidality based on a Mini-International Neuropsychiatric Interview (MINI) conducted by a delegated physician will also be excluded
  • Current symptoms of psychosis or perceptual disturbances of any kind per investigator discretion
  • Pregnancy or breastfeeding women

Study Details

Locations

Princess Margaret Cancer Centre — Toronto, Ontario, Canada

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