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.
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.
Three intranasal ketamine doses given on Days 1, 4 and 7 (dose escalation).
Intranasal: Day 1 50 mg; Day 4 50–100 mg; Day 7 50–150 mg.