This randomised controlled trial (n=50) investigates the effects of low-dose intramuscular ketamine on depression ratings in individuals with major depressive disorder (MDD) and cancer in palliative care.
Open-label Stage 1 (single 1 mg/kg IM) and Stage 2 (repeated ~weekly 1 mg/kg IM for responders) followed by Stage 3 randomisation to single-dose 0.1, 0.5 or 1.0 mg/kg IM under double-blind conditions; primary outcome is change in MADRS over time.
Assessments include MADRS at baseline and 24 hours post-injection, proportion responding (>50% reduction) and remitting (MADRS <7), with additional measures including HADS and demoralisation scales.
Stage 1 single-dose IM ketamine (open-label); Stage 2 weekly repeat IM ketamine (open-label) for responders.
Stage 1: single 1 mg/kg IM
Stage 2: repeated ~weekly 1 mg/kg IM; continue while beneficial
Stage 3 randomized single-dose double-blind arm (dose-comparison).
Stage 3 randomized single-dose double-blind arm (dose-comparison).
Stage 3 randomized single-dose double-blind arm (dose-comparison).