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.
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.
IV ketamine 0.5 mg/kg weekly for 4 weeks.
IV infusion once weekly for 4 weeks
IV placebo infusions matching ketamine schedule.
Placebo infusion weekly for 4 weeks