Subcutaneous ketamine infusion in palliative care patients with advanced life limiting illnesses for major depressive disorder: A phase II pilot feasibility study
This open-label, non-randomised feasibility study (n=32) investigates low-dose individually-tailored subcutaneous ketamine infusions (0.1–0.4 mg/kg over 2 hours) given weekly by response for depression in palliative care patients with advanced life-limiting illnesses.
Details
Open-label, single-group Phase II feasibility study delivering individually tailored subcutaneous ketamine infusions (0.1–0.4 mg/kg over 2 hours) weekly, up to four doses, with 4 weeks of follow-up to assess feasibility, tolerability and preliminary antidepressant effect in palliative care patients with major depressive disorder.
Outcomes include feasibility metrics (accrual, retention, protocol adherence), depression scales (MADRS), and monitoring of serious side effects per CTCAE v4.0; protocol compliance and source data may be monitored by the Trial Management Committee or delegates.