Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
KetaPal is a placebo-controlled randomized trial designed to demonstrate the antidepressant action of ketamine in palliative care situations. Half of participants will receive Ketamine and Milnacipran in combination, while the other half will receive a Placebo and Milnacipran in combination.
Details
Randomized, quadruple-blind, parallel-group Phase II/III trial (n=80) testing a single IV ketamine infusion (0.5 mg/kg over 40 minutes) plus milnacipran versus placebo infusion plus milnacipran in inpatients receiving palliative care with major depressive disorder (MADRS > 19).
Milnacipran is initiated at inclusion and continued for 16 days with doses adjusted by renal function (25–100 mg/day). The primary aim is to assess antidepressant efficacy and improve quality of life in progressive disease.