Randomized, triple-blind, parallel trial (n=36) evaluating two IV infusions of ketamine (0.5 mg/kg each) versus placebo in patients with treatment-resistant MDD and suicidality.
This parallel-group, randomized, triple-blind trial assessed the onset, magnitude and duration of antidepressant effect of two IV ketamine infusions (0.5 mg/kg each) compared with placebo in patients with treatment-resistant major depressive disorder with suicidal risk.
Primary outcomes include antidepressant response timing and change in suicidal ideation; safety monitoring included adverse events and vital signs. Actual enrollment recorded as 36 at Assiut University, Egypt.
Two IV infusions of ketamine (0.5 mg/kg) in parallel-group active arm.
IV infusion, 0.5 mg/kg per infusion
Placebo IV infusions in parallel-group comparator arm.
Placebo IV infusion