Randomized, double-blind, placebo-controlled, parallel Phase II study (n=68) comparing IV ketamine 0.5 mg/kg given 2 or 3 times weekly for 4 weeks in patients with treatment-resistant major depressive disorder to determine optimal dosing frequency.
Double-blind, randomized, parallel-group Phase II trial comparing intravenous ketamine 0.50 mg/kg administered two or three times per week versus matching placebo over a 4-week double-blind treatment phase (Day 1 to Day 29).
Each patient undergoes screening up to 4 weeks, a 4-week double-blind treatment period and a 3-week post-treatment follow-up; key outcomes include antidepressant response and safety/tolerability. Patients were inpatient or agreed to be admitted on dosing days.
IV ketamine 0.50 mg/kg, three times weekly for 4 weeks
IV placebo infusion, three times weekly for 4 weeks
IV ketamine 0.50 mg/kg, two times weekly for 4 weeks
IV placebo infusion, two times weekly for 4 weeks