Randomised multicentric parallel-arm Phase II study (n=60) testing single 0.5 mg/kg IV ketamine infusion versus saline placebo for treatment-resistant depression in Mexican clinical sites.
Multicentre, randomised, triple-blind, parallel-group trial assessing efficacy of a single 0.5 mg/kg IV ketamine infusion compared with saline placebo in adults with treatment-resistant major depressive disorder.
Primary purpose is treatment; dosing is a single 40-minute IV infusion with standard safety monitoring at three national health provider clinics in Mexico.
Single 0.5 mg/kg IV ketamine infusion (active treatment)
IV infusion over 40 minutes
Saline 0.9% IV infusion (placebo comparator)
Saline 0.9% IV infusion over 40 minutes