Double-Blind, Placebo-Controlled Trial of Ketamine Therapy in Treatment-Resistant Depression (TRD)

Multicentre, randomized, quadruple-blind, parallel-group study evaluating the acute efficacy (Day 3) of four fixed IV ketamine doses versus midazolam active placebo added to ongoing antidepressant therapy in TRD.

Primary objective: test whether ketamine doses 0.1, 0.2, 0.5, and 1.0 mg/kg are superior to midazolam 0.045 mg/kg for reduction in depressive symptoms at 72 hours; safety and tolerability monitored through vitals, labs and adverse events.