Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks

Randomised, triple-masked phase III study enrolling 25 adults with severe major depressive disorder to evaluate whether a single ketamine infusion (0.5 mg/kg) added to a 6-week venlafaxine regimen improves depressive symptoms versus venlafaxine with IV saline placebo.

Venlafaxine dosing: D0–D4 75 mg; D4–D14 150 mg/day; D14–D42 150 mg/day up to 375 mg/day if not responder. Primary outcomes assessed over six weeks; safety monitored throughout.