Randomised Phase III trial (n=25) comparing a single IV ketamine infusion (0.5 mg/kg) plus a 6-week venlafaxine regimen versus venlafaxine alone in severe major depressive disorder (MADRS ≥20).
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.
Single IV ketamine 0.5 mg/kg on day 0 plus venlafaxine oral regimen for 6 weeks.
IV infusion on day 0 (0.5 mg/kg).
Venlafaxine schedule: D0–D4 75 mg; D4–D14 150 mg/day; D14–D42 150→375 mg/day if non-responder.
Venlafaxine oral regimen with saline IV placebo on day 0.
Saline placebo infusion on day 0.
Venlafaxine schedule: D0–D4 75 mg; D4–D14 150 mg/day; D14–D42 150→375 mg/day if non-responder.