The Kite Trial: Examining the Effectiveness of Ketamine for Adults with Bipolar Depression

Parallel-group, randomised, double-blind Phase III RCT comparing twice-weekly subcutaneous ketamine (starting 0.6 mg/kg, titratable up to predefined level 4) versus low-dose subcutaneous midazolam (active placebo) over a 3-week treatment phase (maximum 6 treatments).

Primary outcome is binary remission of depression at Day 19 post-treatment commencement assessed by MADRS; tolerability and safety measured via KSET, BPRS and CADSS-6; an optional 3-week open-label extension allows additional twice-weekly ketamine for participants who continue.