Action of Ketamine in Treatment-Resistant Depression
Randomized, double-blind crossover Phase II–III study (n≈46) comparing IV ketamine (0.5 mg/kg, 40 min) to active control midazolam (30 µg/kg, 40 min) in treatment-resistant major depressive disorder, with escalation to repeated infusion schedules to assess durability.
Details
Randomized double-blind crossover evaluation of a single IV infusion of ketamine (0.5 mg/kg over 40 minutes) versus active control midazolam (30 µg/kg over 40 minutes) in patients with treatment-resistant major depressive disorder; responders may receive repeated infusions to assess durability.
Phase II tests repeated ketamine (3×/week for 2 weeks; 6 infusions) in non-responders to determine whether repeated dosing produces greater and more sustained improvement; Phase III provides weekly ketamine for 4 weeks to responders to evaluate maintenance of effect. Biological assays (BDNF genotype, inflammatory markers, cortisol, melatonin) and clinical scales (MADRS, CGI, QIDS-SR) are collected.