Randomized, double-blind, active-placebo crossover imaging trial (n=56) comparing IV ketamine 0.5 mg/kg vs active placebo midazolam 0.045 mg/kg (three infusions per treatment period) in adults 18–55 with treatment-resistant depression.
The study examines effects of ketamine on brain functional connectivity and the relationship between network changes and clinical response in treatment-resistant depression using MRI, EEG, cognitive testing and blood biomarkers.
A double-blind, randomized crossover design delivers three IV infusions per treatment period (ketamine 0.5 mg/kg or midazolam 0.045 mg/kg) with imaging and clinical assessments, aiming to obtain evaluable data from up to 50 subjects (actual enrolled 56).
Three IV infusions of ketamine (0.5 mg/kg) followed by three IV infusions of midazolam (0.045 mg/kg) in crossover order.
0.5 mg/kg per infusion
Active placebo midazolam 0.045 mg/kg per infusion
Three IV infusions of midazolam (0.045 mg/kg) followed by three IV infusions of ketamine (0.5 mg/kg) in crossover order.
Active placebo midazolam 0.045 mg/kg per infusion
0.5 mg/kg per infusion