Randomised, quadruple-blind, crossover study (n=20) comparing a single intranasal ketamine dose (up to 50 mg) versus intranasal saline in treatment-resistant depression.
Randomised, quadruple-blind crossover in 20 participants with treatment-resistant major depressive disorder comparing a single intranasal ketamine dose (up to 50 mg) with intranasal saline.
Primary purpose to evaluate safety and efficacy; eligibility required IDS-C30 thresholds and prior inadequate response to at least one antidepressant. Safety assessed via labs, ECG, and adverse events.
Active intranasal ketamine arm; single-dose crossover.
Intranasal administration up to 50 mg.
Intranasal saline placebo comparator; single-dose crossover.
Intranasal saline.