This interventional trial (n=24) investigates the effects of ketamine (26–52 mg/70 kg) on mood and eating-disorder cognitions in enduring anorexia nervosa (AN).
Randomised, double-blind, balanced crossover Phase II study (n=24) with three weekly single oral doses: ketamine 0.375 mg/kg, ketamine 0.75 mg/kg, and midazolam 0.01 mg/kg; responders (≥50% improvement on mood/anxiety ratings) may enter a 3-month open-label maintenance phase of oral ketamine 1–2× weekly.
Outcomes include mood and eating-disorder cognitions (MADRS and related instruments), 10-minute resting EEG pre/post treatment, and safety assessments performed predose, 2 hours and 24 hours after each dose.
Double-blind balanced crossover: ketamine 0.375 mg/kg, ketamine 0.75 mg/kg, midazolam 0.01 mg/kg; weekly for 3 weeks; responders may enter open-label maintenance.
Single oral dose in crossover phase.
Single oral dose in crossover phase.
Active comparator (midazolam) used as blinded control.
Maintenance phase: open-label oral ketamine 1–2× weekly for 3 months for responders; dose optimised from crossover phase.