Randomized, placebo-controlled, double-blind crossover PET/MR study (n=65) comparing IV racemic ketamine and IV esketamine versus placebo in healthy adults to investigate pharmacodynamic differences using [18F]FDG PET/MR.
This is a randomized, double-blind, placebo-controlled crossover study using [18F]FDG PET/MR to compare pharmacodynamic effects of intravenous racemic ketamine and esketamine in healthy adult volunteers.
The protocol includes pilot studies: a pilot for pharmacokinetics/acute behavioural effects and a Pilot II of 15 healthy volunteers to optimise scanning procedures (two-scan crossover). The main study uses a three-scan schedule with placebo at first scan and active drug at subsequent scans in crossover assignment.
IV esketamine infusion during PET/MR; placebo (saline) infusion at first scan with crossover to active in subsequent scan.
IV infusion during PET/MR; single active session per subject in crossover.
Saline placebo infusion performed during first scan.
IV racemic ketamine infusion during PET/MR; placebo (saline) infusion at first scan with crossover to active in subsequent scan.
IV infusion of racemic ketamine during PET/MR; single active session per subject in crossover.
Saline placebo infusion performed during first scan.
Pilot crossover: esketamine versus placebo across two scans to optimise scanning procedures.
Pilot IV esketamine infusion during PET/MR.
Pilot saline placebo infusion.