Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Phase I randomized, double-blind crossover study (n=150) of IV ketamine (0.5 mg/kg; crossover with saline placebo) in patients with MDD and healthy volunteers; includes a metabolites substudy (single 0.5 mg/kg IV infusion) and a Phase III randomised repeated-dose comparison (0.5 vs 0.1 mg/kg twice weekly).
Details
This multi-phase NIH study evaluates the neuropharmacodynamics and biomarkers of acute and repeated IV ketamine in patients with major depressive disorder and healthy volunteers using fMRI, MEG, EEG, TMS-EP and sleep EEG.
Phase II is a double-blind crossover with four weekly infusions (two ketamine 0.5 mg/kg and two saline placebo) paired with neuroimaging; Phase III randomises relapsing MDD patients to repeated ketamine (0.5 mg/kg or 0.1 mg/kg) twice weekly for 4 weeks.
Primary outcomes include pharmacodynamic fMRI and MEG responses; secondary outcomes include MADRS change at 24 hours, biomarker and metabolite analyses (including CSF in the metabolites substudy), and safety/tolerability.