This double-blind, placebo-controlled therapeutic exploratory trial (n=80) investigates the effectiveness of a single intravenous application of ketamine at subanaesthetic doses in patients with treatment-resistant major depression (TRD).
Randomised, double-blind, placebo-controlled Phase II study assessing single i.v. subanaesthetic ketamine infusion for treatment-resistant major depression (n=80). Primary outcome is improvement on HAMD at 24 hours post-infusion.
Secondary objectives include testing pretreatment pgACC regional homogeneity (ReHo), functional connectivity and glutamine concentrations by MR as predictors of treatment response; MR spectroscopy measures at baseline, 60 minutes and 24 hours are included.
The trial was conducted as a single-site study in Germany with protocol MD-KPSY-01/10 and funded in part by the DFG; healthy control data were collected for biomarker comparisons.
Single intravenous subanaesthetic ketamine infusion (therapeutic arm).
Single i.v. infusion at subanaesthetic dose (exact dose per protocol).
Matched intravenous placebo comparator.
Solution for injection/infusion matched to ketamine.