Ketamine in treatment resistant major depression (TRD)
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).
Details
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.