A Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Patients With Major Depressive Disorder
Interventional study in MDD (n≈12–13) assessing SEPs/MEPs as markers of cortical plasticity after a single IV ketamine infusion (0.5 mg/kg over 40 minutes); includes an initial open-label cohort and a randomized, double-blind, placebo-controlled cohort.
Details
This study tests whether somatosensory and motor evoked potentials measured by EEG and EMG detect cortical plasticity changes in responders versus non-responders to a single IV ketamine infusion (0.5 mg/kg over 40 minutes).
Design: two sequential cohorts — Cohort 1 open-label (12 patients) and Cohort 2 randomized, double-blind, placebo-controlled (multicentre, ~20 planned); each patient undergoes screening, treatment phase (up to 4 weeks), optional open-label treatment, and follow-up, with safety monitoring throughout.