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Clinical and neurobiological predictors of response to ketamine: towards personalized treatment of depression

CompletedRegisteredEudraCT

Open-label Phase III single-arm study (n=40) evaluating neurobiological and clinical predictors of antidepressant response to a single ketamine infusion in patients with moderate–severe depression without psychotic symptoms.

Details

Open-label, single-site study in the Czech Republic assessing whether baseline measures of anhedonia, neurophysiology (EEG/eLORETA) and inflammatory and kynurenine-pathway biomarkers predict antidepressant response to intravenous ketamine in patients with moderate to severe depression.

Primary outcome compares baseline anhedonia between responders and non-responders and correlates change in anhedonia with reduction in depressive symptoms (MADRS) at days 1, 4, 6 and follow-up at day 20; secondary measures include plasma kynurenine metabolites, D-serine, proinflammatory cytokines and electrophysiological correlates during and after infusion.

Topics:Major Depressive Disorder (MDD)

Registry

Registry link2018-001539-39