Biomarkers of Fast Acting Therapies in Major Depression
Single-group, Phase I study (n=60) assessing IV ketamine infusions (0.5 mg/kg over 40 minutes, up to 4 sessions) in adults with major depression to identify neuroimaging and blood biomarkers of rapid response and relapse.
Details
This interventional study enrols 60 adults with major depressive disorder to receive serial subanesthetic IV ketamine infusions (0.5 mg/kg over 40 minutes, up to four doses given two to three times per week) while undergoing multimodal MRI and blood sampling to identify biomarkers of rapid antidepressant response and relapse.
Outcomes include HDRS clinical response, structural and functional MRI metrics, spectroscopy measures of glutamate and related metabolites, inflammatory cytokines, and transcriptome profiling; analyses will examine associations between biomarker changes and symptomatic improvement or relapse.