Esketamine multi-omic biomarker evaluation in major depressive disorder (EMBER-MDD): concept, objectives and methodologies of a non-clinical investigator-initiated study.
European archives of psychiatry and clinical neuroscience June 30, 2026 C Hohoff, T Lange, L Steinbach et al.
Treatment resistance in major depressive disorder affects a substantial minority of patients and is hard to recognize early, delaying intensified care. The EMBER-MDD study is a non-interventional, in-vitro investigation that will analyze biospecimens from approximately 420 adults with major depressive disorder—about 210 who received esketamine nasal spray and 210 who received treatment as usual. Using genomics, epigenomics, transcriptomics, and proteomics/metabolomics, the study aims to discover individual-omic and integrated multi-omic biomarkers and signatures associated with treatment resistance risk and molecular correlates of clinical response. All outputs are research-only and will not support individual clinical decision-making. The study will deliver robust biosignatures and mechanistic hypotheses to guide future validation and inform stratified intervention strategies in subsequent trials.