The Resistant Depression Response to Esketamine Assessing Metabolomics (ReDREAM) Project-Untargeted Metabolomics to Identify Biomarkers of Treatment Response to Intranasal Esketamine in Individuals with Treatment-Resistant Depression: A Study Protocol.
Alpha psychiatry August 1, 2024 Francesco Bartoli, Daniele Cavaleri, Ilaria Riboldi et al. 4 citations
Treatment-resistant depression (TRD) affects about 20-30% of people with major depressive disorder. Esketamine nasal spray was approved for TRD in 2019, but its mechanisms of action remain unclear. This protocol describes the ReDREAM project, an observational, prospective study that will use metabolomics to identify metabolic biosignatures associated with response to esketamine. Sixty people with TRD from three Italian clinical sites will receive esketamine nasal spray twice weekly for four weeks (induction phase), then once weekly for four more weeks (maintenance phase). The study will test correlations between baseline metabolic profile and depressive symptom improvement at weeks 4 and 8, and explore metabolic differences between responders and non-responders. Hypothesized involvement includes energy metabolism, amino acid metabolism, urea cycle, and nitric oxide synthesis.