This observational trial (n=100) will study the metabolic effects of esketamine (administered nasally) in patients with treatment-resistant major depressive disorder (TRD), using a non-targeted metabolomic approach to identify changes in biochemical pathways.
Conducted by the University of Zagreb and led by Dr Tea Fabijanić, the study aims to better understand how esketamine works in the brain by analysing blood samples for metabolic changes associated with symptom improvement.
The trial will include 50 adults aged 18–70 with treatment-resistant MDD—defined as failure to respond to at least two antidepressants—and 50 healthy control participants. By comparing these two groups, researchers hope to uncover metabolic markers related to both the disease and the effects of esketamine treatment. Exclusion criteria include recent use of substances like tryptophan or benzodiazepines, serious medical or neurological conditions, and pregnancy or breastfeeding. The study began in April 2023 and is expected to be completed by the end of 2025.
Trial Details
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