Metabolic Profiling of Esketamine Treatment in Depressive Disorder

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.

Status Recruiting
Results Published No
Start date 01 April 2023
End date 31 December 2025
Phase Not Applicable
Design Open
Type Observational
Generation First
Participants 100
Sex All
Age 18- 70
Therapy No

Trial Details

Major depressive disorder (MDD) is one of the most common psychiatric disorders, characterized by extremely high prevalence, relapse rate and therapeutic resistance. Treatment with ketamine and its enantiomer esketamine is the next step towards the successful treatment and understanding of depression that is resistant to treatment with standard antidepressants. The proposed study will include approximately 50 patients with MDD and 50 healthy control subjects of both sexes. Using untargeted metabolomic approach, we plan to detect changes in biochemical pathways related to the diagnosis of treatment-resistant MDD and changes related to the mechanism of action of esketamine. The proposed research will contribute to further understanding of the mechanism of action of esketamine in patients with MDD. Metabolic changes will be associated with improvements in specific domains of depressive symptoms and symptom severity in subjects with treatment-resistant major depressive disorder.

Trial Number NCT07002684

Data attribution

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