Actively Recruiting
Metabolic Profiling of Esketamine Treatment in Depressive Disorder
Led by University of Zagreb · Updated on 2025-06-03
100
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metabolic Profiling of Esketamine Treatment in Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy control participants aged 18 to 70 years, both sexes, not using psychiatric drugs
- Patients aged 18 to 70 years, both sexes, with treatment-resistant major depressive disorder
- Patients must have failed treatment with at least two antidepressants at appropriate doses and durations
You will not qualify if you...
- Patients treated with tryptophan, St. John's wort, or opioid analgesics in the last month
- Patients with daily benzodiazepine use
- Any participant with psychotic symptoms, alcohol or drug addiction, seizure disorders, eating disorders, dementia, neurodegenerative diseases, epilepsy, intellectual disabilities, or severe somatic diseases including uncontrolled hypertension, diabetes, and thyroid disorders
- Participants currently receiving active psychotherapeutic treatment other than supportive psychotherapy
- Participants following a weight loss diet or taking weight loss medication
- Pregnant or breastfeeding individuals
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tea Fabijanić
Zagreb, Croatia
Actively Recruiting
Research Team
T
Tea Fabijanić, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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