Metabolic profiling of esketamine for major depressive disorder
Metabolic Profiling of Esketamine Treatment in Major Depressive Disorder
This project will test how esketamine changes metabolic markers in adults with treatment‑resistant major depressive disorder compared with healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Zagreb Academic / other |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT07002684 on ClinicalTrials.gov |
What this trial studies
The observational study will enroll about 50 adults with treatment‑resistant major depressive disorder and 50 healthy control participants. Participants receiving esketamine will provide blood samples for untargeted metabolomic profiling before and after treatment, and researchers will compare biochemical pathway changes between patients and controls. Metabolic changes will be correlated with shifts in specific depressive symptom domains and overall symptom severity to link biology with clinical response. The aim is discovery of biochemical signatures related to diagnosis and the mechanism of action of esketamine rather than testing a new clinical regimen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–70 with treatment‑resistant major depressive disorder (failure of at least two adequate antidepressant trials) and healthy adults aged 18–70 without psychiatric medication for the control group.
Not a fit: Patients with psychotic symptoms, active alcohol or drug addiction, uncontrolled serious medical or neurological illnesses, recent use of certain supplements or opioid analgesics, or daily benzodiazepine use are unlikely to be eligible and may not benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could identify biological markers that help predict or explain who benefits from esketamine and support more personalized treatment for resistant depression.
How similar studies have performed: Esketamine's antidepressant effects are supported by prior clinical work, and metabolomics has been used in small studies but remains an exploratory approach to linking biochemical changes to response.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * for healthy control participants: 18-70 years, both sexes, without psychiatric drugs * for patients: from 18- 70 years, both sexes, failed treatment attempts with at least two antidepressants of the appropriate dose and duration. Exclusion Criteria: * for patients: treatment with tryptophan, St. John's wort, and/or opioid analgesics in the last month, daily intake of benzodiazepines; * for all participants: presence of psychotic symptoms, alcohol and/or drug addiction, disorder seizures, eating disorder, dementia and other neurodegenerative diseases, epilepsy, intellectual disabilities, severe somatic diseases (including insufficiently controlled arterial hypertension, diabetes and thyroid diseases), active psychotherapeutic treatment (except supportive psychotherapy, which is an integral part of every psychiatric treatment and will be the same in all groups of respondents). Participants will be excluded if they follow a weight loss diet or take weight loss medication, are pregnant or breastfeeding.
Where this trial is running
Zagreb
- Tea Fabijanić — Zagreb, Croatia (Recruiting)
Study contacts
- Principal investigator: Tea Fabijanić, MD — University of Zagreb
- Study coordinator: Tea Fabijanić, MD
- Email: tea.fabijan@gmail.com
- Phone: +385915698801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.