Metabolic profiling of esketamine for major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.