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Metabolic Profiling of Esketamine Treatment in Depressive Disorder

NCT07002684 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-06-03

No results posted yet for this study

Summary

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

Interventions

DRUG

Esketamine

nasal

Sponsors & Collaborators

  • University of Zagreb

    lead OTHER

Principal Investigators

  • Tea Fabijanić, MD · University of Zagreb School of Medicine

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Croatia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07002684 on ClinicalTrials.gov