Metabolic Profiling of Esketamine Treatment in Depressive Disorder

NCT07002684 | Recruiting

• 1 other identifier: 241-25-11-01-1/2-24-2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• changed metabolomics

  Using a non-targeted metabolomic approach, investigate changes in biochemical pathways related to the mechanism of action of the drug esketamine in patients with treatment-resistant major depressive disorder.

  8 weeks

Study Arms (2)

patients receiving esketamine

patients receiving esketamine

Drug: Esketamine

healthy controls

no intervention

Interventions

Esketamine DRUG

nasal

patients receiving esketamine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical Hospital Centre patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

Tea Fabijanić

Zagreb, Croatia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

human blood

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Tea Fabijanić, MD

  University of Zagreb School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tea Fabijanić, MD

CONTACT

+385915698801; tea.fabijan@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 3, 2025
• Study Start: April 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)