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ClinicalTrials.gov ID

NCT07146503

Lead Sponsor

Riccardo GuglielmoOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

Mar 31, 2026Actual

Start Date

Nov 1, 2022Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Aug 2030Estimated

Official Title

ESKPSY: Esketamine in Real-World Settings: Clinical Outcomes, Predictors of Response, Life Functioning and Biological Pathways

Brief Summary

This observational study investigates the use of Esketamine Intranasal Spray in patients with Treatment-Resistant Depression in Real-World Settings. The study aims to evaluate the clinical outcomes, including efficacy and safety, of esketamine treatment. It also explores predictors of treatment response, focusing on biological pathways such as genetics, neuroimaging, and psychophysical measures. Additionally, the study examines how esketamine impacts patients' life functioning, including social and occupational aspects. The goal is to better understand who benefits most from esketamine and how it affects daily life, to improve personalized care for patients with difficult-to-treat depression.

• Depression and Quality of Life
• Treatment Resistant Depression (TRD)
• Anhedonia
• Apathy
• Anxiety
• Cognition
• Temperament
• Psychiatric Comorbidities

• Esketamine (Intranasal Spray)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria were: (a) age 18-74, (b) DSM-5 diagnosis of a major depressive episode (MDE), (c) failure to respond to at least 2 prior antidepressant treatments (ADTs), and (d) current treatment with an SSRI or SNRI for which esketamine nasal spray was deemed appropriate.

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

Riccardo GuglielmoOTHER

miriamolivola@icloud.com+390239042904