Esketamine nasal spray for people with treatment-resistant depression in routine care
ESKPSY: Esketamine in Real-World Settings: Clinical Outcomes, Predictors of Response, Life Functioning and Biological Pathways
This study will try esketamine nasal spray in adults with treatment-resistant depression to see how well it works and how safe it is in everyday clinical settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Universita degli Studi di Genova Academic / other |
| Locations | 5 sites (Genova, Ge and 4 other locations) |
| Trial ID | NCT07146503 on ClinicalTrials.gov |
What this trial studies
This observational, real-world study follows adults (18–74) with a DSM-5 major depressive episode who have failed at least two prior antidepressant treatments and are receiving esketamine plus an SSRI or SNRI. Clinical outcomes and safety are recorded during routine care while researchers also collect biological and neurobehavioral data to explore predictors of response, including genetics, neuroimaging, and psychophysical measures. The study examines effects on daily functioning, including social and occupational domains, to capture real-life benefits and harms. Data are collected at participating hospitals in Genova and Chieti, Italy, without experimental randomization or placebo control.
Who should consider this trial
Good fit: Adults ages 18 to 74 with a current major depressive episode who have not responded to at least two prior antidepressant treatments and are being treated with an SSRI or SNRI may be eligible.
Not a fit: People younger than 18 or older than 74, those who have not failed two antidepressant regimens, or those with medical reasons preventing esketamine use are unlikely to benefit from joining this study.
Why it matters
Potential benefit: If successful, the study could help clinicians identify which patients are most likely to benefit from esketamine and tailor treatment to improve daily functioning.
How similar studies have performed: Randomized clinical trials have shown that esketamine can produce rapid antidepressant effects in treatment-resistant depression, but real-world outcome data and biomarker-driven predictor studies remain more limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Genova, Ge and 4 other locations
- Ospedale Policlinico San Martino — Genova, Ge, Italy (Recruiting)
- Csm Dds 8 — Genova, Ge, Italy (Recruiting)
- Università di Chieti — Chieti, Italy (Recruiting)
- ASST Fatebenefratelli Sacco — Milan, Italy (Recruiting)
- ASST Pavia — Pavia, Italy (Recruiting)
Study contacts
- Principal investigator: Elisa Briasco, MD — Unige
- Study coordinator: Riccardo Guglielmo, MD
- Email: riccardo.guglielmo@unige.it
- Phone: +390105552202
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.