Esketamine nasal spray for people with treatment-resistant depression in routine care
Official title: ESKPSY: Esketamine in Real-World Settings: Clinical Outcomes, Predictors of Response, Life Functioning and Biological Pathways
Run by Universita degli Studi di Genova · NCT07146503 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 74 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Universita degli Studi di Genova Academic / other |
| Locations | 5 sites (Genova, Ge and 4 other locations) |
| Status | Recruiting |
| Started | November 1, 2022 |
| Main results expected | July 2026 |
| Study ends | August 2030 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT07146503 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.