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Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression

NCT07146503 · ESKPSY · Riccardo Guglielmo

Recruiting
Status
Accepting participants
Not applicable
Phase
100
Target enrolment
5
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Predictive Factors of Treatment Response: Biological, Clinical, and Social Dimensions

    Measured over Time Frame: from enrollment to one year of treatment

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 74 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

5 study sites

FacilityCityRegionCountry
Ospedale Policlinico San MartinoGenovaGeItaly
Csm Dds 8GenovaGeItaly
Università di ChietiChieti—Italy
ASST Fatebenefratelli SaccoMilan—Italy
ASST PaviaPavia—Italy

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07146503 on ClinicalTrials.gov →

Last updated in the registry 2026-03-31. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance