Actively Recruiting

Age: 18Years - 74Years
All Genders
NCT07146503

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

Led by Riccardo Guglielmo · Updated on 2026-03-31

100

Participants Needed

5

Research Sites

404 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 74 years
  • Diagnosis of a major depressive episode according to DSM-5
  • Failure to respond to at least two prior antidepressant treatments
  • Current treatment with an SSRI or SNRI suitable for esketamine nasal spray
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Ospedale Policlinico San Martino

Genova, Ge, Italy, 16132

Actively Recruiting

2

Csm Dds 8

Genova, Ge, Italy, 16158

Actively Recruiting

3

Università di Chieti

Chieti, Italy, 66100

Actively Recruiting

4

ASST Fatebenefratelli Sacco

Milan, Italy, 20157

Actively Recruiting

5

ASST Pavia

Pavia, Italy, 27100

Actively Recruiting

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Research Team

R

Riccardo Guglielmo, MD

CONTACT

E

Elisa Cavanna, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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