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RECRUITING
NCT07146503

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

Sponsor: Riccardo Guglielmo

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2022-11-01

Completion Date

2030-08

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

Esketamine (Intranasal Spray)

Esketamine Intranasal Spray at a dosage ranging from 28 to 84 mg weekly, with twice-weekly administration during the first month of treatment, according to the approved labeling

Locations (5)

Ospedale Policlinico San Martino

Genova, Ge, Italy

Csm Dds 8

Genova, Ge, Italy

Università di Chieti

Chieti, Italy

ASST Fatebenefratelli Sacco

Milan, Italy

ASST Pavia

Pavia, Italy