RecruitingNCT07146503

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

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


Sponsor

Riccardo Guglielmo

Enrollment

100 participants

Start Date

Nov 1, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 74 Years

Interventions

DRUGEsketamine (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(4)

Ospedale Policlinico San Martino

Genova, Ge, Italy

Csm Dds 8

Genova, Ge, Italy

Università di Chieti

Chieti, Italy

ASST Fatebenefratelli Sacco

Milan, Italy

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NCT07146503


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