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

RECRUITINGSponsored by Riccardo Guglielmo
Actively Recruiting
SponsorRiccardo Guglielmo
Started2022-11-01
Est. completion2026-07
Eligibility
Age18 Years – 74 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07146503

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

Age: 18 Years – 74 YearsHealthy volunteers accepted
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.

Conditions9

AnhedoniaAnxietyApathyCognitionDepressionDepression and Quality of LifePsychiatric ComorbiditiesTemperamentTreatment Resistant Depression (TRD)

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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