Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression (ESKPSY)

Riccardo Guglielmo

Status: Enrolling

Conditions: Apathy; Depression and Quality of Life; Temperament; Treatment Resistant Depression (TRD); Anhedonia; Cognition; Psychiatric Comorbidities; Anxiety

Treatments: Drug: Esketamine (Intranasal Spray)

Study type: Observational

Funder types: Other

Identifiers

NCT07146503

D33C22001340002

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design