Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression
Recruiting · NCT07146503 · Observational (researchers observe without assigning treatment) · Lead sponsor: Riccardo Guglielmo
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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.
Where it is running
10 locations listed.
- Università di Chieti - Chieti, Italy
- Università di Chieti - Chieti, Italy
- ASST Fatebenefratelli Sacco - Milan, Italy
- ASST Fatebenefratelli Sacco - Milan, Italy
- ASST Pavia - Pavia, Italy
- ASST Pavia - Pavia, Italy
- Ospedale Policlinico San Martino - Genova, Ge, Italy
- Csm Dds 8 - Genova, Ge, Italy
- Ospedale Policlinico San Martino - Genova, Ge, Italy
- Csm Dds 8 - Genova, Ge, Italy