RecruitingN/Aketamine

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

Sponsored by Riccardo Guglielmo

NCT ID
NCT07146503
Target Enrollment
100 participants
Start Date
2022-11-01
Est. Completion
2030-08

About This Study

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.

Conditions Studied

Depression and Quality of LifeTreatment Resistant Depression (TRD)AnhedoniaApathyAnxietyCognitionTemperamentPsychiatric Comorbidities

Interventions

  • Esketamine (Intranasal Spray)

Eligibility

Age:18 Years - 74 Years
Healthy Volunteers:No
View full eligibility 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.

Study 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

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Riccardo Guglielmo, MD
CONTACT
+390105552202riccardo.guglielmo@unige.it
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source

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