Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression
ESKPSY
ESKPSY: Esketamine in Real-World Settings: Clinical Outcomes, Predictors of Response, Life Functioning and Biological Pathways
1 other identifier
observational
100
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2022
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 20, 2025
CompletedFirst Posted
Study publicly available on registry
August 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
March 31, 2026
September 1, 2025
3.7 years
August 20, 2025
March 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Predictive Factors of Treatment Response: Biological, Clinical, and Social Dimensions
MADRS, HAM-D, HAM-A, TCI-R, BPRS, AES, SHAPS, EQ-5D-5L, BDI-II, WPAI-D, SDS, TEMPS
Time Frame: from enrollment to one year of treatment
Secondary Outcomes (1)
Panel of genetic polymorphisms (SNPs) predictive of clinical response to esketamine in patients with treatment-resistant depression.
from enrollment to one year of treatment
Interventions
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
Eligibility Criteria
Outpatients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Ospedale Policlinico San Martino
Genova, Ge, 16132, Italy
Csm Dds 8
Genova, Ge, 16158, Italy
Università di Chieti
Chieti, 66100, Italy
ASST Fatebenefratelli Sacco
Milan, 20157, Italy
ASST Pavia
Pavia, 27100, Italy
Related Publications (1)
Guglielmo R, Marino M, Briasco E, Cavanna E, Inuggi A, Schiavon F, Giacomini G, Malagamba D, Escelsior A, Martinotti G, Amore M, Serafini G. Predictors of Esketamine Response in Treatment-Resistant Depression: The Role of Temperament and Cumulative Treatment Resistance. CNS Drugs. 2025 Nov;39(11):1187-1191. doi: 10.1007/s40263-025-01210-7. Epub 2025 Aug 2. No abstract available.
PMID: 40751860RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elisa Briasco, MD
Unige
- PRINCIPAL INVESTIGATOR
Elisa Cavanna, MD
Unige
- STUDY CHAIR
Riccardo Guglielmo, MD
Unige
- STUDY DIRECTOR
Gianluca Serafini, MD
Unige
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 20, 2025
First Posted
August 28, 2025
Study Start
November 1, 2022
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
August 1, 2030
Last Updated
March 31, 2026
Record last verified: 2025-09