Predictors of Esketamine Response in Treatment-Resistant Depression: The Role of Temperament and Cumulative Treatment Resistance.
Riccardo Guglielmo, Margherita Marino, Elisa Briasco...
https://pubmed.ncbi.nlm.nih.gov/40751860Actively Recruiting
Age: 18Years - 74Years
All Genders
ID07146503
Esketamine in Real-World Settings: Clinical Outcomes, Predictors of Response, Life Functioning and Biological Pathways
Led by Riccardo Guglielmo · Updated on 2026-03-31
100
Participants Needed
5
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of Esketamine Intranasal Spray in patients with Treatment-Resistant Depression (TRD) in real-world settings. This observational study aims to evaluate clinical outcomes such as how well esketamine works and its safety. It also looks at predictors of treatment response by examining biological pathways like genetics, brain imaging, and psychophysical factors, as well as how esketamine affects patients' social and work life to improve personalized care for those with difficult-to-treat depression. Participants receive Esketamine Intranasal Spray at doses ranging from 28 to 84 mg weekly. During the first month, the spray is given twice a week according to approved labeling. The study observes patients during their usual treatment without assigning specific interventions, focusing on real-life use of the medication and its effects over time. Participants will be monitored from enrollment through one year of treatment. Researchers will collect data on biological, clinical, and social factors that may predict how patients respond to esketamine. Genetic testing will be done to identify markers linked to clinical response. The study also examines overall life functioning, including social and occupational aspects, to better understand treatment impact and guide future care.
CONDITIONS
Brief Title
Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression
Who Can Participate
Age: 18Years - 74Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 74 years
- Diagnosis of a major depressive episode according to DSM-5
- Failure to respond to at least two prior antidepressant treatments
- Current treatment with an SSRI or SNRI considered appropriate for esketamine nasal spray
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 1 year
Participants receive esketamine nasal spray treatment with dosing frequency as per approved labeling, including twice-weekly administration during the first month and weekly thereafter.
Twice-weekly visits during the first month, then weekly visits thereafter
Long-term Monitoring
Duration - Up to 1 year
Participants are observed for clinical outcomes, predictors of response, life functioning, and biological pathways over the course of treatment.
Regular assessments during treatment visits
Trial Site Locations
Total: 5 locations
1
Ospedale Policlinico San Martino
Genova, Ge, Italy, 16132
Actively Recruiting
2
Csm Dds 8
Genova, Ge, Italy, 16158
Actively Recruiting
3
Università di Chieti
Chieti, Italy, 66100
Actively Recruiting
4
ASST Fatebenefratelli Sacco
Milan, Italy, 20157
Actively Recruiting
5
ASST Pavia
Pavia, Italy, 27100
Actively Recruiting
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Research Team
R
Riccardo Guglielmo, MD
E
Elisa Cavanna, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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