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Age: 18Years - 74Years
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ID07146503

Study of Esketamine Nasal Spray for Adults Aged 18 to 74 with Treatment-Resistant Depression Evaluating Treatment Outcomes, Predictors, and Life Impact in Real-World Settings

Led by Riccardo Guglielmo · Updated on 2026-03-31

100

Participants Needed

5

Research Sites

213 weeks

Total Duration

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

Research Team

R

Riccardo Guglielmo, MD

E

Elisa Cavanna, MD

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