Trials / Recruiting
RecruitingNCT07146503
Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression
ESKPSY: Esketamine in Real-World Settings: Clinical Outcomes, Predictors of Response, Life Functioning and Biological Pathways
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Riccardo Guglielmo · Academic / Other
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Depression and Quality of Life
- Treatment Resistant Depression (TRD)
- Anhedonia
- Apathy
- Anxiety
- Cognition
- Temperament
- Psychiatric Comorbidities
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esketamine (Intranasal Spray) | 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 |
Timeline
- Start date
- 2022-11-01
- Primary completion
- 2026-07-01
- Completion
- 2030-08-01
- First posted
- 2025-08-28
- Last updated
- 2026-03-31
Locations
5 sites across 1 country: Italy
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07146503. Inclusion in this directory is not an endorsement.