NCT07146503 Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression
| NCT ID | NCT07146503 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Riccardo Guglielmo |
| Condition | Depression and Quality of Life |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-11-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Elisa Briasco, MD
PRINCIPAL INVESTIGATOR
Unige
Frequently Asked Questions
Who can join the NCT07146503 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Depression and Quality of Life. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07146503 currently recruiting?
Yes, NCT07146503 is actively recruiting participants. Contact the research team at riccardo.guglielmo@unige.it for enrollment information.
Where is the NCT07146503 trial being conducted?
This trial is being conducted at Genova, Italy, Genova, Italy, Chieti, Italy, Milan, Italy and 1 additional location.
Who is sponsoring the NCT07146503 clinical trial?
NCT07146503 is sponsored by Riccardo Guglielmo. The principal investigator is Elisa Briasco, MD at Unige. The trial plans to enroll 100 participants.
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