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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07146503
Acronym
ESKPSY
Enrollment
100
Registered
2025-08-28
Start date
2022-11-01
Completion date
2030-08-01
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression and Quality of Life, Treatment Resistant Depression (TRD), Anhedonia, Apathy, Anxiety, Cognition, Temperament, Psychiatric Comorbidities

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.

Interventions

DRUGEsketamine (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

Sponsors

Riccardo Guglielmo
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Predictive Factors of Treatment Response: Biological, Clinical, and Social DimensionsTime Frame: from enrollment to one year of treatmentMADRS, HAM-D, HAM-A, TCI-R, BPRS, AES, SHAPS, EQ-5D-5L, BDI-II, WPAI-D, SDS, TEMPS

Secondary

MeasureTime frame
Panel of genetic polymorphisms (SNPs) predictive of clinical response to esketamine in patients with treatment-resistant depression.from enrollment to one year of treatment

Countries

Italy

Contacts

CONTACTRiccardo Guglielmo, MD
riccardo.guglielmo@unige.it+390105552202
CONTACTElisa Cavanna, MD
elisa.cavanna01@gmail.com+390105552202
PRINCIPAL_INVESTIGATORElisa Briasco, MD

Unige

PRINCIPAL_INVESTIGATORElisa Cavanna, MD

Unige

STUDY_CHAIRRiccardo Guglielmo, MD

Unige

STUDY_DIRECTORGianluca Serafini, MD

Unige

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026