Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression

Recruiting

• Conditions: Depression and Quality of Life; Treatment Resistant Depression (TRD); Anhedonia; Apathy; Anxiety; Cognition; Temperament; Psychiatric Comorbidities

• Registration Number: NCT07146503
• Lead Sponsor: Riccardo Guglielmo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-08-20
• Study First Posted: 2025-08-28
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-18
• Last Update Posted: 2025-09-24
• Primary Completion: 2026-07
• Study Completion: 2030-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive Factors of Treatment Response: Biological, Clinical, and Social Dimensions	Time Frame: from enrollment to one year of treatment	MADRS, HAM-D, HAM-A, TCI-R, BPRS, AES, SHAPS, EQ-5D-5L, BDI-II, WPAI-D, SDS, TEMPS

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Ospedale Policlinico San Martino; 🇮🇹 Genova, Ge, Italy

Csm Dds 8; 🇮🇹 Genova, Ge, Italy

Università di Chieti; 🇮🇹 Chieti, Italy

ASST Fatebenefratelli Sacco; 🇮🇹 Milan, Italy