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

NCT07146503 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-03-31

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Riccardo Guglielmo

    lead OTHER

Principal Investigators

  • Elisa Briasco, MD · Unige

  • Elisa Cavanna, MD · Unige

  • Riccardo Guglielmo, MD · Unige

  • Gianluca Serafini, MD · Unige

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2026-07-31
Completion
2030-08-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146503 on ClinicalTrials.gov