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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (5)

Other trials for the same condition