RecruitingNCT07146503

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

Sponsor

Riccardo Guglielmo

Enrollment

100 participants

Start Date

Nov 1, 2022

Study Type

OBSERVATIONAL

Conditions

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

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

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how esketamine nasal spray (Spravato) works in the real world for people with treatment-resistant depression — meaning depression that hasn't improved with multiple antidepressant medications. **You may be eligible if...** - You are between 18 and 74 years old - You have been diagnosed with a major depressive episode - At least 2 previous antidepressant medications have not worked for you - You are currently being treated with an SSRI or SNRI antidepressant and your doctor thinks esketamine nasal spray is appropriate for you **You may NOT be eligible if...** - You do not meet the above criteria for treatment-resistant depression - Your doctor determines the treatment is not appropriate for your situation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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