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

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.

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Key information

Conditions

Depression and Quality of Life Anhedonia Anxiety Anxiety Disorders Apathy Behavior Behavioral Symptoms Cognition Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Lethargy Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychiatric Comorbidities Signs and Symptoms Temperament Treatment Resistant Depression (TRD)

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Csm Dds 8, Genova, Ge, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esketamine (Intranasal Spray)

Drug

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

Primary outcomes

Predictive Factors of Treatment Response: Biological, Clinical, and Social Dimensions

Time frame: 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 outcomes

Panel of genetic polymorphisms (SNPs) predictive of clinical response to esketamine in patients with treatment-resistant depression.

Time frame: from enrollment to one year of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Cavanna, MD

CONTACT

[email protected]

+390105552202

Riccardo Guglielmo, MD

CONTACT

[email protected]

+390105552202

Sponsors and collaborators

Lead sponsor

Riccardo Guglielmo

Other

Registry information

Official study title

ESKPSY: Esketamine in Real-World Settings: Clinical Outcomes, Predictors of Response, Life Functioning and Biological Pathways

Acronym: ESKPSY

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2030
First posted: Aug 28, 2025
Registry last updated: Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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