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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-74
SponsorRiccardo Guglielmo

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Outpatients

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

MADRS, HAM-D, HAM-A, TCI-R, BPRS, AES, SHAPS, EQ-5D-5L, BDI-II, WPAI-D, SDS, TEMPS

Time frame
Time Frame: from enrollment to one year of treatment

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Riccardo Guglielmo

Lead sponsor

Universita degli Studi di Genova

Sponsor institution