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RecruitingNCT07146503ESKPSYUpdated Mar 31, 2026

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

An observational study in Depression and Quality of Life, Treatment Resistant Depression (TRD) and Anhedonia, sponsored by Riccardo Guglielmo. Recruiting at 5 sites in Italy. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Riccardo Guglielmo · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Nov 2022; still recruiting 4 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 74 Years
Sex
All
01

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.

02

Conditions studied

  • Depression and Quality of Life
  • Treatment Resistant Depression (TRD)
  • Anhedonia
  • Apathy
  • Anxiety
  • Cognition
  • Temperament
  • Psychiatric Comorbidities
03

In context

Depression

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

This study's planned enrollment of 100 is below the median of 175 across 1,257 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

This is the only study on the registry with Riccardo Guglielmo as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Outpatients

Eligibility criteria

Inclusion criteria were: (a) age 18-74, (b) 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

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

06

What researchers measure

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

07

Study locations

5 of 5 sites recruiting
08

References and documents

Publications

  • Guglielmo R, Marino M, Briasco E, Cavanna E, Inuggi A, Schiavon F, Giacomini G, Malagamba D, Escelsior A, Martinotti G, Amore M, Serafini G. Predictors of Esketamine Response in Treatment-Resistant Depression: The Role of Temperament and Cumulative Treatment Resistance. CNS Drugs. 2025 Nov;39(11):1187-1191. doi: 10.1007/s40263-025-01210-7. Epub 2025 Aug 2. No abstract available. PubMed 40751860 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2022 (actual). Primary completion is estimated for Jul 2026, 44 months after the start.

Of 460 non-industry observational studies under Depression, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 63. This study's planned 44 months is above that.

Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 13 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2025
First posted
Aug 28, 2025
StartActual
Nov 1, 2022
Primary completionEst.
Jul 2026
CompletionEst.
Aug 2030
Last update
Mar 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07146503
Lead sponsor
Riccardo Guglielmo
Responsible party
Riccardo Guglielmo (Principal Investigator, Universita degli Studi di Genova) — Sponsor-investigator
First posted
Aug 28, 2025
Start date
Nov 1, 2022
Primary completion
Jul 2026 (estimated)
Completion
Aug 2030 (estimated)
Last update
Mar 31, 2026

Study contacts

Riccardo Guglielmo, MD
Contact
riccardo.guglielmo@unige.it
+390105552202
Elisa Cavanna, MD
Contact
elisa.cavanna01@gmail.com
+390105552202
Elisa Briasco, MD
principal investigator · Unige
Elisa Cavanna, MD
principal investigator · Unige
Riccardo Guglielmo, MD
study chair · Unige
Gianluca Serafini, MD
study director · Unige

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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