Depression and Quality of LifeESKPSYNCT07146503
Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression
An observational study of Depression and Quality of Life and Treatment Resistant Depression (TRD), run by Riccardo Guglielmo at 5 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Depression and Quality of Life, Treatment Resistant Depression (TRD), Anhedonia
- What is being tested?
- Esketamine (Intranasal Spray)
- How many people
- 100 participants
- Where
- 5 sitesItaly
- Study dates
- 1 Nov 2022to Aug 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients
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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Università di Chieti
Chieti, 66100
Giovanni Martinotti, Ph.D, +3908713551, giovanni.martinotti@unich.it
- Recruiting
Ospedale Policlinico San Martino
Genova, Ge, 16132
Riccardo Guglielmo, riccardo.guglielmo@unige.it
- Recruiting
Csm Dds 8
Genova, Ge, 16158
Daniela Malagamba, MD, +390108499160, daniela.malagamba@asl3.liguria.it
- Recruiting
ASST Fatebenefratelli Sacco
Milan, 20157
Miriam Olivola, Investigator, +390239042904, miriamolivola@icloud.com
- Recruiting
ASST Pavia
Pavia, 27100
Miriam Olivola, Investigator, +390239042904, miriamolivola@icloud.com
About this study
Official title: ESKPSY: Esketamine in Real-World Settings: Clinical Outcomes, Predictors of Response, Life Functioning and Biological Pathways
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.
- Conditions
- Depression and Quality of Life, Treatment Resistant Depression (TRD), Anhedonia, Apathy, Anxiety, Cognition
- Being tested
- Esketamine (Intranasal Spray)
- Medical subject headings
- Depression, Depressive Disorder, Treatment-Resistant, Anhedonia, Lethargy, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: from enrollment to one year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Nov 2022
- Primary completionJul 2026 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression and Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riccardo Guglielmo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Riccardo Guglielmo, Universita degli Studi di Genova
- Investigators
- Elisa Briasco, MD, Principal investigator, UnigeElisa Cavanna, MD, Principal investigator, UnigeRiccardo Guglielmo, MD, Study chair, UnigeGianluca Serafini, MD, Study director, Unige
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146503
- Sponsor's protocol ID
- D33C22001340002
- Acronym
- ESKPSY
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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