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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESKPSY: Esketamine in Real-World Settings: Clinical Outcomes, Predictors of Response, Life Functioning and Biological Pathways
- ClinicalTrials.gov ID
- NCT07146503
- Acronym / sponsor ID
- ESKPSY / D33C22001340002
- Conditions
- Depression and Quality of Life, Treatment Resistant Depression (TRD), Anhedonia, Apathy, Anxiety, Cognition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Riccardo GuglielmoUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esketamine (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 | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Results publication: PubMed 40751860Guglielmo 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.
Related trials for Depression and Quality of Life
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elisa Briasco, MD principal investigator
Unige
Elisa Cavanna, MD principal investigator
Unige
Riccardo Guglielmo, MD study chair
Unige
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Quality of Life and Treatment Resistant Depression (TRD), run by Riccardo Guglielmo at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Guglielmo, MD (+390105552202, riccardo.guglielmo@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Factors of Treatment Response: Biological, Clinical, and Social Dimensions (time frame: Time Frame: from enrollment to one year of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07146503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.