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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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: from enrollment to one year of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Panel of genetic polymorphisms (SNPs) predictive of clinical response to esketamine in patients with treatment-resistant depression. | from enrollment to one year of treatment |
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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.
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Outpatients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Riccardo Guglielmo, MD | Contact | +390105552202 | riccardo.guglielmo@unige.it | |
| Elisa Cavanna, MD | Contact | +390105552202 | elisa.cavanna01@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Elisa Briasco, MD | Unige | Principal Investigator |
| Elisa Cavanna, MD | Unige | Principal Investigator |
| Riccardo Guglielmo, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Policlinico San Martino | Recruiting | Genova | Ge | 16132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40751860 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 20, 2025 | Aug 20, 2025 |
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| Unige |
| Study Chair |
| Gianluca Serafini, MD | Unige | Study Director |
| Csm Dds 8 | Recruiting | Genova | Ge | 16158 | Italy |
|
| Università di Chieti | Recruiting | Chieti | 66100 | Italy |
|
| ASST Fatebenefratelli Sacco | Recruiting | Milan | 20157 | Italy |
|
| ASST Pavia | Recruiting | Pavia | 27100 | Italy |
|
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| D061218 | Depressive Disorder, Treatment-Resistant |
| D059445 | Anhedonia |
| D053609 | Lethargy |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
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