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

NCT ID: NCT07146503

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2030-08-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riccardo Guglielmo

OTHER

Sponsor Role lead

Responsible Party

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Riccardo Guglielmo

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Elisa Briasco, MD

Role: PRINCIPAL_INVESTIGATOR

Unige

Elisa Cavanna, MD

Role: PRINCIPAL_INVESTIGATOR

Unige

Riccardo Guglielmo, MD

Role: STUDY_CHAIR

Unige

Gianluca Serafini, MD

Role: STUDY_DIRECTOR

Unige

Locations

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Ospedale Policlinico San Martino

Genova, Ge, Italy

Site Status RECRUITING

Csm Dds 8

Genova, Ge, Italy

Site Status RECRUITING

Università di Chieti

Chieti, , Italy

Site Status RECRUITING

ASST Fatebenefratelli Sacco

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Riccardo Guglielmo, MD

Role: CONTACT

[email protected]
+390105552202

Elisa Cavanna, MD

Role: CONTACT

[email protected]
+390105552202

Facility Contacts

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Riccardo Guglielmo

Role: primary

[email protected]

Daniela Malagamba, MD

Role: primary

[email protected]
+390108499160

Giovanni Martinotti, Ph.D

Role: primary

[email protected]
+3908713551

Miriam Olivola, Investigator

Role: primary

[email protected]
+390239042904

References

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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.

Reference Type RESULT
PMID: 40751860 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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D33C22001340002

Identifier Type: -

Identifier Source: org_study_id

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