Ignite Creation Date:
2025-12-24 @ 7:31 PM
Ignite Modification Date:
2025-12-25 @ 5:12 PM
Study NCT ID:
NCT07146503
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'id': 'D059445', 'term': 'Anhedonia'}, {'id': 'D053609', 'term': 'Lethargy'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629870', 'term': 'Esketamine'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-08-20', 'size': 160907, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-20T07:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive Factors of Treatment Response: Biological, Clinical, and Social Dimensions', 'timeFrame': 'Time Frame: from enrollment to one year of treatment', 'description': 'MADRS, HAM-D, HAM-A, TCI-R, BPRS, AES, SHAPS, EQ-5D-5L, BDI-II, WPAI-D, SDS, TEMPS'}], 'secondaryOutcomes': [{'measure': 'Panel of genetic polymorphisms (SNPs) predictive of clinical response to esketamine in patients with treatment-resistant depression.', 'timeFrame': 'from enrollment to one year of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression and Quality of Life', 'Treatment Resistant Depression (TRD)', 'Anhedonia', 'Apathy', 'Anxiety', 'Cognition', 'Temperament', 'Psychiatric Comorbidities']}, 'referencesModule': {'references': [{'pmid': '40751860', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients', 'healthyVolunteers': False, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT07146503', 'acronym': 'ESKPSY', 'briefTitle': 'Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression', 'organization': {'class': 'OTHER', 'fullName': 'Universita degli Studi di Genova'}, 'officialTitle': 'ESKPSY: Esketamine in Real-World Settings: Clinical Outcomes, Predictors of Response, Life Functioning and Biological Pathways', 'orgStudyIdInfo': {'id': 'D33C22001340002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Esketamine (Intranasal Spray)', 'type': 'DRUG', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genova', 'state': 'Ge', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Riccardo Guglielmo', 'role': 'CONTACT', 'email': 'riccardo.guglielmo@unige.it', 'phoneExt': '+390105552202'}], 'facility': 'Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '16158', 'city': 'Genova', 'state': 'Ge', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniela Malagamba, MD', 'role': 'CONTACT', 'email': 'daniela.malagamba@asl3.liguria.it', 'phone': '+390108499160'}], 'facility': 'Csm Dds 8', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '66100', 'city': 'Chieti', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Martinotti, Ph.D', 'role': 'CONTACT', 'email': 'giovanni.martinotti@unich.it', 'phone': '+3908713551'}], 'facility': 'Università di Chieti', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'zip': '20157', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Miriam Olivola, Investigator', 'role': 'CONTACT', 'email': 'miriamolivola@icloud.com', 'phone': '+390239042904'}], 'facility': 'ASST Fatebenefratelli Sacco', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Riccardo Guglielmo, MD', 'role': 'CONTACT', 'email': 'riccardo.guglielmo@unige.it', 'phone': '+390105552202'}, {'name': 'Elisa Cavanna, MD', 'role': 'CONTACT', 'email': 'elisa.cavanna01@gmail.com', 'phone': '+390105552202'}], 'overallOfficials': [{'name': 'Elisa Briasco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unige'}, {'name': 'Elisa Cavanna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unige'}, {'name': 'Riccardo Guglielmo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Unige'}, {'name': 'Gianluca Serafini, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Unige'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riccardo Guglielmo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Riccardo Guglielmo', 'investigatorAffiliation': 'Universita degli Studi di Genova'}}}}