Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-28 @ 12:41 AM
Study NCT ID:
NCT05530668
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2022-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective MAOI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events for each patient', 'timeFrame': 'Files analysed retrospectively from January 01, 2018 to March 31, 2022 will be examined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression Disorder', 'Anxiety Disorder', 'intranasal esketamine', 'monoamine oxidase inhibitors (MAOIs)', 'MAOIs', 'antidepressants', 'ketamine'], 'conditions': ['Depression Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '40456292', 'type': 'DERIVED', 'citation': 'Dormegny-Jeanjean LC, Lenoir S, Humbert I, Mainberger OAE, Lozere C, Meyer C, Geny B, Michel B, Foucher JR, de Crespin de Billy C. Cardiovascular Effects of Non-Selective Monoamine Oxidase Inhibitors and Intranasal Esketamine Combination in Depression - A Quasi-Experimental Design with Bayesian Analyses. Pharmacopsychiatry. 2025 Nov;58(6):273-283. doi: 10.1055/a-2590-3469. Epub 2025 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'There are already recently published data on the tolerability and efficacy of the combination of ketamine and/or esketamine with MAOIs. However, these reports are few and far between, and to our knowledge, there are no data involving intranasal esketamine.\n\nGiven the numerous interactions between MAOIs and other antidepressants, and the impossibility of combination, this pharmacological class is neglected. This is despite the fact that MAOIs are the only truly tri-aminergic drugs, that they have unparalleled efficacy in certain forms of resistant apathetic depression, and that new, more dietary permissive forms have appeared on the market. The arrival of antidepressants that can be combined with MAOIs, such as ketamine and esketamine, changes the situation and could offer a new treatment opportunity to many patients in a therapeutic impasse. For these opportunities to become a reality, sharing the clinical experience gained by specialized centers is essential.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Major subject.having been treated with intranasal esketamine between 01/01/2018 and 01/03/2022.', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Major subject.\n* Having been treated with intranasal esketamine between 01/01/2018 and 01/03/2022.\n* Not objecting to the reuse of their data for scientific research purposes.\n\nExclusion Criteria:\n\n\\- Subject who has expressed opposition to the reuse of their data for scientific research purposes.'}, 'identificationModule': {'nctId': 'NCT05530668', 'acronym': 'ESKETAM', 'briefTitle': 'Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective MAOI', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective Monoamine Oxidase Inhibitors (MAOIs)', 'orgStudyIdInfo': {'id': '8588'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de physiologie - Explorations fonctionnelles - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}