Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-26 @ 10:58 PM
Study NCT ID:
NCT04924257
Status:
WITHDRAWN
Last Update Posted:
2022-08-05
First Post:
2021-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECT vs. Esketamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004565', 'term': 'Electroconvulsive Therapy'}], 'ancestors': [{'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No eligible participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2021-06-07', 'studyFirstSubmitQcDate': '2021-06-07', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MADRS score', 'timeFrame': '4 weeks', 'description': 'Reduction of Montgomery-Asberg Depression Rating Scale (MADRS, 0-60 pts.); higher score indicates more depressive symptoms; response to treatment is defined as \\>50% reduction in score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Treatment Resistant Depression', 'Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': "Treatment-resistant depression (TRD) is a common cause of disability and one of the most common psychiatric disorders worldwide.\n\nElectroconvulsive therapy (ECT) is currently the most effective treatment for TRD. Recent developments showed esketamine to be a rapid-acting and effective antidepressant drug and it has been hailed as a breakthrough in treating TRD. Common treatment algorithms for TRD list ECT as a treatment option, but esketamine has not yet found its exact position in those algorithms.\n\nTo the investigators' knowledge, a longitudinal, randomized controlled trial comparing the efficacy of ECT and intranasal esketamine in TRD patients has not been conducted. Furthermore, the investigators intend to measure effects of ECT and intranasal esketamine on brain connectivity and structure, using functional magnetic resonance imaging (fMRI).\n\nIn this study, inpatients with TRD at the University Hospital for Psychiatry I, Medical University Innsbruck, will be randomized to ECT or intranasal esketamine. Short- and medium-term treatment effects on functional and structural connectivity in the brain will be determined using fMRI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. DSM-5 diagnosis of Major Depressive Disorder (MDD) without psychotic features (296.22, 296.23, 296.32, 296.33) made through the Structured Clinical Interview for the DSM-V (SCID-V).\n2. MADRS score ≥ 25\n3. Pharmacologically treatment-resistant depressive episode \\[Stage ≥ II, defined by Thase \\& Rush (1997): failure of at least 2 adequate trials of at least 2 distinctly different classes of antidepressants (≥ 4 weeks each)\\] (88).\n4. Age: 18 - 50 years\n5. Written informed consent\n\nExclusion Criteria:\n\n1. Participation in another interventional clinical trial\n2. Relative contraindications to ECT treatment in accordance with the consensus paper of the Austrian Society of Psychiatry and Psychotherapy:\n3. Patients who meet any exclusion criteria for nasal esketamine treatment as described in the clinical guidelines\n4. Contraindications to the conduction of MRI\n5. History of one or more of the following diagnoses (DSM-5):\n\n * MDD, single or recurrent episode with psychotic features (296.24; 296.34)\n * past or current substance dependence (except caffeine, nicotine) (303.x, 304.x, 305.x)\n * neurodevelopmental disorders (299.x, 307.x, 314.x, 315.x, 319.x)\n * schizophrenia spectrum and other psychotic disorders (293.x, 295.x, 297.x, 298.x)\n * neurocognitive disorders (290.x, 292.x, 294.x, 331.x).\n6. history of ECT (unsuccessful or successful)\n7. suicidal tendency requiring admission in a locked ward\n8. pregnancy or lactation period\n9. lack of anesthetic clearance for any other reason\n10. insufficient command of German language.'}, 'identificationModule': {'nctId': 'NCT04924257', 'acronym': 'ETES', 'briefTitle': 'ECT vs. Esketamine', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Electroconvulsive Therapy vs. Esketamine Nasal Spray in Treatment-resistant Depression: a Longitudinal, Randomized Efficacy Comparison Pilot Study', 'orgStudyIdInfo': {'id': '1417/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal Esketamine', 'interventionNames': ['Drug: Esketamine nasal spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ECT', 'interventionNames': ['Procedure: Electroconvulsive therapy']}], 'interventions': [{'name': 'Esketamine nasal spray', 'type': 'DRUG', 'description': 'Patients will receive two treatments per week for four weeks (maximum of eight treatment sessions) or until clinical remission (MADRS \\<10).', 'armGroupLabels': ['Intranasal Esketamine']}, {'name': 'Electroconvulsive therapy', 'type': 'PROCEDURE', 'otherNames': ['ECT'], 'description': 'Patients will receive three treatments per week for four weeks (maximum of 12 ECT treatments) or until clinical remission (MADRS \\<10).', 'armGroupLabels': ['ECT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}