Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-02-22 @ 8:29 AM
Study NCT ID:
NCT04216095
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2019-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness Clinical Trial of MST Compared to ECT in Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'MST (Magstim Theta device, Magstim Company Limited, Whitfield, Wales, UK) versus ECT (Thymatron IV device, Somatics LLC, USA) assigned per the clinical decision making of the ECT psychiatrist as deemed best for the patient.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2015-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-01', 'studyFirstSubmitDate': '2019-12-23', 'studyFirstSubmitQcDate': '2019-12-31', 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to reorientation (TRO)', 'timeFrame': 'approximately 2.5 weeks', 'description': 'Cognition primarily assessed by Time to Reorientation (TRO)'}, {'measure': 'Depression Scale', 'timeFrame': 'approximately 2.5 weeks', 'description': 'Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)'}], 'secondaryOutcomes': [{'measure': 'Wechsler Memory Scale - Revised:', 'timeFrame': 'approximately 2.5 weeks', 'description': 'Neuropsychological assessment'}, {'measure': 'Wisconsin Card Sorting Test', 'timeFrame': 'approximately 2.5 weeks', 'description': 'Neuropsychological assessment'}, {'measure': 'Brain Single Photon Emission Computed Tomography (SPECT)', 'timeFrame': 'approximately 2.5 weeks', 'description': 'Brain SPECT done for patients pre-post MST course to explore biological changes associated with MST and predictors of treatment response.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MST', 'ECT', 'MDD', 'Depression', 'Major Depressive Disorder', 'Magnetic seizure therapy', 'Electroconvulsive Therapy', 'Treatment Resistant Depression (TRD)'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'This study was a prospective, open-label comparative effectiveness clinical trial, comparing magnetic seizure therapy (MST) to ECT in patients with Major Depressive Disorder (MDD).', 'detailedDescription': 'Magnetic seizure therapy (MST) has previously demonstrated fewer cognitive side effects than ECT in randomized trials of efficacy. However, there are currently no real-world effectiveness trials guided by the clinical decision making of the ECT psychiatrist as deemed best for the patient. The aims of this study are to: (1) Evaluate the comparative effectiveness of MST versus ECT in patients with MDD, and (2) Compare the cognitive adverse effects of MST and ECT, (3) Explore changes in SPECT that is associated with MST treatment and treatment response.\n\nPatients will be clinically assigned to either ECT (n=30) or HD-MST (n=30) twice a week. Efficacy will be primarily assessed by the Hamilton Depression Rating Scale-21 (HAMD-21); primary cognitive side effects were assessed by Time to Reorientation (TRO) and secondarily cognitive battery. Brain SPECT will be done for patients before and after MST.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to consent\n2. Clinically indicated for seizure therapy\n3. Patients with MDD who had either never received antidepressant treatment or had discontinued antidepressants by their own choice for at least six weeks prior to enrollment (as commonly done in routine clinical care in this jurisdiction due to more negative views of psychotropics)\n4. 18-65 years of age.\n\nExclusion Criteria:\n\n1. Dementia,\n2. Delirium\n3. History of significant head trauma\n4. Neurological disorders (e.g., epilepsy, stroke, multiple sclerosis)\n5. Substance dependence\n6. Active comorbidity with another psychiatric disorder\n7. Patients who had previously received ECT or TMS\n8. Current unstable or serious medical illness (e.g., myocardial infarction)\n9. Pregnancy\n10. Presence of implanted electronic devices (e.g., cardiac pacemaker, cochlear implants)\n11. Inability to participate in testing'}, 'identificationModule': {'nctId': 'NCT04216095', 'briefTitle': 'Comparative Effectiveness Clinical Trial of MST Compared to ECT in Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Effectiveness Clinical Trial of Magnetic Seizure Therapy (MST) Compared to Electroconvulsive Therapy (MST) in Major Depressive Disorder', 'orgStudyIdInfo': {'id': '025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Electroconvulsive Therapy (ECT)', 'description': 'Right unilateral (RUL, N=15), or Bitemporal (BT, N=15) ECT', 'interventionNames': ['Device: Electroconvulsive Therapy (n=30)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Magnetic Seizure Therapy (MST)', 'description': 'High-dose magnetic seizure therapy (HD-MST)', 'interventionNames': ['Device: Magnetic Seizure Therapy (n=30)']}], 'interventions': [{'name': 'Electroconvulsive Therapy (n=30)', 'type': 'DEVICE', 'description': 'Right unilateral (RUL) ECT (n=15) or bitemporal (BT) ECT (n=15) using a Thymatron IV device (Somatics LLC, USA) twice weekly.', 'armGroupLabels': ['Electroconvulsive Therapy (ECT)']}, {'name': 'Magnetic Seizure Therapy (n=30)', 'type': 'DEVICE', 'description': 'High-dose magnetic seizure therapy (HD-MST) over the vertex using Magstim Theta device (Magstim Company Limited, Whitfield, Wales, UK) at 100% maximal output of the device (constant), with pulse frequency 100Hz and train duration 10 seconds twice weekly.', 'armGroupLabels': ['Magnetic Seizure Therapy (MST)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fatma El-Deeb, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University, Faculty of Medicine'}, {'name': 'El-Sayed Gad, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University, Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nagy A. Youssef (Consultant on the MST technique)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'El-Sayed Gad', 'investigatorAffiliation': 'Tanta University'}}}}