Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-17 @ 1:27 AM
Study NCT ID:
NCT03016104
Status:
WITHDRAWN
Last Update Posted:
2022-05-11
First Post:
2016-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The problems of MST device', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2016-12-21', 'studyFirstSubmitQcDate': '2017-01-08', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in The Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': 'At baseline, 4-week follow-up, and 8-week follow-up'}], 'secondaryOutcomes': [{'measure': 'changes in MATRICS Consensus Cognitive Battery (MCCB)', 'timeFrame': 'At baseline and 4-week follow-up'}, {'measure': 'changes in Clinical Global Impressions (CGI)', 'timeFrame': 'At baseline and 4-week follow-up'}, {'measure': 'changes in motor threshold (MT)', 'timeFrame': 'At baseline and the day after the first treatment', 'description': 'using single-pulse Transcranial Magnetic Stimulation (sTMS)'}, {'measure': 'changes in brain gamma-aminobutyric acid （GABA）levels', 'timeFrame': 'At baseline, the day after the first treatment, and at 4-week follow-up', 'description': 'measured by Magnetic Resonance Spectroscopy (MRS)'}, {'measure': 'changes in resting state network', 'timeFrame': 'At baseline, the day after the first treatment, and at 4-week follow-up', 'description': 'measured by Magnetic Resonance Imaging (MRI)'}, {'measure': 'changes in auditory evoked potential (AEP)', 'timeFrame': 'At baseline and the day after the first treatment', 'description': 'measured by electroencephalogram (EEG)'}, {'measure': 'changes in Novel P300', 'timeFrame': 'At baseline and the day after the first treatment', 'description': 'measured by electroencephalogram (EEG)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['magnetic seizure therapy', 'electroconvulsive therapy', 'bipolar mania', 'cognition', 'controlled trial'], 'conditions': ['Bipolar Disorder, Manic']}, 'descriptionModule': {'briefSummary': 'This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and its safety for bipolar mania. Half of the participants will receive MST, while the other half will receive electroconvulsive therapy (ECT).', 'detailedDescription': "Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive therapy (ECT).\n\nWidespread stimulation of cortical and subcortical regions is inevitable for ECT since the substantial impedance of the scalp and skull shuts most of the electrical stimulus away from the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area of the brain because they can pass the scalp and skull without resistance. In Addition, electric current will penetrate into deeper structures, while magnetic stimulus are only capable to reach a depth of a few centimeters. As a consequence, MST are able to generate focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the capability to produce comparable therapeutic benefits with the absence of apparent cognitive side effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. DSM-5 diagnosis of bipolar I disorder and currently in a manic episode;\n2. convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;\n3. the positive and negative syndrome scale (PANSS) score ≥ 60;\n4. informed consent in written form.\n\nExclusion Criteria:\n\n1. diagnosis of other mental disorders;\n2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency;\n3. present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants;\n4. failure to respond to an adequate trial of ECT lifetime;\n5. are pregnant or intend to get pregnant during the study;\n6. other conditions that investigators consider to be inappropriate to participate in this trial.'}, 'identificationModule': {'nctId': 'NCT03016104', 'briefTitle': 'Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania', 'orgStudyIdInfo': {'id': 'SHDC12014111b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'magnetic seizure therapy', 'description': '10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks.', 'interventionNames': ['Device: Magpro X100 + Option', 'Other: treatment as usual (TAU)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'electroconvulsive therapy', 'description': '10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks.', 'interventionNames': ['Device: ThymatronSystem Ⅳ Electroconvulsive System', 'Other: treatment as usual (TAU)']}], 'interventions': [{'name': 'Magpro X100 + Option', 'type': 'DEVICE', 'otherNames': ['magnetic seizure therapy'], 'description': 'In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.', 'armGroupLabels': ['magnetic seizure therapy']}, {'name': 'ThymatronSystem Ⅳ Electroconvulsive System', 'type': 'DEVICE', 'otherNames': ['electroconvulsive therapy'], 'description': 'In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of modified ECT in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks', 'armGroupLabels': ['electroconvulsive therapy']}, {'name': 'treatment as usual (TAU)', 'type': 'OTHER', 'description': 'Participants will engage in their inpatient treatment program as-usual.', 'armGroupLabels': ['electroconvulsive therapy', 'magnetic seizure therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Chunbo Li, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Mental Health Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}