Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT02886858
Status:
TERMINATED
Last Update Posted:
2019-04-22
First Post:
2016-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
tDCS in the Prevention of Relapse After Electroconvulsive Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'investigator and sponsor decided by mutual agreement to stop study prematurely', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-19', 'studyFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2016-08-31', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse rate 6 months after remission, defined as the reappearance of a depressive syndrome, measured by a scoring MADRS >15.', 'timeFrame': '6 months', 'description': 'MADRS will be assessed in each follow-up visit (weekly the first month, fortnightly the second and third month, monthly the following 3 months).'}], 'secondaryOutcomes': [{'measure': 'Montreal Cognitive Assesment (MoCA)', 'timeFrame': 'basal and at 6 months'}, {'measure': 'Scores on Clinical Global Impression (CGI)', 'timeFrame': 'after remission basal and at 6 months'}, {'measure': 'Time to relapse', 'timeFrame': 'during 6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Moods disorders', 'electroconvulsive therapy'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive side effects limit its long-term use. There is no consensus about optimal continuation pharmacological treatments after a ECT course.\n\nAdjunction of tDCS to pharmacological continuation treatment after ECT may decrease relapse rates.', 'detailedDescription': 'In a prospective, randomized, double blind, controlled, long-term study, investigators assign 40 depressed patients, in remission after ECT course associated to venlafaxine, with lithium adjunction after ECT course, either to tDCS or sham tDCS. Depressive symptoms and cognition were assessed after acute ECT after six months of continuation therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 ans\n* Remission (MADRS \\<10) of a major depressive episode after acute treatment with ECT + venlafaxine\n* Lithium adjunction 48h after the last ECT session\n* No comorbid psychiatric disorder, excluding personality disorder or nicotine dependance.\n* Capacity to consent\n* Sufficient comprehension of the French language\n\nExclusion Criteria:\n\n* Contra-indications to tDCS\n* Neurologic conditions\n* Severe medical conditions.\n* Pregnancy/breast-feeding.\n* Current use of benzodiazepines or antipsychotics'}, 'identificationModule': {'nctId': 'NCT02886858', 'briefTitle': 'tDCS in the Prevention of Relapse After Electroconvulsive Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital le Vinatier'}, 'officialTitle': 'tDCS as Continuation Treatment to Sustain Remission After Electroconvulsive Therapy in Depression', 'orgStudyIdInfo': {'id': '2016-A00824-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS', 'description': 'The anode will be applied over the F3 area and the cathode over the F4 area. The current dose is 2mA. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.', 'interventionNames': ['Device: Device : Transcranial direct current stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'The anode will be applied over the F3 area and the cathode over the F4 area. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.', 'interventionNames': ['Device: Device : sham Transcranial direct current stimulation']}], 'interventions': [{'name': 'Device : Transcranial direct current stimulation', 'type': 'DEVICE', 'description': 'The anode will be applied over the F3 area and the cathode over the F4 area. The current dose is 2mA. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.', 'armGroupLabels': ['tDCS']}, {'name': 'Device : sham Transcranial direct current stimulation', 'type': 'DEVICE', 'description': 'The anode will be applied over the F3 area and the cathode over the F4 area. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.', 'armGroupLabels': ['Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69678', 'city': 'Bron', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Centre Hospitalier Le Vinatier', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'GALVAO FILIPE, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH LE VINATIER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital le Vinatier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}