Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-01-01 @ 8:12 PM
Study NCT ID:
NCT05388461
Status:
RECRUITING
Last Update Posted:
2023-09-26
First Post:
2022-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2022-05-13', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Montgomery and Åsberg Depression Rating Scale (MADRS) score from pretreatment at posttreatment; MADRS range 0 - 60, with higher scores indicating more severe depression)', 'timeFrame': 'up to 8 weeks', 'description': 'depressive symptoms'}, {'measure': 'Change of Mini Mental State Examination (MMSE-NR) score from pretreatment at posttreatment; MMS-E range 0-30 with lower scores indicating more severe cognitive impairment', 'timeFrame': 'up to 8 weeks', 'description': 'overall cognitive function'}, {'measure': 'Change of Beck depression inventory (BDI) score from pretreatment at posttreatment; BDI range 0-63, with higher scores indicating more severe depression', 'timeFrame': 'up to 8 weeks', 'description': 'depressive symptoms, patient rated'}, {'measure': 'Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at posttreatment with higher scores indicating more severe impairment', 'timeFrame': 'up to 8 weeks', 'description': 'overall subjective cognitive function, patient rated'}], 'secondaryOutcomes': [{'measure': 'Change of Patient rated improvement (PGI) score from pretreatment at posttreatment', 'timeFrame': 'up to 8 weeks', 'description': 'Likert scale'}, {'measure': 'Change of Clinical Global Impression (CGI) score from pretreatment at posttreatment', 'timeFrame': 'up to 8 weeks', 'description': 'Likert scale'}, {'measure': 'Change of Subjective cognitive function score from pretreatment at posttreatment', 'timeFrame': 'up to 8 weeks', 'description': 'Likert scale'}, {'measure': 'Change of Montgomery and Åsberg Depression Rating Scale (MADRS) score from pretreatment at follow up, MADRS range 0 - 60, with higher scores indicating more severe depression)', 'timeFrame': '6 months', 'description': 'depressive symptoms'}, {'measure': 'Change of Mini Mental State Examination (MMSE-NR) score from pretreatment at follow up, MMS-E range 0-30 with lower scores indicating more severe cognitive impairment', 'timeFrame': '6 months', 'description': 'overall cognitive function'}, {'measure': 'Change of Beck depression inventory (BDI) score from pretreatment at follow up, BDI range 0-63, with higher scores indicating more severe depression', 'timeFrame': '6 months', 'description': 'depressive symptoms, patient rated'}, {'measure': 'Change of Everyday Memory Questionnaire (EMQ) score from pretreatment at follow up', 'timeFrame': '6 months', 'description': 'overall subjective cognitive function, patient rated'}, {'measure': 'Change of Patient rated improvement (PGI) score from pretreatment at follow up', 'timeFrame': '6 months', 'description': 'Likert scale'}, {'measure': 'Change of Clinical Global Impression scale (CGI) from pretreatment at follow up', 'timeFrame': '6 months', 'description': 'Likert scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The overall aim of the current project is to assess the acute and long term outcome of ECT (both patient and clinician rated) in a non-selected patient cohort from ordinary clinical activity, and to seek out factors predicting response and remission, side effects and relapse.', 'detailedDescription': 'Patients reffered to electroconvulsive ECT are (after written consent) enroled in a research registry. Based on (clinician and patient rated) measures of depressive symptoms and overall cognitive function, the short and long-term (6 months) efficacy of ECT will be described, and factors predicting response and relapse identified.\n\nThe duration of possible cognitive impairment and factors predicting cognitive outcome will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'population based cohort from ordinary clinical activity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with ECT for major depression (F31.3-5, F32, F33) at Haukeland University Hospital or Stavanger University Hospital after 2013,\n* written consent to enrolment into the Regional Register for neurostimulation.\n\nExclusion Criteria:\n\n* ECT performed on other indications than major depression.\n* No consent to the register.'}, 'identificationModule': {'nctId': 'NCT05388461', 'briefTitle': 'Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy for Severe or Treatment Resistant Depression - Predictors of Response, Side Effects, and Relapse', 'orgStudyIdInfo': {'id': '2018/2541'}}, 'armsInterventionsModule': {'interventions': [{'name': 'electroconvulsive therapy', 'type': 'OTHER', 'description': 'electroconvulsive therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Ute Kessler, PhD', 'role': 'CONTACT', 'email': 'ute.kessler@helse-bergen.no'}, {'name': 'Ute Kessler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Stavanger', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Pernille Hegre Sørensen', 'role': 'CONTACT', 'email': 'pernille.hegre.sorensen@sus.no'}], 'facility': 'Stavanger University Hospital', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}], 'centralContacts': [{'name': 'Ute Kessler, PhD', 'role': 'CONTACT', 'email': 'ute.kessler@helse-bergen.no'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'after approval from data protection manager IPD will be shared on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}