Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-06-27 @ 11:37 PM
Study NCT ID:
NCT02012335
Status:
WITHDRAWN
Last Update Posted:
2015-03-19
First Post:
2013-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine Use in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004565', 'term': 'Electroconvulsive Therapy'}, {'id': 'D007649', 'term': 'Ketamine'}], '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'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Methodologicals and logistics issues.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-18', 'studyFirstSubmitDate': '2013-11-18', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Scale (HAM-D) 17 change', 'timeFrame': 'Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks'}], 'secondaryOutcomes': [{'measure': 'Mini Mental Status Exam change', 'timeFrame': 'Baseline and at the end of hospital stay, an expected average of 5 weeks'}, {'measure': 'Autobiographical Memory Test change', 'timeFrame': 'Baseline and at the end of hospital stay, an expected average of 5 weeks'}, {'measure': 'Rey Auditory Verbal Learning Test change', 'timeFrame': 'Baseline and at the end of hospital stay, an expected average of 5 weeks'}, {'measure': 'WAIS Digit Span change', 'timeFrame': 'Baseline and at the end of hospital stay, an expected average of 5 weeks'}, {'measure': 'FAS verbal fluency change', 'timeFrame': 'Baseline and at the end of hospital stay, an expected average of 5 weeks'}, {'measure': 'Stroop Test change', 'timeFrame': 'Baseline and at the end of hospital stay, an expected average of 5 weeks'}, {'measure': 'Trial Making Test change', 'timeFrame': 'Baseline and at the end of hospital stay, an expected average of 5 weeks'}, {'measure': 'WAIS Vocabulary', 'timeFrame': 'Baseline'}, {'measure': 'Montgomery and Asberg Depression Rating Scale change', 'timeFrame': 'Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks'}, {'measure': 'Brief Psychiatry Rating Scale change', 'timeFrame': 'Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks'}, {'measure': 'Clinical Global Impression-Severity change', 'timeFrame': 'Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether combination of ketamine plus electroconvulsive therapy improves depressive symptoms decreasing cognitive side effects.', 'detailedDescription': 'This study will compare the clinical response to brief pulse ECT with infusion of ketamine 0.5 mg/kg versus brief pulse electroconvulsive therapy with infusion of placebo (saline) in major depression. We also will compare levels of cognitive impairment among these groups, compare levels of quality of life among these groups, compare levels of BDNF among these groups. We also will study if levels of 25-hydroxyvitamin D are associated with cognitive impairment in subjects undergoing ECT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n\\- Patients with unipolar and bipolar depression from The Psychiatric Unit of Hospital de Clinicas de Porto Alegre (diagnosis will be established by the Structured Clinical Interview for DSM-IV Axis I)\n\nExclusion criteria:\n\n* Patients with dementia\n* History of addiction / abuse of psychoactive drugs\n* Other psychiatric diagnoses\n* Refusal to follow the study.'}, 'identificationModule': {'nctId': 'NCT02012335', 'briefTitle': 'Ketamine Use in Electroconvulsive Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Ketamine Use in Electroconvulsive Therapy: Clinical, Cognitives and Neurotrophic Outcomes', 'orgStudyIdInfo': {'id': '13-0196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'ECT + saline', 'description': 'Brief pulse ECT with saline as placebo in each session'}, {'type': 'EXPERIMENTAL', 'label': 'ECT + Ketamine', 'description': 'Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session', 'interventionNames': ['Drug: ECT + Ketamine']}], 'interventions': [{'name': 'ECT + Ketamine', 'type': 'DRUG', 'description': 'Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session', 'armGroupLabels': ['ECT + Ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-003', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}