Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2026-01-05 @ 11:34 PM
Study NCT ID:
NCT00870805
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2009-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-26', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in scores on Memory Tests', 'timeFrame': 'Before ECT, after 6 ECT treatments, after final ECT treatment, one month and six month follow-up'}], 'secondaryOutcomes': [{'measure': 'Change in scores on Depression Rating Scale', 'timeFrame': 'Before ECT, after each week of treatment, at the end of the ECT course'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '16866758', 'type': 'BACKGROUND', 'citation': 'Loo CK, Schweitzer I, Pratt C. Recent advances in optimizing electroconvulsive therapy. Aust N Z J Psychiatry. 2006 Aug;40(8):632-8. doi: 10.1080/j.1440-1614.2006.01862.x.'}, {'pmid': '17706790', 'type': 'BACKGROUND', 'citation': 'Loo C, Sheehan P, Pigot M, Lyndon W. A report on mood and cognitive outcomes with right unilateral ultrabrief pulsewidth (0.3 ms) ECT and retrospective comparison with standard pulsewidth right unilateral ECT. J Affect Disord. 2007 Nov;103(1-3):277-81. doi: 10.1016/j.jad.2007.06.012. Epub 2007 Aug 16.'}, {'pmid': '18752719', 'type': 'BACKGROUND', 'citation': 'Loo CK, Sainsbury K, Sheehan P, Lyndon B. A comparison of RUL ultrabrief pulse (0.3 ms) ECT and standard RUL ECT. Int J Neuropsychopharmacol. 2008 Nov;11(7):883-90. doi: 10.1017/S1461145708009292. Epub 2008 Aug 28.'}, {'pmid': '19756236', 'type': 'BACKGROUND', 'citation': 'Sackeim HA, Prudic J, Nobler MS, Fitzsimons L, Lisanby SH, Payne N, Berman RM, Brakemeier EL, Perera T, Devanand DP. Effects of pulse width and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy. Brain Stimul. 2008 Apr;1(2):71-83. doi: 10.1016/j.brs.2008.03.001.'}, {'type': 'BACKGROUND', 'citation': 'Sienaert, P., Vansteelandt, K., Demyttenaere, K., & Peuskens, J. (2006). Comparison of bifrontal and unilateral ultra-brief pulse electroconvulsive therapy for depression. European Neuropsychopharmacology, 16 (suppl 4), S28.'}, {'pmid': '31056081', 'type': 'DERIVED', 'citation': 'Martin D, Katalinic N, Hadzi-Pavlovic D, Ingram A, Ingram N, Simpson B, McGoldrick J, Dowling N, Loo C. Cognitive effects of brief and ultrabrief pulse bitemporal electroconvulsive therapy: a randomised controlled proof-of-concept trial. Psychol Med. 2020 May;50(7):1121-1128. doi: 10.1017/S0033291719000989. Epub 2019 May 2.'}, {'pmid': '25522389', 'type': 'DERIVED', 'citation': 'Loo CK, Katalinic N, Smith DJ, Ingram A, Dowling N, Martin D, Addison K, Hadzi-Pavlovic D, Simpson B, Schweitzer I. A randomized controlled trial of brief and ultrabrief pulse right unilateral electroconvulsive therapy. Int J Neuropsychopharmacol. 2014 Dec 5;18(1):pyu045. doi: 10.1093/ijnp/pyu045.'}]}, 'descriptionModule': {'briefSummary': 'Electroconvulsive Therapy (ECT) remains essential to contemporary psychiatric practice and is one of the safest and most effective treatments available for depression. Despite modern advances in pharmacotherapy, about 15-20 per cent of all hospitalised patients receive treatment with ECT. Its use, however, is limited by concerns over associated cognitive side effects.\n\nRecent research has suggested that using an ultrabrief pulsewidth with ECT may greatly reduce cognitive side effects, while maintaining efficacy (Sackeim et al 2008). Preliminary results were positive for unilateral ECT, however, suggest that for bilateral ECT, dosing may need to be adjusted to preserve efficacy while reducing side effects. This study will examine the relative cognitive side effects and efficacy of right unilateral and bilateral ECT given with a standard pulsewidth or an ultrabrief pulsewidth. Some participants will also receive an MRI scan before and after ECT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects meet criteria for a DSM-IV-TR Major Depressive Episode\n* Total MADRS score \\>/= 25\n* Age \\>/= 18 years\n* Educated or working in an English medium setting\n\nExclusion Criteria:\n\n* Diagnosis (as defined by DSM-IV-TR) of any psychotic disorder (lifetime with exception of Major Depressive Episode with psychotic features); rapid cycling bipolar disorder, eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year).\n* history of drug or alcohol abuse or dependence (as per DSM-IV-TR) in the last 6 months (except nicotine and caffeine).\n* ECT in last 3 months\n* Subject requires an urgent clinical response due to inanition, psychosis or high suicide risk\n* unable to give informed consent\n* score \\< 24 on Mini Mental State Examination'}, 'identificationModule': {'nctId': 'NCT00870805', 'acronym': 'UB ECT', 'briefTitle': 'Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)', 'organization': {'class': 'OTHER', 'fullName': 'The University of New South Wales'}, 'officialTitle': 'A Controlled Study of Ultrabrief Pulsewidth ECT (Electroconvulsive Therapy)', 'orgStudyIdInfo': {'id': 'UNSW HREC 08322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bilateral-ultrabrief ECT', 'description': 'Patients will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 3-4 times seizure threshold.', 'interventionNames': ['Procedure: bilateral ultrabrief ECT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bilateral standard ECT', 'description': 'Patients will be treated with a standard (1.0ms) pulse with a bilateral placement at 1.5 times seizure threshold.', 'interventionNames': ['Procedure: bilateral standard ECT']}, {'type': 'EXPERIMENTAL', 'label': 'right-unilateral ultrabrief ECT', 'description': 'Patients will be treated with an ultrabrief (0.3ms) pulse with a right unilateral placement at 8 times seizure threshold.', 'interventionNames': ['Procedure: right-unilateral ultrabrief ECT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'right-unilateral standard ECT', 'description': 'Patients will be treated with a standard (1.0ms) pulse with a right unilateral placement at 5 times seizure threshold.', 'interventionNames': ['Procedure: right-unilateral standard ECT']}], 'interventions': [{'name': 'bilateral ultrabrief ECT', 'type': 'PROCEDURE', 'description': 'Bilateral ECT at 3-4 times seizure threshold with an ultrabrief pulse (0.3ms)', 'armGroupLabels': ['bilateral-ultrabrief ECT']}, {'name': 'bilateral standard ECT', 'type': 'PROCEDURE', 'description': 'Bilateral ECT with at 1.5 times seizure threshold with a standard pulse (1.0ms)', 'armGroupLabels': ['bilateral standard ECT']}, {'name': 'right-unilateral ultrabrief ECT', 'type': 'PROCEDURE', 'description': 'Right-unilateral ECT at 6 times seizure threshold with an ultrabrief pulse (0.3ms)', 'armGroupLabels': ['right-unilateral ultrabrief ECT']}, {'name': 'right-unilateral standard ECT', 'type': 'PROCEDURE', 'description': 'Right-unilateral ECT with at 5 times seizure threshold with a standard pulse (1.0ms)', 'armGroupLabels': ['right-unilateral standard ECT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St George Hospital', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Wandene Private Hospital', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Melbourne Clinic', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Assoc/Prof Colleen K Loo, MBBS, FRANZCP, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New South Wales'}, {'name': 'Prof Isaac Schweitzer, MBBS, FRANZCP, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Melbourne Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of New South Wales', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northside Clinic, Australia', 'class': 'OTHER'}, {'name': 'The Melbourne Clinic, Australia', 'class': 'UNKNOWN'}, {'name': 'St George Hospital, Australia', 'class': 'OTHER'}, {'name': 'Wandene Private Hospital, Australia', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Associate Professor Colleen Loo', 'oldOrganization': 'University of New South Wales'}}}}