Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-05-27 @ 6:00 PM
Study NCT ID:
NCT02999269
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2016-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ECT Pulse Amplitude and Medial Temporal Lobe Engagement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cabbott@salud.unm.edu', 'phone': '505272223', 'title': 'Dr. Chris Abbott, Division Chief Neuromodulaton, Department of Psychiatry', 'organization': 'University of New Mexico'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Subjects discontinued scheduled antidepressant and antipsychotic medications prior to the first imaging assessment, but as-needed medications (lorazepam, quetiapine, trazodone) were permissible with dose restrictions during the ECT series. Second, our study design included a change in pulse width (from 0.3 to 1.0 ms). Each amplitude arm had a very limited number of subjects with brief pulse width. The relationship between amplitude and pulse width will require more research.'}}, 'adverseEventsModule': {'timeFrame': 'Each subject was evaluated for adverse effects over the 4-week study protocol.', 'eventGroups': [{'id': 'EG000', 'title': '600 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '700 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 6, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '800 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 6, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'headache', 'notes': 'post-procedure headache, all cases resolved with over the counter medications (Tylenol)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 17, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 17, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Depression Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '600 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current'}, {'id': 'OG001', 'title': '700 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current'}, {'id': 'OG002', 'title': '800 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '14.1', 'spread': '2.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'p-value for time by amplitude interaction', 'groupDescription': 'For the primary outcomes (change in HDRS24), we performed a full longitudinal model with an unstructured repeated measures covariance matrix on subjects who completed the study in the assigned treatment arm. The dependent variable was HDRS at each visit and the independent variables included progress (time within the ECT series: pre-, mid-, and post-ECT), amplitude, age, sex, pulse width and the following interactions: progress/amplitude, progress/sex, and progress/pulse width.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Time-by-amplitude interaction (F4, 72 = 2.65, p = 0.04).'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'post-ECT Hamilton Depression Rating Scale -24 item. The time frame is 4 weeks after study initiation.', 'description': 'Hamilton Depression Rating Scale - 24 item. Scores range from 0 to 76 (higher scores indicate more depression severity)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'full longitudinal model with an unstructured repeated measures covariance matrix'}, {'type': 'PRIMARY', 'title': 'Cognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '600 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current'}, {'id': 'OG001', 'title': '700 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current'}, {'id': 'OG002', 'title': '800 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current'}], 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'spread': '10', 'groupId': 'OG000'}, {'value': '68', 'spread': '9', 'groupId': 'OG001'}, {'value': '62', 'spread': '10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.50', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'p-value is time-by-amplitude interaction', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Progress (F2,71 = 11.15, p \\< 0.01)', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'post-ECT Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better). The time frame is 4 weeks after study initiation.', 'description': 'Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '600 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current'}, {'id': 'FG001', 'title': '700 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current'}, {'id': 'FG002', 'title': '800 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '600 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current'}, {'id': 'BG001', 'title': '700 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current'}, {'id': 'BG002', 'title': '800 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude\n\nMECTA Spectrum 5000Q Amplitude: Current'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '8', 'groupId': 'BG000'}, {'value': '64', 'spread': '7', 'groupId': 'BG001'}, {'value': '67', 'spread': '10', 'groupId': 'BG002'}, {'value': '65', 'spread': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Hamilton Depression Rating Scale - 24 items Clinician rated measure of depression severity, range 0 -76 with higher scores indicating more severe depression', 'unitOfMeasure': 'participants'}, {'title': 'Hamilton Depression Rating Scale 24 items', 'classes': [{'categories': [{'measurements': [{'value': '37.0', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '38.0', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '33.8', 'spread': '6.7', 'groupId': 'BG002'}, {'value': '36.3', 'spread': '7.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Clinician rated scale obtained during structured interview with subject. The scoring range is from 0 to 76 with higher scores indicating more depression severity', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-24', 'size': 97781, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-24T21:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind (participant and outcomes assessor)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects randomized to right unilateral ECT with 600, 700, or 800 mA pulse amplitude.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-30', 'studyFirstSubmitDate': '2016-08-16', 'resultsFirstSubmitDate': '2021-11-24', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-30', 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression Severity', 'timeFrame': 'post-ECT Hamilton Depression Rating Scale -24 item. The time frame is 4 weeks after study initiation.', 'description': 'Hamilton Depression Rating Scale - 24 item. Scores range from 0 to 76 (higher scores indicate more depression severity)'}, {'measure': 'Cognition', 'timeFrame': 'post-ECT Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better). The time frame is 4 weeks after study initiation.', 'description': 'Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['electroconvulsive therapy', 'MRI', 'major depressive disorder'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '32651051', 'type': 'RESULT', 'citation': 'Abbott CC, Quinn D, Miller J, Ye E, Iqbal S, Lloyd M, Jones TR, Upston J, Deng Z, Erhardt E, McClintock SM. Electroconvulsive Therapy Pulse Amplitude and Clinical Outcomes. Am J Geriatr Psychiatry. 2021 Feb;29(2):166-178. doi: 10.1016/j.jagp.2020.06.008. Epub 2020 Jun 17.'}, {'pmid': '36482369', 'type': 'DERIVED', 'citation': 'Qi S, Calhoun VD, Zhang D, Miller J, Deng ZD, Narr KL, Sheline Y, McClintock SM, Jiang R, Yang X, Upston J, Jones T, Sui J, Abbott CC. Links between electroconvulsive therapy responsive and cognitive impairment multimodal brain networks in late-life major depressive disorder. BMC Med. 2022 Dec 8;20(1):477. doi: 10.1186/s12916-022-02678-6.'}]}, 'descriptionModule': {'briefSummary': 'Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with depressive episodes. During a typical four-week ECT series, most depressive episodes will respond to treatment and people will improve their level of functioning (return to work or family). Independent of the antidepressant effect of ECT, many patients experience transient memory impairment. This investigation will examine the impact of one ECT parameter (pulse amplitude or current) on brain changes (structure of connections within the brain) and clinical outcomes. The goal of this investigation is to determine the optimal parameter for an individual patient that will maintain the clinical response (reduce depression severity) and minimize side effects (eliminate memory issues related to treatment).', 'detailedDescription': 'Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with depressive episodes. During a typical four-week ECT series, most depressive episodes remit, and formerly suicidal or psychotically depressed patients will resume their premorbid levels of functioning. Independent of the antidepressant effect of ECT, many patients experience debilitating but transient cognitive effects such as attention and memory deficits. These unwanted side effects are particularly troubling for older patients who are more likely to have existing cognitive deficits. Both the stimulus delivery (electrode placement, pulse amplitude, and pulse width) and seizure induction appear to work in synergy, but the underlying mechanism of action for successful response has yet to be fully elucidated. Moreover, further work is needed to understand the relationship between clinical improvement and cognitive impairment. This investigation will examine the clinical and neurocognitive impact of targeted medial temporal lobe engagement as a function of pulse amplitude, one of several variable factors influencing the ECT charge. The ECT charge is measured in millicoulombs (mC) and derived from multiplying pulse train duration, pulse-pair frequency, pulse width, and pulse amplitude. Pulse amplitude determines the induced electric field strength in the brain and is presently fixed at 900 milliamperes (mA) with no clinical or scientific justification. The central hypothesis of this investigation is that the optimal pulse amplitude for an individual patient will enhance neuroplasticity (clinical response) while minimizing the disruption of dominant hemisphere hippocampal cognitive circuitry (resulting in cognitive stability). The preliminary data informs the dosage range between 600 and 800 mA. Pulse amplitudes outside of this range compromise efficacy (500 mA) or may increase risk of cognitive impairment (900 mA). The first aim of this investigation will identify the electric field strength and neuroplasticity associated with clinical response. Critically, this aim will establish the neuroplasticity threshold, which is defined as the electric field strength necessary to induce neuroplasticity. The second aim will detect the neural correlates of ECT-mediated cognitive changes, which may be related to disrupted dominant hemisphere long-term potentiation. The third aim will use data-driven dual regression to predict the optimal pulse amplitude for an individual patient. This contribution will be significant because the electric field, when manipulated by pulse amplitude, can subsequently maximize hippocampal neuroplasticity (efficacy) and minimize disrupted connectivity (cognitive stability) thus improving clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of major depressive disorder (with or without psychotic features)\n2. the clinical indications for ECT including treatment resistance or a need for a rapid and definitive response\n3. Hamilton Depression Rating Scale 24-item (HDRS-24) \\> 21\n4. age range between 50 and 80 years of age\n5. right-handedness\n\nExclusion Criteria:\n\n1. Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness \\> 5 minutes, epilepsy, Alzheimer's disease)\n2. other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)\n3. current drug or alcohol use disorder, except for nicotine; and 4) contraindications to MRI."}, 'identificationModule': {'nctId': 'NCT02999269', 'briefTitle': 'ECT Pulse Amplitude and Medial Temporal Lobe Engagement', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'ECT Pulse Amplitude and Medial Temporal Lobe Engagement', 'orgStudyIdInfo': {'id': '5U01MH111826', 'link': 'https://reporter.nih.gov/quickSearch/5U01MH111826', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '5U01MH111826', 'link': 'https://reporter.nih.gov/quickSearch/5U01MH111826', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '600 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude', 'interventionNames': ['Device: MECTA Spectrum 5000Q Amplitude']}, {'type': 'EXPERIMENTAL', 'label': '700 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude', 'interventionNames': ['Device: MECTA Spectrum 5000Q Amplitude']}, {'type': 'ACTIVE_COMPARATOR', 'label': '800 mA Right Unilateral ECT', 'description': 'MECTA Spectrum 5000Q Amplitude', 'interventionNames': ['Device: MECTA Spectrum 5000Q Amplitude']}], 'interventions': [{'name': 'MECTA Spectrum 5000Q Amplitude', 'type': 'DEVICE', 'description': 'Current', 'armGroupLabels': ['600 mA Right Unilateral ECT', '700 mA Right Unilateral ECT', '800 mA Right Unilateral ECT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131-0001', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Chris Abbott', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Chris Abbott, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Clinical, cognitive and MRI data was uploaded to NDA.', 'ipdSharing': 'YES', 'description': 'National Data Archive (NDA)', 'accessCriteria': 'per NDA protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Mind Research Network', 'class': 'OTHER'}, {'name': 'University of Texas', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director ECT Service', 'investigatorFullName': 'Christopher Abbott', 'investigatorAffiliation': 'University of New Mexico'}}}}