Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-24 @ 9:58 PM
Study NCT ID:
NCT03113968
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2017-02-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aanand7@bwh.harvard.edu', 'phone': '6177266421', 'title': 'Dr. Amit Anand', 'organization': 'Department of Psychiatry, Mass General Brigham, and Harvard Medical School'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Our trial has several limitations. ECT was started with right unilateral placement and was then switched to bilateral placement in the event of inadequate response. The open-label design of our trial could have influenced response. Maintenance treatment was not studied. Other limitations of our trial include a lack of placebo, the flexibility of treatment methods, and a follow-up period during which the patients received treatment as presc'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline)', 'description': 'Adverse events were reported for the modified Intention-to-Treat population (participants who received at least one treatment and had at least follow-up measurement). The subset of treatment responders in both groups were followed for an observational period of additional six months, and during this period these participants might be on different treatments as clinically needed.', 'eventGroups': [{'id': 'EG000', 'title': 'Electroconvulsive Therapy (ECT)', 'description': 'Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion.\n\nelectroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.', 'otherNumAtRisk': 170, 'deathsNumAtRisk': 170, 'otherNumAffected': 27, 'seriousNumAtRisk': 170, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Ketamine Infusion', 'description': 'Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion.\n\nKetamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.', 'otherNumAtRisk': 195, 'deathsNumAtRisk': 195, 'otherNumAffected': 32, 'seriousNumAtRisk': 195, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension (severe / prolonged)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Pain / Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Cardiac Jaw Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Panic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection requiring antibiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aborted suicide attempt (gesture)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asystole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 195, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroconvulsive Therapy (ECT)', 'description': 'Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion.\n\nelectroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.'}, {'id': 'OG001', 'title': 'Ketamine Infusion', 'description': 'Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion.\n\nKetamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'The Farrington-Manning score test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The Farrington-Manning score test was used to assess the noninferiority of KET.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks', 'description': 'Response is defined as at least a 50% improvement in the QIDS-SR-16 scale from baseline to the End of Treatment visit. The End of Treatment visit will occur 3-5 weeks after the Baseline visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-treat Population (i.e., participants with at least one treatment and at least one follow-up measurement)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electroconvulsive Therapy (ECT)', 'description': 'Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion.\n\nelectroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.'}, {'id': 'OG001', 'title': 'Ketamine Infusion', 'description': 'Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion.\n\nKetamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '9.3', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'P-values not reported'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks', 'description': 'The outcome measure was the percentage of responders at the end-of-treatment visit, defined as a ≥50% decrease in MADRS score from the baseline visit (i.e., first treatment visit) to the end-of-treatment visit (within 3 days of last treatment).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention-to-treat population (i.e., participants with at least one treatment and at least one follow-up measurement). One participant in the ECT group had missing baseline MADRS and was further excluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Electroconvulsive Therapy (ECT)', 'description': 'Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion.\n\nelectroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.'}, {'id': 'FG001', 'title': 'Ketamine Infusion', 'description': 'Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion.\n\nKetamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '196'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': "From March 2017 - September 2022, outpatients or inpatients referred by their clinical providers to a site's ECT service for treatment were invited to participate in the study. Patients suffering from TRD who were interested in participation were enrolled after providing written informed consent.", 'preAssignmentDetails': 'Of 2321 patients assessed, 436 met the inclusion criteria and were screened. 33 had screen failures and 403 were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '403', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Electroconvulsive Therapy (ECT)', 'description': 'Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion.\n\nelectroconvulsive therapy (ECT): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.'}, {'id': 'BG001', 'title': 'Ketamine Infusion', 'description': 'Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion.\n\nKetamine: Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '45.6', 'spread': '14.8', 'groupId': 'BG001'}, {'value': '46.3', 'spread': '14.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '29.5', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '29.9', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Inpatient at first treatment', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age of onset of First Major Depression - yrs', 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '11', 'groupId': 'BG000'}, {'value': '19.7', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '19.5', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Past Major Depression Episodes', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '18'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '16'}, {'value': '5', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Episodes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Duration of Current Episode - month', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '72'}, {'value': '24', 'groupId': 'BG001', 'lowerLimit': '10', 'upperLimit': '75'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of Patients with Family History of Depression', 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Attempted Suicide', 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous ECT', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Ketamine', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)', 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '17.9', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '18.1', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Score ranges from 0 to 27 with higher scores indicating greater depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Montgomery-Åsberg Rating Scale (MADRS)', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'spread': '6', 'groupId': 'BG000'}, {'value': '32.3', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '32.5', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scale ranges from 0 to 60 with higher scores indicating greater depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Global Impression-Severity (CGI-S) scale', 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '5.0', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scale ranges from 1 to 7, with higher scores indicating more severe depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intention-to-treat population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-16', 'size': 1415848, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-21T14:31', 'hasProtocol': True}, {'date': '2022-07-01', 'size': 681013, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-21T14:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Due to the nature of the study treatments it is not possible to blind patients or investigators.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'unblinded prospective randomized open-label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 403}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2017-02-09', 'resultsFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-21', 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16)', 'timeFrame': 'Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks', 'description': 'Response is defined as at least a 50% improvement in the QIDS-SR-16 scale from baseline to the End of Treatment visit. The End of Treatment visit will occur 3-5 weeks after the Baseline visit.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS)', 'timeFrame': 'Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks', 'description': 'The outcome measure was the percentage of responders at the end-of-treatment visit, defined as a ≥50% decrease in MADRS score from the baseline visit (i.e., first treatment visit) to the end-of-treatment visit (within 3 days of last treatment).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Treatment Resistant Depression', 'Electroconvulsive Therapy', 'ECT', 'Ketamine', 'Psychiatric Disorder', 'Depression', 'Major Depressive Disorder', 'Major Depressive Episode', 'Unipolar Depression']}, 'referencesModule': {'references': [{'pmid': '17640154', 'type': 'BACKGROUND', 'citation': 'Nemeroff CB. Prevalence and management of treatment-resistant depression. J Clin Psychiatry. 2007;68 Suppl 8:17-25.'}, {'pmid': '23212054', 'type': 'BACKGROUND', 'citation': 'Kellner CH, Greenberg RM, Murrough JW, Bryson EO, Briggs MC, Pasculli RM. ECT in treatment-resistant depression. Am J Psychiatry. 2012 Dec;169(12):1238-44. doi: 10.1176/appi.ajp.2012.12050648.'}, {'pmid': '17989386', 'type': 'BACKGROUND', 'citation': 'Lisanby SH. Electroconvulsive therapy for depression. N Engl J Med. 2007 Nov 8;357(19):1939-45. doi: 10.1056/NEJMct075234. No abstract available.'}, {'pmid': '26423481', 'type': 'BACKGROUND', 'citation': 'Newport DJ, Carpenter LL, McDonald WM, Potash JB, Tohen M, Nemeroff CB; APA Council of Research Task Force on Novel Biomarkers and Treatments. Ketamine and Other NMDA Antagonists: Early Clinical Trials and Possible Mechanisms in Depression. Am J Psychiatry. 2015 Oct;172(10):950-66. doi: 10.1176/appi.ajp.2015.15040465.'}, {'pmid': '27640324', 'type': 'BACKGROUND', 'citation': 'Sanacora G, Heimer H, Hartman D, Mathew SJ, Frye M, Nemeroff C, Robinson Beale R. Balancing the Promise and Risks of Ketamine Treatment for Mood Disorders. Neuropsychopharmacology. 2017 May;42(6):1179-1181. doi: 10.1038/npp.2016.193. Epub 2016 Sep 19. No abstract available.'}, {'pmid': '40900112', 'type': 'DERIVED', 'citation': 'Kumpf KT, Wilkinson ST, Hu B, Chen R, Krishnan K, Chakrabarti S, Rhee TG, Grezmak T, Mathew SJ, Sanacora G, Murrough JW, Goes FS, Collins KA, Barnett BS, Anand A. Comparing the Cognitive Effects of Repeated Intravenous Ketamine and Electroconvulsive Therapy in Patients With Treatment-Resistant Depression: A Secondary Analysis of the ELEKT-D Trial. J Clin Psychiatry. 2025 Sep 3;86(4):25m15781. doi: 10.4088/JCP.25m15781.'}, {'pmid': '37224232', 'type': 'DERIVED', 'citation': 'Anand A, Mathew SJ, Sanacora G, Murrough JW, Goes FS, Altinay M, Aloysi AS, Asghar-Ali AA, Barnett BS, Chang LC, Collins KA, Costi S, Iqbal S, Jha MK, Krishnan K, Malone DA, Nikayin S, Nissen SE, Ostroff RB, Reti IM, Wilkinson ST, Wolski K, Hu B. Ketamine versus ECT for Nonpsychotic Treatment-Resistant Major Depression. N Engl J Med. 2023 Jun 22;388(25):2315-2325. doi: 10.1056/NEJMoa2302399. Epub 2023 May 24.'}, {'pmid': '30572160', 'type': 'DERIVED', 'citation': 'Mathew SJ, Wilkinson ST, Altinay M, Asghar-Ali A, Chang LC, Collins KA, Dale RM, Hu B, Krishnan K, Kellner CH, Malone DA, Murrough JW, Ostroff RB, Sanacora G, Shao M, Anand A. ELEctroconvulsive therapy (ECT) vs. Ketamine in patients with Treatment-resistant Depression: The ELEKT-D study protocol. Contemp Clin Trials. 2019 Feb;77:19-26. doi: 10.1016/j.cct.2018.12.009. Epub 2018 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the study is to conduct a comparative randomized trial of electroconvulsive therapy (ECT) vs. ketamine for patients with treatment resistant depression (TRD) in a real world setting with patient reported outcomes as primary and secondary outcome measures.', 'detailedDescription': 'Patients with treatment resistant depression who meet all inclusion criteria and do not meet any exclusion criteria will be randomized to either electroconvulsive therapy (ECT) three times per week or ketamine infusion two times per week. Patients will answer questionnaires about their symptoms prior to treatments. The acute treatment phase of the study will last three to five weeks. Depending on response to treatment, some patients will be followed for an additional six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Written informed consent before any study related procedures are performed\n2. Inpatients or outpatients referred by their providers for ECT treatment and eligible for ECT treatment\n3. Males/females at least 21 years of age but no older than 75 years of age\n4. Meet DSM-5 criteria for Major Depressive Episode as determined by both:\n\n A. a clinician's diagnostic evaluation and B. confirmed with the MINI International Neuropsychiatric Interview (MINI 7.0.2)\n5. A current depressive episode that has lasted a minimum of 4 weeks\n6. Meet all of the following criteria on symptom rating scales at screening:\n\n A. Montgomery Asberg Depression Rating Scale (MADRS) score \\>20 B. Young Mania Rating Scale (YMRS) of ≤ 5 C. Montreal Cognitive Assessment (MoCA) of ≥18\n7. Have had ≥2 adequate trials of antidepressants or augmentation strategies during their lifetime. An adequate trial is defined as 4 weeks of medication at the minimum FDA approved dose. This will be equal to a trial rating of 3 or more.\n8. In the opinion of the investigator, the patient is willing and able to comply with scheduled visits, treatment plan, and other trial procedures for the duration of the study\n\nExclusion Criteria:\n\n1. Meet DSM-5 criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or pervasive developmental disorder\n2. Meets any exclusion criteria for ECT or ketamine treatment as described in the clinical guidelines or according to investigator judgment\n3. The patient is pregnant or breast feeding\n4. The patient has a severe medical illness or severe neurological disorder\n5. The patient has a known ketamine allergy or is taking a medication that may interact with ketamine\n6. Diagnosis of major depressive disorder with psychotic features during the current depressive episode\n7. Unable to give informed consent\n8. Was previously enrolled/randomized into the trial"}, 'identificationModule': {'nctId': 'NCT03113968', 'acronym': 'ELEKT-D', 'briefTitle': 'ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)', 'orgStudyIdInfo': {'id': 'ELEKT-D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'electroconvulsive therapy (ECT)', 'description': 'Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion.', 'interventionNames': ['Procedure: electroconvulsive therapy (ECT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ketamine infusion', 'description': 'Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion.', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'electroconvulsive therapy (ECT)', 'type': 'PROCEDURE', 'description': 'ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.', 'armGroupLabels': ['electroconvulsive therapy (ECT)']}, {'name': 'Ketamine', 'type': 'DRUG', 'description': 'Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.', 'armGroupLabels': ['ketamine infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Amit Anand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bo Hu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Bo Hu', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}