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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electroconvulsive therapy (ECT) | Active Comparator | 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. |
|
| ketamine infusion | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electroconvulsive therapy (ECT) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16) | 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. | Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS) | 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). | Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks |
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Inclusion Criteria:
Written informed consent before any study related procedures are performed
Inpatients or outpatients referred by their providers for ECT treatment and eligible for ECT treatment
Males/females at least 21 years of age but no older than 75 years of age
Meet DSM-5 criteria for Major Depressive Episode as determined by both:
A. a clinician's diagnostic evaluation and B. confirmed with the MINI International Neuropsychiatric Interview (MINI 7.0.2)
A current depressive episode that has lasted a minimum of 4 weeks
Meet all of the following criteria on symptom rating scales at screening:
A. Montgomery Asberg Depression Rating Scale (MADRS) score >20 B. Young Mania Rating Scale (YMRS) of ≤ 5 C. Montreal Cognitive Assessment (MoCA) of ≥18
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.
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Anand, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States | ||
| Johns Hopkins University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17640154 | Background | Nemeroff CB. Prevalence and management of treatment-resistant depression. J Clin Psychiatry. 2007;68 Suppl 8:17-25. | |
| 23212054 | Background | 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. |
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Of 2321 patients assessed, 436 met the inclusion criteria and were screened. 33 had screen failures and 403 were randomized.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Electroconvulsive Therapy (ECT) | 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. electroconvulsive 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2022 | Jul 21, 2023 |
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unblinded prospective randomized open-label
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Due to the nature of the study treatments it is not possible to blind patients or investigators.
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|
| Ketamine | Drug | 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. |
|
| Baltimore |
| Maryland |
| 21205 |
| United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| 17989386 | Background | Lisanby SH. Electroconvulsive therapy for depression. N Engl J Med. 2007 Nov 8;357(19):1939-45. doi: 10.1056/NEJMct075234. No abstract available. |
| 26423481 | Background | 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. |
| 27640324 | Background | 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. |
| 40900112 | Derived | 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. |
| 37224232 | Derived | 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. |
| 30572160 | Derived | 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. |
| FG001 | Ketamine Infusion | 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. Ketamine: 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | Electroconvulsive Therapy (ECT) | 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. electroconvulsive 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. |
| BG001 | Ketamine Infusion | 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. Ketamine: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Inpatient at first treatment | Count of Participants | Participants |
| ||||||||||||||||
| Age of onset of First Major Depression - yrs | Mean | Standard Deviation | years |
| |||||||||||||||
| Number of Past Major Depression Episodes | Median | Inter-Quartile Range | Episodes |
| |||||||||||||||
| Duration of Current Episode - month | Median | Inter-Quartile Range | months |
| |||||||||||||||
| Number of Patients with Family History of Depression | Count of Participants | Participants |
| ||||||||||||||||
| Attempted Suicide | Count of Participants | Participants |
| ||||||||||||||||
| Previous ECT | Count of Participants | Participants |
| ||||||||||||||||
| Previous Ketamine | Count of Participants | Participants |
| ||||||||||||||||
| 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) | Score ranges from 0 to 27 with higher scores indicating greater depression | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Montgomery-Åsberg Rating Scale (MADRS) | Scale ranges from 0 to 60 with higher scores indicating greater depression | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Clinical Global Impression-Severity (CGI-S) scale | Scale ranges from 1 to 7, with higher scores indicating more severe depression | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16) | 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. | Modified Intention-to-treat Population (i.e., participants with at least one treatment and at least one follow-up measurement) | Posted | Count of Participants | Participants | Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS) | 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). | 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. | Posted | Count of Participants | Participants | Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks |
|
Adverse events are reported for the period from baseline to the end-of-treatment visit (up to 5 weeks from baseline)
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electroconvulsive Therapy (ECT) | 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. electroconvulsive 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. | 0 | 170 | 4 | 170 | 27 | 170 |
| EG001 | Ketamine Infusion | 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. Ketamine: 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. | 0 | 195 | 5 | 195 | 32 | 195 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Systematic Assessment |
| ||
| Infection requiring antibiotics | Infections and infestations | Systematic Assessment |
| ||
| Homicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Aborted suicide attempt (gesture) | Psychiatric disorders | Systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Asystole | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
| ||
| Hypertension (severe / prolonged) | Cardiac disorders | Systematic Assessment |
| ||
| Muscle Pain / Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Non-Cardiac Jaw Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Panic | Psychiatric disorders | Systematic Assessment |
| ||
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
|
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
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amit Anand | Department of Psychiatry, Mass General Brigham, and Harvard Medical School | 6177266421 | aanand7@bwh.harvard.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2022 | Jul 21, 2023 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D001523 | Mental Disorders |
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004565 | Electroconvulsive Therapy |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|