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ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD) (ELEKT-D)

Primary Purpose

Treatment Resistant Depression, Electroconvulsive Therapy, ECT

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
electroconvulsive therapy (ECT)
Ketamine
Sponsored by
Bo Hu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent before any study related procedures are performed
  2. Inpatients or outpatients referred by their providers for ECT treatment and eligible for ECT treatment
  3. Males/females at least 21 years of age but no older than 75 years of age

  4. Meet DSM-5 criteria for Major Depressive Episode in a as determined by both:

    A. clinician's diagnostic evaluation and B. confirmed with the MINI International Neuropsychiatric Interview

  5. A current depressive episode that has lasted a minimum of 4 weeks

  6. 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

  7. Have had ≥2 adequate trials of antidepressants or augmentation strategies during their lifetime (Refer to ATHF Guidelines for Completion for guidelines on dose/duration required for a trial to be considered adequate.)
  8. 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:

  1. Meet DSM-5 criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or pervasive developmental disorder
  2. Meets any exclusion criteria for ECT or ketamine treatment as described in the clinical guidelines or according to investigator judgment
  3. The patient is pregnant or breast feeding
  4. The patient has a severe medical illness or severe neurological disorder
  5. The patient has a known ketamine allergy or is taking a medication that may interact with ketamine
  6. Diagnosis of major depressive disorder with psychotic features during the current depressive episode
  7. Unable to give informed consent
  8. Was previously enrolled/randomized into the trial

Sites / Locations

  • Yale School of Medicine
  • Johns Hopkins University School of Medicine
  • Mount Sinai
  • Cleveland Clinic
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

electroconvulsive therapy (ECT)

ketamine infusion

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
February 9, 2017
Last Updated
September 1, 2023
Sponsor
Bo Hu
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03113968
Brief Title
ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)
Acronym
ELEKT-D
Official Title
ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 7, 2017 (Actual)
Primary Completion Date
October 28, 2022 (Actual)
Study Completion Date
November 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bo Hu
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression, Electroconvulsive Therapy, ECT, Ketamine, Psychiatric Disorder, Depression, Major Depressive Disorder, Major Depressive Episode, Unipolar Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
unblinded prospective randomized open-label
Masking
None (Open Label)
Masking Description
Due to the nature of the study treatments it is not possible to blind patients or investigators.
Allocation
Randomized
Enrollment
403 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electroconvulsive therapy (ECT)
Arm Type
Active Comparator
Arm 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.
Arm Title
ketamine infusion
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
electroconvulsive therapy (ECT)
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention 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.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16)
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.
Time Frame
Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS)
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).
Time Frame
Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Meet DSM-5 criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or pervasive developmental disorder Meets any exclusion criteria for ECT or ketamine treatment as described in the clinical guidelines or according to investigator judgment The patient is pregnant or breast feeding The patient has a severe medical illness or severe neurological disorder The patient has a known ketamine allergy or is taking a medication that may interact with ketamine Diagnosis of major depressive disorder with psychotic features during the current depressive episode Unable to give informed consent Was previously enrolled/randomized into the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Anand, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17640154
Citation
Nemeroff CB. Prevalence and management of treatment-resistant depression. J Clin Psychiatry. 2007;68 Suppl 8:17-25.
Results Reference
background
PubMed Identifier
23212054
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.
Results Reference
background
PubMed Identifier
17989386
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.
Results Reference
background
PubMed Identifier
26423481
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.
Results Reference
background
PubMed Identifier
27640324
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.
Results Reference
background
PubMed Identifier
30572160
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.
Results Reference
derived

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ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)

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