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

Depression Clinical Trial

— ELEKT-D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113968
• Other study ID #: ELEKT-D
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 7, 2017
• Est. completion date: November 17, 2022

Study information

• Verified date: September 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: November 17, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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 as determined by both:

A. a clinician's diagnostic evaluation and B. confirmed with the MINI International Neuropsychiatric Interview (MINI 7.0.2)

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. 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.

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• ECT
• Electroconvulsive Therapy
• Ketamine
• Major Depressive Disorder
• Major Depressive Episode
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder
• Treatment Resistant Depression
• Unipolar Depression

Intervention

Procedure:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Cleveland Clinic	Cleveland	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	Yale School of Medicine	New Haven	Connecticut
United States	Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Bo Hu	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View Citation

Nemeroff CB. Prevalence and management of treatment-resistant depression. J Clin Psychiatry. 2007;68 Suppl 8:17-25. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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).	Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks