Overview

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

Status:
Recruiting

Trial end date:
2022-04-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

The Cleveland Clinic

Collaborator:

Patient-Centered Outcomes Research Institute

Treatments:

Ketamine

Criteria

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