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CompletedPhase 2 / Phase 3Results posted

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

NCT03113968 · ELEKT-D · Bo Hu

Closed to entry
Status
Not accepting participants
Phase 2 / Phase 3
Phase
403
Target enrolment
5
Study sites
5 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

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)

    Measured over Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 75 Years
Ages
All
Sex
Not accepted
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 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

Where

5 study sites

FacilityCityRegionCountry
Yale School of MedicineNew HavenConnecticutUnited States
Johns Hopkins University School of MedicineBaltimoreMarylandUnited States
Mount SinaiNew YorkNew YorkUnited States
Cleveland ClinicClevelandOhioUnited States
Baylor College of MedicineHoustonTexasUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03113968 on ClinicalTrials.gov →

Last updated in the registry 2023-09-28. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits