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

Last updated: September 1, 2023
Sponsor: Bo Hu
Overall Status: Completed

Phase

2/3

Condition

Depression (Major/severe)

Kleptomania

Depression

Treatment

Ketamine

electroconvulsive therapy (ECT)

Clinical Study ID

NCT03113968
ELEKT-D
  • Ages 21-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 eligiblefor 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 InternationalNeuropsychiatric 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 RatingScale (YMRS) of ≤ 5 C. Montreal Cognitive Assessment (MoCA) of ≥18
  7. Have had ≥2 adequate trials of antidepressants or augmentation strategies during theirlifetime. An adequate trial is defined as 4 weeks of medication at the minimum FDAapproved 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 withscheduled visits, treatment plan, and other trial procedures for the duration of thestudy

Exclusion

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 theclinical 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 interactwith ketamine
  6. Diagnosis of major depressive disorder with psychotic features during the currentdepressive episode
  7. Unable to give informed consent
  8. Was previously enrolled/randomized into the trial

Study Design

Total Participants: 403
Treatment Group(s): 2
Primary Treatment: Ketamine
Phase: 2/3
Study Start date:
April 07, 2017
Estimated Completion Date:
November 17, 2022

Study 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.

Connect with a study center

  • Yale School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

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