Clinical TrialTreatment-Resistant Depression (TRD)KetamineCompleted

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

Comparative randomised, open-label, parallel-group trial (n≈403) of ECT (3×/week, up to 9 sessions) versus ketamine infusion (0.5 mg/kg IV, 2×/week, up to 6 sessions) for treatment-resistant depression with patient-reported outcomes as primary measures.

Target Enrollment
403 participants
Study Type
Phase II/III interventional
Design
Randomized

Detailed Description

Randomised, open-label, parallel-group study comparing ECT given three times per week (up to nine treatments) with intravenous ketamine given twice per week (initial 0.5 mg/kg over 40 minutes, up to six treatments) in adults with treatment-resistant major depressive episode.

Primary outcomes are patient-reported symptom measures collected during an acute treatment phase of three to five weeks; responders may be followed for up to six months. Eligibility requires MADRS >20 and prior inadequate response to ≥2 antidepressant trials.

Study Arms & Interventions

ECT

active comparator

Electroconvulsive therapy given 3 times/week up to 9 treatments over 3–5 weeks; initial RUL ultra-brief pulse at ~6x seizure threshold with adjustment per investigator.

Interventions

  • Compound
    via Other• three times per week• 9 doses total

    Right unilateral ultra-brief pulse at ~6x seizure threshold; seizure threshold and dose may be increased per investigator/patient discretion.

Ketamine infusion

active comparator

Intravenous ketamine infusions given 2 times/week up to 6 treatments over 3–5 weeks; initial standard dose 0.5 mg/kg over 40 minutes, adjustable.

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice weekly• 6 doses total

    0.5 mg/kg infusion over 40 minutes; dose may be modified if clinically warranted.

Participants

Ages
21 – 75
Sexes
Male & Female

Inclusion 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 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

  • 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

Study Details

Locations

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

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