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

Inclusion Criteria

• Written informed consent before any study related procedures are performed
• Inpatients or outpatients referred by their providers for ECT treatment and eligible for ECT treatment
• Males/females at least 21 years of age but no older than 75 years of age
• 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)

• A current depressive episode that has lasted a minimum of 4 weeks
• 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

• 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.
• 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

• Meet DSM-5 criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or pervasive developmental disorder
• Meets any exclusion criteria for ECT or ketamine treatment as described in the clinical guidelines or according to investigator judgment
• The patient is pregnant or breast feeding
• The patient has a severe medical illness or severe neurological disorder
• The patient has a known ketamine allergy or is taking a medication that may interact with ketamine
• Diagnosis of major depressive disorder with psychotic features during the current depressive episode
• Unable to give informed consent
• Was previously enrolled/randomized into the trial