ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD) (ELEKT-D)
Treatment Resistant Depression, Electroconvulsive Therapy, ECT
About this trial
This is an interventional treatment trial for Treatment Resistant Depression
Eligibility Criteria
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 in a as determined by both:
A. clinician's diagnostic evaluation and B. confirmed with the MINI International Neuropsychiatric Interview
- 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 (Refer to ATHF Guidelines for Completion for guidelines on dose/duration required for a trial to be considered adequate.)
- 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
Sites / Locations
- Yale School of Medicine
- Johns Hopkins University School of Medicine
- Mount Sinai
- Cleveland Clinic
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
electroconvulsive therapy (ECT)
ketamine infusion
Treatments will be given 3 times a week up to a total of 9 treatments over 3 - 5 weeks. Initial ECT treatment is Right Unilateral (RUL) ultra-brief pulse at 6X seizure threshold. Seizure threshold and dose can be increased per investigator and patient discretion.
Treatments will be given 2 times a week up to a total of 6 treatment over 3 - 5 weeks. Initial standard dose will be 0.5 mg/kg infusion over 40 min. The dose can be modified if clinically warranted per investigator and patient discretion.