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



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD), Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 75
Updated:10/12/2018
Start Date:April 7, 2017
End Date:April 1, 2022
Contact:Kelly Brezina, BSN
Email:brezink@ccf.org
Phone:(216) 445-8561

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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.

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.

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 in a as determined by both:

A. clinician's diagnostic evaluation and B. confirmed with the MINI International
Neuropsychiatric Interview

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 (Refer to ATHF Guidelines for Completion for guidelines on dose/duration
required for a trial to be considered adequate.)

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
We found this trial at
4
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Roman Dale, MD
Phone: 216-363-2492
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Sanjay Mathew, MD
Phone: 713-798-5541
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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New Haven, Connecticut 06520
Principal Investigator: Gerard Sanacora, MD, PhD
Phone: 203-764-9131
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New Haven, CT
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New York, New York
Principal Investigator: James Murrough, MD
Phone: 212-241-8538
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New York, NY
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