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

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ClinicalTrials.gov Identifier: NCT03113968
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Amit Anand, MD, The Cleveland Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Electroconvulsive Therapy ECT Ketamine Psychiatric Disorder Depression Major Depressive Disorder Major Depressive Episode Unipolar Depression Procedure: electroconvulsive therapy (ECT) Drug: Ketamine Phase 2 Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: unblinded prospective randomized open-label
Masking: None (Open Label)
Masking Description: Due to the nature of the study treatments it is not possible to blind patients or investigators.
Primary Purpose: Treatment
Official Title: ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)
Actual Study Start Date : April 7, 2017
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: electroconvulsive therapy (ECT)
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.
Procedure: electroconvulsive therapy (ECT)
ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.

Active Comparator: ketamine infusion
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.
Drug: Ketamine
Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.




Primary Outcome Measures :
  1. Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks ]
    Response is defined as at least a 50% improvement in Baseline QIDS-SR-16 score at End of Treatment Visit. The End of Treatment Visit will occur 3-5 weeks after the Baseline Visit.


Secondary Outcome Measures :
  1. Clinician reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks ]
    Number of patients with an improvement in their Baseline MADRS score at the End of Treatment Visit. The End of Treatment Visit will occur 3-5 weeks after the Baseline Visit.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113968


Contacts
Contact: Kelly Brezina, BSN (216) 445-8561 brezink@ccf.org

Locations
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Jane Wanyiri, RN    203-764-9131    jane.wanyiri@yale.edu   
Principal Investigator: Gerard Sanacora, MD, PhD         
Sub-Investigator: Samuel Wilkinson, Md         
United States, New York
Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Mora Grehl    212-241-8538    mora.grehl@mssm.edu   
Principal Investigator: James Murrough, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kelly Bryant    216-363-2492    anglek@ccf.org   
Principal Investigator: Roman Dale, MD         
Sub-Investigator: Murat Altinay, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Sidra Iqbal    713-798-5541    sidra.iqbal@bcm.edu   
Principal Investigator: Sanjay Mathew, MD         
Sub-Investigator: Ali Abbas Asghar-Ali, MD         
Sponsors and Collaborators
The Cleveland Clinic
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Amit Anand, MD The Cleveland Clinic

Publications:
Responsible Party: Amit Anand, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03113968     History of Changes
Other Study ID Numbers: ELEKT-D
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Mental Disorders
Problem Behavior
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action