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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 : Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Amit Anand, MD, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE February 9, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date April 22, 2020
Actual Study Start Date  ICMJE April 7, 2017
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)
Official Title  ICMJE ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Treatment Resistant Depression
  • Electroconvulsive Therapy
  • ECT
  • Ketamine
  • Psychiatric Disorder
  • Depression
  • Major Depressive Disorder
  • Major Depressive Episode
  • Unipolar Depression
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: electroconvulsive therapy (ECT)
  • 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.
    Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2017)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2022
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03113968
Other Study ID Numbers  ICMJE ELEKT-D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Amit Anand, MD, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Amit Anand, MD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP