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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2022
  • participants needed
    400
  • sponsor
    The Cleveland Clinic
Updated on 26 January 2021
ketamine
depression
depressive disorder
antidepressants
depressive symptoms
depressed mood
mania
depressive episode
major depressive disorder
electroconvulsive therapy
antidepressant therapy
treatment resistant depression
major depressive disorder, single episode

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.

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.

Details
Condition Benign Rolandic Epilepsy, mood disorder, Mental illness, Major depression, Endogenous depression, Depression, Electroconvulsive Therapy, Ketamine, Depression (Major/Severe), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Treatment Resistant Depression, Major Depressive Episode, Depressed, Psychological Disorders, Mood Disorders (Pediatric), Affective Disorders, Mood Disorders, depressive disorder, major depressive disorder, psychiatric disorder, psychiatric illness, mental disorder, psychiatric disorders, mental disorders, psychological disorder, psychiatric diseases, psychiatric disease, mental disease, major depressive disorders, bects, depressed mood, miserable, electroconvulsive therapy (ect), depressive disorders, major depressive disorder, single episode
Treatment Ketamine, Electroconvulsive therapy (ECT)
Clinical Study IdentifierNCT03113968
SponsorThe Cleveland Clinic
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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
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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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