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

Sponsor

Bo Hu (Other)

Overall Status

Recruiting

CT.gov ID

NCT03113968

Collaborator

Patient-Centered Outcomes Research Institute (Other)

400

Enrollment

Locations

Arms

68.8

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

unblinded prospective randomized open-labelunblinded 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 :

Apr 7, 2017

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Patient reported response to treatment [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

Clinician reported response to treatment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale School of Medicine	New Haven	Connecticut	United States	06510
2	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21205
3	Mount Sinai	New York	New York	United States	10029
4	Cleveland Clinic	Cleveland	Ohio	United States	44195
5	Baylor College of Medicine	Houston	Texas	United States	77030