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electroconvulsive therapy (ECT) for Mental Illness (ELEKT-D Trial)

Phase 2 & 3

Waitlist Available

Led By Amit Anand, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up acute study phase (baseline visit to end of treatment visit) - approximately 3-5 weeks

Awards & highlights

ELEKT-D Trial Summary

This trial will compare electroconvulsive therapy (ECT) to ketamine for patients with treatment resistant depression (TRD).

Eligible Conditions

Mental Illness
Electroconvulsive Therapy
Ketamine
Major Depressive Disorder
Depression
Major Depression

ELEKT-D Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ acute study phase (baseline visit to end of treatment visit) - approximately 3-5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~acute study phase (baseline visit to end of treatment visit) - approximately 3-5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and acute study phase (baseline visit to end of treatment visit) - approximately 3-5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16)

Secondary outcome measures

Number of Participants With Treatment Responses Based on the Montgomery-Åsberg Rating Scale (MADRS)

ELEKT-D Trial Design

2Treatment groups

Active Control

Group I: electroconvulsive therapy (ECT)Active Control1 Intervention

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.

Group II: ketamine infusionActive Control1 Intervention

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.

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Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,363,615 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

552 Previous Clinical Trials

29,997,455 Total Patients Enrolled

Bo HuLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients of all ages eligible for this clinical trial?

"This trial is only for people aged 21-75. There are 555 other clinical trials for people under 18 and 1781 for those over 65."

Answered by AI

Could you please walk me through other research that has been conducted on ketamine infusion?

"The first documented clinical trial involving ketamine infusions took place in 2013 at Cedars Sinai Medical Center. As of now, 439 such studies have been completed with 115 more actively recruiting patients. New york, New York has a significant number of these active trials."

Answered by AI

Is it possible to still enroll in this clinical trial?

"The most recent information available on clinicaltrials.gov suggests that this research project is still enrolling patients. The trial was first advertised on April 7th, 2017 and was last updated on October 6th, 2022."

Answered by AI

Which demographics are being sought for this clinical trial?

"This clinical trial is enrolling 400 patients who meet the following criteria: A. 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.), Written informed consent before any study related procedures are performed, Inpatients or outpatients referred by their providers for ECT treatment and eligible"

Answered by AI