CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 403 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03113968
NCT03113968Phase 3Completed
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ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)

Bo Hu·interventional·Posted Apr 14, 2017·Updated Sep 28, 2023

In Brief

A Phase 3 clinical trial evaluating electroconvulsive therapy (ECT) and Ketamine for Treatment Resistant Depression and 8 related conditions. Completed, enrolled 403 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTreatment Resistant Depression, Electroconvulsive Therapy, ECT, Ketamine, Psychiatric Disorder, Depression, Major Depressive Disorder, Major Depressive Episode, Unipolar Depression
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 14, 2017
Enrollment StartApr 7, 2017
Primary CompletionOct 28, 2022
Study CompletionNov 17, 2022
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 9.2 years ago

Interventions

electroconvulsive therapy (ECT)procedure

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.

Ketaminedrug

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.