NCT03113968

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 403 (actual)
• Sponsor: Bo Hu · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment Resistant Depression
• Electroconvulsive Therapy
• ECT
• Ketamine
• Psychiatric Disorder
• Depression
• Major Depressive Disorder
• Major Depressive Episode
• Unipolar Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-07
• Primary completion: 2022-10-28
• Completion: 2022-11-17
• First posted: 2017-04-14
• Last updated: 2023-09-28
• Results posted: 2023-08-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study