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.
Compound Ketamine
Country United States of America
Visit trial
Status
Recruiting
Results Published
Start date
04 July 2017
End date
31 December 2022
Chance of happening
100%
Phase
Phase II
Phase III
Design
Open
Type
Interventional
Generation
First
Participants
400
Sex
All
Age
21- 75
Therapy
No
Trial Details
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.NCT Number NCT03113968
Sponsors & Collaborators
The Cleveland ClinicThis company doesn't have a full profile yet, it is linked to a clinical trial.
Patient-Centered Outcomes Research Institute
This company doesn't have a full profile yet, it is linked to a clinical trial.
Papers
Ketamine versus ECT for Nonpsychotic Treatment-Resistant Major DepressionThis open-label, randomized trial (n=403) compared the effectiveness of iv ketamine (35mg/70kg, 6x, 3w) and electroconvulsive therapy (ECT) in treating treatment-resistant major depression (TRD). The results showed that 55.4% of patients in the ketamine group and 41.2% in the ECT group responded to the treatment, indicating ketamine was noninferior to ECT. ECT was associated with a temporary decrease in memory recall, while ketamine was associated with dissociation. Both treatments had similar improvements in patient-reported quality of life, with ECT having musculoskeletal adverse effects.