Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Depression
  • ECT
  • Electroconvulsive Therapy
  • Ketamine
  • Major Depressive Disorder
  • Major Depressive Episode
  • Psychiatric Disorder
  • Treatment Resistant Depression
  • Unipolar Depression
Type
Interventional
Phase
Phase 2Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: unblinded prospective randomized open-labelMasking: 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

Participation Requirements

Age
Between 21 years and 75 years
Gender
Both males and females

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 prio...

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.

Tracking Information

NCT #
NCT03113968
Collaborators
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Amit Anand, MD The Cleveland Clinic