Ketamine Use in Electroconvulsive Therapy: Clinical, Cognitives and Neurotrophic Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Hamilton Depression Scale (HAM-D) 17 change
Study Overview
Brief Summary
The purpose of this study is to determine whether combination of ketamine plus electroconvulsive therapy improves depressive symptoms decreasing cognitive side effects.
Detailed Description
This study will compare the clinical response to brief pulse ECT with infusion of ketamine 0.5 mg/kg versus brief pulse electroconvulsive therapy with infusion of placebo (saline) in major depression. We also will compare levels of cognitive impairment among these groups, compare levels of quality of life among these groups, compare levels of BDNF among these groups. We also will study if levels of 25-hydroxyvitamin D are associated with cognitive impairment in subjects undergoing ECT.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ECT + Ketamine
Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session
Intervention: ECT + Ketamine (Drug)
Outcomes
Primary Outcomes
Hamilton Depression Scale (HAM-D) 17 change
Time Frame: Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks
Secondary Outcomes
- Brief Psychiatry Rating Scale change(Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks)
- Autobiographical Memory Test change(Baseline and at the end of hospital stay, an expected average of 5 weeks)
- WAIS Vocabulary(Baseline)
- Clinical Global Impression-Severity change(Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks)
- Rey Auditory Verbal Learning Test change(Baseline and at the end of hospital stay, an expected average of 5 weeks)
- Mini Mental Status Exam change(Baseline and at the end of hospital stay, an expected average of 5 weeks)
- Stroop Test change(Baseline and at the end of hospital stay, an expected average of 5 weeks)
- Trial Making Test change(Baseline and at the end of hospital stay, an expected average of 5 weeks)
- Montgomery and Asberg Depression Rating Scale change(Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks)
- WAIS Digit Span change(Baseline and at the end of hospital stay, an expected average of 5 weeks)
- FAS verbal fluency change(Baseline and at the end of hospital stay, an expected average of 5 weeks)