Ketamine Use in Electroconvulsive Therapy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether combination of ketamine plus electroconvulsive therapy improves depressive symptoms decreasing cognitive side effects.

Detailed Description
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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.

Official Title
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Ketamine Use in Electroconvulsive Therapy: Clinical, Cognitives and Neurotrophic Outcomes

Conditions
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Depression

Intervention / Treatment
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* Drug: ECT + Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria - Patients with unipolar and bipolar depression from The Psychiatric Unit of Hospital de Clinicas de Porto Alegre (diagnosis will be established by the Structured Clinical Interview for DSM-IV Axis I) Exclusion criteria: Patients with dementia History of addiction / abuse of psychoactive drugs Other psychiatric diagnoses Refusal to follow the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: ECT + saline<br>Brief pulse ECT with saline as placebo in each session | |
| Experimental: ECT + Ketamine<br>Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session | Drug: ECT + Ketamine<br>* Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale (HAM-D) 17 change |  | Baseline, week 1, week 2, week 3, week 4, and at the end of hospital stay, an expected average of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Mental Status Exam change |  | Baseline 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 | 
| Rey Auditory Verbal Learning Test change |  | Baseline 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 | 
| 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 | 
| WAIS Vocabulary |  | Baseline | 
| 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 | 
| 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 | 
| 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 |