Ketamine Use in Electroconvulsive Therapy

Not Applicable

Withdrawn

• Conditions: Depression
• Interventions: Drug: ECT + Ketamine

• Registration Number: NCT02012335
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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 Timeline

• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-16
• Study Start: 2014-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-19
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECT + Ketamine	ECT + Ketamine	Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA); 🇧🇷 Porto Alegre, RS, Brazil