Ketamine Use in Electroconvulsive Therapy

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

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

Study Overview

• Status: Withdrawn
• Conditions: Depression
• Intervention / Treatment: Drug: ECT + Ketamine

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
      • Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 13-0196