Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)

Phase 4

Completed

• Conditions: Major Depressive Episode
• Interventions: Drug: Ketamine; Drug: Saline

• Registration Number: NCT00680433
• Lead Sponsor: Northside Clinic, Australia

Brief Summary

Research into the mechanisms underlying memory impairment in ECT suggests that its development may be prevented by the administration of certain medications at the time of ECT treatment. For example there are reasons to believe that ketamine, also used as an anaesthetic agent, may have such protective properties.

In this clinical study patients undergoing a course of ECT will be offered the opportunity to receive a small dose of ketamine (or a placebo) as part of their anaesthetic at the time of ECT treatment. Mood changes and any memory changes will be evaluated to see if the subjects who received ketamine had less memory side effects than those who did not, while still improving their depression.

Detailed Description

This study will report on two related trials. In the outpatient trial, patients will be administered adjunctive ketamine at two different doses (0.25mg/kg; 0.5mg/kg), and a placebo (saline), across 3 consecutive sessions within their regular maintenance ECT course. The order of conditions will be randomised across participants. Patients will be required to learn some words and faces 20 minutes prior to ECT, and complete a detailed cognitive battery 4 hours after ECT on each of the 3 occasions. The purpose of this trial is to determine whether ketamine is superior to placebo in reducing cognitive impairment following ECT and what the optimal dose of ketamine is for minimising cognitive and other side effects. Projected sample for this trial is N = 17.

In the inpatient trial, patients will be randomly assigned to receive ketamine or placebo for the duration of the acute ECT course. Patients will be administered a detailed cognitive battery the day before commencing ECT treatment, the day after the 6th treatment, and 1-3 days and 1 month following the end of the acute ECT course. The purpose of this trial is to examine whether patients in the ketamine condition had superior cognitive outcomes to those in the placebo condition during and following a course of ECT. In addition, depressive symptomatology will be examined throughout the ECT course to determine whether ketamine anaesthesia during ECT has antidepressant, as well as, cognitive benefits. Projected sample for this trial is N = 34.

This entry gives details of the main clinical trial: The effects of ketamine across a course of ECT.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-20
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Satisfy DSM-IV-TR criteria for Major Depressive Episode
• 18 years or over
• Does not have a diagnosis of schizophrenia, schizoaffective disorder, rapid cycling bipolar disorder, or current psychotic symptoms
• No known sensitivity to ketamine
• No ECT in the last 3 months
• No drug or alcohol abuse in the last 12 months
• Able to give informed consent
• Score at least 24 on Mini Mental State Examination

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Ketamine	Ketamine
Placebo	Saline	Saline (placebo)

Primary Outcome Measures

Name	Time	Method
Memory tests	Before ECT, after 6 ECT treatments, at the end of the ECT course

Secondary Outcome Measures

Name	Time	Method
Depression rating scale	Before ECT, after each week of treatment, at the end of the ECT course

Trial Locations

Locations (1)

Wesley Hospital; 🇦🇺 Sydney, New South Wales, Australia