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Completed

NCT Number: NCT00680433

Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)

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.

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Key information

Conditions

Major Depressive Episode

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wesley Hospital

Sydney, New South Wales, 2217, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

Ketamine IV will be administered after the administration of the normal anaesthetic agents for ECT.

Saline

Drug

Saline (placebo) will be administered after the normal anaesthetic agents in ECT.

Primary outcomes

  1. Memory tests

    Time frame: Before ECT, after 6 ECT treatments, at the end of the ECT course

Secondary outcomes

  1. Depression rating scale

    Time frame: Before ECT, after each week of treatment, at the end of the ECT course

Sponsors and collaborators

Lead sponsor

Northside Clinic, Australia

Other

Collaborators

  • Wesley Mission

Registry information

Official study title

A Double-blind Randomised, Placebo-controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 20, 2008
Registry last updated
Mar 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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