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Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680433
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : March 29, 2013
Wesley Mission
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales

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.

Condition or disease Intervention/treatment Phase
Major Depressive Episode Drug: Ketamine Drug: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Randomised, Placebo-controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)
Study Start Date : April 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Active
Drug: Ketamine
Ketamine IV will be administered after the administration of the normal anaesthetic agents for ECT.

Placebo Comparator: Placebo
Saline (placebo)
Drug: Saline
Saline (placebo) will be administered after the normal anaesthetic agents in ECT.

Primary Outcome Measures :
  1. Memory tests [ Time Frame: Before ECT, after 6 ECT treatments, at the end of the ECT course ]

Secondary Outcome Measures :
  1. Depression rating scale [ Time Frame: Before ECT, after each week of treatment, at the end of the ECT course ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680433

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Australia, New South Wales
Wesley Hospital
Sydney, New South Wales, Australia, 2217
Sponsors and Collaborators
Northside Clinic, Australia
Wesley Mission
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Principal Investigator: Colleen K Loo, MB BS FRANZCP, MD University of New South Wales

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Colleen Loo, Associate Professor, The University of New South Wales Identifier: NCT00680433     History of Changes
Other Study ID Numbers: HREC 07281
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action