Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)

This study has been completed.
Sponsor:
Collaborator:
Wesley Hospitals
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00680433
First received: May 16, 2008
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Major Depressive Episode
Drug: Ketamine
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Randomised, Placebo-controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)

Resource links provided by NLM:


Further study details as provided by Northside Clinic, Australia:

Primary Outcome Measures:
  • Memory tests [ Time Frame: Before ECT, after 6 ECT treatments, at the end of the ECT course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression rating scale [ Time Frame: Before ECT, after each week of treatment, at the end of the ECT course ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: April 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Ketamine
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680433

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Colleen Loo, Associate Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT00680433     History of Changes
Other Study ID Numbers: HREC 07281
Study First Received: May 16, 2008
Last Updated: March 27, 2013
Health Authority: Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anesthetics
Ketamine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 20, 2014