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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.
 
ClinicalTrials.gov Identifier: NCT00680433
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : March 29, 2013
Sponsor:
Collaborator:
Wesley Mission
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales

Tracking Information
First Submitted Date  ICMJE May 16, 2008
First Posted Date  ICMJE May 20, 2008
Last Update Posted Date March 29, 2013
Study Start Date  ICMJE April 2008
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2008)
Memory tests [ Time Frame: Before ECT, after 6 ECT treatments, at the end of the ECT course ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2008)
Depression rating scale [ Time Frame: Before ECT, after each week of treatment, at the end of the ECT course ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)
Official Title  ICMJE A Double-blind Randomised, Placebo-controlled Study of Adjunctive Ketamine Anaesthesia in ECT (Electroconvulsive Therapy)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Episode
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine IV will be administered after the administration of the normal anaesthetic agents for ECT.
  • Drug: Saline
    Saline (placebo) will be administered after the normal anaesthetic agents in ECT.
Study Arms  ICMJE
  • Experimental: Active
    Ketamine
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Saline (placebo)
    Intervention: Drug: Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2013)
83
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2008)
34
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00680433
Other Study ID Numbers  ICMJE HREC 07281
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Colleen Loo, The University of New South Wales
Original Responsible Party Associate Professor Colleen Loo, University of New South Wales
Current Study Sponsor  ICMJE Northside Clinic, Australia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Wesley Mission
Investigators  ICMJE
Principal Investigator: Colleen K Loo, MB BS FRANZCP, MD University of New South Wales
PRS Account Northside Clinic, Australia
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP