Ketamine as an Anaesthetic Agent in Electroconvulsive Therapy (ECT)

Ketamine

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.

Intervention / Treatment

  • 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.

Condition or Disease

  • Major Depressive Episode

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 83 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Apr 01, 2008
    Primary Completion: Oct 01, 2012 ACTUAL
    Completion Date: Oct 01, 2012 ACTUAL
    Study First Posted: May 20, 2008 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Mar 27, 2013

    Sponsors / Collaborators

    Lead Sponsor: Northside Clinic, Australia
    Responsible Party: N/A

    Location

    New South Wales, Australia
    Sydney, New South Wales, Australia

    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.

    Participant Groups

    • Ketamine

    • Saline (placebo)

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Memory tests Before ECT, after 6 ECT treatments, at the end of the ECT course
    Secondary Outcomes
    • Depression rating scale Before ECT, after each week of treatment, at the end of the ECT course

    More Details

    NCT Number: NCT00680433
    Other IDs: HREC 07281
    Study URL: https://clinicaltrials.gov/study/NCT00680433
    Last updated: Sep 29, 2023