The Use of Ketamine as an Anaesthetic During Electroconvulsive Therapy (KANECT)

September 7, 2016 updated by: University of Aberdeen

The Use of Ketamine as an Anaesthetic During Electroconvulsive Therapy (ECT) for Depression: Does it Improve Treatment Outcome?

The main aim of this research is to ascertain whether Ketamine would be a more effective anaesthetic for Electroconvulsive Therapy (ECT) than the standard anaesthetic. In doing so the investigators aim to examine the effect of ketamine on ratings of depressive symptoms, the number of required ECT treatments, and the effect of this anaesthetic on memory.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

According to WHO statistics, depression is amongst the leading causes of disability worldwide. In its more severe forms, it can be life threatening. The most severe forms of depression, or those that fail to respond to chemical treatment are treated with electroconvulsive therapy (ECT). The treatment is highly effective, and undoubtedly saves lives, but a range of factors, including side effect profile, the necessity for extended hospital care, and stigma, restricts its use.

A recent study has shown that patients who receive ketamine as the anaesthetic for ECT experience an earlier reduction in depressive symptoms and have a greater reduction in depressive symptoms than those receiving propofol (Okamoto et al., 2009). However, in this study eight ECT treatments were given to all participants so it is unknown whether ketamine could have reduced the number of treatments required. Overall, these studies suggest that as well as being a neuroprotective agent; ketamine may also have an antidepressant effect. Given these findings it is hypothesized that the use of ketamine in ECT treatment may reduce the number of ECT sessions required due to this drug's effects on depression ratings.

Our main research question is whether the use of ketamine as the anaesthetic for ECT treatment for depression improves the treatment outcome with respect to speed of response and reduction in side effects when compared to conventional anaesthesia.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZH
        • Royal Cornhill Hospital, NHS Grampian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • between the ages of 18 and 65 years old
  • diagnosed with depression and being referred for ECT
  • American Society of Anesthesiologists (ASA) score of 1 or 2
  • patient receiving ECT on an informal basis (i.e. consenting to treatment and able to give informed consent)

Exclusion Criteria:

  • pre-existing neurological disease or cognitive impairment
  • co-morbid psychiatric diagnoses
  • pre-existing hypertension
  • severe respiratory tract disease
  • major cardiovascular disease
  • pacemakers
  • cerebrovascular disorder or malformation
  • intracranial mass lesions
  • seizure disorder
  • intracranial electrode or clips
  • intra-ocular pathology
  • endocrine or metabolic disease
  • severe hematologic disease
  • severe fracture
  • not able to give consent
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine
Ketamine used as the anaesthetic during ECT.
Drug: Ketamine
Ketamine used as the anaesthetic during ECT.
Other Names:
  • Ketalar
Active Comparator: Propofol
Propofol, the standard anaesthetic, used during ECT.
Drug: Propofol
The standard anaesthetic used for ECT.
Other Names:
  • Diprivan 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depressive symptoms
Time Frame: After 4th treatment
The primary outcome measure will be change in depressive symptoms after the fourth ECT treatment. This will be assessed by the change in MADRS and 17-item HDRS scores between start of treatment and this timepoint.
After 4th treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive side-effects
Time Frame: 2 months
This will be assessed using the spatial recognition test from the CANTAB battery. This test was chosen as previous research has shown that this test is most sensitive to anterograde memory impairments associated with ECT. By administering this test before, during (after 4th treatment) and after treatment (immediately following and at 1 month follow-up) we will be able to determine whether ketamine can reduce the anterograde memory dysfunction as compared to propofol.
2 months
Change in depressive symptoms after treatment
Time Frame: 2 months
The secondary measure of treatment efficacy will be assessed by the change in MADRS and 17-item HADRS scores immediately after treatment and at 1 month follow-up. Secondly, this will be assessed by the number of treatments required to achieve remission of symptoms, as judged by treating clinicians. By monitoring the number of treatments required we will be able to assess whether ketamine can reduce the number of ECT treatments required.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

NHS Grampian
Chief Scientist Office of the Scottish Government

Investigators

  • Principal Investigator: Ian C Reid, PhD, University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 1, 2011

First Posted (Estimate)

March 2, 2011

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSO ETM/6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Ketamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe