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

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: NCT01306760
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : September 8, 2016
Sponsor:
Collaborators:
NHS Grampian
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Aberdeen

Tracking Information
First Submitted Date  ICMJE March 1, 2011
First Posted Date  ICMJE March 2, 2011
Last Update Posted Date September 8, 2016
Study Start Date  ICMJE March 2011
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2011)
  • 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.
  • 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.
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 The Use of Ketamine as an Anaesthetic During Electroconvulsive Therapy
Official Title  ICMJE The Use of Ketamine as an Anaesthetic During Electroconvulsive Therapy (ECT) for Depression: Does it Improve Treatment Outcome?
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine used as the anaesthetic during ECT.
    Other Name: Ketalar
  • Drug: Propofol
    The standard anaesthetic used for ECT.
    Other Name: Diprivan 1%
Study Arms  ICMJE
  • Experimental: Ketamine
    Ketamine used as the anaesthetic during ECT.
    Intervention: Drug: Ketamine
  • Active Comparator: Propofol
    Propofol, the standard anaesthetic, used during ECT.
    Intervention: Drug: Propofol
Publications * Fernie G, Currie J, Perrin JS, Stewart CA, Anderson V, Bennett DM, Hay S, Reid IC. Ketamine as the anaesthetic for electroconvulsive therapy: the KANECT randomised controlled trial. Br J Psychiatry. 2017 Jun;210(6):422-428. doi: 10.1192/bjp.bp.116.189134. Epub 2017 Mar 2. Erratum in: Br J Psychiatry. 2018 May;212(5):323.

*   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 1, 2011)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01306760
Other Study ID Numbers  ICMJE CSO ETM/6
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aberdeen
Study Sponsor  ICMJE University of Aberdeen
Collaborators  ICMJE
  • NHS Grampian
  • Chief Scientist Office of the Scottish Government
Investigators  ICMJE
Principal Investigator: Ian C Reid, PhD University of Aberdeen
PRS Account University of Aberdeen
Verification Date September 2016

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