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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Aberdeen.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
NHS Grampian
Chief Scientist Office of the Scottish Government
Information provided by:
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01306760
First received: March 1, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 1, 2011
March 1, 2011
March 2011
April 2013   (final data collection date for primary outcome measure)
Change in depressive symptoms [ Time Frame: After 4th treatment ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
  • Cognitive side-effects [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
The Use of Ketamine as an Anaesthetic During Electroconvulsive Therapy
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Drug: Ketamine
    Ketamine used as the anaesthetic during ECT.
    Other Name: Ketalar
  • Drug: Propofol
    The standard anaesthetic used for ECT.
    Other Name: Diprivan 1%
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
June 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Ian C Reid, PhD +44(0)1224557950 i.reid@abdn.ac.uk
United Kingdom
 
NCT01306760
CSO ETM/6
Not Provided
Professor Ian Reid, University of Aberdeen
University of Aberdeen
  • NHS Grampian
  • Chief Scientist Office of the Scottish Government
Principal Investigator: Ian C Reid, PhD University of Aberdeen
University of Aberdeen
March 2011

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