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

This study is not yet open for participant recruitment.
Verified March 2011 by University of Aberdeen
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
  Purpose

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.


Condition Intervention Phase
Depression
 Drug: Ketamine
Drug: Propofol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Ketamine as an Anaesthetic During Electroconvulsive Therapy (ECT) for Depression: Does it Improve Treatment Outcome?

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine
Ketamine used as the anaesthetic during ECT.
 Drug: Ketamine
Ketamine used as the anaesthetic during ECT.
Other Name: Ketalar
Active Comparator: Propofol
Propofol, the standard anaesthetic, used during ECT.
 Drug: Propofol
The standard anaesthetic used for ECT.
Other Name: Diprivan 1%

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306760

Contacts
Contact: Ian C Reid, PhD +44(0)1224557950 i.reid@abdn.ac.uk

Locations
United Kingdom
Royal Cornhill Hospital, NHS Grampian Not yet recruiting
Aberdeen, United Kingdom, AB25 2ZH
Contact: Ian C Reid, PhD     +44(0)1224557950     i.reid@abdn.ac.uk    
Sub-Investigator: Jennifer S Perrin, PhD, MA, BSc            
Sponsors and Collaborators
University of Aberdeen
NHS Grampian
Chief Scientist Office of the Scottish Government
Investigators
Principal Investigator: Ian C Reid, PhD University of Aberdeen
  More Information

No publications provided

Responsible Party: Professor Ian Reid, University of Aberdeen
ClinicalTrials.gov Identifier: NCT01306760     History of Changes
Other Study ID Numbers: CSO ETM/6
Study First Received: March 1, 2011
Last Updated: March 1, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Aberdeen:
depression
electroconvulsive therapy
ketamine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anesthetics
Ketamine
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 23, 2013