The Use of Ketamine as an Anaesthetic During Electroconvulsive Therapy

Depression Clinical Trial

— KANECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306760
• Other study ID #: CSO ETM/6
• Status: Completed
• Phase: Phase 4
• First received: March 1, 2011
• Last updated: September 7, 2016
• Start date: March 2011
• Est. completion date: February 2014

Study information

• Verified date: September 2016
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Ketamine
Ketamine used as the anaesthetic during ECT.
• Propofol
The standard anaesthetic used for ECT.

Locations

Country	Name	City	State
United Kingdom	Royal Cornhill Hospital, NHS Grampian	Aberdeen

Sponsors (3)

Lead Sponsor	Collaborator
University of Aberdeen	Chief Scientist Office of the Scottish Government, NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depressive symptoms	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	No
Secondary	Cognitive side-effects	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	No
Secondary	Change in depressive symptoms after treatment	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	No