The Use of Ketamine as an Anaesthetic During Electroconvulsive Therapy

NCT ID: NCT01306760

Last Updated: 2016-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ketamine

Ketamine used as the anaesthetic during ECT.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Ketamine used as the anaesthetic during ECT.

Propofol

Propofol, the standard anaesthetic, used during ECT.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

The standard anaesthetic used for ECT.

Interventions

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Ketamine

Ketamine used as the anaesthetic during ECT.

Intervention Type DRUG

Propofol

The standard anaesthetic used for ECT.

Intervention Type DRUG

Other Intervention Names

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Ketalar Diprivan 1%

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Grampian

OTHER_GOV

Sponsor Role collaborator

Chief Scientist Office of the Scottish Government

OTHER_GOV

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian C Reid, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

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Royal Cornhill Hospital, NHS Grampian

Aberdeen, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 28254962 (View on PubMed)

Other Identifiers

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CSO ETM/6

Identifier Type: -

Identifier Source: org_study_id

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