Condition category
Signs and Symptoms
Date applied
19/04/2006
Date assigned
07/06/2006
Last edited
06/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Klaus Ebmeier

ORCID ID

Contact details

Kennedy Tower
Morningside Park
Edinburgh
EH10 5HF
United Kingdom
+44 (0)131 5376505
k.ebmeier@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0401083

Study information

Scientific title

Acronym

Study hypothesis

We propose a two-year pilot randomised controlled trial of electroconvulsive treatment (ECT) versus magnetic seizure therapy (MST) in 80 Edinburgh patients recruited from 100 new treatment courses started per year in Edinburgh (75 after giving informed consent) to examine the following questions:
1. Is MST less liable than ECT to cause anterograde and retrograde memory impairment and what is the likely size of the effect?
2. Is MST equally effective to ECT within the power of a moderately large randomised study with blind evaluation of symptom change?
3. Is MST more user-friendly and user-acceptable than ECT?
4. What is the balance of cost versus benefit comparing ECT and MST in patients referred for ECT?

Ethics approval

Ethics approval not yet received as of 07/06/06

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Memory impairment

Intervention

1. Randomisation to either ECT or MST groups
2. ECT protocol (treatment as usual): ECT will be administered in line with the latest guidelines from the Royal College of Psychiatrists. Seizure threshold will be measured at the outset of treatment, bilateral ECT given with a dose 50% above threshold, and right unilateral ECT given with a dose initially 300% above threshold. Treatment will be given with a modern constant current ECT machine using doses of 100-400 mC (mode = 150 mC, 800 mA, 20-120 Hz; pulse width 1 ms; MECTA Spectrumâ„¢ 5000 M), and monitored by electroencephalogram (EEG). The clinical team responsible for the patient will determine the need for and duration of treatment, usually between 6 and 12 treatments.
3. MST protocol: MST will be administered mirroring the dose titration process above. Prefrontal coil placement will be used with a stimulation frequency between 50 and 100 Hz at various output strengths. Seizures will be monitored using EEG (split electrodes to prevent heating). The clinical team responsible for the patient will determine the need for and duration of treatment, usually between 6 and 12 treatments. The responsible team can request exit from the protocol and transfer to ECT, if there are clinical concerns, such as deterioration or emerging suicidality.

Added 06/10/09: the trial was stopped due to participant recruitment issues.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Last follow-up six months after course of treatment of last recruited subject recruited before 31st March 2008 or 80th subject recruited

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2006

Overall trial end date

31/05/2008

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

1. Referred to and accepted by ECT service for treatment of major depressive episode
2. Able to give informed consent to ECT and to trial procedure
3. If patient is detained, ECT would be given with patient's consent (valid T2 form completed)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2 x 40

Participant exclusion criteria

1. Contraindications for ECT or anaesthesia
2. Unable or unwilling to give informed consent to ECT or to trial procedure
3. Patients with organic diagnoses (e.g. dementia, schizophrenia and substance abuse)
4. Patients with metallic implants or pacemakers
5. Pregnancy
6. Aged <18 years

Recruitment start date

01/04/2006

Recruitment end date

31/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Kennedy Tower
Edinburgh
EH10 5HF
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

The University of Edinburgh
Old College
South Bridge
Edinburgh
EH8 9YL
United Kingdom

Sponsor type

University/education

Website

http://www.ed.ac.uk/contact.html

Funders

Funder type

Government

Funder name

The Medical Research Council (MRC) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes