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 Spectrum™ 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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list