Condition category
Mental and Behavioural Disorders
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
25/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Declan McLoughlin

ORCID ID

Contact details

Department of Psychiatry
Trinity College Institute of Neuroscience
St Patrick’s Hospital
James’s Street
Dublin
8
Ireland
(01) 249 3200
d.mcloughlin@tcd.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 98/11/04

Study information

Scientific title

Investigating if repetitive transcranial magnetic stimulation (rTMS) was as effective as electroconvulsive therapy (ECT) in treating major depressive episodes and performing a cost-effectiveness analysis.

Acronym

Study hypothesis

1. To carry out a multi-centre Randomised Controlled Trial (RCT), with 6 months follow-up, of repetitive Transcranial Magnetic Stimulation (rTMS) versus Electroconvulsive Therapy (ECT) in patients with severe depression. Ninety patients will be entered into each arm of the trial, sufficient to obtain a 95% confidence interval to demonstrate equivalence or a subtle difference between rTMS and ECT. The objectives are:
1.1. To determine if rTMS is as effective as ECT
1.2. To determine if rTMS is associated with fewer side effects than ECT
1.3. To identify patient characteristics indicative of a beneficial response to rTMS
1.4. To ascertain patient preference for rTMS or ECT

2. To carry out a cost-effectiveness analysis of the use of rTMS versus ECT. The objectives are:
2.1. To calculate the short and longer term costs of treatment with both rTMS and ECT
2.2. To establish if there are any economic, as well as therapeutic, advantages in the use of rTMS compared to ECT in both the immediate and long term

Please note that, as of 16 January 2008, the start and end date of this trial have been updated from 1 May 2001 and 30 April 2004 to 1 August 2001 and 30 April 2005, respectively.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Depression, anxiety, neuroses

Intervention

1. Repetitive Transcranial Magnetic Stimulation (rTMS)
2. ECT

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The following will be used to obtain baseline, intra-treatment and follow-up data as appropriate:
1. The Hamilton Rating Scale for Depression, Visual Analog Mood Scale, Brief Psychiatric Rating Scale
2. Treatment side-effects and adverse events inventories
3. Cambridge Cognitive Examination (CAMCOG) plus specific tests of memory and frontal-executive function
4. Client Service Receipt Inventory and attendant methodologies for estimating unit costs of services and costs of treatment/care packages falling to the family and the NHS

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2001

Overall trial end date

30/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All in-patients referred for ECT with severe depressive episodes (Diagnostic Research Criteria [DCR-10]), including patients refractory to standard medical/psychological treatments

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

46 enrolled

Participant exclusion criteria

1. Age under 18 years
2. Evidence of dementia
3. History of substance misuse in previous 6 months
4. Schizophrenia or other functional psychosis
5. History of epilepsy or recent Cardiovascular Accident (CVA)/Myocardial Infarction (MI)/cardiac failure
6. Medically unfit to receive anaesthetic
7. Electronic and metallic implants or foreign bodies
8. Raised intracranial pressure
9. Inability to provide informed consent

Recruitment start date

01/08/2001

Recruitment end date

30/04/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychiatry
Dublin
8
Ireland

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
0113 2546186 (S Greener)
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Not defined

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

1. 2007 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/17580003
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17202547

Publication citations

  1. HTA monograph

    McLoughlin DM, Mogg A, Eranti S, Pluck G, Purvis R, Edwards D, Landau S, Brown R, Rabe-Heskith S, Howard R, Philpot M, Rothwell J, Romeo R, Knapp M, The clinical effectiveness and cost of repetitive transcranial magnetic stimulation versus electroconvulsive therapy in severe depression: a multicentre pragmatic randomised controlled trial and economic analysis., Health Technol Assess, 2007, 11, 24, 1-54.

  2. Results

    Eranti S, Mogg A, Pluck G, Landau S, Purvis R, Brown RG, Howard R, Knapp M, Philpot M, Rabe-Hesketh S, Romeo R, Rothwell J, Edwards D, McLoughlin DM, A randomized, controlled trial with 6-month follow-up of repetitive transcranial magnetic stimulation and electroconvulsive therapy for severe depression., Am J Psychiatry, 2007, 164, 1, 73-81, doi: 10.1176/appi.ajp.164.1.73.

Additional files

Editorial Notes