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Clinical effectiveness and cost of repetitive transcranial magnetic stimulation versus electroconvulsive therapy in severe depression: a multi-centre randomised controlled trial and economic analysis
DOI 10.1186/ISRCTN67096930
ClinicalTrials.gov identifier
EudraCT number
Public title Clinical effectiveness and cost of repetitive transcranial magnetic stimulation versus electroconvulsive therapy in severe depression: a multi-centre randomised controlled trial and economic analysis
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 N/A
Serial number at source HTA 98/11/04
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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Depression, anxiety, neuroses
Participants - 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
Participants - 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
Anticipated start date 01/08/2001
Anticipated end date 30/04/2005
Status of trial Completed
Patient information material
Target number of participants 46 enrolled
Interventions 1. Repetitive Transcranial Magnetic Stimulation (rTMS)
2. ECT
Primary outcome measure(s) 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 measure(s) Not provided at time of registration
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 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
Contact name Dr  Declan  McLoughlin
  Address Department of Psychiatry
Trinity College Institute of Neuroscience
St Patrickís Hospital
Jamesís Street
  City/town Dublin
  Zip/Postcode 8
  Country Ireland
  Tel (01) 249 3200
  Email d.mcloughlin@tcd.ie
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Tel 0113 2546186 (S Greener)
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 25/04/2003
Last edited 25/11/2010
Date ISRCTN assigned 25/04/2003
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