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| [ Print-friendly version ] |
| Clinical effectiveness and cost of repetitive transcranial magnetic stimulation versus electroconvulsive therapy in severe depression: a multi-centre randomised controlled trial and economic analysis |
| ISRCTN | ISRCTN67096930 |
| ClinicalTrials.gov identifier | |
| 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 | |
| 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 |
| 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 |
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.
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 |
HTA monograph on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17580003
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17202547 |
| Contact name | Dr Declan McLoughlin |
| Address |
Department of Psychiatry
Trinity College Institute of Neuroscience St Patrick’s Hospital James’s Street |
| City/town | Dublin 8 |
| Zip/Postcode | - |
| Country | Ireland |
| Tel | +353 (0)1 2493343 |
| d.mcloughlin@tcd.ie | |
| Sponsor | Department of Health (UK) |
| Address |
Quarry House
Quarry Hill |
| City/town | Leeds |
| Zip/Postcode | LS2 7UE |
| Country | United Kingdom |
| Sheila.Greener@doh.gsi.gov.uk | |
| Sponsor website: | http://www.dh.gov.uk/en/index.htm |
| Date applied | 25/04/2003 |
| Last edited | 16/01/2008 |
| Date ISRCTN assigned | 25/04/2003 |
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