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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67096930 |
| Secondary identifying numbers | HTA 98/11/04 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 25/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Declan McLoughlin
Scientific
Scientific
Department of Psychiatry
Trinity College Institute of Neuroscience
St Patricks Hospital
Jamess Street
Dublin
8
Ireland
| Phone | (01) 249 3200 |
|---|---|
| d.mcloughlin@tcd.ie |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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. |
| 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(s) | Not provided at time of registration |
| Condition | Depression, anxiety, neuroses |
| Intervention | 1. Repetitive Transcranial Magnetic Stimulation (rTMS) 2. ECT |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/08/2001 |
| Overall study end date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 46 enrolled |
| 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 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
- Ireland
- United Kingdom
Study participating centre
Department of Psychiatry
Dublin
8
Ireland
8
Ireland
Sponsor information
Department of Health (UK)
Not defined
Not defined
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | 0113 2546186 (S Greener) |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2007 | Yes | No | |
| Other publications | HTA monograph | 01/07/2007 | Yes | No |
