Clinical effectiveness and cost of repetitive transcranial magnetic stimulation versus electroconvulsive therapy in severe depression: a multi-centre randomised controlled trial and economic analysis
Completed
- Conditions
- Depression, anxiety, neurosesMental and Behavioural DisordersDepression
- Registration Number
- ISRCTN67096930
- Lead Sponsor
- Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The following will be used to obtain baseline, intra-treatment and follow-up data as appropriate: <br>1. The Hamilton Rating Scale for Depression, Visual Analog Mood Scale, Brief Psychiatric Rating Scale<br>2. Treatment side-effects and adverse events inventories<br>3. Cambridge Cognitive Examination (CAMCOG) plus specific tests of memory and frontal-executive function<br>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
Name Time Method ot provided at time of registration