|
Welcome
|
|
02 September 2010
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Clinical effectiveness of repetitve transcranial magnetic stimulation (rTMS) as an adjunctive therapy in depression - a catchment area-based randomised controlled trial |
| ISRCTN | ISRCTN70121208 |
| ClinicalTrials.gov identifier | |
| Public title | Clinical effectiveness of repetitve transcranial magnetic stimulation (rTMS) as an adjunctive therapy in depression - a catchment area-based randomised controlled trial |
| Scientific title | |
| Acronym | TMSplus Trial |
| Serial number at source | N/A |
| Study hypothesis | TMS can be used as an adjunctive treatment for depression |
| Ethics approval | Institute of Psychiatry Ethical Committee (Research), ref: 251/00 |
| Study design | Parallel group randomised placebo-controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Major depressive disorder |
| Participants - inclusion criteria | Over 18 years old, right-handed and have a diagnosis of major depressive disorder (DSM-IV) |
| Participants - exclusion criteria |
1. History of seizures
2. Head injury with loss of consciousness 3. Brain surgery 4. Presence of metallic implants 5. Evidence of dementia or other Axis 1 diagnosis 6. Substance misuse within the previous six months 7. Previous treatment with rTMS 8. Inability to provide informed consent |
| Anticipated start date | 01/03/2002 |
| Anticipated end date | 31/12/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 54 |
| Interventions | Real or sham repetitve transcranial magnetic stimulation (rTMS) |
| Primary outcome measure(s) | Hamilton Rating Scale for Depression (HDRS) |
| Secondary outcome measure(s) |
Clinical:
1. Beck Depression Inventory-II (BDI-II) 2. Visual Analogue Mood Scales (VAMS) 3. Brief Psychiatric Rating Scale (BPRS) Subjective side-effects: 1. Modified Columbia ECT Subjective Side Effects Schedule (CSSES) Cognition: 1. CAMCOG, digit-span test 2. Digit symbols modalities test 3. Grooved pegboard test Quality of life: SF-36 questionnaire Economic: Client Service Receipt Inventory (CSRI) |
| Sources of funding | Guy's & St Thomas' Charitable Foundation (R001126) (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Declan McLoughlin |
| Address |
Section of Old Age Psychiatry PO70
Institute of Psychiatry De Crespigny Park |
| City/town | London |
| Zip/Postcode | SE5 8AF |
| Country | United Kingdom |
| Tel | +44 (0)20 78480547 |
| d.mcloughlin@iop.kcl.ac.uk | |
| Sponsor | South London and Maudsley NHS Trust (UK) |
| Address |
Denmark Hill
London SE5 8AZ |
| City/town | London |
| Zip/Postcode | SE5 8AZ |
| Country | United Kingdom |
| Sponsor website: | http://www.slam.nhs.uk/ |
| Date applied | 07/02/2007 |
| Last edited | 05/03/2007 |
| Date ISRCTN assigned | 05/03/2007 |
|
|
|
|
|
| © 2010 ISRCTN unless otherwise stated. | |
|
|
|
|