Clinical effectiveness of repetitve transcranial magnetic stimulation (rTMS) as an adjunctive therapy in depression - a catchment area-based randomised controlled trial
| ISRCTN | ISRCTN70121208 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70121208 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/02/2007
- Registration date
- 05/03/2007
- Last edited
- 03/05/2011
- 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
Section of Old Age Psychiatry PO70
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 78480547 |
|---|---|
| d.mcloughlin@iop.kcl.ac.uk |
Study information
| Study design | Parallel group randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | TMSplus Trial |
| Study hypothesis | TMS can be used as an adjunctive treatment for depression |
| Ethics approval(s) | Institute of Psychiatry Ethical Committee (Research), ref: 251/00 |
| Condition | Major depressive disorder |
| Intervention | Real or sham repetitve transcranial magnetic stimulation (rTMS) |
| Intervention type | Other |
| Primary outcome measure | Hamilton Rating Scale for Depression (HDRS) |
| Secondary outcome measures | 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) |
| Overall study start date | 01/03/2002 |
| Overall study end date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 54 |
| Participant inclusion criteria | Over 18 years old, right-handed and have a diagnosis of major depressive disorder (DSM-IV) |
| Participant 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 |
| Recruitment start date | 01/03/2002 |
| Recruitment end date | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Section of Old Age Psychiatry PO70
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
South London and Maudsley NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Denmark Hill
London
SE5 8AZ
London
SE5 8AZ
England
United Kingdom
| Website | http://www.slam.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/015803449 |
Funders
Funder type
Charity
Guy's & St Thomas' Charitable Foundation (R001126) (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 | 01/03/2008 | Yes | No |
