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
Protocol serial number	N/A
Sponsor	South London and Maudsley NHS Trust (UK)
Funder	Guy's & St Thomas' Charitable Foundation (R001126) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Declan McLoughlin
Scientific

Section of Old Age Psychiatry PO70
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Phone	+44 (0)20 78480547
Email	d.mcloughlin@iop.kcl.ac.uk

Primary study design	Interventional
Study design	Parallel group randomised placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	TMSplus Trial
Study objectives	TMS can be used as an adjunctive treatment for depression
Ethics approval(s)	Institute of Psychiatry Ethical Committee (Research), ref: 251/00
Health condition(s) or problem(s) studied	Major depressive disorder
Intervention	Real or sham repetitve transcranial magnetic stimulation (rTMS)
Intervention type	Other
Primary outcome measure(s)	Hamilton Rating Scale for Depression (HDRS)
Key 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)
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	54
Key inclusion criteria	Over 18 years old, right-handed and have a diagnosis of major depressive disorder (DSM-IV)
Key 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
Date of first enrolment	01/03/2002
Date of final enrolment	31/12/2005

Section of Old Age Psychiatry PO70

London
SE5 8AF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2008		Yes	No