Condition category
Mental and Behavioural Disorders
Date applied
07/02/2007
Date assigned
05/03/2007
Last edited
03/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Declan McLoughlin

ORCID ID

Contact details

Section of Old Age Psychiatry PO70
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 78480547
d.mcloughlin@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

TMSplus Trial

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Major depressive disorder

Intervention

Real or sham repetitve transcranial magnetic stimulation (rTMS)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/03/2002

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Over 18 years old, right-handed and have a diagnosis of major depressive disorder (DSM-IV)

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

54

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

United Kingdom

Trial participating centre

Section of Old Age Psychiatry PO70
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

South London and Maudsley NHS Trust (UK)

Sponsor details

Denmark Hill
London
SE5 8AZ
London
SE5 8AZ
United Kingdom

Sponsor type

Government

Website

http://www.slam.nhs.uk/

Funders

Funder type

Charity

Funder name

Guy's & St Thomas' Charitable Foundation (R001126) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17935639

Publication citations

  1. Results

    Mogg A, Pluck G, Eranti SV, Landau S, Purvis R, Brown RG, Curtis V, Howard R, Philpot M, McLoughlin DM, A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression., Psychol Med, 2008, 38, 3, 323-333, doi: 10.1017/S0033291707001663.

Additional files

Editorial Notes