Condition category
Mental and Behavioural Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/09/2014
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 Joe Johnson

ORCID ID

Contact details

Newsham Ward
Broadoak Unit
Broadgreen Hospital
Thomas Drive
Liverpool
L14 3PJ
United Kingdom
+44 (0) 151 250 5075

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0156116088

Study information

Scientific title

Acronym

Study hypothesis

It is hypothesised that bilateral transcranial magnetic stimulation (TMS) produces a more rapid symptom response than unilateral TMS in the treatment of major depression.

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind placebo-controlled crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Mental and Behavioural Disorders: Depression

Intervention

Unilateral rTMS versus bilateral TMS versus sham TMS.

The study will be done in two phases. Phase 1 will be done as a pilot study aimed at generating a power calculation to determine the size of the subsequent trial (Phase 2).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

It is hoped that the outcome of this project will be improvements in symptom rating scales in depression using the Hamilton Rating Scale and the Beck Depression Inventory

Secondary outcome measures

Not provided at time of registration

Overall trial start date

22/07/2002

Overall trial end date

22/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Suitable subjects will be recruited from the outpatient clinics and inpatient units within Mersey Care NHS Trust in Liverpool, who have been diagnosed as having depression using the Hamilton Depression Rating Scale and Beck Depression Inventory, and are between the ages of 16 to 65 years.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

22/07/2002

Recruitment end date

22/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newsham Ward
Liverpool
L14 3PJ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Mersey Care NHS Trust (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

Publication citations

Additional files

Editorial Notes