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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list