Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000145606
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
15/08/2005
Date last updated
4/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Repetitive Transcranial Magnetic Stimulation (rTMS) in the treatment of depression.
Scientific title
Repetitive Transcranial Magnetic Stimulation (rTMS) in the treatment of depression, assessed with HAMD-21 over a four week period.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression. 235 0
Condition category
Condition code
Mental Health 266 266 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active control comparison of two different rTMS parameter sets, over the left dorsolateral prefrontal cortex. Additional to current medication.
a) 10Hz frequency. 100% MT.
b) Variable frequency dependent upon background activity. 100% MT.
Intervention code [1] 155 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 316 0
Rating scales for depression for clinicians (Hamilton 21 point).
Timepoint [1] 316 0
Before and after four weeks of treatment.
Primary outcome [2] 317 0
Rating scales for depression, self administered (Beck Depression Inventory).
Timepoint [2] 317 0
Before and after four weeks of treatment.
Secondary outcome [1] 704 0
EEG recordings and a battery of cognition tests will also be administered.
Timepoint [1] 704 0
Prior to treatment, after 4 weeks treatment, and 6 months post treatment.

Eligibility
Key inclusion criteria
Minimum age
No limit
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A random sequence was generated prior to recruitment, and used to allocate from a central station by phone. Staff involved in intervention or assessment have no access to the sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer package (SPSS for Windows11.5) randomly selected from 200 cases. Participants assigned in sequence of recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 323 0
Government body
Name [1] 323 0
WA Health Department
Country [1] 323 0
Australia
Primary sponsor type
University
Name
Centre for Clinical Research in Neuropsychiatry
Address
Country
Australia
Secondary sponsor category [1] 254 0
Government body
Name [1] 254 0
North Metropolitan Area Health Service
Address [1] 254 0
Country [1] 254 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1236 0
Human Research Ethics Committee,North Metropolitan Health Service, Perth
Ethics committee address [1] 1236 0
Ethics committee country [1] 1236 0
Australia
Date submitted for ethics approval [1] 1236 0
Approval date [1] 1236 0
Ethics approval number [1] 1236 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35205 0
Address 35205 0
Country 35205 0
Phone 35205 0
Fax 35205 0
Email 35205 0
Contact person for public queries
Name 9344 0
Dr Greg Price
Address 9344 0
Centre for Clinical Research in Neuropsychiatry
John XXIII Avenue
Mount Claremont WA 6010
Country 9344 0
Australia
Phone 9344 0
+61 8 93476493
Fax 9344 0
+61 8 93845128
Email 9344 0
[email protected]
Contact person for scientific queries
Name 272 0
Dr Joseph Lee
Address 272 0
Graylands Hospital
Brockway Road
Mount Claremont WA 6010
Country 272 0
Australia
Phone 272 0
+61 8 93476801
Fax 272 0
+61 8 93852701
Email 272 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.