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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00168272




Registration number
NCT00168272
Ethics application status
Date submitted
14/09/2005
Date registered
15/09/2005
Date last updated
16/04/2007

Titles & IDs
Public title
Priming rTMS In Major Depression
Scientific title
A Randomised Double-Blind Trial of Low and High Frequency Stimulation rTMS (Repetitive Transcranial Magnetic Stimulation) In Major Depression
Secondary ID [1] 0 0
5/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Transcranial Magnetic Stimulation

Treatment: Devices: Transcranial Magnetic Stimulation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). At study end response criteria is defined as a 50% reduction in total MADRS score and remission defined as less or equal to 10.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale), CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical Global Impression Scale), GAF (Global Assessment of Functioning Scale).
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Moderate to severe depressive symptoms as indicated as MADRS >20

- Failure to respond to a minimum of two antidepressant medications

- No increase or initiation of new antidepressant therapy in the four weeks prior to
entering the trial
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have an unstable medical condition, neurological disorder or any history of seizure
disorder or are currently pregnant or lactating

- Previous brain injury or surgery, any metal clips, plates or other metal items in the
head, cardiac pacemaker

- In the opinion of the investigator, are a sufficient suicide risk to require immediate
electro-convulsive therapy

- Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis
of a personality disorder or another axis 1 disorder

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assist in understanding the most effective parameters for TMS
in Depressive Disorders. Most research conducted has used high frequency stimulation on the
left hemisphere.However, low frequency on the right hemisphere has also been shown to have
antidepressant properties and appears to be better tolerated. A promising approach to improve
responses to rTMS may be to combine high and low frequency stimulation where they are both
applied to the right side of the brain. In this approach, high frequency stimulation is
provided first which may 'prime' or pre-prepare the brain for low frequency stimulation in a
way that enhances its response. Participants are randomised to receive active or placebo
priming stimulation.If participants do not respond to this treatment condition after 10
sessions applied over a two week period they will be offered 10 session of high frequency
left sided TMS treatment. Alternatively, if participants respond favorably they may continue
with that treatment condition for another 10 sessions.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00168272
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul B Fitzgerald, MBBS, PhD
Address 0 0
Alfred Psychiatry Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries