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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/NCT00168376
Registration number
NCT00168376
Ethics application status
Date submitted
14/09/2005
Date registered
15/09/2005
Date last updated
16/04/2007
Titles & IDs
Public title
A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
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Scientific title
A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
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Secondary ID [1]
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57/04
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Transcranial Magnetic Stimulation
Treatment: Devices: Transcranial Magnetic Stimulation
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis.
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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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).
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Assessment method [1]
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Timepoint [1]
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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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
electroconvulsive therapy
- Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis
of a personality disorder or another axis 1 disorder
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Study design
Purpose of the study
Educational/counselling/training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2006
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Psychiatry Research Centre - Melbourne
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Recruitment postcode(s) [1]
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3181 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The study will involve a 3-week (15 session) randomized double-blind clinical trial of two
repetitive transcranial magnetic stimulation (rTMS) conditions in patients with treatment
resistant depression. rTMS site selection will be localized from structural MRI scans.
The patients will be randomized to one of two conditions
1. rTMS targeted to the border of Brodmann area 46 and Brodmann area 9,
2. rTMS targeted to premotor cortex (this condition will act as the non-dorsolateral
prefrontal cortex targeted control).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00168376
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul B Fitzgerald, MBBS, PhD
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Address
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Alfred Psychiatry Research Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00168376
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