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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
Scientific title
A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
Secondary ID [1] 0 0
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

Study type
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

Primary outcome [1] 0 0
The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis.
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

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
Both males and females
Can healthy volunteers participate?
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

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
The Alfred

Ethics approval
Ethics application status

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).
Trial website
Trial related presentations / publications
Public notes

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

Summary results
Other publications