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Trial registered on ANZCTR


Registration number
ACTRN12610000998044
Ethics application status
Approved
Date submitted
28/09/2010
Date registered
17/11/2010
Date last updated
21/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study evaluating the efficacy of right unilateral and bilateral repetitive transcranial magnetic stimulation for the treatment of depression.
Scientific title
A comparative trial of sequential bilateral and unilateral right sided priming repetitive transcranial magnetic stimulation on the severity of depressive symptoms in major depressive disorder.
Secondary ID [1] 252774 0
Nil
Universal Trial Number (UTN)
U1111-1117-2577
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment Resistant Depression 258275 0
Condition category
Condition code
Mental Health 258467 258467 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Priming Right Sided Transcranial Magnetic Stimulation (TMS).

TMS will be administered with a Medtronic Magpro30 magnetic stimulator using a 70mm figure of 8 coil. Prior to the commencement of treatment TMS, single pulse TMS will be used to measure the resting motor threshold (RMT) for the abductor pollicis brevis (APB) in the right hand using standard methods

20 trains of 5 seconds duration at 6 Hz and 90% of the RMT followed by 1Hz stimulation: 110% of motor threshold, 1 continuous train of 900 pulses.

Each treatment will be administered for up to four weeks, five days per week (total of 20 treatment sessions). Patients will receive an assessment at baseline, 2 and 4 weeks and the primary study analysis will be based on this data

Each treatment will last approximately 20 minutes
Intervention code [1] 257289 0
Treatment: Devices
Comparator / control treatment
Bilateral Transcranial Magnetic Stimulation.

TMS will be administered with a Medtronic Magpro30 magnetic stimulator using a 70mm figure of 8 coil. Prior to the commencement of treatment TMS, single pulse TMS will be used to measure the Resting Motor Threshold (RMT) for the abductor pollicis brevis (APB) in the right hand using standard methods

Sequential Bilateral Dorsolateral Prefrontal Cortex (DLPFC) repetitive TMS (rTMS). Right-sided TMS at low frequency (1Hz, 110% of motor threshold, 1 continuous train of 900 pulses) followed by left-sided TMS at high frequency (10Hz, 110% of motor threshold, 15 trains of 50 pulses each with 25 second interval between trains).

Each treatment will be administered for up to four weeks, five days per week (total of 20 treatment sessions). Patients will receive an assessment at baseline, 2 and 4 weeks and the primary study analysis will be based on this data


Each treatment will last approximately 45 minutes
Control group
Active

Outcomes
Primary outcome [1] 259301 0
Hamiliton Depression Rating Scale (HAM-D)
Timepoint [1] 259301 0
Baseline and every two weeks for a total of 8 weeks
Secondary outcome [1] 265731 0
Beck Depression Inventory (BDI)
Timepoint [1] 265731 0
Baseline and every two weeks for a total of 8 weeks.

Eligibility
Key inclusion criteria
1. Have a Diagnostic and Statistical Manual -IV (DSM-IV) diagnosis of a major depressive episode.
2. Have failed to respond to adequate antidepressant medical therapy. This will be defined by at least two courses of antidepressant medication (from two medication classes) at therapeutic doses for a minimum of six weeks. Adequate daily dose will be considered to be a minimum of: 150mg of Imipramine or equivalent for tricyclic antidepressants, 20mg of Fluoxetine or equivalent for serotonin re-uptake inhibitors, 600mg of Moclobemide, 600mg of Nefazadone, 150mg of Venlafaxine, 60mg of Phenelzine or equivalent for monoamine oxidase inhibitors
3. Have a Hamilton Depression Rating Scale of > 16 (moderate – severe depression)
4. Have had no increase or initiation of new antidepressant therapy in the 4 weeks prior to screening.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who:
1. Have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating,
2. In the opinion of the investigator, are a sufficient suicidal risk to require immediate electro-convulsive therapy,
3. Have a current DSM IV 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
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257728 0
Self funded/Unfunded
Name [1] 257728 0
Address [1] 257728 0
Country [1] 257728 0
Primary sponsor type
Hospital
Name
Healthscope
Address
Level 1, 312 St Kilda Road Melbourne VIC 3004
PO Box 7586, Melbourne VIC 8004
Country
Australia
Secondary sponsor category [1] 256945 0
Individual
Name [1] 256945 0
Prof Paul Fitzgerald
Address [1] 256945 0
Level 4, 607 St Kilda Road Melbourne VIC 3004
Country [1] 256945 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259779 0
Melbourne Clinic Research Ethics Committee
Ethics committee address [1] 259779 0
Ethics committee country [1] 259779 0
Australia
Date submitted for ethics approval [1] 259779 0
Approval date [1] 259779 0
Ethics approval number [1] 259779 0

Summary
Brief summary
The purpose of this project is to help understand the most effective delivery methods for TMS treatment in Major Depression. Previous research suggests that administration of repetitive Transcranial Magnetic Stimulation (rTMS) in the frontal regions of the brain clearly has antidepressant effects (i.e. it helps people with depression) and that the response to rTMS is clinically significant in some patients. Most research conducted has used stimulation to a single side of the brain (left or right) using rTMS that is applied at either high (5-10 pulses per second) or low frequency (1 pulse per second). Recently we have conducted research that has suggested that we can improve the response to rTMS by combining low and high frequency stimulation types. We have done this when the stimulation is applied across both sides of the brain (high frequency on the left and low frequency on the right) and when we have applied both to the right side of the brain. Both seem more effective than stimulation applied in only one way. However, we have not compared these two methods to see if one is better than the other. That is the purpose of the current research trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31704 0
Prof Paul Fitzgerald
Address 31704 0
MAPrc, Level 4, 607 St Kilda Rd Melbourne VIC, 3004
Country 31704 0
Australia
Phone 31704 0
+61 3 9076 6552
Fax 31704 0
Email 31704 0
paul.fitzgerald@monash.edu
Contact person for public queries
Name 14951 0
Mrs Transcranial Magnetic Stimulation (TMS) coordinator
Address 14951 0
The Victoria Clinic
324 Malvern Road, Prahran VIC 3181
Country 14951 0
Australia
Phone 14951 0
+61 3 9520 0200
Fax 14951 0
Email 14951 0
p.fitzgerald@alfred.org.au
Contact person for scientific queries
Name 5879 0
Prof Prof. Paul Fitzgerald
Address 5879 0
The Victoria Clinic
324 Malvern Road, Prahran VIC 3181
Country 5879 0
Australia
Phone 5879 0
+61 3 9520 0200
Fax 5879 0
Email 5879 0
p.fitzgerald@alfred.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary