Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000044729
Ethics application status
Approved
Date submitted
14/01/2013
Date registered
14/01/2013
Date last updated
23/06/2022
Date data sharing statement initially provided
23/06/2022
Date results information initially provided
23/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Accelerated Repetitive Transcranial Magnetic Stimulation in the Treatment Of Depression
Scientific title
A Study of the Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in the Treatment of Depression
Secondary ID [1] 281750 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment Resistant Major Depression 288059 0
Mental Health 288060 0
Major Depressive Disorder 326754 0
Condition category
Condition code
Mental Health 288432 288432 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Repetitive Transcranial Magnetic Stimulation (rTMS).

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

Patients will be randomised to one of two treatment conditions:

1. Three treatment sessions daily over three consecutive days in week one, two days in week two and one day in week three (total of 18 treatments). The three treatment sessions will provide 83, 83 and 84 trains respectively of 10 Hz rTMS to the left DLPFC. 4.5 second trains will be applied at 120% of the resting motor threshold with a 15 second inter-train interval, each session will take approximately 27 minutes (10,500 pulses per day across the three sessions).

2. Daily treatment sessions provided on week days over four consecutive weeks (total of 20 treatments). Each treatment sessions will involve the provision of 75 trains of 10Hz rTMS to the left DLPFC. 4.5 second trains will be applied at 120% of the resting motor threshold with a 10 second inter-train interval (3150 pulses per session over 24 minutes).

Patients will receive an assessment at baseline, 1, 2, 3, and 4 weeks (briefer assessments at weeks 1, 2 and 3), and the primary study analysis will be based on this data.

Intervention code [1] 286290 0
Treatment: Devices
Comparator / control treatment
Standard daily repetitive Transcranial Magnetic Stimulation, as described above
Control group
Dose comparison

Outcomes
Primary outcome [1] 288602 0
Change in severity of depressive symptoms, defined as: Hamilton Depression Rating Scale (HAMD; 17 item version) - Clinical response defined as a reduction of at least 50% from baseline, clinical remission defined as a score <8.
Timepoint [1] 288602 0
Week 4, after completion of treatment.
Secondary outcome [1] 300609 0
Change in severity of depressive symptoms as shown by score on the Montgomery Asperg Depression Rating Scale (MADRS).
Timepoint [1] 300609 0
Week 4, after completion of treatment
Secondary outcome [2] 300610 0
Change in severity of depressive symptoms as shown by score on the Beck Depression Inventory (BDI)
Timepoint [2] 300610 0
Week 4, after completion of treatment
Secondary outcome [3] 300611 0
Score on Scale of Suicidal Ideation (SSI)
Timepoint [3] 300611 0
Week 4

Eligibility
Key inclusion criteria
Patients will be included if they:
1. Have a DSM-IV diagnosis of a Major Depressive Episode

2. Have treatment resistant depression at Stage II of the Thase and Rush Classification

3. Have a Hamilton Depression Rating Scale of >20 (moderate-severe depresssion).

4. Have had no increase in, or initiation of new antidepressant (or other psychoactive) therapy in the four weeks prior to screening.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have an unstable medical condition(s), neurological disorder or any history of a seizure disorder or are currently pregnant or lactating or are professional drivers.

2. Have a current DSM-IV diagnosis of Substance Abuse or Dependence disorder, a diagnosis of a personality disorder (SCID II), 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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2013
Actual
1/02/2013
Date of last participant enrolment
Anticipated
Actual
1/02/2017
Date of last data collection
Anticipated
Actual
1/04/2017
Sample size
Target
120
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 286542 0
Government body
Name [1] 286542 0
National Health and Medical Research Council (NHMRC)
Country [1] 286542 0
Australia
Primary sponsor type
Individual
Name
Professor Paul Fitzgerald
Address
Monash Alfred Psychiatry Research Centre
Level 4
607 St Kilda Rd
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 285329 0
None
Name [1] 285329 0
Address [1] 285329 0
Country [1] 285329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288611 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 288611 0
Alfred Hospital
Commercial Rd
Prahran
VIC 3181
Ethics committee country [1] 288611 0
Australia
Date submitted for ethics approval [1] 288611 0
Approval date [1] 288611 0
21/12/2012
Ethics approval number [1] 288611 0

Summary
Brief summary
Major depressive disorder is a severe illness of high prevalence. A significant percentage of patients fail to respond to standard treatments and continue to experience marked disability and high morbidity. Repetitive transcranial magnetic stimulation (rTMS) has been subject to intensive evaluation as an antidepressant strategy especially in patients with treatment resistant depression (TRD). Previous research conducted by our group and others clearly indicates that rTMS has antidepressant activity and that the response to rTMS is clinically meaningful. It is now being increasingly used in clinical practice in the US and more recently in Australia. A major barrier to the utilisation of rTMS is a relatively slow rate of response to treatment, often requiring daily treatments over a four to six week period. Therefore rTMS, as it currently stands, requires a considerable time commitment from both patients and clinicians. In addition, it is not considered appropriate for acutely suicidal patients, with these patients currently requiring treatment with electroconvulsive therapy (ECT) as this is clearly the most rapidly acting antidepressant treatment. If the time to response to rTMS could be substantially compressed, the treatment would be cheaper to administer and more acceptable to patients. In addition, it would also become a viable alternative strategy for the treatment of patients with acute suicidal ideation and other acute depression related risks, for example patients who have stopped eating and drinking and require intervention with a rapidly acting treatment.

Therefore, the primary goal of this study is to investigate whether response to rTMS can be substantially enhanced through the use of an accelerated treatment protocol. We will compare antidepressant response between a standard and an accelerated rTMS protocol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36930 0
Prof Paul Fitzgerald
Address 36930 0
MAPrc
Level 4
607 St Kilda Rd
Melbourne
VIC 3004
Country 36930 0
Australia
Phone 36930 0
+61 3 9076 6564
Fax 36930 0
Email 36930 0
paul.fitzgerald@monash.edu
Contact person for public queries
Name 36931 0
Dr Sally Herring
Address 36931 0
MAPrc
Level 4
607 St Kilda Rd
Melbourne
VIC 3004
Country 36931 0
Australia
Phone 36931 0
+61 3 9076 6596
Fax 36931 0
Email 36931 0
sally.herring@monash.edu
Contact person for scientific queries
Name 36932 0
Prof Paul Fitzgerald
Address 36932 0
MAPrc
Level 4
607 St Kilda Rd
Melbourne
VIC 3004
Country 36932 0
Australia
Phone 36932 0
+61 3 9076 6564
Fax 36932 0
Email 36932 0
paul.fitzgerald@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Published on: 05 February 2018 Fitzgerald, P. B... [More Details] 363468-(Uploaded-22-06-2022-13-13-21)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAccelerated repetitive transcranial magnetic stimulation in the treatment of depression.2018https://dx.doi.org/10.1038/s41386-018-0009-9
Dimensions AIDepressive symptom trajectories associated with standard and accelerated rTMS2020https://doi.org/10.1016/j.brs.2020.02.021
N.B. These documents automatically identified may not have been verified by the study sponsor.