Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001953224
Ethics application status
Approved
Date submitted
29/11/2018
Date registered
3/12/2018
Date last updated
20/12/2021
Date data sharing statement initially provided
3/12/2018
Date results information initially provided
28/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A New Zealand Neuroimaging Study of Repetitive Transcranial
Magnetic Stimulation (rTMS) in Treatment-Resistant Depression as assessed by the Montgomery–Åsberg Depression Rating Scale.
Scientific title
A New Zealand Neuroimaging Study of Repetitive Transcranial
Magnetic Stimulation (rTMS) in Treatment-Resistant Depression as assessed by the Montgomery–Åsberg Depression Rating Scale.
Secondary ID [1] 296738 0
Nil
Universal Trial Number (UTN)
Trial acronym
TMSTRD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder 310607 0
Condition category
Condition code
Mental Health 309321 309321 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4,000 pulses of transcranial magnetic stimulation delivered by the research team to the left dorsal prefrontal cortex, at 10 Hz for 5 seconds every 15 seconds at 120% of motor threshold per session. Sessions will be completed each week day for 4 weeks (20 sessions). Stimulation location will be determined using the Beam F3 Method.
Intervention code [1] 313044 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308284 0
Change in depressive symptomology measured with the Montgomery-Asberg Depression Rating Scale
Timepoint [1] 308284 0
At the completion of 20 rTMS treatment sessions (~4 weeks after treatment commences).
Secondary outcome [1] 354519 0
Concentration of GABA in the left dorsalateral prefrontal cortex as measured with magnetic resonance spectroscopy
Timepoint [1] 354519 0
At the completion of 20 rTMS treatment sessions (~4 weeks after treatment commences).

Eligibility
Key inclusion criteria
• Patient is willing and able to give informed consent for participation in the trial
• Male or female, aged 18 years or above
• In the Investigators’ opinion, is able and willing to comply with all trial requirements
• Major depressive disorder for at least three months, as assessed by a Clinical Interview using DSM-IV criteria
• MADRS >20
An inadequate response to at least two antidepressants courses one of which can include the current episode.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Contraindications to repetitive transcranial magnetic stimulation, assessed using the University of Auckland safety checklist
• Contraindications for MRI as per the CAMRI screening form
• History of psychosis
• Any unstable medical or neurologic condition
• Planned major changes to psychotropic medication
• Imminent risk of suicide as determined by the CSSRS and clinical interview with a consultant psychiatrist
• Planned or probable use of ECT
• >2 years of depressive episode
• Substance abuse or dependence in previous 6 months
• Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial
• Regular use of any medication deemed to be contraindicating as judged by the screening physicians
• Inability to speak or read English
• Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
Enrolment was stopped in March due to Covid-19 lockdown and not recommenced due to lack of resources.
Date of first participant enrolment
Anticipated
Actual
4/07/2018
Date of last participant enrolment
Anticipated
1/05/2020
Actual
26/02/2020
Date of last data collection
Anticipated
1/07/2020
Actual
23/03/2020
Sample size
Target
40
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 21088 0
New Zealand
State/province [1] 21088 0

Funding & Sponsors
Funding source category [1] 301317 0
Charities/Societies/Foundations
Name [1] 301317 0
Oakley Mental Health Foundation
Country [1] 301317 0
New Zealand
Primary sponsor type
University
Name
The university of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 300983 0
None
Name [1] 300983 0
Address [1] 300983 0
Country [1] 300983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302060 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 302060 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington, 6011
Ethics committee country [1] 302060 0
New Zealand
Date submitted for ethics approval [1] 302060 0
08/03/2017
Approval date [1] 302060 0
17/05/2017
Ethics approval number [1] 302060 0
17/NTA/51

Summary
Brief summary
Major depressive disorder (MDD), as described in the DSM IV, is the most prevalent mental health disorder in New Zealand. It affects at least 5.3% of the population and consequently poses a substantial health, social and economic burden. A particularly concerning subpopulation of MDD is the treatment resistant (TR) class, defined as those patients who are unresponsive to at least two adequate courses of different antidepressant treatments. This subgroup makes up approximately 30% of the population with MDD.

Over the past two decades, numerous randomised, double-blind, and sham-controlled trials summarised in multiple meta-analyses have established the efficacy of repetitive transcranial magnetic stimulation (rTMS) for the treatment of TR MDD. In addition to being a viable alternative to those that cannot tolerate or unresponsive to pharmacological treatments, rTMS also has the advantage of not posing adverse effects upon metabolism and sexual function as many pharmacological antidepressants do.

Despite extensive research demonstrating the effectiveness of rTMS, understanding of the mechanisms underlying the antidepressant effects produced remains incomplete. This likely accounts for the unpredictability of whether patients will respond and the modest response rates. The aim of this study is to investigate the biological correlates of successful treatment outcomes with rTMS using magnetic resonance imaging.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88986 0
Dr Suresh Muthukumaraswamy
Address 88986 0
SCHOOL OF PHARMACY
THE UNIVERSITY OF AUCKLAND
M&HS BUILDING 505 - Bldg 505
85 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country 88986 0
New Zealand
Phone 88986 0
64 9 373 7599 ext 85398
Fax 88986 0
Email 88986 0
[email protected]
Contact person for public queries
Name 88987 0
Dr Suresh Muthukumaraswamy
Address 88987 0
SCHOOL OF PHARMACY
THE UNIVERSITY OF AUCKLAND
M&HS BUILDING 505 - Bldg 505
85 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country 88987 0
New Zealand
Phone 88987 0
64 9 373 7599 ext 85398
Fax 88987 0
Email 88987 0
[email protected]
Contact person for scientific queries
Name 88988 0
Dr Suresh Muthukumaraswamy
Address 88988 0
SCHOOL OF PHARMACY
THE UNIVERSITY OF AUCKLAND
M&HS BUILDING 505 - Bldg 505
85 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country 88988 0
New Zealand
Phone 88988 0
64 9 373 7599 ext 85398
Fax 88988 0
Email 88988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in any article, after deidentification (text, tables, figures, and appendices).
When will data be available (start and end dates)?
Beginning 9 months and ending 36 months following article publication.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve aims in the approved proposal and/or for meta-analyses
How or where can data be obtained?
Proposals should be directed to [email protected]. To gain access, data requestors will need to sign a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5679Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Godfrey, K.E., S. Muthukumaraswamy, C.M. Stinear, ... [More Details]

Documents added automatically
No additional documents have been identified.