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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/NCT01906905




Registration number
NCT01906905
Ethics application status
Date submitted
17/07/2013
Date registered
24/07/2013
Date last updated
3/04/2023

Titles & IDs
Public title
A Comparative Trial of TMS Approaches to Treating Depression
Scientific title
A Comparative Trial of TMS Approaches to Treating Depression
Secondary ID [1] 0 0
HC13053
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Transcranial Magnetic Stimulation

Active Comparator: Transcranial Magnetic Stimulation - Active TMS (1)

Active Comparator: Transcranial Magnetic Stimulation 2 - Active TMS (2)

Active Comparator: Transcranial Magnetic Stimulation 3 - Active TMS (3)


Treatment: Devices: Transcranial Magnetic Stimulation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Montgomery-Åsberg Depression Rating Scale(MADRS)
Timepoint [1] 0 0
Participants will be assessed for changes for duration of trial, an expected average of 6 weeks.

Eligibility
Key inclusion criteria
1. Age =18 years.

2. DSM-IV diagnosis of current Major Depressive Episode.

3. MADRS score of 20 or more.

4. Able to give informed consent.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. DSM-IV psychotic disorder.

2. Drug or alcohol abuse or dependence (preceding 3 months).

3. Inadequate response to ECT (current episode of depression).

4. Rapid clinical response required, e.g. high suicide risk.

5. Significant neurological disorder, which may pose increased risks with TMS, e.g.,
epilepsy.

6. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or
other electronic device.

7. Pregnancy.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute, University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
2052 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trancranial Magnetic Stimulation (TMS) is a non-drug and non-invasive treatment for
depression and has been investigated for the treatment of psychiatric illness for over 15
years. There is now established evidence indicating TMS is an effective treatment for
depression. However, the effectiveness of TMS varies between people, thus requiring further
research to investigate its optimal application. Investigators want to compare the
effectiveness of different forms of TMS, given with differing stimulation settings to the
right or left side of the brain that has been associated with depression. This could
potentially help clinicians in the future to improve the prescription of TMS as a treatment
for depression.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01906905
Trial related presentations / publications
Loo CK, Mitchell PB. A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy. J Affect Disord. 2005 Nov;88(3):255-67. doi: 10.1016/j.jad.2005.08.001. Epub 2005 Sep 2.
Andrews G, Henderson S, Hall W. Prevalence, comorbidity, disability and service utilisation. Overview of the Australian National Mental Health Survey. Br J Psychiatry. 2001 Feb;178:145-53. doi: 10.1192/bjp.178.2.145. Erratum In: Br J Psychiatry 2001 Dec;179:561-2.
Dodick DW, Schembri CT, Helmuth M, Aurora SK. Transcranial magnetic stimulation for migraine: a safety review. Headache. 2010 Jul;50(7):1153-63. doi: 10.1111/j.1526-4610.2010.01697.x. Epub 2010 Jun 10.
Kupfer DJ, Frank E. The interaction of drug- and psychotherapy in the long-term treatment of depression. J Affect Disord. 2001 Jan;62(1-2):131-7. doi: 10.1016/s0165-0327(00)00357-8.
Sachdev PS, McBride R, Loo C, Mitchell PM, Malhi GS, Croker V. Effects of different frequencies of transcranial magnetic stimulation (TMS) on the forced swim test model of depression in rats. Biol Psychiatry. 2002 Mar 15;51(6):474-9. doi: 10.1016/s0006-3223(01)01298-7.
Slade T, Johnston A, Oakley Browne MA, Andrews G, Whiteford H. 2007 National Survey of Mental Health and Wellbeing: methods and key findings. Aust N Z J Psychiatry. 2009 Jul;43(7):594-605. doi: 10.1080/00048670902970882.
Public notes

Contacts
Principal investigator
Name 0 0
Colleen Loo, MB.BS. (Hons), FRANZCP, MD.
Address 0 0
Black Dog Institute, University of New South Wales
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01906905