Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
A Comparative Trial of TMS Approaches to Treating Depression
Query!
Secondary ID [1]
0
0
HC13053
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Depression
0
0
Query!
Condition category
Condition code
Mental Health
0
0
0
0
Query!
Depression
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Montgomery-Åsberg Depression Rating Scale(MADRS)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Participants will be assessed for changes for duration of trial, an expected average of 6 weeks.
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
99
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Withdrawn
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2013
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
0
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Black Dog Institute, University of New South Wales - Sydney
Query!
Recruitment postcode(s) [1]
0
0
2052 - Sydney
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
The University of New South Wales
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01906905
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Colleen Loo, MB.BS. (Hons), FRANZCP, MD.
Query!
Address
0
0
Black Dog Institute, University of New South Wales
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01906905
Download to PDF