DepressionPhase 4NCT01906905
A Comparative Trial of TMS Approaches to Treating Depression
A Phase 4 study testing Transcranial Magnetic Stimulation in people with Depression, run by The University of New South Wales at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Depression
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2013to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- DSM-IV diagnosis of current Major Depressive Episode.
- MADRS score of 20 or more.
- Able to give informed consent.
Who cannot join
- DSM-IV psychotic disorder.
- Drug or alcohol abuse or dependence (preceding 3 months).
- Inadequate response to ECT (current episode of depression).
- Rapid clinical response required, e.g. high suicide risk.
- Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
- Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Black Dog Institute, University of New South Wales
Sydney, New South Wales, 2052
About this study
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.
- Conditions
- Depression
- Being tested
- Transcranial Magnetic Stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation | Active comparator | Active TMS (1) Receives: Device: Transcranial Magnetic Stimulation |
| Transcranial Magnetic Stimulation 2 | Active comparator | Active TMS (2) Receives: Device: Transcranial Magnetic Stimulation |
| Transcranial Magnetic Stimulation 3 | Active comparator | Active TMS (3) Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale(MADRS)
Measured: Participants will be assessed for changes for duration of trial, an expected average of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Loo, The University of New South Wales
- Investigators
- Colleen Loo, MB.BS. (Hons), FRANZCP, MD., Principal investigator, Black Dog Institute, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906905
- Sponsor's protocol ID
- HC13053
- Status last verified
- Mar 2023
- First submitted
- 17 Jul 2013
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 16139895Andrews 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.
PubMed 11157427Dodick 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.
PubMed 20553334Kupfer 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.
PubMed 11172880Sachdev 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.
PubMed 11922882Slade 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.
PubMed 19530016George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
PubMed 20439832Loo CK, McFarquhar TF, Mitchell PB. A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Int J Neuropsychopharmacol. 2008 Feb;11(1):131-47. doi: 10.1017/S1461145707007717. Epub 2007 Sep 20.
PubMed 17880752Nahas Z, Bohning DE, Molloy MA, Oustz JA, Risch SC, George MS. Safety and feasibility of repetitive transcranial magnetic stimulation in the treatment of anxious depression in pregnancy: a case report. J Clin Psychiatry. 1999 Jan;60(1):50-2. doi: 10.4088/jcp.v60n0111.
PubMed 10074879O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
PubMed 17573044Padberg F, Zwanzger P, Keck ME, Kathmann N, Mikhaiel P, Ella R, Rupprecht P, Thoma H, Hampel H, Toschi N, Moller HJ. Repetitive transcranial magnetic stimulation (rTMS) in major depression: relation between efficacy and stimulation intensity. Neuropsychopharmacology. 2002 Oct;27(4):638-45. doi: 10.1016/S0893-133X(02)00338-X.
PubMed 12377400Pascual-Leone A, Rubio B, Pallardo F, Catala MD. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet. 1996 Jul 27;348(9022):233-7. doi: 10.1016/s0140-6736(96)01219-6.
PubMed 8684201Pascual-Leone A, Valls-Sole J, Wassermann EM, Hallett M. Responses to rapid-rate transcranial magnetic stimulation of the human motor cortex. Brain. 1994 Aug;117 ( Pt 4):847-58. doi: 10.1093/brain/117.4.847.
PubMed 7922470Slotema CW, Blom JD, Hoek HW, Sommer IE. Should we expand the toolbox of psychiatric treatment methods to include Repetitive Transcranial Magnetic Stimulation (rTMS)? A meta-analysis of the efficacy of rTMS in psychiatric disorders. J Clin Psychiatry. 2010 Jul;71(7):873-84. doi: 10.4088/JCP.08m04872gre. Epub 2010 Mar 9.
PubMed 20361902Speer AM, Benson BE, Kimbrell TK, Wassermann EM, Willis MW, Herscovitch P, Post RM. Opposite effects of high and low frequency rTMS on mood in depressed patients: relationship to baseline cerebral activity on PET. J Affect Disord. 2009 Jun;115(3):386-94. doi: 10.1016/j.jad.2008.10.006. Epub 2008 Nov 22.
PubMed 19027962
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Trial of TMS Approaches to Treating Depression
- ClinicalTrials.gov ID
- NCT01906905
- Acronym / sponsor ID
- HC13053
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation | Active comparator | Device: Transcranial Magnetic StimulationActive TMS (1) |
| Transcranial Magnetic Stimulation 2 | Active comparator | Device: Transcranial Magnetic StimulationActive TMS (2) |
| Transcranial Magnetic Stimulation 3 | Active comparator | Device: Transcranial Magnetic StimulationActive TMS (3) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- DSM-IV diagnosis of current Major Depressive Episode.
- MADRS score of 20 or more.
- Able to give informed consent.
Key exclusion criteria (7 listed)
- DSM-IV psychotic disorder.
- Drug or alcohol abuse or dependence (preceding 3 months).
- Inadequate response to ECT (current episode of depression).
- Rapid clinical response required, e.g. high suicide risk.
- Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation | Device | Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation 2, Transcranial Magnetic Stimulation 3 |
Primary outcome
Montgomery-Åsberg Depression Rating Scale(MADRS)
Time frame: Participants will be assessed for changes for duration of trial, an expected average of 6 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 16139895Loo 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.
- Background: PubMed 11157427Andrews 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.
- Background: PubMed 20553334Dodick 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.
- Background: PubMed 11172880Kupfer 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.
- Background: PubMed 11922882Sachdev 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.
- Background: PubMed 19530016Slade 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.
- Results publication: PubMed 20439832George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
- Results publication: PubMed 17880752Loo CK, McFarquhar TF, Mitchell PB. A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Int J Neuropsychopharmacol. 2008 Feb;11(1):131-47. doi: 10.1017/S1461145707007717. Epub 2007 Sep 20.
- Results publication: PubMed 10074879Nahas Z, Bohning DE, Molloy MA, Oustz JA, Risch SC, George MS. Safety and feasibility of repetitive transcranial magnetic stimulation in the treatment of anxious depression in pregnancy: a case report. J Clin Psychiatry. 1999 Jan;60(1):50-2. doi: 10.4088/jcp.v60n0111.
- Results publication: PubMed 17573044O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
- Results publication: PubMed 12377400Padberg F, Zwanzger P, Keck ME, Kathmann N, Mikhaiel P, Ella R, Rupprecht P, Thoma H, Hampel H, Toschi N, Moller HJ. Repetitive transcranial magnetic stimulation (rTMS) in major depression: relation between efficacy and stimulation intensity. Neuropsychopharmacology. 2002 Oct;27(4):638-45. doi: 10.1016/S0893-133X(02)00338-X.
- Results publication: PubMed 8684201Pascual-Leone A, Rubio B, Pallardo F, Catala MD. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet. 1996 Jul 27;348(9022):233-7. doi: 10.1016/s0140-6736(96)01219-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen Loo, MB.BS. (Hons), FRANZCP, MD. principal investigator
Black Dog Institute, University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transcranial Magnetic Stimulation in people with Depression, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale(MADRS) (time frame: Participants will be assessed for changes for duration of trial, an expected average of 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01906905, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.