A Comparative Trial of TMS Approaches to Treating Depression

NCT ID: NCT01906905

Last Updated: 2023-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcranial Magnetic Stimulation

Active TMS (1)

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Transcranial Magnetic Stimulation 2

Active TMS (2)

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Transcranial Magnetic Stimulation 3

Active TMS (3)

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Interventions

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Transcranial Magnetic Stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of New South Wales

OTHER

Sponsor Role lead

Responsible Party

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Colleen Loo

Professor Colleen Loo, Black Dog Institute, The Prince of Wales Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Colleen Loo, MB.BS. (Hons), FRANZCP, MD.

Role: PRINCIPAL_INVESTIGATOR

Black Dog Institute, University of New South Wales

Locations

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Black Dog Institute, University of New South Wales

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type BACKGROUND
PMID: 16139895 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11157427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20553334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11172880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11922882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19530016 (View on PubMed)

George 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.

Reference Type RESULT
PMID: 20439832 (View on PubMed)

Loo 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.

Reference Type RESULT
PMID: 17880752 (View on PubMed)

Nahas 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.

Reference Type RESULT
PMID: 10074879 (View on PubMed)

O'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.

Reference Type RESULT
PMID: 17573044 (View on PubMed)

Padberg 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.

Reference Type RESULT
PMID: 12377400 (View on PubMed)

Pascual-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.

Reference Type RESULT
PMID: 8684201 (View on PubMed)

Pascual-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.

Reference Type RESULT
PMID: 7922470 (View on PubMed)

Slotema 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.

Reference Type RESULT
PMID: 20361902 (View on PubMed)

Speer 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.

Reference Type RESULT
PMID: 19027962 (View on PubMed)

Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16. doi: 10.1016/s0168-5597(97)00096-8.

Reference Type RESULT
PMID: 9474057 (View on PubMed)

Other Identifiers

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HC13053

Identifier Type: -

Identifier Source: org_study_id

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