Clinical trial NCT01906905: A Comparative Trial of TMS Approaches to Treating Depression
Official title: A Comparative Trial of TMS Approaches to Treating Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Depression
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale(MADRS)
timeFrame: Participants will be assessed for changes for duration of trial, an expected average of 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Black Dog Institute, University of New South Wales
state: New South Wales
Study officials:
affiliation: Black Dog Institute, University of New South Wales
name: Colleen Loo, MB.BS. (Hons), FRANZCP, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.