Clinical trial NCT01409304: Effectiveness of Deep Transcranial Magnetic Stimulation in Depression
Official title: Effectiveness of Deep Transcranial Magnetic Stimulation for Treating Major Depression: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Keywords: Major depression
Deep Transcranial Magnetic Stimulation
Naturalistic Trial
DTMS
Lead sponsor: Douglas Mental Health University Institute
Sponsor class: OTHER
Collaborators: name: Brainsway
First posted: 2011-08-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We intend to investigate whether deep transcranial magnetic stimulation (DTMS), a novel brain stimulation technique, is effective for treating major depression. We hypothesize that 4 weeks of DTMS will be associated with significant improvements in depressive and anxious symptoms without significant side effects.

Detailed description: The aim of this pilot study is to assess, naturalistically, the effectiveness of deep transcranial magnetic stimulation (DTMS) in a sample of subjects with treatment-resistant depression. To do this, enrolled depressed outpatients will be assigned to receive 4 weeks of daily DTMS and will be evaluated at baseline and during week 5. We hypothesize that treatment with DTMS will be associated with significant clinical improvements in depressive and anxious symptoms, and will be well tolerated.

Eligibility criteria: Inclusion Criteria:

* Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 1 but ≤ 5 adequate antidepressant trial(s) in the current episode
* Baseline score ≥ 15 on the QIDS-C
* Stable medication regimen (\> 4 weeks)

Exclusion Criteria:

* Psychotic features in the current episode
* Lifetime history of psychotic disorders and/or bipolar I or II disorders
* Substance or alcohol abuse/dependence in the past 6 months
* Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
* Uncontrolled medical disease (e.g., cardiovascular, renal)
* Pregnancy and/or lactation
* Presence of a specific contraindication for DTMS (e.g., personal history of epilepsy, metallic head implant)
* Hearing loss
* Personal history of abnormal brain MRI findings

Primary outcomes:
measure: 21-item Hamilton Depression Rating Scale (HAM-D21)
timeFrame: week 5
Secondary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
timeFrame: week 5
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Neuromodulation Research Clinic, Douglas Mental Health University Institute
state: Quebec
Study officials:
affiliation: McGill University & Douglas Mental Health University Institute
name: Marcelo T Berlim, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Isserles M, Rosenberg O, Dannon P, Levkovitz Y, Kotler M, Deutsch F, Lerer B, Zangen A. Cognitive-emotional reactivation during deep transcranial magnetic stimulation over the prefrontal cortex of depressive patients affects antidepressant outcome. J Affect Disord. 2011 Feb;128(3):235-42. doi: 10.1016/j.jad.2010.06.038. Epub 2010 Jul 21.
citation: Levkovitz Y, Harel EV, Roth Y, Braw Y, Most D, Katz LN, Sheer A, Gersner R, Zangen A. Deep transcranial magnetic stimulation over the prefrontal cortex: evaluation of antidepressant and cognitive effects in depressive patients. Brain Stimul. 2009 Oct;2(4):188-200. doi: 10.1016/j.brs.2009.08.002. Epub 2009 Sep 16.
citation: Levkovitz Y, Roth Y, Harel EV, Braw Y, Sheer A, Zangen A. A randomized controlled feasibility and safety study of deep transcranial magnetic stimulation. Clin Neurophysiol. 2007 Dec;118(12):2730-44. doi: 10.1016/j.clinph.2007.09.061. Epub 2007 Oct 30.
citation: McGirr A, Van den Eynde F, Chachamovich E, Fleck MP, Berlim MT. Personality dimensions and deep repetitive transcranial magnetic stimulation (DTMS) for treatment-resistant depression: a pilot trial on five-factor prediction of antidepressant response. Neurosci Lett. 2014 Mar 20;563:144-8. doi: 10.1016/j.neulet.2014.01.037. Epub 2014 Jan 30.