Effectiveness of Deep Transcranial Magnetic Stimulation in Depression

Major Depressive Disorder Clinical Trial

Official title:

Effectiveness of Deep Transcranial Magnetic Stimulation for Treating Major Depression: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409304
• Other study ID #: DTMS-ERB10/18-2011
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 2, 2011
• Last updated: January 16, 2013
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Douglas Mental Health University Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Deep Transcranial Magnetic Stimulation (DTMS)
DTMS will be administered according to the following parameters: 18 Hz in 84 trains of 2 seconds duration, with 20 seconds inter-train interval (3,024 pulses per session) at 120% of the resting motor threshold.

Locations

Country	Name	City	State
Canada	Neuromodulation Research Clinic, Douglas Mental Health University Institute	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute	Brainsway

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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. Epub 2007 Oct 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	21-item Hamilton Depression Rating Scale (HAM-D21)	Response to treatment is defined as a = 50% reduction in the scores of the HAM-D21. Remission is defined as a HAM-D21 score = 9.	week 5	No
Secondary	Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)	Response to treatment is defined as a = 50% reduction in the scores of the QIDS-SR. Remission is defined as a QIDS-SR score = 5.	week 5	No

External Links

•   Neuromodulation Research Clinic, Douglas Mental Health University Institute