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Effectiveness of Deep Transcranial Magnetic Stimulation in Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Deep Transcranial Magnetic Stimulation (DTMS)
Sponsored by
Douglas Mental Health University Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depression, Deep Transcranial Magnetic Stimulation, Naturalistic Trial, DTMS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neuromodulation Research Clinic, Douglas Mental Health University Institute

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 2, 2011
Last Updated
January 16, 2013
Sponsor
Douglas Mental Health University Institute
Collaborators
Brainsway
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1. Study Identification

Unique Protocol Identification Number
NCT01409304
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Douglas Mental Health University Institute
Collaborators
Brainsway

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depression, Deep Transcranial Magnetic Stimulation, Naturalistic Trial, DTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Deep Transcranial Magnetic Stimulation (DTMS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
21-item Hamilton Depression Rating Scale (HAM-D21)
Description
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.
Time Frame
week 5
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Description
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.
Time Frame
week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo T Berlim, MD, MSc
Organizational Affiliation
McGill University & Douglas Mental Health University Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuromodulation Research Clinic, Douglas Mental Health University Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4H1R3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20663568
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.
Results Reference
background
PubMed Identifier
20633419
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.
Results Reference
background
PubMed Identifier
17977787
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.
Results Reference
background
PubMed Identifier
24486892
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.
Results Reference
derived
Links:
URL
http://www.douglas.qc.ca/page/neuromodulation-program
Description
Neuromodulation Research Clinic, Douglas Mental Health University Institute

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Effectiveness of Deep Transcranial Magnetic Stimulation in Depression

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