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Effectiveness of Deep Transcranial Magnetic Stimulation in Depression

This study has been completed.
Sponsor:
Collaborator:
Brainsway
Information provided by (Responsible Party):
MARCELO T. BERLIM, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier:
NCT01409304
First received: August 2, 2011
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
 Device: Deep Transcranial Magnetic Stimulation (DTMS)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Deep Transcranial Magnetic Stimulation for Treating Major Depression: a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Douglas Mental Health University Institute:

Primary Outcome Measures:
  • 21-item Hamilton Depression Rating Scale (HAM-D21) [ Time Frame: week 5 ] [ Designated as safety issue: No ]
    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) [ Time Frame: week 5 ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409304

Locations
Canada, Quebec
Neuromodulation Research Clinic, Douglas Mental Health University Institute
Montreal, Quebec, Canada, H4H1R3
Sponsors and Collaborators
Douglas Mental Health University Institute
Brainsway
Investigators
Principal Investigator: Marcelo T Berlim, MD, MSc McGill University & Douglas Mental Health University Institute
  More Information

Additional Information:
Neuromodulation Research Clinic, Douglas Mental Health University Institute  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: MARCELO T. BERLIM, Director, Neuromodulation Research Clinic, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier: NCT01409304     History of Changes
Other Study ID Numbers: DTMS-ERB10/18-2011
Study First Received: August 2, 2011
Last Updated: January 16, 2013
Health Authority: Canada: Health Canada

Keywords provided by Douglas Mental Health University Institute:
Major depression
Deep Transcranial Magnetic Stimulation
Naturalistic Trial
DTMS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013