NCT01409304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2 major-depressive-disorder

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

August 2, 2011

Last Update Submit

January 16, 2013

Conditions

Major Depressive Disorder

Keywords

Major depressionDeep Transcranial Magnetic StimulationNaturalistic TrialDTMS

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)

    week 5

Interventions

Deep Transcranial Magnetic Stimulation (DTMS)DEVICE

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuromodulation Research Clinic, Douglas Mental Health University Institute

Montreal, Quebec, H4H1R3, Canada

Location

Related Publications (4)

  • 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.

    PMID: 20663568BACKGROUND

  • 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.

    PMID: 20633419BACKGROUND

  • 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.

    PMID: 17977787BACKGROUND

  • 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.

    PMID: 24486892DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Marcelo T Berlim, MD, MSc

    McGill University & Douglas Mental Health University Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neuromodulation Research Clinic

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 4, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

CA(1)