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Major Depressive DisorderPhase 2/3NCT01409304

Effectiveness of Deep Transcranial Magnetic Stimulation in Depression

A Phase 2/3 study testing Deep Transcranial Magnetic Stimulation (DTMS) in people with Major Depressive Disorder, run by Douglas Mental Health University Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Deep Transcranial Magnetic Stimulation (DTMS)
Type of treatment
Medical device
How many people
18 participants
Where
1 siteCanada
Study dates
Oct 2011to Dec 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Neuromodulation Research Clinic, Douglas Mental Health University Institute

    Montreal, Quebec, H4H1R3

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Deep Transcranial Magnetic Stimulation (DTMS)
Keywords
Major depression, Deep Transcranial Magnetic Stimulation, Naturalistic Trial, DTMS
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: week 5

Secondary outcomes (1)

  1. 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.

    Measured: week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01409304
Sponsor's protocol ID
DTMS-ERB10/18-2011
Status last verified
Jan 2013
First submitted
2 Aug 2011
Last updated
18 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20663568

  • 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.

    PubMed 20633419

  • 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.

    PubMed 17977787

  • 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.

    PubMed 24486892

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Deep Transcranial Magnetic Stimulation (DTMS) in people with Major Depressive Disorder, run by Douglas Mental Health University Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

21-item Hamilton Depression Rating Scale (HAM-D21) (time frame: week 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01409304, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.

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