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Completed

NCT Number: NCT01409304

Effectiveness of Deep Transcranial Magnetic Stimulation in Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Neuromodulation Research Clinic, Douglas Mental Health University Institute

Montreal, Quebec, H4H1R3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 21-item Hamilton Depression Rating Scale (HAM-D21)

    Time frame: week 5

    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 outcomes

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

    Time frame: week 5

    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.

Sponsors and collaborators

Lead sponsor

Douglas Mental Health University Institute

Other

Collaborators

  • Brainsway

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 4, 2011
Registry last updated
Jan 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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