Effectiveness of Deep Transcranial Magnetic Stimulation in Depression

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Deep Transcranial Magnetic Stimulation (DTMS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depression, Deep Transcranial Magnetic Stimulation, Naturalistic Trial, DTMS