Effectiveness of Deep Transcranial Magnetic Stimulation in Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No