Effectiveness of Deep Transcranial Magnetic Stimulation in Depression

Phase 2

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT01409304
• Lead Sponsor: Douglas Mental Health University Institute

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.

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.

Study Timeline

• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-04
• Study Start: 2011-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
21-item Hamilton Depression Rating Scale (HAM-D21)	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 Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)	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.

Trial Locations

Locations (1)

Neuromodulation Research Clinic, Douglas Mental Health University Institute; 🇨🇦 Montreal, Quebec, Canada