Effectiveness of Deep Transcranial Magnetic Stimulation in Depression

Douglas Mental Health University Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Major Depressive Disorder

Treatments: Device: Deep Transcranial Magnetic Stimulation (DTMS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01409304

DTMS-ERB10/18-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)