Effectiveness of Deep Transcranial Magnetic Stimulation for Treating Major Depression: a Pilot Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- 21-item Hamilton Depression Rating Scale (HAM-D21)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)(week 5)
Investigators
MARCELO T. BERLIM
Director, Neuromodulation Research Clinic
Douglas Mental Health University Institute