Major Depressive Disorder
Conditions
Keywords
Major depression, Deep Transcranial Magnetic Stimulation, Naturalistic Trial, DTMS
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.
Interventions
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.
Sponsors
Brainsway
Douglas Mental Health University Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed