Major Depressive Disorder
Conditions
Brief summary
High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks. Accelerated HF-TMS (aHF-rTMS), in which all treatments are delivered in less time, would have significant advantages in terms of access, patient acceptance and costs. In the present open label trial the investigators intend to assess the effectiveness and acceptability of a novel aHF-rTMS protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per day). For this, depressed outpatients will receive the aHF-rTMS protocol and will be assessed at baseline and at weeks 3 and 9 with several clinician- and patient- reported measures as well as with computerized neurocognitive tests.
Interventions
DEVICEAccelerated HF-rTMS (Magstim Rapid 2 stimulator)
Twice daily rTMS sessions involving 10 Hz in 75 trains of 4 seconds duration, with 26 seconds intertrain intervals (6,000 pulses per day) at 120% of the resting motor threshold.
Sponsors
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 2 adequate antidepressant trial(s) in the current episode; * Baseline score ≥ 13 on the QIDS-C * Stable medication regimen (\>= 4 weeks) prior to study enrolment
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 rTMS (e.g., personal history of epilepsy, metallic head implant) * Hearing loss
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depressive Symptomatology - Clinician Version | Week 3 | Response to treatment is defined as a ≥ 50% reduction in the scores of the QIDS-C. Remission is defined as a QIDS-C score ≤ 5. |
Countries
Canada
Outcome results
None listed