Accelerated rTMS for Treatment-Resistant Major Depression

Douglas Mental Health University Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Major Depressive Disorder

Treatments: Device: Accelerated HF-rTMS (Magstim Rapid 2 stimulator)

Study type: Interventional

Funder types: Other

Identifiers

NCT02125799

IRB12/38 (Other Identifier)

ERB12/38

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 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 ≥ 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Accelerated HF-rTMS

Experimental group

Description:

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.

Treatment:

Device: Accelerated HF-rTMS (Magstim Rapid 2 stimulator)