Accelerated rTMS for Treatment-Resistant Major Depression

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Trial on the Effectiveness and Tolerability of Accelerated High Frequency Repetitive Transcranial Magnetic Stimulation for Treating Resistant Major Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Accelerated HF-rTMS (Magstim Rapid 2 stimulator)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accelerated HF-rTMS<br>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. | Device: Accelerated HF-rTMS (Magstim Rapid 2 stimulator)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory of Depressive Symptomatology - Clinician Version | 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. | Week 3 |