Accelerated rTMS for Treatment-Resistant Major Depression

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: Accelerated HF-rTMS (Magstim Rapid 2 stimulator)

• Registration Number: NCT02125799
• Lead Sponsor: Douglas Mental Health University Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-04-25
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-02
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Accelerated HF-rTMS	Accelerated 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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Douglas Mental Health University Institute; 🇨🇦 Montreal, Quebec, Canada