Accelerated rTMS for Treatment-Resistant Major Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Douglas Mental Health University Institute

Montreal, Quebec, H4H1R3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accelerated HF-rTMS (Magstim Rapid 2 stimulator)

Device

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 outcomes

Quick Inventory of Depressive Symptomatology - Clinician Version

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Douglas Mental Health University Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Apr 29, 2014
Registry last updated: Oct 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed