Accelerated rTMS for Treatment-Resistant Major Depression

NCT ID: NCT02125799

Last Updated: 2014-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Accelerated HF-rTMS

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.

Group Type: EXPERIMENTAL

Accelerated HF-rTMS (Magstim Rapid 2 stimulator)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Douglas Mental Health University Institute

OTHER

Sponsor Role: lead

Responsible Party

MARCELO T. BERLIM

Director, Neuromodulation Research Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcelo Berlim, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

McGill University - Dept of Psychiatry

Locations

Douglas Mental Health University Institute

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

IRB12/38

Identifier Type: OTHER

Identifier Source: secondary_id

ERB12/38

Identifier Type: -

Identifier Source: org_study_id