Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depressive Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ontario Mental Health Foundation
Information provided by (Responsible Party):
Z. J. Daskalakis, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01515215
First received: January 18, 2012
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

Major Depressive Disorder (MDD) is one of the most prevalent mental illnesses in North America, in which 30% - 40% fail to respond to conventional treatment. Repetitive Transcranial Magnetic Stimulation (rTMS) has been shown to be an effective therapeutic tool for the treatment of MDD. This form of treatment involves a series of magnetic pulses directed to the brain for about 30 minutes. Importantly, such treatment is very safe and well tolerated. However, to date, most treatment studies show modest efficacy due to limitations, including: 1) treatments that are delivered to only one side of the brain; 2) treatment that does not directly target a specific brain region associated with depression; 3) treatments that are of short duration; 4) treatments that are of insufficient intensity; and 5) insufficient understanding of the brain mechanisms responsible for therapeutic effect. This study is designed to directly address all of these limitations, as well as explore brain mechanisms (e.g. cortical excitability) through which treatment is optimized.


Condition Intervention
Major Depressive Disorder
Device: Repetitive Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Degree of Change in HAM-D17 Scores [ Time Frame: At weeks 3 and/or 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of Change in Montgomery-Asberg Depression Rating Scale Scores [ Time Frame: At weeks 3 and/or 6 ] [ Designated as safety issue: No ]
  • Degree of Change in Beck Depression Inventory Scores [ Time Frame: At weeks 3 and/or 6 ] [ Designated as safety issue: No ]
  • Degree of Change in Brief Psychiatric Ratings Scale Scores [ Time Frame: At weeks 3 and/or 6 ] [ Designated as safety issue: No ]
  • Changes in Cortical Excitability [ Time Frame: At weeks 3 and/or 6 ] [ Designated as safety issue: No ]
    Assessed via TMS-EEG protocol.


Estimated Enrollment: 120
Study Start Date: July 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High-frequency Left rTMS

Intensity: rTMS treatment intensity determined by using resting motor threshold (RMT). Treatment will be delivered at 120% of the RMT.

Site of Stimulation: left hemisphere of DLPFC.

Frequency: 10 Hz.

Duration: 42 Trains, 5 second duration, 25 second inter-train interval.

Device: Repetitive Transcranial Magnetic Stimulation
Magnetic pulses to specific brain regions. (MagPro X100)
Other Name: MagPro X100 Series (Magventure A/S, Farum, Denmark)
Active Comparator: Bilateral rTMS

Intensity: rTMS treatment intensity determined by the RMT. Treatment will be delivered at 120% of the RMT.

Sites of Stimulation: right and left hemispheres of the DLPFC.

Frequency: 1 Hz over the right DLPFC followed by 10 Hz over the left DLPFC.

Duration: right: 1 Train of 600 pulses; left: 30 Trains, 5 second duration, 25 second inter-train interval.

Device: Repetitive Transcranial Magnetic Stimulation
Magnetic pulses to specific brain regions. (MagPro X100)
Other Name: MagPro X100 Series (Magventure A/S, Farum, Denmark)
Sham Comparator: Sham rTMS
Sham rTMS Treatment is applied as either Bilateral rTMS or HFL-rTMS (randomly assigned), but with the coil angled 90 degrees away from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.
Device: Repetitive Transcranial Magnetic Stimulation
Magnetic pulses to specific brain regions. (MagPro X100)
Other Name: MagPro X100 Series (Magventure A/S, Farum, Denmark)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • voluntary and competent to consent
  • diagnosis of MDD, as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV)
  • 18 - 85 years of age
  • failed to achieve clinical response, or did not tolerate, at least 2 separate antidepressant trials of sufficient dosage for at least 6 wks
  • have a score of 20 or greater on the HAM-D17
  • have not had an increase or initiation of any psychoactive therapy in the 4 wks prior to testing
  • if a woman of childbearing potential, must be on an effective means of birth control

Exclusion Criteria:

  • history of DSM-IV confirmed diagnosis of substance dependence in the last 6 months, or substance abuse in the last month
  • concomitant, major, unstable medical or neurologic illness
  • history of seizures
  • acutely suicidal and/or homicidal
  • pregnant
  • have metal implants
  • history of psychosurgery
  • co-morbid diagnosis of borderline and/or antisocial personality disorder. as confirmed by the SCID for Axis II Disorders (SCID-II)
  • are currently (or in the past 4 weeks) taking more than 2 mg of lorazepam, or equivalent, daily
  • ECT treatment in the current episode
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515215

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Mental Health Foundation
Investigators
Principal Investigator: Z. Jeffrey Daskalakis, MD, PhD. Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Z. J. Daskalakis, Chair, Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01515215     History of Changes
Other Study ID Numbers: 040 / 2008
Study First Received: January 18, 2012
Last Updated: May 1, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre for Addiction and Mental Health:
Major Depression Disorder
Treatment Resistance
repetitive Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 28, 2014