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Randomized Controlled Trial of Conventional vs Theta Burst rTMS (HFL vs TBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01887782
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : January 30, 2017
University Health Network, Toronto
Information provided by (Responsible Party):
Daniel Blumberger, Centre for Addiction and Mental Health

Brief Summary:
This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the standard conventional high frequency left sided stimulation protocol. The Left dorsolateral prefrontal cortex will be the site of stimulation in both treatment conditions. The site of stimulation will be targeted using MRI co-registration. The study seeks to determine if the two treatment protocols have similar effectiveness in treating major depression.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: HFL rTMS Device: iTBS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Conventional Versus Theta Burst Repetitive Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder
Study Start Date : September 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HFL rTMS
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks
Device: HFL rTMS
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator

Active Comparator: iTBS
intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks
Device: iTBS
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator

Primary Outcome Measures :
  1. HAM-D17 score [ Time Frame: baseline, after each 5 treatment sessions, and 1, 4, and 12 weeks post-treatment ]
    Outcome measure is measured by a change in the HAM-D17 score from baseline to week 4 or 6. A 50% improvement in the score is considered response to rTMS. A final score of <8 is categorized as remission.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • outpatients
  • voluntary and competent to consent
  • Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD, single, recurrent
  • between ages 18-65
  • failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of ≥ 3 in the current episode or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
  • have a score of ≥ 18 on the HAMD-17 item
  • have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
  • able to adhere to the treatment schedule
  • Pass the TMS adult safety screening (TASS) questionnaire
  • have normal thyroid functioning based on pre-study blood work

Exclusion Criteria:

  • have a history of substance dependence or abuse within the last 3 months
  • have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
  • have active suicidal intent
  • are pregnant
  • have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
  • have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than MDD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01887782

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Canada, British Columbia
Non-Invasive Neurostimulation Therapies Centre, University of British Columbia
Vancouver, British Columbia, Canada, V6T 2A1
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4
Sponsors and Collaborators
Centre for Addiction and Mental Health
University Health Network, Toronto
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Principal Investigator: Daniel Blumberger, MD, MSc Centre for Addiction and Mental Health
Principal Investigator: Jonathan Downar, MD, PhD University Health Network, Toronto Western Hospital
Principal Investigator: Fidel Vila-Rodriguez, MD University of British Columbia

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Daniel Blumberger, Medical Head, Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health Identifier: NCT01887782    
Other Study ID Numbers: 179/2012
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual patient level data will be shared once the investigators have completed all proposed analyses from the data set.
Keywords provided by Daniel Blumberger, Centre for Addiction and Mental Health:
brain stimulation
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms