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

This study has been completed.
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Daniel Blumberger, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01887782
First received: June 25, 2013
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
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 Intervention
Major Depressive Disorder
Device: HFL rTMS
Device: iTBS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

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

Primary Outcome Measures:
  • 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.


Enrollment: 414
Study Start Date: September 2013
Study Completion Date: October 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  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: NCT01887782

Locations
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
Investigators
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
  More Information

Responsible Party: Daniel Blumberger, Medical Head, Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01887782     History of Changes
Other Study ID Numbers: 179/2012
Study First Received: June 25, 2013
Last Updated: January 26, 2017
Individual Participant Data  
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 Centre for Addiction and Mental Health:
depression
magnetic
brain stimulation
treatment-resistant

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

ClinicalTrials.gov processed this record on April 26, 2017