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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HFL rTMS
iTBS
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, magnetic, brain stimulation, treatment-resistant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Non-Invasive Neurostimulation Therapies Centre, University of British Columbia
  • Toronto Western Hospital
  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HFL rTMS

iTBS

Arm Description

High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks

intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks

Outcomes

Primary Outcome Measures

HAM-D17 score
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.

Secondary Outcome Measures

Full Information

First Posted
June 25, 2013
Last Updated
January 26, 2017
Sponsor
Centre for Addiction and Mental Health
Collaborators
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01887782
Brief Title
Randomized Controlled Trial of Conventional vs Theta Burst rTMS
Acronym
HFL vs TBS
Official Title
A Randomized Controlled Study of Conventional Versus Theta Burst Repetitive Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, magnetic, brain stimulation, treatment-resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
414 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFL rTMS
Arm Type
Experimental
Arm Description
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks
Arm Title
iTBS
Arm Type
Active Comparator
Arm Description
intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks
Intervention Type
Device
Intervention Name(s)
HFL rTMS
Intervention Description
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
Intervention Type
Device
Intervention Name(s)
iTBS
Intervention Description
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
Primary Outcome Measure Information:
Title
HAM-D17 score
Description
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.
Time Frame
baseline, after each 5 treatment sessions, and 1, 4, and 12 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Blumberger, MD, MSc
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Downar, MD, PhD
Organizational Affiliation
University Health Network, Toronto Western Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fidel Vila-Rodriguez, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Non-Invasive Neurostimulation Therapies Centre, University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2A1
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Individual patient level data will be shared once the investigators have completed all proposed analyses from the data set.
Citations:
PubMed Identifier
32382720
Citation
Trevizol AP, Downar J, Vila-Rodriguez F, Thorpe KE, Daskalakis ZJ, Blumberger DM. Predictors of remission after repetitive transcranial magnetic stimulation for the treatment of major depressive disorder: An analysis from the randomised non-inferiority THREE-D trial. EClinicalMedicine. 2020 Apr 30;22:100349. doi: 10.1016/j.eclinm.2020.100349. eCollection 2020 May.
Results Reference
derived
PubMed Identifier
31668646
Citation
Ge R, Downar J, Blumberger DM, Daskalakis ZJ, Vila-Rodriguez F. Functional connectivity of the anterior cingulate cortex predicts treatment outcome for rTMS in treatment-resistant depression at 3-month follow-up. Brain Stimul. 2020 Jan-Feb;13(1):206-214. doi: 10.1016/j.brs.2019.10.012. Epub 2019 Oct 18.
Results Reference
derived
PubMed Identifier
31350213
Citation
Hsu JH, Downar J, Vila-Rodriguez F, Daskalakis ZJ, Blumberger DM. Impact of prior treatment on remission with intermittent theta burst versus high-frequency repetitive transcranial magnetic stimulation in treatment resistant depression. Brain Stimul. 2019 Nov-Dec;12(6):1553-1555. doi: 10.1016/j.brs.2019.07.011. Epub 2019 Jul 17.
Results Reference
derived
PubMed Identifier
30764649
Citation
Kaster TS, Downar J, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Blumberger DM. Trajectories of Response to Dorsolateral Prefrontal rTMS in Major Depression: A THREE-D Study. Am J Psychiatry. 2019 May 1;176(5):367-375. doi: 10.1176/appi.ajp.2018.18091096. Epub 2019 Feb 15.
Results Reference
derived
PubMed Identifier
30425640
Citation
Shalbaf R, Brenner C, Pang C, Blumberger DM, Downar J, Daskalakis ZJ, Tham J, Lam RW, Farzan F, Vila-Rodriguez F. Non-linear Entropy Analysis in EEG to Predict Treatment Response to Repetitive Transcranial Magnetic Stimulation in Depression. Front Pharmacol. 2018 Oct 30;9:1188. doi: 10.3389/fphar.2018.01188. eCollection 2018.
Results Reference
derived
PubMed Identifier
29726344
Citation
Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26. Erratum In: Lancet. 2018 Jun 23;391(10139):e24.
Results Reference
derived

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Randomized Controlled Trial of Conventional vs Theta Burst rTMS

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