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Pilot Study Comparing 10hz vs Theta Burst Stimulation

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
10Hz
iTBS
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

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 Major Depressive Disorder (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 Hamilton Depression Rating Score 17-item (HDRS-17)
  • 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 lab, University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

10Hz

iTBS

Arm Description

High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4-6 weeks

intermittent Theta Burst Stimulation (iTBS) five days per week for 4-6 weeks

Outcomes

Primary Outcome Measures

Change in the Hamilton Depression Rating scale 17-item (HDRS-17) score
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 10, 2016
Last Updated
August 8, 2018
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02800226
Brief Title
Pilot Study Comparing 10hz vs Theta Burst Stimulation
Official Title
Pilot Study Comparing 10Hz Repetitive Transcranial Magnetic Stimulation (rTMS) vs. Intermittent Theta Burst Stimulation (iTBS) for Treatment Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore potential biomarkers of treatment response

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10Hz
Arm Type
Experimental
Arm Description
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4-6 weeks
Arm Title
iTBS
Arm Type
Active Comparator
Arm Description
intermittent Theta Burst Stimulation (iTBS) five days per week for 4-6 weeks
Intervention Type
Device
Intervention Name(s)
10Hz
Intervention Description
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
Intervention Type
Device
Intervention Name(s)
iTBS
Intervention Description
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
Primary Outcome Measure Information:
Title
Change in the Hamilton Depression Rating scale 17-item (HDRS-17) score
Description
A 50% improvement in the score is considered response to rTMS. A final score of <8 is categorized as remission.
Time Frame
baseline, 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 Major Depressive Disorder (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 Hamilton Depression Rating Score 17-item (HDRS-17) 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
Fidel Vila-Rodriguez, MD
Organizational Affiliation
University of British Columia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Non-Invasive Neurostimulation Therapies lab, University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T2A1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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
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
Links:
URL
http://NINET.CA
Description
Laboratory Website

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Pilot Study Comparing 10hz vs Theta Burst Stimulation

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