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High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Major Depression

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-frequency rTMS
Low-frequency rTMS
Sham rTMS
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring brain stimulation, rTMS

Eligibility Criteria

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

Inclusion Criteria (Patient):

  • Voluntary and competent to consent to treatment
  • MINI confirmed diagnosis of MDD
  • Outpatient
  • Between the ages of 18-65
  • Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode.
  • Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening
  • Must adhere to study assessment and intervention schedule.
  • Pass the TMS Safety Screening Questionnaire.

Exclusion Criteria (Patient):

  • Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical 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
  • Have received rTMS for any previous indication due to the potential compromise of subject blinding.

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

High-frequency rTMS

Low-frequency rTMS

Sham rTMS

Arm Description

20 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks

1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks

Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks

Outcomes

Primary Outcome Measures

HAM-D17 score
Outcome measured by a change in HAM-D17 score from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of <8 is categorized as remission.

Secondary Outcome Measures

Beck Depression Inventory-II
Beck anxiety inventory

Full Information

First Posted
March 2, 2016
Last Updated
March 29, 2018
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02702154
Brief Title
High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Major Depression
Official Title
A Randomized Sham-Controlled Study of High- and Low-frequency Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The trial will include structural and functional MRI, EEG, and behavioral measures obtained before, during, and after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
brain stimulation, rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-frequency rTMS
Arm Type
Experimental
Arm Description
20 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
Arm Title
Low-frequency rTMS
Arm Type
Experimental
Arm Description
1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
Intervention Type
Device
Intervention Name(s)
High-frequency rTMS
Other Intervention Name(s)
Magventure Cool DB80 Active/Placebo Coil
Intervention Description
20 Hz active stimulation, twice daily
Intervention Type
Device
Intervention Name(s)
Low-frequency rTMS
Other Intervention Name(s)
Magventure Cool DB80 Active/Placebo Coil
Intervention Description
1 Hz active stimulation, twice daily
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Other Intervention Name(s)
Magventure Cool DB80 Active/Placebo Coil
Intervention Description
Sham stimulation, twice daily
Primary Outcome Measure Information:
Title
HAM-D17 score
Description
Outcome measured by a change in HAM-D17 score from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of <8 is categorized as remission.
Time Frame
Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Secondary Outcome Measure Information:
Title
Beck Depression Inventory-II
Time Frame
Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Title
Beck anxiety inventory
Time Frame
Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Other Pre-specified Outcome Measures:
Title
Resting-state functional MRI
Description
10 min resting-state functional MRI acquisition at 3T
Time Frame
1 week pre- and 1 week post-intervention
Title
Electroencephalography
Description
10 min resting-state and task-based (response inhibition, reward sensitivity) acquisitions
Time Frame
Day 1 and day 15 (final day) of rTMS intervention

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 (Patient): Voluntary and competent to consent to treatment MINI confirmed diagnosis of MDD Outpatient Between the ages of 18-65 Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode. Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening Must adhere to study assessment and intervention schedule. Pass the TMS Safety Screening Questionnaire. Exclusion Criteria (Patient): Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical 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 Have received rTMS for any previous indication due to the potential compromise of subject blinding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Downar, MD PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Major Depression

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