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

March 29, 2018 updated by: Jonathan Downar, University Health Network, Toronto

A Randomized Sham-Controlled Study of High- and Low-frequency Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex in Major Depressive Disorder

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T2S8
        • Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-frequency rTMS
20 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
Device: High-frequency rTMS
20 Hz active stimulation, twice daily
Other Names:
  • Magventure Cool DB80 Active/Placebo Coil
Experimental: Low-frequency rTMS
1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
Device: Low-frequency rTMS
1 Hz active stimulation, twice daily
Other Names:
  • Magventure Cool DB80 Active/Placebo Coil
Sham Comparator: Sham rTMS
Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
Device: Sham rTMS
Sham stimulation, twice daily
Other Names:
  • Magventure Cool DB80 Active/Placebo Coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HAM-D17 score
Time Frame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
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.
Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Depression Inventory-II
Time Frame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Beck anxiety inventory
Time Frame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting-state functional MRI
Time Frame: 1 week pre- and 1 week post-intervention
10 min resting-state functional MRI acquisition at 3T
1 week pre- and 1 week post-intervention
Electroencephalography
Time Frame: Day 1 and day 15 (final day) of rTMS intervention
10 min resting-state and task-based (response inhibition, reward sensitivity) acquisitions
Day 1 and day 15 (final day) of rTMS intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Jonathan Downar, MD PhD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-9276-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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