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Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression (ReDeeMD)

Primary Purpose

Major Depressive Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcranial magnetic stimulation
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, TMS, deep TMS

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of Major Depressive Disorder, at least moderate intensity, single or recurrent episode HRSD-17 score of at least 18 No improvement to at least two adequate courses of antidepressants (based on the ATHF) or were unable to tolerate at least two separate trials of antidepressants of inadequate dose and duration On a stable antidepressant regimen for the past four weeks before screening Patients with a chronic depressive episode >2 years and who have previously received ECT or ketamine will be eligible to participate Exclusion Criteria: Having previously received TMS; Substance use disorder within the last three months Diagnosis of bipolar or psychosis spectrum disorder Anxiety or personality disorder that is assessed by a study investigator to be the primary cause and causing greater impairment than MDD Concomitant major unstable medical or neurological illness Intracranial implant, cardiac pacemaker or implanted medication pump Significant laboratory abnormality; Active suicidal intent Pregnancy If participating in psychotherapy, must have been in stable treatment for at least three months before entry into the study, with no anticipation of change Currently taking more than the equivalent of 2 mg of lorazepam of a benzodiazepine daily or any dose of an anticonvulsant due to the potential to limit TMS effectiveness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    repetitive Transcranial Magnetic Stimulation

    deep Transcranial Magnetic Stimulation

    Arm Description

    rTMS on a MagPro X100 research grade stimulator (MagVenture) equipped with a B70 fluid-cooled coil. Participant will receive the MDD FDA-approved iTBS protocol (triplet 50 Hz bursts repeated at 5 Hz, 2 s ON and 8 s OFF; 600 pulses per session; total duration of 3 min 9 s, 120% hand motor threshold)

    dTMS on a research Brainsway system equipped with an H7-Coil. Participants will receive the MDD FDA-cleared 18 Hz stimulation protocol (2 sec ON, 20 sec OFF, 55 trains; 1980 pulses per session; 20 min 10 s duration; 120% hand motor threshold)

    Outcomes

    Primary Outcome Measures

    Hamilton Rating Scale for Depression-17 (HRSD-17)
    score change. Higher score means worse outcome. (Min = 0, Max = 53)
    Response (yes/no) on Hamilton Rating Scale for Depression-17
    Defined as a score reduction of 50% or more
    Remission (yes/no) on Hamilton Rating Scale for Depression-17
    Defined as a score of 7 or less

    Secondary Outcome Measures

    Hamilton Rating Scale for Depression-17
    score change. Higher score means worse outcome. (Min = 0, Max = 53)
    Hamilton Rating Scale for Depression-17
    score change. Higher score means worse outcome. (Min = 0, Max = 53)
    Hamilton Rating Scale for Depression-17
    score change. Higher score means worse outcome. (Min = 0, Max = 53)
    Response (yes/no) on Hamilton Rating Scale for Depression-17
    Defined as a score reduction of 50% or more
    Response (yes/no) on Hamilton Rating Scale for Depression-17
    Defined as a score reduction of 50% or more
    Response (yes/no) on Hamilton Rating Scale for Depression-17
    Defined as a score reduction of 50% or more
    Remission (yes/no) on Hamilton Rating Scale for Depression-17
    Defined as a score of 7 or less
    Remission (yes/no) on Hamilton Rating Scale for Depression-17
    Defined as a score of 7 or less
    Remission (yes/no) on Hamilton Rating Scale for Depression-17
    Defined as a score of 7 or less
    Hamilton Rating Scale for Depression-28
    score change. Higher score means worse outcome. (Min = 0, Max = 90)
    Hamilton Anxiety Rating Scale (HAM-A)
    score change. Higher score means worse outcome. (Min = 0, Max = 56)
    Quick Inventory of Depressive Symptomatology (self-report) (QIDS-SR 16)
    score change. Higher score means worse outcome. (Min = 0, Max = 42)
    General Anxiety Disorder-7 (GAD-7)
    score change. Higher score means worse outcome. (Min = 0, Max = 21)
    Snaith-Hamilton Pleasure Scale (SHAPS)
    score change. Higher score means worse outcome. (Min= 0, Max = 56)
    Columbia-Suicide Severity Rating Scale (C-SSRS)
    score change. Higher score means worse outcome. (Min = 0, Max = 30)
    Rumination Response Scale (RRS)
    score change. Higher score means worse outcome. (Min = 0, Max = 88)
    Adult AHDH Self-Report Scale
    qualitative.
    McLean Screening Instrument for Borderline Personality Disorder
    score. Higher score means worse outcome. (Min = 0, Max = 10)
    World Health Organization Quality of Life Short Version (WHOQOL-BREF)
    Difference score. Lower score means worse outcome. (Min = 26, Max = 130)
    Cognitive Difficulties Scale (MacNair-R)
    Difference score. Higher score means worse outcome. (Min = 0, Max = 156)
    Memory Complaints Scale (MacNair)
    score. Higher score means worse outcome. (Min = 0, Max = 45)
    Sheehan Disability Scale
    score. Higher score means worse outcome. (Min = 0, Max = 30)
    Visual Pain Scale
    Maximum score (during treatment). Higher score means worse outcome. (Min = 0, Max = 10).
    Sex and Gender scale
    Descriptive statistics

    Full Information

    First Posted
    May 31, 2023
    Last Updated
    July 12, 2023
    Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
    Collaborators
    Canadian Institutes of Health Research (CIHR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05902312
    Brief Title
    Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression
    Acronym
    ReDeeMD
    Official Title
    Comparative Effectiveness of Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2027 (Anticipated)
    Study Completion Date
    September 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
    Collaborators
    Canadian Institutes of Health Research (CIHR)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this randomized controlled trial is to he effectiveness of two different TMS techniques in TRD, repetitive TMS (rTMS) and deep TMS (dTMS). The main questions it aims to answer are: type of study: clinical trial participant population/health conditions : Major Depressive Disorder To assess the superiority of dTMS over rTMS in TRD To evaluate the predictive capacity of scalable candidate biomarkers Participants will be randomly allocated to one of the two intervention groups (rTMS or dTMS).
    Detailed Description
    The primary aim of this trial is to compare the effectiveness of two different TMS techniques in TRD, repetitive TMS (rTMS) and deep TMS (dTMS). Compared to rTMS, dTMS delivers a broader magnetic field, which in turn reduces coil positioning error and maximizes the probability of optimal cortical stimulation. A past RCT comparing both approaches found a greater depression score decrease and response/remission rates for dTMS, but was short of reaching significance for remission rates (primary outcome). Critical components of this RCT were suboptimal, including too few treatment sessions and insufficient statistical power, both of which could have obscured an actual difference between modalities. Proof of a more effective type of TMS over another would translate into increased odds of improvement for TRD patients who live with a chronic and disabling illness.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized, single-center, two-arm, parallel-group superiority trial
    Masking
    Outcomes Assessor
    Masking Description
    Given the study's design, blinding participants and TMS operators will not be possible. Still, staff responsible for participant assessments and data analysis will be blinded to treatment conditions and external to the clinic staff. Patients will be instructed not to reveal their group assignment to the raters. Patients will not be given the specifics of the treatment parameters and will be instructed not to talk to each other during the study period. Both treatments will be presented as effective to them. Lastly, the data management center will strictly control access to the randomization code.
    Allocation
    Randomized
    Enrollment
    220 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    repetitive Transcranial Magnetic Stimulation
    Arm Type
    Active Comparator
    Arm Description
    rTMS on a MagPro X100 research grade stimulator (MagVenture) equipped with a B70 fluid-cooled coil. Participant will receive the MDD FDA-approved iTBS protocol (triplet 50 Hz bursts repeated at 5 Hz, 2 s ON and 8 s OFF; 600 pulses per session; total duration of 3 min 9 s, 120% hand motor threshold)
    Arm Title
    deep Transcranial Magnetic Stimulation
    Arm Type
    Experimental
    Arm Description
    dTMS on a research Brainsway system equipped with an H7-Coil. Participants will receive the MDD FDA-cleared 18 Hz stimulation protocol (2 sec ON, 20 sec OFF, 55 trains; 1980 pulses per session; 20 min 10 s duration; 120% hand motor threshold)
    Intervention Type
    Device
    Intervention Name(s)
    transcranial magnetic stimulation
    Other Intervention Name(s)
    deep transcranial magnetic stimulation
    Intervention Description
    Participants will receive either rTMS or dTMS
    Primary Outcome Measure Information:
    Title
    Hamilton Rating Scale for Depression-17 (HRSD-17)
    Description
    score change. Higher score means worse outcome. (Min = 0, Max = 53)
    Time Frame
    Baseline to Week 6
    Title
    Response (yes/no) on Hamilton Rating Scale for Depression-17
    Description
    Defined as a score reduction of 50% or more
    Time Frame
    baseline to Week 6
    Title
    Remission (yes/no) on Hamilton Rating Scale for Depression-17
    Description
    Defined as a score of 7 or less
    Time Frame
    Week 6
    Secondary Outcome Measure Information:
    Title
    Hamilton Rating Scale for Depression-17
    Description
    score change. Higher score means worse outcome. (Min = 0, Max = 53)
    Time Frame
    Baseline to Week 7
    Title
    Hamilton Rating Scale for Depression-17
    Description
    score change. Higher score means worse outcome. (Min = 0, Max = 53)
    Time Frame
    Baseline to Week 10
    Title
    Hamilton Rating Scale for Depression-17
    Description
    score change. Higher score means worse outcome. (Min = 0, Max = 53)
    Time Frame
    Baseline to Week 18
    Title
    Response (yes/no) on Hamilton Rating Scale for Depression-17
    Description
    Defined as a score reduction of 50% or more
    Time Frame
    Baseline to Week 7
    Title
    Response (yes/no) on Hamilton Rating Scale for Depression-17
    Description
    Defined as a score reduction of 50% or more
    Time Frame
    Baseline to Week 10
    Title
    Response (yes/no) on Hamilton Rating Scale for Depression-17
    Description
    Defined as a score reduction of 50% or more
    Time Frame
    Baseline to Week 18
    Title
    Remission (yes/no) on Hamilton Rating Scale for Depression-17
    Description
    Defined as a score of 7 or less
    Time Frame
    Baseline to Week 7
    Title
    Remission (yes/no) on Hamilton Rating Scale for Depression-17
    Description
    Defined as a score of 7 or less
    Time Frame
    Baseline to Week 10
    Title
    Remission (yes/no) on Hamilton Rating Scale for Depression-17
    Description
    Defined as a score of 7 or less
    Time Frame
    Baseline to Week 18
    Title
    Hamilton Rating Scale for Depression-28
    Description
    score change. Higher score means worse outcome. (Min = 0, Max = 90)
    Time Frame
    Baseline to Week 6, Week 7, Week 10, Week 18
    Title
    Hamilton Anxiety Rating Scale (HAM-A)
    Description
    score change. Higher score means worse outcome. (Min = 0, Max = 56)
    Time Frame
    Baseline to Week 6, Week 7, Week 10, Week 18
    Title
    Quick Inventory of Depressive Symptomatology (self-report) (QIDS-SR 16)
    Description
    score change. Higher score means worse outcome. (Min = 0, Max = 42)
    Time Frame
    Baseline to Week 6, Week 7, Week 10, Week 18
    Title
    General Anxiety Disorder-7 (GAD-7)
    Description
    score change. Higher score means worse outcome. (Min = 0, Max = 21)
    Time Frame
    Baseline to Week 6, Week 7, Week 10, Week 18
    Title
    Snaith-Hamilton Pleasure Scale (SHAPS)
    Description
    score change. Higher score means worse outcome. (Min= 0, Max = 56)
    Time Frame
    Baseline to Week 6, Week 7, Week 10, Week 18
    Title
    Columbia-Suicide Severity Rating Scale (C-SSRS)
    Description
    score change. Higher score means worse outcome. (Min = 0, Max = 30)
    Time Frame
    Baseline to Week 6, Week 7, Week 10, Week 18
    Title
    Rumination Response Scale (RRS)
    Description
    score change. Higher score means worse outcome. (Min = 0, Max = 88)
    Time Frame
    Baseline to Week 6, Week 7, Week 10, Week 18
    Title
    Adult AHDH Self-Report Scale
    Description
    qualitative.
    Time Frame
    Baseline to Week 18
    Title
    McLean Screening Instrument for Borderline Personality Disorder
    Description
    score. Higher score means worse outcome. (Min = 0, Max = 10)
    Time Frame
    Baseline
    Title
    World Health Organization Quality of Life Short Version (WHOQOL-BREF)
    Description
    Difference score. Lower score means worse outcome. (Min = 26, Max = 130)
    Time Frame
    Baseline to Week 6, Week 7, Week 10, Week 18
    Title
    Cognitive Difficulties Scale (MacNair-R)
    Description
    Difference score. Higher score means worse outcome. (Min = 0, Max = 156)
    Time Frame
    Baseline to Week 6, Week 7, Week 10, Week 18
    Title
    Memory Complaints Scale (MacNair)
    Description
    score. Higher score means worse outcome. (Min = 0, Max = 45)
    Time Frame
    Baseline to Week 6, Week 7, Week 10, Week 18
    Title
    Sheehan Disability Scale
    Description
    score. Higher score means worse outcome. (Min = 0, Max = 30)
    Time Frame
    Baseline to Week 6, Week 7, Week 10, Week 18
    Title
    Visual Pain Scale
    Description
    Maximum score (during treatment). Higher score means worse outcome. (Min = 0, Max = 10).
    Time Frame
    Each treatment day
    Title
    Sex and Gender scale
    Description
    Descriptive statistics
    Time Frame
    Baseline
    Other Pre-specified Outcome Measures:
    Title
    Electroencephalogram to predict treatment response
    Description
    individual alpha frequency
    Time Frame
    Baseline
    Title
    Electroencephalogram event-related potentials
    Description
    Reward positivity
    Time Frame
    Baseline
    Title
    Electrocardiogram
    Description
    corrected QT interval
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of Major Depressive Disorder, at least moderate intensity, single or recurrent episode HRSD-17 score of at least 18 No improvement to at least two adequate courses of antidepressants (based on the ATHF) or were unable to tolerate at least two separate trials of antidepressants of inadequate dose and duration On a stable antidepressant regimen for the past four weeks before screening Patients with a chronic depressive episode >2 years and who have previously received ECT or ketamine will be eligible to participate Exclusion Criteria: Having previously received TMS; Substance use disorder within the last three months Diagnosis of bipolar or psychosis spectrum disorder Anxiety or personality disorder that is assessed by a study investigator to be the primary cause and causing greater impairment than MDD Concomitant major unstable medical or neurological illness Intracranial implant, cardiac pacemaker or implanted medication pump Significant laboratory abnormality; Active suicidal intent Pregnancy If participating in psychotherapy, must have been in stable treatment for at least three months before entry into the study, with no anticipation of change Currently taking more than the equivalent of 2 mg of lorazepam of a benzodiazepine daily or any dose of an anticonvulsant due to the potential to limit TMS effectiveness
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jean-Philippe Miron, MD PhD
    Phone
    514-890-8000
    Ext
    26489
    Email
    jean-philippe.miron@umontreal.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Véronique Desbeaumes Jodoin, PhD
    Phone
    514-890-8000
    Ext
    26489
    Email
    vdesbeaumes@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean-Philippe Miron, MD PhD
    Organizational Affiliation
    Centre de Recherche du Centre Hospitalier de l'Université de Montréal
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://labo-unp.ca/
    Description
    research website

    Learn more about this trial

    Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression

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