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Major Depressive DisorderReDeeMDNCT05902312

Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression

A study testing transcranial magnetic stimulation in people with Major Depressive Disorder, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
transcranial magnetic stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
1 Jan 2024to 1 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • CHUM

    Montreal, Quebec, H2X 0C1

Other trials in Canada

About this study

Official title: Comparative Effectiveness of Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression: A Randomized Controlled Trial

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).

Read the 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.

Keywords
MDD, TMS, deep TMS
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05902312
Study groupRoleWhat they receive
repetitive Transcranial Magnetic StimulationActive comparatorrTMS 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)
Receives: Device: transcranial magnetic stimulation
deep Transcranial Magnetic StimulationExperimentaldTMS 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)
Receives: Device: transcranial magnetic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Rating Scale for Depression-17 (HRSD-17)

    score change. Higher score means worse outcome. (Min = 0, Max = 53)

    Measured: Baseline to Week 6

  2. Response (yes/no) on Hamilton Rating Scale for Depression-17

    Defined as a score reduction of 50% or more

    Measured: baseline to Week 6

  3. Remission (yes/no) on Hamilton Rating Scale for Depression-17

    Defined as a score of 7 or less

    Measured: Week 6

Secondary outcomes (23)

  1. Hamilton Rating Scale for Depression-17

    score change. Higher score means worse outcome. (Min = 0, Max = 53)

    Measured: Baseline to Week 7

  2. Hamilton Rating Scale for Depression-17

    score change. Higher score means worse outcome. (Min = 0, Max = 53)

    Measured: Baseline to Week 10

  3. Hamilton Rating Scale for Depression-17

    score change. Higher score means worse outcome. (Min = 0, Max = 53)

    Measured: Baseline to Week 18

  4. Response (yes/no) on Hamilton Rating Scale for Depression-17

    Defined as a score reduction of 50% or more

    Measured: Baseline to Week 7

  5. Response (yes/no) on Hamilton Rating Scale for Depression-17

    Defined as a score reduction of 50% or more

    Measured: Baseline to Week 10

  6. Response (yes/no) on Hamilton Rating Scale for Depression-17

    Defined as a score reduction of 50% or more

    Measured: Baseline to Week 18

  7. Remission (yes/no) on Hamilton Rating Scale for Depression-17

    Defined as a score of 7 or less

    Measured: Baseline to Week 7

  8. Remission (yes/no) on Hamilton Rating Scale for Depression-17

    Defined as a score of 7 or less

    Measured: Baseline to Week 10

  9. Remission (yes/no) on Hamilton Rating Scale for Depression-17

    Defined as a score of 7 or less

    Measured: Baseline to Week 18

  10. Hamilton Rating Scale for Depression-28

    score change. Higher score means worse outcome. (Min = 0, Max = 90)

    Measured: Baseline to Week 6, Week 7, Week 10, Week 18

  11. Hamilton Anxiety Rating Scale (HAM-A)

    score change. Higher score means worse outcome. (Min = 0, Max = 56)

    Measured: Baseline to Week 6, Week 7, Week 10, Week 18

  12. Quick Inventory of Depressive Symptomatology (self-report) (QIDS-SR 16)

    score change. Higher score means worse outcome. (Min = 0, Max = 42)

    Measured: Baseline to Week 6, Week 7, Week 10, Week 18

  13. General Anxiety Disorder-7 (GAD-7)

    score change. Higher score means worse outcome. (Min = 0, Max = 21)

    Measured: Baseline to Week 6, Week 7, Week 10, Week 18

  14. Snaith-Hamilton Pleasure Scale (SHAPS)

    score change. Higher score means worse outcome. (Min= 0, Max = 56)

    Measured: Baseline to Week 6, Week 7, Week 10, Week 18

  15. Columbia-Suicide Severity Rating Scale (C-SSRS)

    score change. Higher score means worse outcome. (Min = 0, Max = 30)

    Measured: Baseline to Week 6, Week 7, Week 10, Week 18

  16. Rumination Response Scale (RRS)

    score change. Higher score means worse outcome. (Min = 0, Max = 88)

    Measured: Baseline to Week 6, Week 7, Week 10, Week 18

  17. Adult AHDH Self-Report Scale

    qualitative.

    Measured: Baseline to Week 18

  18. McLean Screening Instrument for Borderline Personality Disorder

    score. Higher score means worse outcome. (Min = 0, Max = 10)

    Measured: Baseline

  19. World Health Organization Quality of Life Short Version (WHOQOL-BREF)

    Difference score. Lower score means worse outcome. (Min = 26, Max = 130)

    Measured: Baseline to Week 6, Week 7, Week 10, Week 18

  20. Cognitive Difficulties Scale (MacNair-R)

    Difference score. Higher score means worse outcome. (Min = 0, Max = 156)

    Measured: Baseline to Week 6, Week 7, Week 10, Week 18

  21. Memory Complaints Scale (MacNair)

    score. Higher score means worse outcome. (Min = 0, Max = 45)

    Measured: Baseline to Week 6, Week 7, Week 10, Week 18

  22. Visual Pain Scale

    Maximum score (during treatment). Higher score means worse outcome. (Min = 0, Max = 10).

    Measured: Each treatment day

  23. Sex and Gender scale

    Descriptive statistics

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2023
  2. Study start1 Jan 2024
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, single-center, two-arm, parallel-group superiority trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05902312
Sponsor's protocol ID
2023-11389
Other IDs
2023
Acronym
ReDeeMD
Status last verified
Jul 2025
First submitted
31 May 2023
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Desbeaumes Jodoin V, Bousseau E, Trottier-Duclos F, Jutras-Aswad D, Lesperance F, Assi EB, Nguyen DK, Blumberger DM, Baker TE, Arns M, Daskalakis ZJ, Lesperance P, Miron JP. Pilot randomized trial of intermittent theta-burst stimulation versus H-Coil transcranial magnetic stimulation for treatment-resistant depression. Psychiatry Res. 2026 Oct;364:117274. doi: 10.1016/j.psychres.2026.117274. Epub 2026 Jun 11.

    PubMed 42302659

Questions about this trial

What is this clinical trial studying?

A study testing transcranial magnetic stimulation in people with Major Depressive Disorder, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Rating Scale for Depression-17 (HRSD-17) (time frame: Baseline to Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05902312, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.

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