Can a simpler brain stimulation match the gold standard for depression?

NCT ID NCT04999553

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial investigates whether low-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the right side of the brain works as well as the established intermittent theta burst stimulation (iTBS) on the left side for people with treatment-resistant depression and suicidal ideation. The study will enroll 480 adults aged 18-65 with major depressive disorder who haven't responded to adequate antidepressant treatment. Participants will be randomly assigned to receive one of the two rTMS protocols, and researchers will measure changes in depression severity, suicidal thoughts, and anxiety to see if the two approaches are comparable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Repetitive transcranial magnetic stimulation (rTMS) using two different protocols: intermittent theta burst stimulation (iTBS) on the left side of the brain and low-frequency rTMS on the right side.
What this could lead to
If low-frequency rTMS proves as effective as the established iTBS, it could offer a simpler, more accessible treatment option for people with treatment-resistant depression and suicidal thoughts.
What could go wrong
This is a non-inferiority trial, meaning it's testing whether the newer approach is not worse than the standard, not necessarily better. Results may vary, and the treatment may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. are female or male; 2. are outpatients; 3. are voluntary and competent to consent to treatment; 4. have a DSM 5 diagnosis of MDD,55 single or recurrent confirmed by Mini-International Neuropsychiatric Interview (MINI) version 7.0; 5. are 18yo to 65yo; 6. have 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 two separate trials of antidepressants at less than the minimum adequate dose and/or duration (ATHF 1 or 2); 7. have a score ≥ 18 on the Hamilton Depression Rating Scale (HDRS-17 item); 8. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening; 9. are able to adhere to the treatment schedule; 10. pass the TMS and MRI adult safety screening questionnaires. Exclusion Criteria: 1. have a history of substance use within the last 3 months; 2. have a concomitant major unstable medical illness; 3. have active suicidal intent; 4. are pregnant; 5. have a lifetime (MINI) diagnosis of any psychotic or bipolar disorder; 6. have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDD; 7. have failed a course of ECT in the current episode; 8. have any significant neurological disorder, any history of seizure (except those therapeutically induced by ECT), significant head trauma with loss of consciousness for \> 5 min; 9. have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; 10. are participating in psychotherapy, must have been in stable treatment for at least 3 months prior to study entry, with no anticipated change in the frequency of therapeutic sessions, or focus of therapeutic sessions over the duration of the study; 11. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators; 12. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre for Addiction and Mental Health

    RECRUITING

    Toronto, Ontario, M6J 1H4, Canada

  • Non-Invasive Neurostimulation Therapies Centre, University of British Columbia

    RECRUITING

    Vancouver, British Columbia, V6T 2A1, Canada

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