Can a simpler brain stimulation match the gold standard for depression?
NCT ID NCT04999553
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
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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
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About 480 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Centre for Addiction and Mental Health
RECRUITINGToronto, Ontario, M6J 1H4, Canada
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Non-Invasive Neurostimulation Therapies Centre, University of British Columbia
RECRUITINGVancouver, British Columbia, V6T 2A1, Canada
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