An interventional study of Theta burst stimulation in Major Depressive Disorder (MDD) and Treatment Resistant Depression (TRD), sponsored by The Royal Ottawa Mental Health Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by The Royal Ottawa Mental Health Centre · Not applicable, Interventional, and Treatment
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Among 312 studies in Depressive Disorder, Major with a site in Canada — 66 open to participants now, 82 under way, 12 of them phase 3. Depressive Disorder, Major · Canada.
Among the 312 studies in Depressive Disorder, Major with a site in Canada, this one is the 228th largest by planned enrollment of the 284 interventional ones that give a count, is one of 16 that started in 2026, is one of 132 with no phase, reaches primary completion later than 36 of the 81 other live ones, and was the 284th registered.
3,047 studies on the registry are indexed under Depressive Disorder, Major; 593 are open to participants now.
Browse Depressive Disorder, Major studies →66 of the 312 studies in Depressive Disorder, Major with a site in Canada are open now. Recruiting first, the newest first:
The Royal's Institute of Mental Health Research · Sites in Canada
Ages 18–65
Sunnybrook Health Sciences Centre · Sites in Canada
Ages 18–65
Lawson Research Institute of St. Joseph's · Sites in Canada
Ages 18+
Eli Lilly and Company · Sites in Canada, United States, Australia and 12 more countries
Ages 18–75
University of Toronto · Sites in Canada
Ages 18+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 413 Depressive Disorder, Major studies recruiting now, 93 (23%) set no upper age limit and 294 (71%) stop at 75 or younger; 55 take children under 18; 99 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
312 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 45 · Phase 3 76 · Phase 4 28
First in 1999; this study’s year is marked. 16 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 79 across 2,533 interventional studies indexed under Depressive Disorder, Major.
Median enrollment 70 across the 284 interventional studies, 120 across the 27 observational. Of the 196 that completed or were terminated, 50 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
76 of 312 have an industry lead sponsor. The 10 most frequent:
The Royal Ottawa Mental Health Centre is the lead sponsor of 22 studies on the registry; 16 are open to participants now.
The Royal Ottawa Mental Health Centre has 7 studies filed under Depressive Disorder, Major — fewer than ten, so there is no comparison to draw.
24 of the studies in Depressive Disorder, Major with a site in Canada that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07262008Phase 3Women's College HospitalSustained Mood Improvement With Laughing Gas Exposure | 2027-02-01 |
| NCT06891300Phase 3The Royal's Institute of Mental Health ResearchUnderstanding and Treating Suicidal Ideation With Ketamine | 2027-03 |
| NCT06963021Phase 3Neurocrine BiosciencesNBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | 2027-07 |
| NCT05423275University of British ColumbiaLight and Ion Maintenance In Treatment for Depression (LIMIT-D): Feasibility Study | 2026-12 |
| NCT06163625Unity Health TorontoThe Impact of Working Memory and Reward Markers on DLPFC Activity in Treatment-resistant Depression | 2026-12-31 |
Add all 24 to your calendar (.ics) → With an account.
Among the 312 studies in Depressive Disorder, Major with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this study is to collect feasibility data on combining structured exercise aimed to improve physical fitness, and intermittent TBS (iTBS) in treating individuals diagnosed with difficult-to-treat depression who are physically inactive. By conducting this trial, we will compare the therapeutic benefits of the combined approach against the standard treatment of iTBS alone (without exercise). These findings will be used to inform future large-scale projects in which we will investigate, in a larger sample size, whether structured exercise aimed to improve fitness as recommended by most public exercise guidelines (i.e., ≥3x/week, moderate-to-vigorous intensity) serves as an active ingredient that amplifies the effectiveness of iTBS. Ultimately, the insights gained from this study will be valuable for clinicians seeking to alleviate depressive symptoms in MDD through neuromodulation techniques such as iTBS.
This is a randomized, two-arm, pilot feasibility clinical trial design involving physically inactive individuals diagnosed with treatment-resistant depression (TRD). Participants will be randomly assigned to either: 1) 4-weeks of exercise (moderate-to-vigorous intensity; \~1h session, 3x/week) followed by 6 weeks of iTBS combined with exercise (intervention group), or 2) 4 weeks of stable treatment (i.e. no change in psychotropic medication/psychotherapy regimen or physical activity) followed by 6 weeks of iTBS alone (control group). The intervention group is divided into two phases: the priming phase and the synergetic phase. Due to the neuroplasticity-enhancing effects of exercise and fitness, and based on pilot results demonstrating superior antidepressant effects of TBS in physically active participants, the main objective of the priming phase is to enhance brain plasticity mechanisms through increases in fitness from the 4 weeks of exercise training. In other words, this phase aims to build capacity for a better response to TBS treatment. The synergetic phase (interventional group) follows the priming and involves integrating TBS treatment into the exercise training regimen. Participants in the interventional group will maintain their exercise routine to enhance and sustain gains while undergoing TBS treatment for 6 weeks. In accordance with the recommended guidelines for both exercise and TBS treatment for depression, participants in the interventional group will engage in exercise sessions lasting approximately 1 hour, three times per week. In both interventional and control groups, TBS treatment will be administered five times per week, with treatment delivery lasting 3 minutes. We hypothesize that all aspects of this project will be feasible, that is the exercise and iTBS delivery and outcomes assessment. Additionally, we expect participants to show high levels of adherence and compliance with the strategy. The ultimate goal, to be investigated in a larger-scale study following this one, is to determine whether exercise acts as an active ingredient that enhances the effectiveness of iTBS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4-weeks of exercise (moderate-to-vigorous intensity) followed by 6 weeks of iTBS combined with exercise.
Device: Theta burst stimulation
Standard care of 4 weeks of stable treatment (i.e. no changes to antidepressant regimen or physical activity) followed by 6 weeks of iTBS alone.
Device: Theta burst stimulation
Cool B70 cooled-coil (left DLPFC) with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)
Also known as: rTMS
Assessing feasibility on combining structured exercise and intermittent Theta Burst Stimulation (iTBS) in participants with treatment-resistant depression (TRD)
Feasibility outcomes are crucial metrics that will guide the refinement of our protocols, thereby enhancing our preparedness for future design endeavors. These will include: 1) recruitment, 2) adherence, 3) compliance, 4) retention, 5) satisfaction, and 6) adverse events.
Time frame: Assessed at the end of the study once all participants have completed the study.
Compare the effects on clinical response of exercise on enhancing iTBS treatment efficacy vs. iTBS alone
Clinical response will be defined as a ≥ 50% reduction in the 17-item Grid Hamilton Rating Scale for Depression (Grid-HRSD-17). The Grid HRSD is a clinician-rated instrument with seventeen items used to measure the severity of depressive episodes. The overall score ranges from 0 to 52, where scores of 0 to 7 are considered as being normal, 8 to 16 suggest mild depression, 17 to 23 moderate depression, and scores ≥ 24 indicate severe depression.
Time frame: Administered at screening, before iTBS treatment course (week 4), at the end of the treatment course (week 10), then at the 6-week follow-up (week 16)
Change in self-reported depression symptoms as measured by Beck Depression Inventory (BDI-II).
As a secondary measure of depressive symptoms. Score scale from 0 (better outcome, no depression) to 63 (worst outcome, extreme depression).
Time frame: Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)
Change in self-reported anxiety symptoms as measured by Beck Anxiety Inventory (BAI)
As a secondary measure of anxiety symptoms. Score scale from 0 (better outcome, no depression) to 63 (worst outcome, extreme anxiety).
Time frame: Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)
Change in self-reported suicidal thoughts symptoms as measured by Beck Scale for Suicidal Ideation (BSS)
To assess the effect of treatment on suicidal thoughts that may be improved by iTBS. Score scale from 0 (better outcome, no desire for suicide) to 38 (worst outcome, extreme desire for suicide).
Time frame: Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)
Change in self-reported hopelessness as measured by State Hope Scale (SHS)
To assess the effect of treatment on self-report symptoms and perceptions of stress that may be improved by iTBS. 6-item measure where responses are rated on an 8-point Likert scale. Score scale from 1 (Definitely True) to 8 (Definitely False).
Time frame: Administered at screening, before the first iTBS treatment (week 4) and every week after that for 6 weeks (week 5, week 6, week 7, week 8, week 9, week 10), and at the 6-week follow-up assessment (week 16)
Change in neuroplasticity as measured by neurophysiology (TMS) and MRI (Arterial Spin Labelling measures of brain blood flow)
To assess the effect of treatment on biomarkers. Greater improvements in these biomarkers will also be associated with greater reductions in depressive symptoms.
Time frame: Administered at pre-assessment (baseline), before iTBS treatment course (week 4), end of iTBS treatment course (week 10)
Change in grip strength as measured by dynamometer
To assess the effect of treatment on biomarkers. Greater improvements in these biomarkers will also be associated with greater reductions in depressive symptoms.
Time frame: Administered at pre-assessment (baseline), before iTBS treatment course (week 4), end of iTBS treatment course (week 10), and at 6-week follow-up assessment (week 16)
Change in physical measures as assessed by anthropometrics
To assess the effect of the intervention on physical health.
Time frame: Administered at pre-assessment (baseline), before iTBS treatment course (week 4), end of iTBS treatment course (week 10), and at 6-week follow-up assessment (week 16)
Incidence of Treatment-Emergent Adverse Events
Adverse events will be tracked and recorded.
Time frame: Daily Monday-Friday throughout study (16 weeks).
Side Effects
Side effects will be tracked and recorded on any TMS visits, using the TMS side effects questionnaire.
Time frame: Daily Monday-Friday throughout study (16 weeks).
Plan to share: Yes — All Individual Participant Data collected from this study (IPD) will be de-identified for all parties who have permission to access it. This de-identified data may be shared with other researchers at the Royal's Institute of Mental Health Research. De-identified may be shared with the public only upon request. Please note that all data that has the potential of revealing participants' identity will NOT be used to share.
Time frame: De-identified data may become available (upon request) when the study is completed and published (anticipated time frame: the year of 2027)
Access criteria: De-identified data will be accessible only through the permission of the lead research scientist. All requests must be made and accepted by her.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Jan 2027, 10 months after the start.
Of 649 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's planned 10 months is below that.
Counting every sponsor, half of 689 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
Start moved once since we started tracking on Sep 25, 2026: Dec 2025 → Mar 2026, on Sep 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The Royal Ottawa Mental Health Centre