An interventional study of repetitive Transcranial Magnetic Stimulation in Depression, Depression - Major Depressive Disorder and Depressive Episode, sponsored by The Royal Ottawa Mental Health Centre. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by The Royal Ottawa Mental Health Centre · Not applicable, Interventional, and Treatment
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Among 532 studies in Depression with a site in Canada — 107 open to participants now, 124 under way, 7 of them phase 3. Depression · Canada.
Among the 532 studies in Depression with a site in Canada, this one is the 416th largest by planned enrollment of the 487 interventional ones that give a count, is one of 17 that started in 2026, is one of 334 with no phase, reaches primary completion later than 106 of the 123 other live ones, and was the 522nd registered.
8,590 studies on the registry are indexed under Depression; 1,728 are open to participants now.
Browse Depression studies →107 of the 532 studies in Depression with a site in Canada are open now. Recruiting first, the newest first:
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 Regina · Sites in Canada
Ages 18+
University of Toronto · Sites in Canada
Ages 18+
Lakshmi N Yatham · Sites in Canada
Ages 19–65
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 1,090 Depression studies recruiting now, 470 (43%) set no upper age limit and 520 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years to 55 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.
532 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 25 · Phase 2 45 · Phase 3 55 · Phase 4 37
First in 1997; this study’s year is marked. 17 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 81 across 7,074 interventional studies indexed under Depression.
Median enrollment 76 across the 487 interventional studies, 262 across the 45 observational. Of the 345 that completed or were terminated, 45 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
59 of 532 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 6 studies filed under Depression — fewer than ten, so there is no comparison to draw.
35 of the studies in Depression with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| 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 |
| NCT05543681IGC Pharma, LLCClinical Trial on Agitation in Alzheimer's Dementia | 2026-11 |
| NCT07313657Bruyère Health Research Institute.Improving Care and Mental Well-Being for Adults With Heart Failure | 2026-11-30 |
| NCT05543720University Health Network, TorontoEvaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study | 2026-12 |
| NCT06745349University of ReginaThe Sleep Course: An Online Sleep Intervention for Adults With Self-reported Sleep Difficulties | 2026-12 |
Add all 35 to your calendar (.ics) → With an account.
Among the 532 studies in Depression with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The proposed project will investigate the neurobiological mechanisms of accelerated intermittent Theta Burst Stimulation (iTBS) in major depressive disorder (MDD) using an advanced multimodal imaging approach. This single-arm, within-subject study will deliver one week of accelerated iTBS and use pre-/post-treatment PET/MRI to quantify changes in synaptic density, functional connectivity, and microstructural integrity. We will combine [¹⁸F]SynVesT-1 PET with functional, neurochemical and anatomical MRI, such as resting-state fMRI, magnetic resonance spectroscopy (MRS) and neurite orientation dispersion and density imaging (NODDI), to capture treatment-related plasticity. This integrated design will link molecular and network-level mechanisms to clinical improvement, providing an unprecedented mechanistic map of how accelerated iTBS restores brain function in depression.
Major depressive disorder (MDD) is one of the most prevalent and disabling disorders worldwide, affecting approximately one in 20 Canadians at any given time and ranking among the leading causes of lost productivity, poor quality of life, and suicide. Despite major advances in pharmacological and psychotherapeutic interventions, only 40-60% of patients respond to first-line treatments. Theta Burst Stimulation (TBS) represents the next generation of rTMS technology: by delivering patterned bursts of magnetic pulses that mimic intrinsic theta-gamma coupling, TBS is thought to more efficiently engage synaptic plasticity mechanisms that underlie mood regulation. Clinically, iTBS achieves antidepressant efficacy comparable to conventional 10 Hz rTMS in one-tenth of the stimulation time, enabling faster, more accessible treatments. Yet, despite its growing clinical use and regulatory approval in multiple countries, the fundamental mechanisms by which iTBS modulates limbic-cortical networks to alleviate depressive symptoms remain poorly understood. Addressing this knowledge gap is essential to optimizing treatment protocols and advancing precision neuromodulation strategies.
Understanding how iTBS drives recovery thus requires moving beyond traditional symptom-based approaches toward multi-level indices of brain plasticity that capture functional, neurochemical, and microstructural change. Current evidence remains largely descriptive, with limited direct insight into the underlying synaptic or cellular mechanisms of iTBS-induced modulation. Integrating PET with high-resolution MRI techniques provides a unique window on these processes. We now have full capacity for in-house synthesis and imaging with [F18]SynVesT-1. Thus, this tracer quantifies synaptic density in vivo, providing a direct molecular measure of plasticity. The ability to pair [F18]SynVesT-1 PET simultaneously with MRI represents a transformative advance for mechanistic neuromodulation research.
Clinical trials show that accelerated TBS, individually targeted to the DLPFC region most anti-correlated to sgACC, can produce rapid symptom relief within days rather than weeks. However, the neurobiological mechanisms underlying these effects remain unknown. It is hypothesized that repeated stimulation sessions promote cumulative synaptic potentiation and large-scale network reorganization. Elucidating these processes is crucial to optimize dosing parameters, understand inter-individual variability in response, and guide the next generation of biologically informed treatment strategies.
The proposed project will investigate the neurobiological mechanisms of accelerated TBS in MDD using an advanced multimodal imaging approach. In this single-arm, within-subject study, participants will undergo one week of accelerated iTBS treatment while completing pre- and post-treatment positron emission tomography (PET) and magnetic resonance imaging (MRI). PET imaging with the synaptic vesicle tracer [¹⁸F]SynVesT-1 will quantify changes in synaptic density, while MRI sequences such as resting-state functional MRI, magnetic resonance spectroscopy, and neurite orientation dispersion and density imaging (NODDI) will assess functional connectivity and microstructural plasticity. By integrating molecular, functional, and structural measures of brain plasticity, the study will provide new insight into how accelerated iTBS alters brain circuits implicated in depression and how these changes relate to clinical improvement.
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.
For inclusion in the study, participants must fulfill all the following criteria:
Exclusion Criteria
Participants fulfilling any of the following criteria will be excluded from the study:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One week of accelerated iTBS and use pre-/post-treatment PET/MRI to quantify changes in synaptic density, functional connectivity, and microstructural integrity.
Device: repetitive Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Typical treatments involve 30 to 45 minutes daily sessions delivered over 4 to 6 weeks. Recent technical advances allowed the development of theta burst stimulation (TBS), a novel rTMS paradigm that reduces daily sessions to 3 to 4 minutes while maintaining the same clinical efficacy. This study will specifically be administering intermittent TBS (iTBS), which is a novel refinement of conventional rTMS and consists of bursts of 3 stimulations at 50 Hz at theta frequency (5 Hz).
Also known as: rTMS, TMS, iTBS, TBS
Change in Synaptic Density Following iTBS Measured by [¹⁸F]SynVesT-1 PET
We will quantify changes in synaptic density (expressed as non-displaceable binding potential (BPND)) within (a) the sgACC (primary ROI) and (b) the stimulated DLPFC (secondary ROI), with exploratory analyses in frontal, parietal and cerebellar regions identified in the seed dataset.
Time frame: Administered at baseline (prior to first iTBS treatment), and after the iTBS treatment course (i.e. one week later).
Change in Resting-State Functional Connectivity Following accelerated iTBS
Resting-state functional MRI (rs-fMRI) will be used to assess changes in functional connectivity (Fisher z-transformed correlation coefficients) within fronto-limbic networks following accelerated iTBS.
Time frame: Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
Change in Cortical Neurochemistry Following iTBS
Magnetic resonance spectroscopy (MRS) will be used to assess changes in cortical neurochemical metabolite concentrations or metabolite ratios (e.g., Glx, GABA+/Cr) following accelerated iTBS.
Time frame: Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
Change in Cerebral Perfusion Following iTBS
Arterial spin labelling (ASL) MRI will be used to assess changes in regional cerebral blood flow levels following accelerated iTBS.
Time frame: Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
Change in Neurite Microstructure Following iTBS
Neurite Orientation Dispersion and Density Imaging (NODDI) will be used to assess changes in neurite microstructure following accelerated iTBS, as measured by changes in neurite density index (NDI) and orientation dispersion index (ODI).
Time frame: Administered at baseline (prior to first iTBS treatment) and after the iTBS treatment course (i.e. one week later).
Incidence of Treatment-Emergent Adverse Events
Adverse events will be tracked and recorded.
Time frame: Daily Monday-Friday throughout treatment course (1 week).
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 (1 week).
Plan to share: Yes — After participants have completed their participation, we will ask them for informed consent for the storage of their de-identified data on OpenNeuro (an open access database) for the purpose of unspecified research for unspecified future research. If they do agree to participate, they will be given a unique study code (different from the participant ID used in the previous study) will be assigned to all of the study data instead of personal identifying information (ex. 'John Smith' replaced by the unique study code 'A283422'). This unique study code will be used in the Open Access database to ensure privacy and confidentiality (i.e. de-identified study data cannot be linked to participant in any way). In addition to an unique study code, their de-identified study data used in the Open Access database will include: age, sex, handedness, education level, medical diagnosis, medication, summary scores from clinical interviews, and MRI scans.
Supporting information: Statistical analysis plan
Time frame: Once data has been included in the OpenNeuro database, data cannot be removed or withdrawn as we will be unable to identify participant information to separate it from the database.
Access criteria: The shared data will be hosted on the OpenNeuro (https://openneuro.org/) platform. The dataset becomes publicly available under the Creative Commons Zero (CC0) Public Domain Dedication which places no restrictions on who can use the data or what can be done with them. The OpenNeuro is supported by the United States National Institutes of Mental Health BRAIN Initiative. The OpenNeuro follows the FAIR principles, which states that in order for shared data to be maximally useful for the scientific community, they need to be Findable, Accessible, Interoperable, and Reusable.
Data sharing details ↗ · openneuro.org
Start is estimated for Aug 2026; primary completion for Jul 2028, 23 months later.
Of 3,476 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 23 months is close to that.
Counting every sponsor, half of 3,574 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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The Royal Ottawa Mental Health Centre