Using brain imaging and TMS to treat severe depression
Official title: Interleaved TMS-fMRI to Evaluate Intermittent Theta-burst and Dorsolateral Prefrontal Circuit Engagement in Ultra-treatment Resistant Depression
Run by Sunnybrook Health Sciences Centre · NCT05813093 · Data updated 2026-11-12
This study is testing a new way to treat severe depression using brain scans and a special type of magnetic stimulation to see if it helps people who haven't found relief from other treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 65 Years |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | September 27, 2023 |
| Main results expected | July 7, 2025 |
| Study ends | July 7, 2025 |
| Registry record updated | November 15, 2024 |
| Trial ID | NCT05813093 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 20-65 with major depressive disorder or persistent depressive disorder who have experienced treatment resistance.
✕Probably not a fit
Patients with contraindications to MRI or those whose depression is not the primary concern may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to recruit patients with ultra-treatment resistant depression from neurosurgery and TMS clinics to assess brain connectivity and mood regulation through advanced imaging techniques. Participants will undergo a one-week accelerated repetitive transcranial magnetic stimulation (rTMS) protocol, guided by pre-treatment brain imaging. The study will evaluate the effectiveness of rTMS in patients who have not responded to multiple treatments and may be candidates for neurosurgery. Researchers will also analyze how brain activity patterns predict responses to rTMS treatment.
Why it matters
Potential benefit: If successful, this approach could provide a new, non-invasive treatment option for patients with severe depression who have not responded to traditional therapies.
How similar studies have gone: Previous studies have shown promise in using rTMS for depression, but this specific approach combining imaging and accelerated treatment is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Age 20-65 * Have a diagnosis of MDD or persistent depressive disorder and meet criteria for a major depressive episode (moderate-severe) according to the DSM 5.0 with a 17-item Hamilton Rating Scale Score in Depression (HRSD-17) of \>=18 * UTRD subjects will also have a duration of depressive symptoms \>=5 years, treatment resistance to antidepressants will be defined by Maudsley-staging, failing \>6 antidepressants (level 4) and \>1 adjunctive antidepressants of adequate dose/duration, failed at \>=1 psychotherapy, and no response to \>=1 trial of esketamine, IV ketamine, ECT or rTMS * Milder TRD participants will have failed at least 1 antidepressant medication of adequate dose/duration and never had neuromodulation treatment Exclusion criteria: * Contraindications to MRI * Medical/psychiatric co-morbidities that prevent participation in the study or where depression is not the primary psychiatric symptom of concern * History of psychosis, pregnancy, substance dependence within the last 6 months * Active neurological disorder * History of seizure disorder * Cognitive impairment * Unable to provide informed consent on their own * Pregnant
Where it's running
-
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Anusha Baskaran, PhD
- Email: anusha.baskaran@sunnybrook.ca
- Phone: 416-480-6100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.