Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
Recruiting now NCT05813093
Run by Sunnybrook Health Sciences Centre · for 20 to 65 · All sexes
What this study is about
This is a study that will recruit patients from the neurosurgery clinic and the regular TMS clinic. It's a smaller study designed to collect brain imaging pre-treatment and then use image guided TMS to treat patient with a one week "accelerated" rTMS protocol using the research TMS machine that is housed in Dr. Sean Nestor's lab. The idea is to examine whether severe treatment resistant depression has a different brain signature than less severe/TRD and whether the investigators can get a therapeutic response from patients that would otherwise undergo neurosurgery or will ultimately undergo neurosurgery.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- 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 this trial is running
- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Who to contact
Anusha Baskaran, PhD · 416-480-6100 · anusha.baskaran@sunnybrook.ca
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05813093.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.