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Study identifier: NCT05813093 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Recruiting

Interleaved TMS-fMRI in Ultra-treatment Resistant Depression

Condition: Major Depressive Disorder  ·  Sponsor: Sunnybrook Health Sciences Centre

PhaseNA
Planned participants88
Who can joinAll sexes, 20 Years to 65 Years
Healthy volunteersNoCheck eligibility criteria ↓
WhereToronto, Ontario, Canada

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Anusha Baskaran, PhD  ·  416-480-6100  ·  anusha.baskaran@sunnybrook.ca

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (1)

Sunnybrook Health Sciences CentreToronto, Ontario, CanadaRecruiting

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