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Interleaved TMS-fMRI in Ultra-treatment Resistant Depression

RecruitingNAAges 20 Years - 65 YearsAllSunnybrook Health Sciences Centre
NCT05813093 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • rTMS
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Where

1 site
Sunnybrook Health Sciences Centre
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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