Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
Interleaved TMS-fMRI to Evaluate Intermittent Theta-burst and Dorsolateral Prefrontal Circuit Engagement in Ultra-treatment Resistant Depression
Sunnybrook Health Sciences Centre
88 participants
Sep 27, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria8
- 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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Interventions
Accelerated iTBS treatment
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05813093