NCT05813093Recruiting
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
Source: ClinicalTrials.gov · Last updated 15 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 13 Mar 2023
- Start date
- 27 Sept 2023
- Primary completion date
- 7 Jul 2025
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Depression
- NCT number
- NCT05813093
What you commit to
- Study type: Interventional
- Planned participants: 88
- From 27 Sept 2023 to the primary completion date, 7 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Contraindications to MRI
- Unable to provide informed consent on their own
- Pregnant
Who the study is looking for
- 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
Age in the registry: 20 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
Related publications
- An exploratory study of glycemic biomarkers and rTMS treatment outcomes in treatment-resistant depression.BMC Psychiatry · 2026 · PMID 41872771
This page is information, not medical advice. Discuss any trial with your doctor.