Using brain imaging and TMS to treat severe depression
Interleaved TMS-fMRI to Evaluate Intermittent Theta-burst and Dorsolateral Prefrontal Circuit Engagement in Ultra-treatment Resistant Depression
This study is testing a new way to treat severe depression using brain scans and a special type of magnetic stimulation to see if it helps people who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05813093 on ClinicalTrials.gov |
What this trial studies
This study aims to recruit patients with ultra-treatment resistant depression from neurosurgery and TMS clinics to assess brain connectivity and mood regulation through advanced imaging techniques. Participants will undergo a one-week accelerated repetitive transcranial magnetic stimulation (rTMS) protocol, guided by pre-treatment brain imaging. The study will evaluate the effectiveness of rTMS in patients who have not responded to multiple treatments and may be candidates for neurosurgery. Researchers will also analyze how brain activity patterns predict responses to rTMS treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-65 with major depressive disorder or persistent depressive disorder who have experienced treatment resistance.
Not a fit: Patients with contraindications to MRI or those whose depression is not the primary concern may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, non-invasive treatment option for patients with severe depression who have not responded to traditional therapies.
How similar studies have performed: Previous studies have shown promise in using rTMS for depression, but this specific approach combining imaging and accelerated treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Anusha Baskaran, PhD
- Email: anusha.baskaran@sunnybrook.ca
- Phone: 416-480-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.