This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The trial will include structural and functional MRI, EEG, and behavioral measures obtained before, during, and after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
20 Hz active stimulation, twice daily
1 Hz active stimulation, twice daily
Sham stimulation, twice daily
Toronto Western Hospital
Toronto, Ontario, Canada
HAM-D17 score
Outcome measured by a change in HAM-D17 score from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of \<8 is categorized as remission.
Time frame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Beck Depression Inventory-II
Time frame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Beck anxiety inventory
Time frame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
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