Study of Accelerated Intermittent Theta Burst Stimulation iTBS for Adults with Major Depressive Disorder Evaluating Treatment Effects and Changes in Biological Markers

What this Trial Is About

Major depressive disorder MDD is a common and disabling psychiatric condition that often does not respond well to standard antidepressant treatments. This research aims to evaluate the effectiveness of accelerated bilateral dorsomedial prefrontal cortex intermittent theta burst stimulation iTBS in adults with MDD who have had an inadequate response to at least one antidepressant trial. The study also investigates changes in neurobiological biomarkers such as cortisol, ACTH, BDNF, inflammatory markers, and their relationship with treatment response. Participants aged 18 to 65 will receive accelerated bilateral DMPFC iTBS delivered using a double-cone coil over five consecutive days with four sessions each day, totaling 20 sessions. Each session delivers 1200 pulses at 120% of the motor threshold. Those showing partial improvement without remission after these sessions may receive an additional 10 sessions according to clinical assessment. During the study, clinical assessments will be conducted at baseline, during treatment, after treatment completion, and at one-month follow-up. These include depression and anxiety rating scales, suicidal ideation measures, and global impression ratings. Blood samples will be collected to measure various biomarkers before and after treatment. The main outcome measured is the change in depression severity on the Hamilton Depression Rating Scale HAM-D. Safety and symptom monitoring will continue throughout the study period.

Accelerated iTBS for Major Depression