This randomized clinical trial aims to compare the effectiveness and safety of accelerated intermittent theta burst stimulation (iTBS) with standard iTBS in adults with major depressive disorder.
Participants will be randomly assigned to receive either accelerated or standard iTBS targeting the left dorsolateral prefrontal cortex, in addition to pharmacotherapy. The accelerated iTBS group will receive 45 treatment sessions over approximately 15 treatment days, while the standard iTBS group will receive 20 treatment sessions over 4 weeks.
The primary objective is to compare changes in depressive symptom severity between the two treatment groups from baseline to the end of treatment. Depressive symptoms will be assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17). The study will also evaluate other clinical outcomes, cognitive function, quality of life, sleep quality, neurophysiological measures, and treatment safety.
Age 18 to 65 years.
Diagnosis of major depressive disorder (MDD), confirmed by a specialist according to DSM-5 criteria.
Hamilton Depression Rating Scale, 17-item version (HAM-D17) score ≥18 at screening/baseline.
Stable background pharmacotherapy for at least 4 weeks before randomization, with no planned changes in medication regimen or drug class during the intervention period unless clinically required.
History of epilepsy or seizures, except childhood febrile seizures.
Bipolar disorder or psychotic disorder.
Acute suicide risk, including HAM-D17 item 3 score ≥3 or clear suicidal intent or behavior.
Alcohol or illicit drug abuse or dependence within the previous 6 months.