An interventional study of Accelerated Intermittent Theta Burst Stimulation and Standard Intermittent Theta Burst Stimulation in Major Depressive Disorder, sponsored by Military Hospital 175. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Military Hospital 175 · Not applicable, Interventional, and Treatment
This randomized, rater-blinded clinical trial aims to compare the effectiveness, safety, and tolerability of accelerated intermittent theta burst stimulation (iTBS) with standard iTBS in adults with major depressive disorder (MDD).
Participants will be randomly assigned in a 1:1 ratio to receive either accelerated or standard iTBS targeting the left dorsolateral prefrontal cortex. Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria. 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, measured using the 17-item Hamilton Depression Rating Scale (HAM-D17), from baseline to the end-of-treatment assessment. Secondary and exploratory assessments include treatment response and remission, sleep quality, quality of life, cognitive measures, safety and tolerability, resting electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG).
Exclusion Criteria:
Participants receive accelerated intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex. Treatment is administered at 100% of the resting motor threshold, with 1,200 pulses per session. Participants receive three sessions per treatment day, separated by 30 ± 5-minute intervals, over 15 treatment days, for a total of 45 sessions. Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria.
Device: Accelerated Intermittent Theta Burst Stimulation
Participants receive standard intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex. Treatment is administered at 120% of the resting motor threshold, with 600 pulses per session. Participants receive one session per treatment day, 5 days per week for 4 weeks, for a total of 20 sessions. Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria.
Device: Standard Intermittent Theta Burst Stimulation
Intermittent theta burst stimulation (iTBS) is delivered to the left dorsolateral prefrontal cortex using the Beam F3 approach. Stimulation consists of triplet bursts at 50 Hz repeated at 5 Hz, with 2 seconds on and 8 seconds off. Each session consists of 1,200 pulses delivered at 100% of the resting motor threshold. Participants receive three sessions per treatment day, separated by 30 ± 5-minute intervals, over 15 treatment days, for a total of 45 sessions.
Intermittent theta burst stimulation (iTBS) is delivered to the left dorsolateral prefrontal cortex using the Beam F3 approach. Stimulation consists of triplet bursts at 50 Hz repeated at 5 Hz, with 2 seconds on and 8 seconds off. Each session consists of 600 pulses delivered at 120% of the resting motor threshold. Participants receive one session per treatment day, 5 days per week for 4 weeks, for a total of 20 sessions.
Change in 17-Item Hamilton Depression Rating Scale (HAM-D17) Score From Baseline to End of Treatment
Depressive symptom severity will be assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17). The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. The primary outcome is the change in HAM-D17 total score from baseline (T0) to the end-of-treatment assessment (T4).
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Treatment Response Based on HAM-D17
Treatment response is defined as a reduction of at least 50% in the 17-item Hamilton Depression Rating Scale (HAM-D17) total score from baseline.
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Remission Based on HAM-D17
Remission is defined as a 17-item Hamilton Depression Rating Scale (HAM-D17) total score of 7 or less at the end of treatment.
Time frame: End of treatment (T4), assessed 24-72 hours after the final treatment session
Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Change in PSQI global score from baseline to the end of treatment will be evaluated.
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in Quality of Life Assessed by the WHOQOL-BREF
Quality of life is assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), which evaluates four domains: physical health, psychological health, social relationships, and environment. Each domain score is transformed to a 0-100 scale, with higher scores indicating better quality of life. Change in each domain score from baseline to the end-of-treatment assessment will be evaluated.
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)
Cognitive function is assessed using the Montreal Cognitive Assessment (MoCA). The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Change in MoCA total score from baseline to the end of treatment will be evaluated.
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in Cognitive Function Assessed by the Mini-Mental State Examination (MMSE)
Cognitive function is assessed using the Mini-Mental State Examination (MMSE). The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Change in MMSE total score from baseline to the end of treatment will be evaluated.
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Incidence of Adverse Events and Serious Adverse Events
Safety and tolerability will be assessed by monitoring adverse events (AEs) and serious adverse events (SAEs) throughout the treatment period. Adverse events potentially associated with iTBS, including headache, scalp discomfort, dizziness, and other reported adverse events, will be recorded. The number and proportion of participants experiencing at least one AE or SAE will be summarized by treatment group.
Time frame: From the first treatment session through the end-of-treatment assessment (T4)
Change in Individual Alpha Frequency (IAF)
Individual alpha frequency (IAF) will be derived from resting-state electroencephalography (EEG). Change in IAF from baseline to the post-treatment neurophysiological assessment will be evaluated as an exploratory neurophysiological outcome.
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in TMS-EEG TMS-Evoked Potential Amplitudes (N45, P60, and N100)
Transcranial magnetic stimulation-electroencephalography (TMS-EEG) will be used to assess neurophysiological changes. TMS-evoked potential amplitudes, including N45, P60, and N100, will be measured. Changes in N45, P60, and N100 amplitudes from baseline (T0) to the end-of-treatment assessment (T4) will be evaluated as exploratory neurophysiological outcomes.
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
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