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Accelerated Versus Standard Intermittent Theta Burst Stimulation for Major Depressive Disorder

NCT07768397 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Accelerated 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 day, separated by 30-minute intervals, over 15 consecutive weekdays, for a total of 45 sessions.

DEVICE

Standard Intermittent Theta Burst Stimulation

Intermittent theta burst stimulation (iTBS) is delivered to the left dorsolateral prefrontal cortex. 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, with a duration of approximately 3 minutes. Participants receive one session per weekday, 5 days per week for 4 weeks, for a total of 20 sessions.

Sponsors & Collaborators

  • Military Hospital 175

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Vietnam

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07768397 on ClinicalTrials.gov