Major Depressive DisorderNCT07768397
Accelerated Versus Standard Intermittent Theta Burst Stimulation for Major Depressive Disorder
A study testing Accelerated Intermittent Theta Burst Stimulation and Standard Intermittent Theta Burst Stimulation in people with Major Depressive Disorder, run by Military Hospital 175 at 1 site in Vietnam.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Accelerated Intermittent Theta Burst Stimulation and Standard Intermittent Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteVietnam
- Study dates
- 27 Aug 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years.
- Right-handed.
- Diagnosis of major depressive disorder according to ICD-10 criteria (F32 or F33), confirmed by a psychiatrist.
- 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥18 at screening/baseline.
- Able and willing to provide written informed consent and comply with essential study procedures.
- Participants may be psychotropic-medication naïve or may be receiving psychotropic medication. Participants currently receiving psychotropic medication must have maintained the same medication(s) and dose(s) for at least 2 weeks before randomization; for fluoxetine, the required stable period is at least 4 weeks.
Who cannot join
- Intracranial or head/neck metallic foreign bodies or implants that constitute a contraindication to TMS or MRI.
- Implanted electronic devices such as a cardiac pacemaker, implantable cardioverter-defibrillator, or deep brain stimulator.
- Untreated or clinically unstable thyroid dysfunction based on abnormal TSH and/or free T4 levels.
- Clinically significant intracranial structural abnormalities that may affect TMS safety, neuropsychiatric presentation, or study neurophysiological measures.
- History of epilepsy or seizures, except febrile seizures in childhood.
- Bipolar disorder.
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- Other major psychiatric disorders, including schizophrenia, delusional disorder, or eating disorders.
- Acute suicide risk, defined as a score ≥3 on item 3 of the HAM-D17 or clear suicidal ideation or behavior.
- Alcohol or substance abuse or dependence within the previous 6 months.
- A medical condition associated with a high seizure risk or a history of cranial surgery.
- Current use of medication judged by the screening physician to substantially increase seizure risk, or rapid reduction/discontinuation of benzodiazepines, antiseizure medications, or other centrally acting medications associated with withdrawal or increased seizure risk.
- Serum vitamin D level <20 ng/mL that has not been adequately corrected.
- Elevated C-reactive protein associated with clinically significant acute infection or acute inflammatory illness that, in the investigator's judgment, may affect participant safety or study outcome assessment.
- Pregnant or breastfeeding.
- Unable to understand or complete essential study procedures. Participants with potentially reversible temporary exclusion conditions may be rescreened once the condition has been adequately corrected or clinically stabilized.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Military Hospital 175
Ho Chi Minh City, 700000
Dang Minh Ly, MD, +84359999741, drminhdang@outlook.com
About this study
Official title: A Randomized Rater-Blinded Trial Comparing Accelerated and Standard Intermittent Theta Burst Stimulation for Major Depressive Disorder
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).
- Conditions
- Major Depressive Disorder
- Being tested
- Accelerated Intermittent Theta Burst Stimulation, Standard Intermittent Theta Burst Stimulation
- Keywords
- Intermittent Theta Burst Stimulation, iTBS, Transcranial Magnetic Stimulation, Accelerated iTBS, Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Intermittent Theta Burst StimulationDevice
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.
Standard Intermittent Theta Burst StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated iTBS | Experimental | 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. Receives: Device: Accelerated Intermittent Theta Burst Stimulation |
| Standard iTBS | Active comparator | 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. Receives: Device: Standard Intermittent Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the first treatment session through the end-of-treatment assessment (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start27 Aug 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with major depressive disorder are randomly assigned in a 1:1 ratio to one of two parallel active-treatment groups: accelerated intermittent theta burst stimulation (iTBS) or standard iTBS.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Hospital 175
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoang Tien Trong Nghia, Military Hospital 175
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768397
- Sponsor's protocol ID
- KCB-TT.15-MDD
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Rater-Blinded Trial Comparing Accelerated and Standard Intermittent Theta Burst Stimulation for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07768397
- Acronym / sponsor ID
- KCB-TT.15-MDD
- Conditions
- Major Depressive Disorder
- Keywords
- Intermittent Theta Burst Stimulation, iTBS, Transcranial Magnetic Stimulation, Accelerated iTBS, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Military Hospital 175University, hospital or other
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants with major depressive disorder are randomly assigned in a 1:1 ratio to one of two parallel active-treatment groups: accelerated intermittent theta burst stimulation (iTBS) or standard iTBS.
| Arm | Type | Receives |
|---|---|---|
| Accelerated iTBS | Experimental | Device: Accelerated Intermittent Theta Burst StimulationParticipants 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. |
| Standard iTBS | Active comparator | Device: Standard Intermittent Theta Burst StimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 65 years.
- Right-handed.
- Diagnosis of major depressive disorder according to ICD-10 criteria (F32 or F33), confirmed by a psychiatrist.
- 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥18 at screening/baseline.
- Able and willing to provide written informed consent and comply with essential study procedures.
Key exclusion criteria (15 listed)
- Intracranial or head/neck metallic foreign bodies or implants that constitute a contraindication to TMS or MRI.
- Implanted electronic devices such as a cardiac pacemaker, implantable cardioverter-defibrillator, or deep brain stimulator.
- Untreated or clinically unstable thyroid dysfunction based on abnormal TSH and/or free T4 levels.
- Clinically significant intracranial structural abnormalities that may affect TMS safety, neuropsychiatric presentation, or study neurophysiological measures.
- History of epilepsy or seizures, except febrile seizures in childhood.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated Intermittent Theta Burst StimulationIntermittent 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. | Device | Accelerated iTBS |
| Standard Intermittent Theta Burst StimulationIntermittent 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. | Device | Standard iTBS |
Primary outcome
Change in 17-Item Hamilton Depression Rating Scale (HAM-D17) Score From Baseline to End of Treatment
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
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).
7 secondary outcomes
Treatment Response Based on HAM-D17
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Remission Based on HAM-D17
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)
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in Quality of Life Assessed by the WHOQOL-BREF
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)
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)
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Incidence of Adverse Events and Serious Adverse Events
Time frame: From the first treatment session through the end-of-treatment assessment (T4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated Intermittent Theta Burst Stimulation and Standard Intermittent Theta Burst Stimulation in people with Major Depressive Disorder, run by Military Hospital 175 at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dang Minh Ly, MD (+84359999741, drminhdang@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 17-Item Hamilton Depression Rating Scale (HAM-D17) Score From Baseline to End of Treatment (time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.