Intermittent Theta Burst StimulationNCT07198438
Deep Versus Standard Prolonged Intermittent Theta Burst Stimulation for Depression
A study testing Deep Prolonged Intermittent Theta Burst Stimulation and Standard Prolonged Intermittent Theta Burst Stimulation in people with Intermittent Theta Burst Stimulation and Repetitive Transcranial Magnetic Stimulation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study compares two types of non-invasive brain stimulation to treat major depression in patients who have not found relief from at least one antidepressant medication. The study will use a specific type of brain stimulation called prolonged intermittent Theta Burst Stimulation (piTBS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intermittent Theta Burst Stimulation, Repetitive Transcranial Magnetic Stimulation, Depression
- What is being tested?
- Deep Prolonged Intermittent Theta Burst Stimulation and Standard Prolonged Intermittent Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Nov 2025to 30 Jun 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18 and 70 years, inclusive.
- Diagnosis of Major Depressive Disorder (MDD) with a current major depressive episode, according to DSM-5 criteria, as confirmed by a psychiatrist.
- History of inadequate response to at least one trial of an antidepressant medication of adequate dose and duration.
- A score of 18 or greater on the 17-item Hamilton Depression Rating Scale (HAM-D17) at the screening visit.
Who cannot join
- Lifetime diagnosis of any primary psychotic disorder (e.g., schizophrenia spectrum disorders) or bipolar and related disorders according to DSM-5.
- Significant current suicide risk, as indicated by a score of 4 on item 3 of the HAM-D17.
- Current substance use disorder (excluding tobacco) within the last 3 months, according to DSM-5.
- Presence of significant cognitive impairment, such as intellectual disability, delirium, or a diagnosed neurocognitive disorder.
- Any personal history of seizures, stroke, brain tumor, brain aneurysm, increased intracranial pressure, or other major neurological disorders.
- Presence of metal implants in the head (excluding dental fillings) or any implanted medical devices such as a cardiac pacemaker or defibrillator.
- Currently pregnant.
- Any other major medical condition that, in the investigator's judgment, could compromise participant safety or interfere with the study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Department of Psychiatry, National Taiwan University Hospital, Yunlin Branch
Douliu, Yunlin County, 640
About this study
Official title: A Block-Randomized Study Comparing Deep and Standard Prolonged Intermittent Theta Burst Stimulation on Emotional Symptoms and Physiological Indicators in Patients With Major Depression
This study compares two types of non-invasive brain stimulation to treat major depression in patients who have not found relief from at least one antidepressant medication.
The study will use a specific type of brain stimulation called prolonged intermittent Theta Burst Stimulation (piTBS). The standard way to use piTBS for depression is to target an area on the side of the head called the dorsolateral prefrontal cortex (DLPFC). This study will compare this standard piTBS method with a newer approach, deep piTBS, which targets a different, deeper area in the middle of the brain called the anterior cingulate cortex (ACC).
Participants will be randomly assigned to one of two groups. One group will receive the deep piTBS treatment, and the other will receive the standard piTBS treatment. Both treatments are given once a day, five days a week, for four weeks. The study aims to find out if the deep piTBS approach is more effective at reducing symptoms of depression than the standard approach. Researchers will also look at effects on anxiety and other related symptoms.
Read the detailed description
Background:
Major depressive disorder (MDD) is associated with dysfunction in large-scale brain networks, including the central executive network (CEN), default mode network (DMN), and the salience network (SN). The anterior cingulate cortex (ACC) is a key hub in the SN, and its dysfunction is believed to be a core pathological feature of depression. While high-frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) is an evidence-based treatment for treatment-resistant depression (TRD), it only indirectly modulates deeper structures like the ACC. Deep TMS techniques using a double-cone coil can directly stimulate deeper regions such as the medial prefrontal cortex (mPFC) and ACC, which may offer a more direct and potentially more effective therapeutic approach. Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that significantly shortens treatment time, but its application to deep brain targets like the ACC has not been well-studied.
Objective:
This study aims to compare the therapeutic efficacy of prolonged intermittent theta burst stimulation (piTBS) targeting the ACC (deep piTBS) versus the standard protocol targeting the left DLPFC (standard piTBS) for patients with TRD. The study will also evaluate the effects of these interventions on comorbid anxiety, obsessive-compulsive, and somatic symptoms, as well as on physiological indicators.
Study Design:
This is a single-center, block-randomized study. A maximum of 90 participants meeting DSM-5 criteria for major depressive disorder, who have failed to respond to at least one adequate trial of an antidepressant, will be recruited. Participants will be randomly assigned in a 2:1 ratio (deep piTBS: standard piTBS, within blocks of six) to one of two treatment arms:
Deep piTBS Group: Participants will receive stimulation targeting the ACC using a double-cone coil. Stimulation intensity will be set at 90% of the resting motor threshold (rMT) determined from the tibialis anterior muscle.
Standard piTBS Group: Participants will receive stimulation targeting the left DLPFC using a standard figure-8 coil. Intensity will be set at 90% of the rMT determined from the abductor pollicis brevis muscle.
For both groups, the piTBS protocol consists of 1800 pulses per session, delivered daily (5 days/week) for 4 weeks, for a total of 20 sessions.
Outcome Measures:
The primary outcome is the change in the 17-item Hamilton Depression Rating Scale (HAM-D17) score from baseline to the end of treatment (after 20 sessions). Secondary outcomes include changes in scores on the Hamilton Anxiety Rating Scale (HAM-A), Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Patient Health Questionnaire-15 (PHQ-15), Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), and various physiological measures including heart rate variability (HRV). Assessments will be conducted at baseline, after every 5 treatment sessions, and one week after the completion of the 20th session.
- Conditions
- Intermittent Theta Burst Stimulation, Repetitive Transcranial Magnetic Stimulation, Depression
- Being tested
- Deep Prolonged Intermittent Theta Burst Stimulation, Standard Prolonged Intermittent Theta Burst Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, intermittent theta burst stimulation, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Prolonged Intermittent Theta Burst StimulationDevice
This intervention uses a Deymed Repetitive Transcranial Magnetic Stimulator with a double-cone coil (90BFVT-LQC) to target the anterior cingulate cortex (ACC). The resting motor threshold (rMT) is determined from the tibialis anterior muscle. Stimulation is delivered at 90% of the rMT. The protocol consists of 3-pulse 50Hz bursts repeated at a 5Hz frequency, administered in cycles of 2 seconds on and 8 seconds off, for a total of 1800 pulses per session. Treatment consists of 20 sessions administered over four weeks.
Standard Prolonged Intermittent Theta Burst StimulationDevice
This intervention uses a Deymed Repetitive Transcranial Magnetic Stimulator with a planar coil (70BF-LQC) to target the left dorsolateral prefrontal cortex (DLPFC). The resting motor threshold (rMT) is determined from the abductor pollicis brevis muscle. The DLPFC is localized using Beam F3 method. Stimulation is delivered at 90% of the rMT. The protocol consists of 3-pulse 50Hz bursts repeated at a 5Hz frequency, administered in cycles of 2 seconds on and 8 seconds off, for a total of 1800 pulses per session. Treatment consists of 20 sessions administered over four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Deep piTBS | Experimental | Participants assigned to the experimental group receive prolonged intermittent theta burst stimulation (piTBS) with a double-cone coil targeting the anterior cingulate cortex (ACC). Receives: Device: Deep Prolonged Intermittent Theta Burst Stimulation |
| Standard piTBS | Active comparator | Participants assigned to the active comparator group receive prolonged intermittent theta burst stimulation (piTBS) with a planar coil targeting the left dorsolateral prefrontal cortex (DLPFC). Receives: Device: Standard Prolonged Intermittent Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D17) Score
The 17-item Hamilton Depression Rating Scale (HAM-D17) is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is derived from a structured interview conducted by a trained outcomes assessor who is blinded to the participant's treatment group. Scores range from 0-52, where higher scores indicate more severe depression.
Measured: Baseline (Day 1, prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Secondary outcomes (11)
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A) Score
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-rated scale used to assess the severity of anxiety symptoms. A trained outcomes assessor, who is blinded to the participant's treatment group, determines the score based on a clinical interview. Higher scores indicate more severe anxiety.
Measured: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a clinician-rated scale designed to measure the severity of obsessive-compulsive symptoms. The score is determined through an interview conducted by a trained outcomes assessor who is blinded to the treatment allocation. Higher scores reflect greater symptom severity.
Measured: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in the Beck Depression Inventory-II (BDI-II) Score
The Beck Depression Inventory-II (BDI-II) is a 21-item self-report questionnaire designed to measure the severity of depression. Participants rate various depressive symptoms based on their experiences over the past two weeks. This scale provides a patient-reported perspective on depression, complementing the clinician-rated HAM-D17. Higher scores indicate greater depression severity.
Measured: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in the Beck Anxiety Inventory (BAI) Score
The Beck Anxiety Inventory (BAI) is a 21-item self-report scale that measures the severity of anxiety symptoms. It is completed by the participant and assesses how much they have been bothered by common symptoms of anxiety over the past week. This serves as a patient-reported measure of anxiety, complementing the clinician-rated HAM-A. Higher scores indicate greater anxiety levels.
Measured: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in the Young Mania Rating Scale (YMRS) Score
The Young Mania Rating Scale (YMRS) is an 11-item, clinician-rated scale used to evaluate the severity of manic symptoms. It is administered via interview by a trained assessor who is blinded to the treatment group. In this study, it is used to monitor for potential treatment-emergent mania or hypomania. Higher scores indicate more severe manic symptoms.
Measured: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in the Patient Health Questionnaire-15 (PHQ-15) Score
The Patient Health Questionnaire-15 (PHQ-15) is a self-report scale that assesses the severity of 15 common somatic symptoms. This questionnaire is completed by the participant. Higher scores indicate greater somatic symptom severity.
Measured: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in the Health Anxiety Questionnaire (HAQ) Score
The Health Anxiety Questionnaire (HAQ) is a self-report scale designed to measure the severity of health-related anxiety. Participants rate their health-related worries and beliefs. Higher scores indicate a greater degree of health anxiety. It is a self-administered questionnaire.
Measured: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in Heart Rate Variability (HRV) Indices
Heart Rate Variability (HRV) is a physiological measure of autonomic nervous system function, measured using an electrocardiogram (EKG). Specific indices will be analyzed, including the ratio of low-frequency to high-frequency power (LF/HF) and the standard deviation of normal to normal RR intervals (SDNN).
Measured: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in Skin Conductance
Skin conductance is a physiological measure of electrodermal activity that reflects sympathetic nervous system arousal. It is measured non-invasively via electrodes placed on the skin to assess changes in physiological arousal levels throughout the course of treatment.
Measured: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in Respiratory Sinus Arrhythmia (RSA)
Respiratory Sinus Arrhythmia (RSA) is the naturally occurring variation in heart rate that occurs during the breathing cycle. It is considered a key measure of parasympathetic nervous system activity (vagal tone) and is derived from simultaneously recorded electrocardiogram (EKG) and respiratory signals.
Measured: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in Finger Temperature
Finger temperature is a physiological measure of peripheral blood flow, which is influenced by the autonomic nervous system. It is measured non-invasively and used as an indicator of physiological stress and arousal.
Measured: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start24 Nov 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent Theta Burst StimulationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Hao Ma, MD, Principal investigator, Department of Psychiatry, National Taiwan University Hospital, Yunlin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198438
- Sponsor's protocol ID
- 202506034RINB
- Status last verified
- Dec 2025
- First submitted
- 21 Sep 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Block-Randomized Study Comparing Deep and Standard Prolonged Intermittent Theta Burst Stimulation on Emotional Symptoms and Physiological Indicators in Patients With Major Depression
- ClinicalTrials.gov ID
- NCT07198438
- Acronym / sponsor ID
- 202506034RINB
- Conditions
- Intermittent Theta Burst Stimulation, Repetitive Transcranial Magnetic Stimulation, Depression
- Keywords
- Repetitive Transcranial Magnetic Stimulation, intermittent theta burst stimulation, depression
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Sep 2025 (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 study compares two types of non-invasive brain stimulation to treat major depression in patients who have not found relief from at least one antidepressant medication.
The study will use a specific type of brain stimulation called prolonged intermittent Theta Burst Stimulation (piTBS). The standard way to use piTBS for depression is to target an area on the side of the head called the dorsolateral prefrontal cortex (DLPFC). This study will compare this standard piTBS method with a newer approach, deep piTBS, which targets a different, deeper area in the middle of the brain called the anterior cingulate cortex (ACC).
Participants will be randomly assigned to one of two groups. One group will receive the deep piTBS treatment, and the other will receive the standard piTBS treatment. Both treatments are given once a day, five days a week, for four weeks. The study aims to find out if the deep piTBS approach is more effective at reducing symptoms of depression than the standard approach. Researchers will also look at effects on anxiety and other related symptoms.
Detailed description
Background:
Major depressive disorder (MDD) is associated with dysfunction in large-scale brain networks, including the central executive network (CEN), default mode network (DMN), and the salience network (SN). The anterior cingulate cortex (ACC) is a key hub in the SN, and its dysfunction is believed to be a core pathological feature of depression. While high-frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) is an evidence-based treatment for treatment-resistant depression (TRD), it only indirectly modulates deeper structures like the ACC. Deep TMS techniques using a double-cone coil can directly stimulate deeper regions such as the medial prefrontal cortex (mPFC) and ACC, which may offer a more direct and potentially more effective therapeutic approach. Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that significantly shortens treatment time, but its application to deep brain targets like the ACC has not been well-studied.
Objective:
This study aims to compare the therapeutic efficacy of prolonged intermittent theta burst stimulation (piTBS) targeting the ACC (deep piTBS) versus the standard protocol targeting the left DLPFC (standard piTBS) for patients with TRD. The study will also evaluate the effects of these interventions on comorbid anxiety, obsessive-compulsive, and somatic symptoms, as well as on physiological indicators.
Study Design:
This is a single-center, block-randomized study. A maximum of 90 participants meeting DSM-5 criteria for major depressive disorder, who have failed to respond to at least one adequate trial of an antidepressant, will be recruited. Participants will be randomly assigned in a 2:1 ratio (deep piTBS: standard piTBS, within blocks of six) to one of two treatment arms:
Deep piTBS Group: Participants will receive stimulation targeting the ACC using a double-cone coil. Stimulation intensity will be set at 90% of the resting motor threshold (rMT) determined from the tibialis anterior muscle.
Standard piTBS Group: Participants will receive stimulation targeting the left DLPFC using a standard figure-8 coil. Intensity will be set at 90% of the rMT determined from the abductor pollicis brevis muscle.
For both groups, the piTBS protocol consists of 1800 pulses per session, delivered daily (5 days/week) for 4 weeks, for a total of 20 sessions.
Outcome Measures:
The primary outcome is the change in the 17-item Hamilton Depression Rating Scale (HAM-D17) score from baseline to the end of treatment (after 20 sessions). Secondary outcomes include changes in scores on the Hamilton Anxiety Rating Scale (HAM-A), Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Patient Health Questionnaire-15 (PHQ-15), Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), and various physiological measures including heart rate variability (HRV). Assessments will be conducted at baseline, after every 5 treatment sessions, and one week after the completion of the 20th session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep piTBS | Experimental | Device: Deep Prolonged Intermittent Theta Burst StimulationParticipants assigned to the experimental group receive prolonged intermittent theta burst stimulation (piTBS) with a double-cone coil targeting the anterior cingulate cortex (ACC). |
| Standard piTBS | Active comparator | Device: Standard Prolonged Intermittent Theta Burst StimulationParticipants assigned to the active comparator group receive prolonged intermittent theta burst stimulation (piTBS) with a planar coil targeting the left dorsolateral prefrontal cortex (DLPFC). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages between 18 and 70 years, inclusive.
- Diagnosis of Major Depressive Disorder (MDD) with a current major depressive episode, according to DSM-5 criteria, as confirmed by a psychiatrist.
- History of inadequate response to at least one trial of an antidepressant medication of adequate dose and duration.
- A score of 18 or greater on the 17-item Hamilton Depression Rating Scale (HAM-D17) at the screening visit.
Key exclusion criteria (8 listed)
- Lifetime diagnosis of any primary psychotic disorder (e.g., schizophrenia spectrum disorders) or bipolar and related disorders according to DSM-5.
- Significant current suicide risk, as indicated by a score of 4 on item 3 of the HAM-D17.
- Current substance use disorder (excluding tobacco) within the last 3 months, according to DSM-5.
- Presence of significant cognitive impairment, such as intellectual disability, delirium, or a diagnosed neurocognitive disorder.
- Any personal history of seizures, stroke, brain tumor, brain aneurysm, increased intracranial pressure, or other major neurological disorders.
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 |
|---|---|---|
| Deep Prolonged Intermittent Theta Burst StimulationThis intervention uses a Deymed Repetitive Transcranial Magnetic Stimulator with a double-cone coil (90BFVT-LQC) to target the anterior cingulate cortex (ACC). The resting motor threshold (rMT) is determined from the tibialis anterior muscle. Stimulation is delivered at 90% of the rMT. The protocol consists of 3-pulse 50Hz bursts repeated at a 5Hz frequency, administered in cycles of 2 seconds on and 8 seconds off, for a total of 1800 pulses per session. Treatment consists of 20 sessions administered over four weeks. | Device | Deep piTBS |
| Standard Prolonged Intermittent Theta Burst StimulationThis intervention uses a Deymed Repetitive Transcranial Magnetic Stimulator with a planar coil (70BF-LQC) to target the left dorsolateral prefrontal cortex (DLPFC). The resting motor threshold (rMT) is determined from the abductor pollicis brevis muscle. The DLPFC is localized using Beam F3 method. Stimulation is delivered at 90% of the rMT. The protocol consists of 3-pulse 50Hz bursts repeated at a 5Hz frequency, administered in cycles of 2 seconds on and 8 seconds off, for a total of 1800 pulses per session. Treatment consists of 20 sessions administered over four weeks. | Device | Standard piTBS |
Primary outcome
Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D17) Score
Time frame: Baseline (Day 1, prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
The 17-item Hamilton Depression Rating Scale (HAM-D17) is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is derived from a structured interview conducted by a trained outcomes assessor who is blinded to the participant's treatment group. Scores range from 0-52, where higher scores indicate more severe depression.
11 secondary outcomes
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A) Score
Time frame: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score
Time frame: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in the Beck Depression Inventory-II (BDI-II) Score
Time frame: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in the Beck Anxiety Inventory (BAI) Score
Time frame: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in the Young Mania Rating Scale (YMRS) Score
Time frame: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in the Patient Health Questionnaire-15 (PHQ-15) Score
Time frame: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in the Health Anxiety Questionnaire (HAQ) Score
Time frame: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in Heart Rate Variability (HRV) Indices
Time frame: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in Skin Conductance
Time frame: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in Respiratory Sinus Arrhythmia (RSA)
Time frame: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
Change From Baseline in Finger Temperature
Time frame: Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
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 11 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Chia-Hao Ma, MD principal investigator
Department of Psychiatry, National Taiwan University Hospital, Yunlin Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Prolonged Intermittent Theta Burst Stimulation and Standard Prolonged Intermittent Theta Burst Stimulation in people with Intermittent Theta Burst Stimulation and Repetitive Transcranial Magnetic Stimulation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 11 Feb 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D17) Score (time frame: Baseline (Day 1, prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.). 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 11 Feb 2026.