Posttraumatic Stress Disorder (PTSD)NCT07327385
To Investigate the Change of Brain and Autonomic Function From Different Protocols of Repeated Transcranial Magnetic Stimulation Therapy for Patients With Post-traumatic Stress Disorder Comorbid Major Depressive Disorder
A study testing Prolonged Intermittent Theta-Burst Stimulation (prolonged iTBS) and High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-rTMS) in people with Posttraumatic Stress Disorder (PTSD) and Depression - Major Depressive Disorder, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
This study aims to investigate the immediate neurophysiological and autonomic effects of two noninvasive brain stimulation protocols-prolonged intermittent theta-burst stimulation (prolonged iTBS) and high-frequency repetitive transcranial magnetic stimulation (HF-rTMS)-in patients with posttraumatic stress disorder… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD), Depression - Major Depressive Disorder
- What is being tested?
- Prolonged Intermittent Theta-Burst Stimulation (prolonged iTBS) and High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Feb 2026to 31 Dec 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
- Adults aged 18 to 65 years.
- Clinical diagnosis of posttraumatic stress disorder (PTSD) according to DSM-5 criteria, confirmed by a board-certified psychiatrist.
- Presence of comorbid major depressive disorder with stable clinical condition.
- PTSD symptom severity defined as: PTSD Checklist for DSM-5, Chinese version (C-PCL-5) total score ≥ 31.
- Depressive symptom severity defined as: Patient Health Questionnaire-9 (PHQ-9) total score ≥ 10.
- Stable psychiatric medication regimen for at least 4 weeks prior to enrollment, or medication-free.
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- Ability to understand the study procedures and provide written informed consent.
- Normal or corrected-to-normal vision and hearing.
- Ability to comply with study procedures and visit schedule.
Who cannot join
- Lifetime diagnosis of schizophrenia spectrum disorders, bipolar disorder, or pervasive developmental disorders.
- Alcohol or substance use disorder (excluding caffeine and nicotine) within the past 6 months.
- Ongoing trauma-focused psychotherapy during the study period.
- Prior exposure to repetitive TMS treatment exceeding five sessions.
- Current or recent (within the past year) suicidal ideation or behavior, defined as: PHQ-9 item 9 score ≥ 1, confirmed by clinical psychiatric evaluation.
- Self-injurious behavior requiring medical attention within the past 3 months.
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- History of epilepsy, seizure disorder, or family history of epilepsy.
- Significant neurological disorders, severe traumatic brain injury, or history of brain surgery.
- Presence of implanted metallic or electronic medical devices (e.g., pacemakers, cochlear implants, neurostimulators).
- Uncontrolled major medical illnesses or severe cardiovascular disease.
- Pregnancy or breastfeeding.
- Skin lesions or infections at the stimulation site.
- Use of medications known to significantly lower seizure threshold (e.g., tricyclic antidepressants or certain analgesics).
- Any condition deemed by the investigator to render the participant unsuitable for rTMS.
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
Tri-Service General Hospital
Taipei, Neihu, 114
Tso-Yi Chao, BS, 886-2-87923311 ext. 754660, loveinazuma1917@gmail.com
Tien-Yu Chen, PhD, MD
About this study
Official title: The Pathophysiological Mechanisms and Novel Treatments Linking Stress and Mental Health Conditions -To Investigate the Change of Brain and Autonomic Function From Different Protocols of Repeated Transcranial Magnetic Stimulation Therapy for Patients With Post-traumatic Stress Disorder Comorbid Major Depressive Disorder: a Randomized, Double-blind, Crossover Study
This study aims to investigate the immediate neurophysiological and autonomic effects of two noninvasive brain stimulation protocols-prolonged intermittent theta-burst stimulation (prolonged iTBS) and high-frequency repetitive transcranial magnetic stimulation (HF-rTMS)-in patients with posttraumatic stress disorder (PTSD) comorbid with major depressive disorder (MDD). Using a randomized, double-blind, sham-controlled crossover design, changes in prefrontal cortical activity measured by functional near-infrared spectroscopy (fNIRS) and autonomic nervous system function measured by heart rate variability (HRV) will be assessed before and immediately after a single stimulation session.
Read the detailed description
Posttraumatic stress disorder (PTSD) is a chronic psychiatric condition frequently accompanied by depressive symptoms and autonomic dysregulation. Although pharmacotherapy and psychotherapy are standard treatments, many patients show limited response or experience significant side effects. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising noninvasive neuromodulatory intervention; however, the optimal stimulation protocol for PTSD remains unclear.
This randomized, double-blind, crossover study is designed to compare the immediate effects of prolonged iTBS and HF-rTMS applied to the right dorsolateral prefrontal cortex (DLPFC) on brain function and autonomic regulation in adults with PTSD comorbid with MDD. Each participant will receive one active stimulation session (either prolonged iTBS or HF-rTMS) and one sham stimulation session in a randomized order, separated by a 7-day washout period to minimize carryover effects.
Prefrontal cortical activation will be measured using multi-channel functional near-infrared spectroscopy (fNIRS), and autonomic nervous system activity will be assessed using heart rate variability (HRV) analysis derived from electrocardiographic recordings. The primary objective is to characterize protocol-specific neurophysiological response patterns and identify quantifiable biomarkers of brain stimulation response that may inform future personalized treatment strategies for PTSD with comorbid depression.
- Being tested
- Prolonged Intermittent Theta-Burst Stimulation (prolonged iTBS), High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-rTMS), Sham Transcranial Magnetic Stimulation
- Keywords
- PTSD, functional near-infrared spectroscopy, Heart Rate Variability; HRV, rTMS
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Intermittent Theta-Burst Stimulation (prolonged iTBS)Device
Prolonged intermittent theta-burst stimulation is delivered using a Magstim Rapid2 stimulator with a figure-eight coil targeting the right dorsolateral prefrontal cortex (DLPFC), localized with the Beam F4 method. Stimulation is administered at 80% of individual motor threshold using an intermittent theta-burst pattern (2 seconds on, 8 seconds off), consisting of 3-pulse bursts at 50 Hz repeated at 5 Hz. A single session lasts approximately 9.5 minutes and delivers a total of 1,800 pulses.
High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-rTMS)Device
High-frequency rTMS is delivered using a Magstim Rapid2 stimulator with a figure-eight coil targeting the right dorsolateral prefrontal cortex (DLPFC), localized with the Beam F4 method. Stimulation follows the DASH protocol at 120% of motor threshold and 10 Hz frequency, with 4-second stimulation trains (40 pulses per train) followed by an 11-second inter-train interval, for a total of 75 trains. The single-session duration is approximately 18.75 minutes, delivering 3,000 pulses.
Sham Transcranial Magnetic StimulationDevice
Sham stimulation is delivered using a placebo coil identical in appearance and acoustic output to the active coil but without producing a magnetic field sufficient to induce cortical stimulation. Sham sessions match the corresponding active stimulation protocol in duration and procedure to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged iTBS With Sham Control | Experimental | Participants in this arm receive a single-session prolonged intermittent theta-burst stimulation (prolonged iTBS) targeting the right dorsolateral prefrontal cortex, as well as a sham stimulation session in a randomized crossover sequence. Each stimulation session is separated by a 7-day washout period. Neurophysiological and autonomic measures are obtained immediately before and after each session. Receives: Device: Prolonged Intermittent Theta-Burst Stimulation (prolonged iTBS); Device: Sham Transcranial Magnetic Stimulation |
| HF-rTMS With Sham Control | Experimental | Participants in this arm receive a single-session high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) targeting the right dorsolateral prefrontal cortex, as well as a sham stimulation session in a randomized crossover sequence. Each stimulation session is separated by a 7-day washout period. Neurophysiological and autonomic measures are obtained immediately before and after each session. Receives: Device: High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-rTMS); Device: Sham Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prefrontal Cortical Activation
Change in prefrontal cortical activation, measured as differences in oxygenated hemoglobin (HbO₂) concentration using multi-channel functional near-infrared spectroscopy (fNIRS). Measurements are obtained at rest immediately before and immediately after each stimulation session to assess acute neurophysiological effects of prolonged intermittent theta-burst stimulation and high-frequency repetitive transcranial magnetic stimulation.
Measured: Immediately before stimulation and immediately after each single stimulation session (active and sham), within each study period
Secondary outcomes (4)
Change in Autonomic Nervous System Activity
Autonomic nervous system activity assessed by heart rate variability (HRV) derived from 5-minute resting-state electrocardiographic recordings. HRV parameters are analyzed to evaluate acute changes in autonomic regulation following active versus sham brain stimulation.
Measured: Immediately before stimulation and immediately after each single stimulation session (active and sham), within each study period
Incidence of Adverse Events
Frequency and type of adverse events, including local discomfort, headache, dizziness, autonomic symptoms, or other reported events, assessed using standardized safety checklists immediately after stimulation, during 24-hour follow-up, and at post-study visit.
Measured: From the start of the first stimulation session through 7 days after the second stimulation session
Change in PTSD Symptom Severity
Change in posttraumatic stress disorder symptom severity measured by the PTSD Checklist for DSM-5, Chinese version (C-PCL-5), used to monitor symptom stability and safety during the crossover study. This instrument consists of 20 items, each scored from 0 to 4, resulting in a total score range of 0-80. A cut-off score between 31 and 33 is commonly used to indicate clinically significant symptoms, with higher scores reflecting greater symptom severity.
Measured: Baseline, before the second stimulation session (Day 8), and 7 days after completion of the crossover phase
Change in Depressive Symptom Severity
Change in depressive symptom severity assessed using the Patient Health Questionnaire-9 (PHQ-9), primarily for safety monitoring and detection of symptom exacerbation during the study period. The 9-item PHQ-9 utilizes a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day), with a total score range of 0-27. Scores are interpreted as mild (10-14), moderate (15-19), or severe (≥ 20) depressive symptoms.
Measured: Baseline, before the second stimulation session (Day 8), and 7 days after completion of the crossover phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start9 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies 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
- Crossover
- Model description
- This study uses a randomized, double-blind, sham-controlled, crossover design to examine the immediate neurophysiological effects of noninvasive brain stimulation in patients with posttraumatic stress disorder comorbid with major depressive disorder. Each participant receives both an active stimulation session (either prolonged intermittent theta-burst stimulation or high-frequency repetitive transcranial magnetic stimulation) and a sham stimulation session in a randomized sequence. A washout period of 7 days is implemented between sessions to minimize potential carryover effects. Blinding is maintained for participants and outcome assessors, while stimulation operators are not involved in outcome evaluation. Prefrontal cortical activity and autonomic nervous system responses are assessed immediately before and after each stimulation session.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tien-Yu Chen, Tri-Service General Hospital (TSGH)
- Investigators
- Tien-Yu Chen, PhD, MD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327385
- Sponsor's protocol ID
- C202405067
- Status last verified
- Feb 2026
- First submitted
- 24 Dec 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pathophysiological Mechanisms and Novel Treatments Linking Stress and Mental Health Conditions -To Investigate the Change of Brain and Autonomic Function From Different Protocols of Repeated Transcranial Magnetic Stimulation Therapy for Patients With Post-traumatic Stress Disorder Comorbid Major Depressive Disorder: a Randomized, Double-blind, Crossover Study
- ClinicalTrials.gov ID
- NCT07327385
- Acronym / sponsor ID
- C202405067
- Keywords
- PTSD, functional near-infrared spectroscopy, Heart Rate Variability; HRV, rTMS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 9 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jan 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 study aims to investigate the immediate neurophysiological and autonomic effects of two noninvasive brain stimulation protocols-prolonged intermittent theta-burst stimulation (prolonged iTBS) and high-frequency repetitive transcranial magnetic stimulation (HF-rTMS)-in patients with posttraumatic stress disorder (PTSD) comorbid with major depressive disorder (MDD). Using a randomized, double-blind, sham-controlled crossover design, changes in prefrontal cortical activity measured by functional near-infrared spectroscopy (fNIRS) and autonomic nervous system function measured by heart rate variability (HRV) will be assessed before and immediately after a single stimulation session.
Detailed description
Posttraumatic stress disorder (PTSD) is a chronic psychiatric condition frequently accompanied by depressive symptoms and autonomic dysregulation. Although pharmacotherapy and psychotherapy are standard treatments, many patients show limited response or experience significant side effects. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising noninvasive neuromodulatory intervention; however, the optimal stimulation protocol for PTSD remains unclear.
This randomized, double-blind, crossover study is designed to compare the immediate effects of prolonged iTBS and HF-rTMS applied to the right dorsolateral prefrontal cortex (DLPFC) on brain function and autonomic regulation in adults with PTSD comorbid with MDD. Each participant will receive one active stimulation session (either prolonged iTBS or HF-rTMS) and one sham stimulation session in a randomized order, separated by a 7-day washout period to minimize carryover effects.
Prefrontal cortical activation will be measured using multi-channel functional near-infrared spectroscopy (fNIRS), and autonomic nervous system activity will be assessed using heart rate variability (HRV) analysis derived from electrocardiographic recordings. The primary objective is to characterize protocol-specific neurophysiological response patterns and identify quantifiable biomarkers of brain stimulation response that may inform future personalized treatment strategies for PTSD with comorbid depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a randomized, double-blind, sham-controlled, crossover design to examine the immediate neurophysiological effects of noninvasive brain stimulation in patients with posttraumatic stress disorder comorbid with major depressive disorder. Each participant receives both an active stimulation session (either prolonged intermittent theta-burst stimulation or high-frequency repetitive transcranial magnetic stimulation) and a sham stimulation session in a randomized sequence. A washout period of 7 days is implemented between sessions to minimize potential carryover effects. Blinding is maintained for participants and outcome assessors, while stimulation operators are not involved in outcome evaluation. Prefrontal cortical activity and autonomic nervous system responses are assessed immediately before and after each stimulation session.
| Arm | Type | Receives |
|---|---|---|
| Prolonged iTBS With Sham Control | Experimental | Device: Prolonged Intermittent Theta-Burst Stimulation (prolonged iTBS), Device: Sham Transcranial Magnetic StimulationParticipants in this arm receive a single-session prolonged intermittent theta-burst stimulation (prolonged iTBS) targeting the right dorsolateral prefrontal cortex, as well as a sham stimulation session in a randomized crossover sequence. Each stimulation session is separated by a 7-day washout period. Neurophysiological and autonomic measures are obtained immediately before and after each session. |
| HF-rTMS With Sham Control | Experimental | Device: High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-rTMS), Device: Sham Transcranial Magnetic StimulationParticipants in this arm receive a single-session high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) targeting the right dorsolateral prefrontal cortex, as well as a sham stimulation session in a randomized crossover sequence. Each stimulation session is separated by a 7-day washout period. Neurophysiological and autonomic measures are obtained immediately before and after each session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults aged 18 to 65 years.
- Clinical diagnosis of posttraumatic stress disorder (PTSD) according to DSM-5 criteria, confirmed by a board-certified psychiatrist.
- Presence of comorbid major depressive disorder with stable clinical condition.
- PTSD symptom severity defined as: PTSD Checklist for DSM-5, Chinese version (C-PCL-5) total score ≥ 31.
- Depressive symptom severity defined as: Patient Health Questionnaire-9 (PHQ-9) total score ≥ 10.
Key exclusion criteria (14 listed)
- Lifetime diagnosis of schizophrenia spectrum disorders, bipolar disorder, or pervasive developmental disorders.
- Alcohol or substance use disorder (excluding caffeine and nicotine) within the past 6 months.
- Ongoing trauma-focused psychotherapy during the study period.
- Prior exposure to repetitive TMS treatment exceeding five sessions.
- Current or recent (within the past year) suicidal ideation or behavior, defined as: PHQ-9 item 9 score ≥ 1, confirmed by clinical psychiatric evaluation.
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 |
|---|---|---|
| Prolonged Intermittent Theta-Burst Stimulation (prolonged iTBS)Prolonged intermittent theta-burst stimulation is delivered using a Magstim Rapid2 stimulator with a figure-eight coil targeting the right dorsolateral prefrontal cortex (DLPFC), localized with the Beam F4 method. Stimulation is administered at 80% of individual motor threshold using an intermittent theta-burst pattern (2 seconds on, 8 seconds off), consisting of 3-pulse bursts at 50 Hz repeated at 5 Hz. A single session lasts approximately 9.5 minutes and delivers a total of 1,800 pulses. | Device | Prolonged iTBS With Sham Control |
| High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-rTMS)High-frequency rTMS is delivered using a Magstim Rapid2 stimulator with a figure-eight coil targeting the right dorsolateral prefrontal cortex (DLPFC), localized with the Beam F4 method. Stimulation follows the DASH protocol at 120% of motor threshold and 10 Hz frequency, with 4-second stimulation trains (40 pulses per train) followed by an 11-second inter-train interval, for a total of 75 trains. The single-session duration is approximately 18.75 minutes, delivering 3,000 pulses. | Device | HF-rTMS With Sham Control |
| Sham Transcranial Magnetic StimulationSham stimulation is delivered using a placebo coil identical in appearance and acoustic output to the active coil but without producing a magnetic field sufficient to induce cortical stimulation. Sham sessions match the corresponding active stimulation protocol in duration and procedure to maintain blinding. | Device | HF-rTMS With Sham Control, Prolonged iTBS With Sham Control |
Primary outcome
Change in Prefrontal Cortical Activation
Time frame: Immediately before stimulation and immediately after each single stimulation session (active and sham), within each study period
Change in prefrontal cortical activation, measured as differences in oxygenated hemoglobin (HbO₂) concentration using multi-channel functional near-infrared spectroscopy (fNIRS). Measurements are obtained at rest immediately before and immediately after each stimulation session to assess acute neurophysiological effects of prolonged intermittent theta-burst stimulation and high-frequency repetitive transcranial magnetic stimulation.
4 secondary outcomes
Change in Autonomic Nervous System Activity
Time frame: Immediately before stimulation and immediately after each single stimulation session (active and sham), within each study period
Incidence of Adverse Events
Time frame: From the start of the first stimulation session through 7 days after the second stimulation session
Change in PTSD Symptom Severity
Time frame: Baseline, before the second stimulation session (Day 8), and 7 days after completion of the crossover phase
Change in Depressive Symptom Severity
Time frame: Baseline, before the second stimulation session (Day 8), and 7 days after completion of the crossover phase
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 17 Feb 2026.
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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.
Tien-Yu Chen, PhD, MD principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Intermittent Theta-Burst Stimulation (prolonged iTBS) and High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-rTMS) in people with Posttraumatic Stress Disorder (PTSD) and Depression - Major Depressive Disorder, run by Tri-Service General Hospital (TSGH) 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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 17 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?
Contact Tao-Yi Chao, BS (886-2-87923311 ext. 754660, loveinazuma1917@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prefrontal Cortical Activation (time frame: Immediately before stimulation and immediately after each single stimulation session (active and sham), within each study period). 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 17 Feb 2026.