Postpartum Depression (PPD)NCT07210255
SAINT in Postpartum Depression (PPD)
A study testing SAINT Neuromodulation System in people with Postpartum Depression (PPD), run by Magnus Medical at 4 sites in United States.
Trial summary
This study is a large, multi-site clinical trial testing whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), a fast-acting form of repetitive transcranial magnetic stimulation (rTMS), can more effectively reduce symptoms of postpartum depression (PPD) compared to a sham treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression (PPD)
- What is being tested?
- SAINT Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Nov 2025to 31 Oct 2029
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Reproductive Women ages 18-45 at the time of consent.
- Diagnosis of non-psychotic Major Depressive Episode (MDE) with peripartum onset as assessed through the Quick Structured Clinical Interview for DSM-5.
- 0-12 months postpartum. Participants must be 0-12 months postpartum at screening and remain within 12 months postpartum at the 5-day post-treatment visit.
- If currently taking an antidepressant medication and/or receiving psychotherapy must be on a stable regimen for 30 days at the time of enrollment.
- Severe depression as measured by MADRS ≥20 at screening.
- A good candidate for repetitive transcranial magnetic stimulation (rTMS) as determined by a physician.
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- Participants must be capable of giving informed consent. Participants must be proficient in English in order to comprehend study requirements.
- Agree to use effective contraception in the postpartum period for the study duration.
- Willing and able to comply with all study procedures, complete required assessments and visits, and be available for the duration of the study.
Who cannot join
- Participant has attempted suicide in the last 6 months and/or expressed suicidal ideation with intent as determined by physician assessment at the time of enrollment.
- Score of 6 on MADRS item 10 (high rating of suicidal ideation) at screening.
- Participant has active psychosis per investigator assessment.
- Participant with a primary lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder and/or obsessive-compulsive disorder.
- Participant has an active eating disorder or substance use disorder in the past 6 months and/or has a positive urine toxicity screen that the Principal Investigator (PI) deems exclusionary.
- Participant is using any exclusionary medications: high dose of benzodiazepines (>2mg lorazepam daily equivalent and/or >3 times per week) or medications that would interfere with treatment with TMS as per PI or designee discretion.
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- Participant has a history of untreated or insufficiently treated sleep apnea.
- Participant has a history of significant neurologic disease, including developmental disability, dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma.
- Any untreated major somatic illness such as hypertension/cardiovascular disease/diabetes/endocrine disorders etc.
- Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion).
- Contraindications to MRI (e.g., ferromagnetic metal in their body).
- Currently pregnant.
- History of receiving rTMS for any reason, as this may compromise blinding.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Texas at Austin, Dell Medical School, Health Discovery Building
Austin, Texas, 78712
Ambreen Rana, 512-766-6209, ambreen.rana@austin.utexas.edu
Jeffrey Newport, MD, MS, MDiv
- Recruiting
The Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Myranda Reppart, MPH, 843.714.8985, repppart@musc.edu
Connie Guille, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Francesca Rutherford, 646-853-3316, francesca.rutherford@mssm.edu
Carolina Jimenez, 646-493-1684, Carolina.Jimenez@mountsinai.org
- Recruiting
UMass Chan Medical School
Worcester, Massachusetts, 01655
Erin Hanzlik, 774.370.8613, erin.hanzlik@umassmemorial.org
Sherry Stumpo, 508-334-1055, sherry.stumpo@umassmed.edu
About this study
Official title: A Randomized Controlled Multi-site Trial Evaluating SAINT for Postpartum Depression
This study is a large, multi-site clinical trial testing whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), a fast-acting form of repetitive transcranial magnetic stimulation (rTMS), can more effectively reduce symptoms of postpartum depression (PPD) compared to a sham treatment.
It will enroll 192 women within 12 months postpartum who are experiencing depression, and will track their progress for up to 12 months. The trial's main goal is to see if SAINT leads to reduction in depression severity in women with postpartum depression.
Read the detailed description
SAINT combines an accelerated rTMS stimulation protocol with individualized functional connectivity (FC)-based brain targeting. It has demonstrated dramatic remission rates of 80-90% in patients with treatment resistant depression (TRD) in 5 days or fewer of treatment. SAINT is FDA cleared for the treatment of major depressive disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
This is a multi-site, randomized trial to assess SAINT versus sham stimulation for PPD in women. This study will evaluate whether SAINT is superior to placebo in reducing symptoms of depression in women with PPD. Unlike traditional treatments, SAINT is designed to provide rapid relief from depressive symptoms, potentially within just a few days. The rationale for this study is based on the need for a faster, more effective treatment option that can quickly stabilize the mental health of new mothers, allowing them to better care for their infants and themselves.
This study will primarily benefit women who have recently given birth and are struggling with a postpartum depression. These women often face intense emotional distress that can interfere with their ability to bond with their newborns and manage daily responsibilities. By offering a quicker route to recovery, SAINT has the potential to restore these mothers' mental health, enabling them to fully engage in their new role as parents. The study also aims to include a diverse population, ensuring that the benefits of SAINT are generalizable.
There are two phases in this study:
- A blinded phase where participants will be randomized to receive either 5 days of active SAINT, an accelerated and individualized form of rTMS, or a sham (placebo).
- After the blinded phase, participants will enter the 6 month follow-up phase. During this phase, if participants experience worsening symptoms, they may be eligible to receive 1 course of active SAINT treatment. (5 days).
Total study duration for each participant is approximately 7.5 months.
- Conditions
- Postpartum Depression (PPD)
- Being tested
- SAINT Neuromodulation System, Sham SAINT Stimulation
- Keywords
- SAINT, Stanford Accelerated Intelligent Neuromodulation Therapy, Repetitive Transcranial Magnetic Stimulation (rTMS), Intermittent Theta Burst Stimulation (iTBS), Noninvasive Brain Stimulation, Postpartum depression, Neuromodulation
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAINT Neuromodulation SystemDevice
Also called SAINT NMS, SAINT
SAINT will be delivered via a MagPro X100 edition (MagVenture, Skovlunde, Denmark) TMS device equipped with a Cool-B65 A/P coil. The stimulation paradigm consists of 10 daily sessions (50 total sessions over 5 days) of SAINT stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be administered at 90% of the participant's resting motor threshold, with depth correction applied to adjust for the measured distance between the scalp and cortical surface. The stimulation target, the L-DLPFC, will be identified and localized by the study investigator using the Localite neuronavigation system.
Sham SAINT StimulationDevice
Sham stimulation will be delivered using the MagVenture MagPro X100 TMS system with the Cool-B65 A/P coil and targeted to the L-DLPFC. The stimulation paradigm will be identical to the active SAINT stimulation with the exception that active stimulation will not be delivered.
| Study group | Role | What they receive |
|---|---|---|
| Active SAINT Stimulation | Active comparator | Active SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC) Receives: Device: SAINT Neuromodulation System |
| Sham SAINT Stimulation | Sham comparator | Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC). Receives: Device: Sham SAINT Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in depression symptom severity, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment, which will be compared between the acute active SAINT and sham arms.
The change in depression symptom severity will be measured by Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment. Outcomes will be compared between the acute active SAINT and sham arms. Scores range from 0-60 (10 questions, each scored 0-6) with higher scores indicating a worsening of depressive symptoms and lower scores indicating better outcomes.
Measured: Baseline and 5 days post-acute treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Nov 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postpartum Depression (PPD)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
- Parallel groups
- Model description
- This is a multisite, randomized controlled trial. This study has two phases, a blinded/acute phase in which participants are randomized to receive either 5 days of active or sham SAINT and a follow-up phase in which all participants will be followed for 6 months and may be eligible to receive 1 course of open-label active SAINT (5 days).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magnus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210255
- Sponsor's protocol ID
- CLN-0108
- Other IDs
- CDMRP-PR240070
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality concerns. Aggregate study results will be made publicly available on ClinicalTrials.gov and through publications.
Publications
Williams NR, Sudheimer KD, Bentzley BS, Pannu J, Stimpson KH, Duvio D, Cherian K, Hawkins J, Scherrer KH, Vyssoki B, DeSouza D, Raj KS, Keller J, Schatzberg AF. High-dose spaced theta-burst TMS as a rapid-acting antidepressant in highly refractory depression. Brain. 2018 Mar 1;141(3):e18. doi: 10.1093/brain/awx379. No abstract available.
PubMed 29415152Cole EJ, Phillips AL, Bentzley BS, Stimpson KH, Nejad R, Barmak F, Veerapal C, Khan N, Cherian K, Felber E, Brown R, Choi E, King S, Pankow H, Bishop JH, Azeez A, Coetzee J, Rapier R, Odenwald N, Carreon D, Hawkins J, Chang M, Keller J, Raj K, DeBattista C, Jo B, Espil FM, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022 Feb;179(2):132-141. doi: 10.1176/appi.ajp.2021.20101429. Epub 2021 Oct 29.
PubMed 34711062Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.
PubMed 32252538
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multi-site Trial Evaluating SAINT for Postpartum Depression
- ClinicalTrials.gov ID
- NCT07210255
- Acronym / sponsor ID
- CLN-0108
- Conditions
- Postpartum Depression (PPD)
- Keywords
- SAINT, Stanford Accelerated Intelligent Neuromodulation Therapy, Repetitive Transcranial Magnetic Stimulation (rTMS), Intermittent Theta Burst Stimulation (iTBS), Noninvasive Brain Stimulation, Postpartum depression, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Magnus MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 7 Oct 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 is a large, multi-site clinical trial testing whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), a fast-acting form of repetitive transcranial magnetic stimulation (rTMS), can more effectively reduce symptoms of postpartum depression (PPD) compared to a sham treatment.
It will enroll 192 women within 12 months postpartum who are experiencing depression, and will track their progress for up to 12 months. The trial's main goal is to see if SAINT leads to reduction in depression severity in women with postpartum depression.
Detailed description
SAINT combines an accelerated rTMS stimulation protocol with individualized functional connectivity (FC)-based brain targeting. It has demonstrated dramatic remission rates of 80-90% in patients with treatment resistant depression (TRD) in 5 days or fewer of treatment. SAINT is FDA cleared for the treatment of major depressive disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
This is a multi-site, randomized trial to assess SAINT versus sham stimulation for PPD in women. This study will evaluate whether SAINT is superior to placebo in reducing symptoms of depression in women with PPD. Unlike traditional treatments, SAINT is designed to provide rapid relief from depressive symptoms, potentially within just a few days. The rationale for this study is based on the need for a faster, more effective treatment option that can quickly stabilize the mental health of new mothers, allowing them to better care for their infants and themselves.
This study will primarily benefit women who have recently given birth and are struggling with a postpartum depression. These women often face intense emotional distress that can interfere with their ability to bond with their newborns and manage daily responsibilities. By offering a quicker route to recovery, SAINT has the potential to restore these mothers' mental health, enabling them to fully engage in their new role as parents. The study also aims to include a diverse population, ensuring that the benefits of SAINT are generalizable.
There are two phases in this study:
- A blinded phase where participants will be randomized to receive either 5 days of active SAINT, an accelerated and individualized form of rTMS, or a sham (placebo).
- After the blinded phase, participants will enter the 6 month follow-up phase. During this phase, if participants experience worsening symptoms, they may be eligible to receive 1 course of active SAINT treatment. (5 days).
Total study duration for each participant is approximately 7.5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multisite, randomized controlled trial. This study has two phases, a blinded/acute phase in which participants are randomized to receive either 5 days of active or sham SAINT and a follow-up phase in which all participants will be followed for 6 months and may be eligible to receive 1 course of open-label active SAINT (5 days).
| Arm | Type | Receives |
|---|---|---|
| Active SAINT Stimulation | Active comparator | Device: SAINT Neuromodulation SystemActive SAINT stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC) |
| Sham SAINT Stimulation | Sham comparator | Device: Sham SAINT StimulationSham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (L-DLPFC). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Reproductive Women ages 18-45 at the time of consent.
- Diagnosis of non-psychotic Major Depressive Episode (MDE) with peripartum onset as assessed through the Quick Structured Clinical Interview for DSM-5.
- 0-12 months postpartum. Participants must be 0-12 months postpartum at screening and remain within 12 months postpartum at the 5-day post-treatment visit.
- If currently taking an antidepressant medication and/or receiving psychotherapy must be on a stable regimen for 30 days at the time of enrollment.
- Severe depression as measured by MADRS ≥20 at screening.
Key exclusion criteria (13 listed)
- Participant has attempted suicide in the last 6 months and/or expressed suicidal ideation with intent as determined by physician assessment at the time of enrollment.
- Score of 6 on MADRS item 10 (high rating of suicidal ideation) at screening.
- Participant has active psychosis per investigator assessment.
- Participant with a primary lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder and/or obsessive-compulsive disorder.
- Participant has an active eating disorder or substance use disorder in the past 6 months and/or has a positive urine toxicity screen that the Principal Investigator (PI) deems exclusionary.
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 |
|---|---|---|
| SAINT Neuromodulation SystemAlso: SAINT NMS, SAINTSAINT will be delivered via a MagPro X100 edition (MagVenture, Skovlunde, Denmark) TMS device equipped with a Cool-B65 A/P coil. The stimulation paradigm consists of 10 daily sessions (50 total sessions over 5 days) of SAINT stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be administered at 90% of the participant's resting motor threshold, with depth correction applied to adjust for the measured distance between the scalp and cortical surface. The stimulation target, the L-DLPFC, will be identified and localized by the study investigator using the Localite neuronavigation system. | Device | Active SAINT Stimulation |
| Sham SAINT StimulationSham stimulation will be delivered using the MagVenture MagPro X100 TMS system with the Cool-B65 A/P coil and targeted to the L-DLPFC. The stimulation paradigm will be identical to the active SAINT stimulation with the exception that active stimulation will not be delivered. | Device | Sham SAINT Stimulation |
Primary outcome
The change in depression symptom severity, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment, which will be compared between the acute active SAINT and sham arms.
Time frame: Baseline and 5 days post-acute treatment
The change in depression symptom severity will be measured by Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment. Outcomes will be compared between the acute active SAINT and sham arms. Scores range from 0-60 (10 questions, each scored 0-6) with higher scores indicating a worsening of depressive symptoms and lower scores indicating better outcomes.
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 28 Sep 2026.
- Background: PubMed 29415152Williams NR, Sudheimer KD, Bentzley BS, Pannu J, Stimpson KH, Duvio D, Cherian K, Hawkins J, Scherrer KH, Vyssoki B, DeSouza D, Raj KS, Keller J, Schatzberg AF. High-dose spaced theta-burst TMS as a rapid-acting antidepressant in highly refractory depression. Brain. 2018 Mar 1;141(3):e18. doi: 10.1093/brain/awx379. No abstract available.
- Background: PubMed 34711062Cole EJ, Phillips AL, Bentzley BS, Stimpson KH, Nejad R, Barmak F, Veerapal C, Khan N, Cherian K, Felber E, Brown R, Choi E, King S, Pankow H, Bishop JH, Azeez A, Coetzee J, Rapier R, Odenwald N, Carreon D, Hawkins J, Chang M, Keller J, Raj K, DeBattista C, Jo B, Espil FM, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022 Feb;179(2):132-141. doi: 10.1176/appi.ajp.2021.20101429. Epub 2021 Oct 29.
- Background: PubMed 32252538Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality concerns. Aggregate study results will be made publicly available on ClinicalTrials.gov and through publications.
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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.
Icahn School of Medicine at Mount Sinai
New York, United States
The Medical University of South Carolina (MUSC)
Charleston, United States
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAINT Neuromodulation System in people with Postpartum Depression (PPD), run by Magnus Medical at 4 sites in United States.
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 13 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 28 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 4 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in depression symptom severity, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to 5 days post-treatment, which will be compared between the acute active SAINT and sham arms. (time frame: Baseline and 5 days post-acute treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210255, which also lists 3 linked publications.
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 28 Sep 2026.