Postpartum DepressionPRY-DNCT06004232
Prenatal Yoga to Prevent Postpartum Depression
A study testing Prenatal Yoga to Prevent Postpartum Depression (PRY-D) intervention and Treatment as Usual (TAU) in people with Postpartum Depression, run by Henry Ford Health System at 1 site in United States.
Trial summary
Although psychological interventions exist for the prevention of PPD, a yoga-based intervention to prevent PPD among at-risk women utilizes a similar theoretical foundation (i.e., mindfulness), may be more acceptable to women of minority status, and may confer additional physical activity benefits. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Prenatal Yoga to Prevent Postpartum Depression (PRY-D) intervention and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2025to 19 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age,
- pregnant between 8-28 weeks gestation
- receiving prenatal care at Henry Ford Health
- have a history of depression
- have an internet-enabled device with video capability for the purpose of viewing virtual yoga classes
Who cannot join
- not being fluent in English since this will be required to engage in yoga classes
- physician guidance NOT to participate in exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prenatal Yoga to Prevent Postpartum Depression (PRY-D)
Although psychological interventions exist for the prevention of PPD, a yoga-based intervention to prevent PPD among at-risk women utilizes a similar theoretical foundation (i.e., mindfulness), may be more acceptable to women of minority status, and may confer additional physical activity benefits. The purpose of this pilot study is to determine the effectiveness of using a virtually delivered prenatal yoga intervention for the prevention of PPD among at-risk women in a diverse health care system and explore preliminary factors which influence implementation of the intervention. This study has 2 phases: Phase 1 will evaluate facilitators and barriers to intervention implementation among patient, clinician, and health system stakeholders, followed by an open trial, and Phase 2 will include conducting an 8-session pilot randomized controlled trial to assess the feasibility and acceptability of the proposed prenatal yoga intervention among women with a history of depression, as well as the onset and course of PPD and mediating factors. The specific aims are to: 1) Optimize delivery of a yoga intervention within a healthcare system to prevent PPD through examining facilitators and barriers of implementation, 2) Examine feasibility, acceptability and satisfaction of the intervention within a health care system, and 3) Evaluate preliminary effectiveness of the intervention on PPD and proposed mechanisms. For Phase 1, separate focus groups with patient stakeholders and clinician and administrative stakeholders will inform intervention implementation, and an open trial to refine and optimize the intervention. For Phase 2, women with a history of depression who are 8-28 weeks pregnant will be randomized to the intervention group (n=24) or treatment-as-usual (n=24) and will complete survey measures at baseline, post-intervention, and 1 and 3 months postpartum. It is hypothesized that the intervention will be feasible and acceptable, engage women of racial/ethnic minority status, and contribute to lower rates of PPD onset. Embodiment and mindfulness are the proposed mediators. Knowledge gained from this study can support prevention efforts for PPD and improve the adverse public health impact of this disorder.
Read the detailed description
Postpartum depression (PPD) affects approximately 13% of women, contributing to poorer overall maternal psychological health, as well as adverse infant health, behavior, and emotional development. Women with a history of depression are 21 times more likely to experience PPD, which most commonly occurs within 4 weeks of delivery. Intervening in pregnancy to prevent the onset of perinatal mental health disorders can ameliorate these adverse outcomes and contribute to significant cost savings at $32,300/affected woman. Despite evidence-based prenatal preventive mental health services for depression, there are barriers to access, and these services do not offer the adjunctive benefits provided by yoga-based interventions, including shorter labor duration and increased likelihood of vaginal birth. Yoga interventions during pregnancy have been shown to significantly improve depressive symptoms in pregnancy. Yet, previous work examining prenatal yoga was not prevention-focused; prior studies of prenatal yoga for depression have only examined treatment for women with current depression or did not evaluate PPD. Because nearly half of women with a history of depression who develop PPD did not exhibit depressive symptoms in pregnancy, it is important to include this high-risk group in preventive interventions.
Yoga is more beneficial than other physical activity interventions for depression symptoms, including fatigue and stress, and PPD interventions yield greater benefits with targeted populations. Specifically, yoga may prevent PPD through embodiment-facilitated improvements in body image and increasing mindfulness. Yet, there are several gaps in examining effectiveness of yoga for preventing PPD: 1) although racial/ethnic minority women have higher rates of PPD than White women, they are significantly less likely to initiate treatment for PPD; yoga interventions may be more engaging; 2) generalizability of previous studies of prenatal yoga for depression have also been limited by excluding women with particular psychiatric disorders and/or excluding women already practicing yoga. Expanding this evidence-based practice to women vulnerable to developing PPD (i.e., those with a history of depression) within a health care system may be effective for engaging high-risk women in a preventive intervention to decrease the risk of PPD. The proposed study focuses on preventing PPD and improving generalizability by delivering a virtual prenatal yoga intervention for at-risk, racially diverse women in a health care system.
The proposed study seeks to pilot test the effectiveness of an adapted evidence-based, virtually-delivered 8-session group prenatal yoga pilot preventive intervention for women at high risk of PPD (i.e., history of depression) to assess onset and evaluate factors which influence implementation within a health care system. The intervention incorporates evidence-based integrated yoga with mindfulness and embodiment techniques (i.e., proposed mechanisms). The investigators will also promote the inclusion of individuals of racial/ethnic minority status in yoga interventions by assessing strategies for inclusion of these individuals from patient stakeholders. Pregnant participants with a history of depression will be recruited from Henry Ford Health (HFH), a metropolitan health system that delivers prenatal care for diverse women (29% non-Hispanic Black). The inclusion of patient, provider, and administrative stakeholders will inform recruitment, engagement, and delivery of the intervention, facilitating scalability and sustainability by assessing barriers and facilitators to implementation.
The specific aims are to:
- Optimize a yoga intervention to prevent PPD within a healthcare system.
1.a. Examine facilitators and barriers of implementation. Conduct 3 focus groups with patient (n=6-10 pregnant women in each group with a history of depression) and qualitative interviews administrative (n=10-15 HFH women's health clinicians and administrators) stakeholders to assess logistics, engagement of racially/ethnically diverse women with a history of depression, and sustainability of the intervention. Phenomenological analyses will be used to analyze qualitative findings to increase patient-centeredness.
- b. Optimize delivery. An open trial of pregnant women (n=14) will aid in refining intervention delivery.
- Examine feasibility, acceptability, and satisfaction of the intervention within a health care system. Pregnant women (n=48) with a history of depression will be randomized to the intervention (n=24) or treatment as usual (TAU; n=24). Feasibility will be assessed by measuring enrollment, retention across follow-up time points, and engagement (e.g., attendance at yoga sessions) rates. A post-intervention survey will measure acceptability and satisfaction. The investigators hypothesize that the intervention will be effective for engaging racial/ethnic minorities and that there will be representative enrollment rates of these groups.
- Evaluate effectiveness of the intervention on PPD and proposed mechanisms. Participants will complete measures of depression, embodiment, and mindfulness at baseline, post-intervention, and 1 and 3 months post-delivery. The investigators anticipate that the intervention group will have lower rates of PPD (primary outcome) at each follow-up time point, higher levels of mindfulness and embodiment (i.e., proposed mediators; a path), and that these mediators will be associated with reduced likelihood of PPD (b path).
- Conditions
- Postpartum Depression
- Being tested
- Prenatal Yoga to Prevent Postpartum Depression (PRY-D) intervention, Treatment as Usual (TAU)
- Keywords
- Postpartum, Depression, Prenatal, Pregnant, Yoga, Mindfulness, Embodiment
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal Yoga to Prevent Postpartum Depression (PRY-D) interventionBehavioural
The PRY-D curriculum is a mindfulness-based prenatal yoga intervention which utilizes techniques to build both embodiment and mindfulness, and has previously been shown to reduce depression in a small sample of pregnant women with clinical depression.
Treatment as Usual (TAU)Behavioural
TAU involves routine prenatal care, during which time all patients are given information on the importance of physical activity during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| PRY-D intervention | Experimental | Participants in the intervention group will complete 8 prenatal yoga sessions (1x/week) in a virtual group format. The first session will be in person, in which they will meet the instructor, connect with one another through brief introductions, receive their yoga practice materials, practice basic yoga poses, and be given the schedule for the remaining sessions, including virtual access links (e.g., Webex). Receives: Behavioral: Prenatal Yoga to Prevent Postpartum Depression (PRY-D) intervention |
| Treatment as Usual (TAU) | Active comparator | Participants in the the TAU group will receive routine prenatal care, during which time all patients are given information on the importance of physical activity during pregnancy. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) will be used to measure presence of postpartum depression (yes/no). EPDS scores range from 0 to 30; a score of 10 or above indicates the presence of current depression symptoms.
Measured: 1-month and 3-months postpartum
Secondary outcomes (1)
Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) will be used to measure severity of postpartum depression (continuous). EPDS scores range from 0 to 30.
Measured: 1-month and 3-months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start26 Feb 2025
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PRY-D intervention vs treatment as usual (TAU)
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Colorado, Boulder
- Responsible party
- Principal investigator, Amy Loree, Henry Ford Health System
- Investigators
- Amy M Loree, PhD, Principal investigator, Henry Ford HealthSara Santarossa, PhD, Principal investigator, Henry Ford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004232
- Sponsor's protocol ID
- R34MH131573
- Other IDs
- R34MH131573
- Acronym
- PRY-D
- Status last verified
- Jul 2026
- First submitted
- 16 Aug 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Quantitative data from this study will be transferred to a de-identified dataset that will be available for noncommercial research use by outside investigators via a data-sharing agreement and under the auspices of the investigators. The study team will be available for support. Information related to errors in the data, future releases, and publication lists will also be shared with users.
Publications
Loree AM, Santarossa S, Coyne P, Haley EN, Boulay M, Pappas C, Braciszewski JM, Miller-Matero LR, Hicks LM. Virtually-delivered prenatal yoga to prevent postpartum depression (PRYD) in women with a history of depression: Protocol for an exploratory pilot randomized controlled trial. Contemp Clin Trials. 2025 Sep;156:108032. doi: 10.1016/j.cct.2025.108032. Epub 2025 Jul 28.
PubMed 40738219
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Yoga to Prevent Postpartum Depression (PRY-D)
- ClinicalTrials.gov ID
- NCT06004232
- Acronym / sponsor ID
- PRY-D / R34MH131573
- Conditions
- Postpartum Depression
- Keywords
- Postpartum, Depression, Prenatal, Pregnant, Yoga, Mindfulness, Embodiment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Colorado, Boulder
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 22 Aug 2023 (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.
Although psychological interventions exist for the prevention of PPD, a yoga-based intervention to prevent PPD among at-risk women utilizes a similar theoretical foundation (i.e., mindfulness), may be more acceptable to women of minority status, and may confer additional physical activity benefits. The purpose of this pilot study is to determine the effectiveness of using a virtually delivered prenatal yoga intervention for the prevention of PPD among at-risk women in a diverse health care system and explore preliminary factors which influence implementation of the intervention. This study has 2 phases: Phase 1 will evaluate facilitators and barriers to intervention implementation among patient, clinician, and health system stakeholders, followed by an open trial, and Phase 2 will include conducting an 8-session pilot randomized controlled trial to assess the feasibility and acceptability of the proposed prenatal yoga intervention among women with a history of depression, as well as the onset and course of PPD and mediating factors. The specific aims are to: 1) Optimize delivery of a yoga intervention within a healthcare system to prevent PPD through examining facilitators and barriers of implementation, 2) Examine feasibility, acceptability and satisfaction of the intervention within a health care system, and 3) Evaluate preliminary effectiveness of the intervention on PPD and proposed mechanisms. For Phase 1, separate focus groups with patient stakeholders and clinician and administrative stakeholders will inform intervention implementation, and an open trial to refine and optimize the intervention. For Phase 2, women with a history of depression who are 8-28 weeks pregnant will be randomized to the intervention group (n=24) or treatment-as-usual (n=24) and will complete survey measures at baseline, post-intervention, and 1 and 3 months postpartum. It is hypothesized that the intervention will be feasible and acceptable, engage women of racial/ethnic minority status, and contribute to lower rates of PPD onset. Embodiment and mindfulness are the proposed mediators. Knowledge gained from this study can support prevention efforts for PPD and improve the adverse public health impact of this disorder.
Detailed description
Postpartum depression (PPD) affects approximately 13% of women, contributing to poorer overall maternal psychological health, as well as adverse infant health, behavior, and emotional development. Women with a history of depression are 21 times more likely to experience PPD, which most commonly occurs within 4 weeks of delivery. Intervening in pregnancy to prevent the onset of perinatal mental health disorders can ameliorate these adverse outcomes and contribute to significant cost savings at $32,300/affected woman. Despite evidence-based prenatal preventive mental health services for depression, there are barriers to access, and these services do not offer the adjunctive benefits provided by yoga-based interventions, including shorter labor duration and increased likelihood of vaginal birth. Yoga interventions during pregnancy have been shown to significantly improve depressive symptoms in pregnancy. Yet, previous work examining prenatal yoga was not prevention-focused; prior studies of prenatal yoga for depression have only examined treatment for women with current depression or did not evaluate PPD. Because nearly half of women with a history of depression who develop PPD did not exhibit depressive symptoms in pregnancy, it is important to include this high-risk group in preventive interventions.
Yoga is more beneficial than other physical activity interventions for depression symptoms, including fatigue and stress, and PPD interventions yield greater benefits with targeted populations. Specifically, yoga may prevent PPD through embodiment-facilitated improvements in body image and increasing mindfulness. Yet, there are several gaps in examining effectiveness of yoga for preventing PPD: 1) although racial/ethnic minority women have higher rates of PPD than White women, they are significantly less likely to initiate treatment for PPD; yoga interventions may be more engaging; 2) generalizability of previous studies of prenatal yoga for depression have also been limited by excluding women with particular psychiatric disorders and/or excluding women already practicing yoga. Expanding this evidence-based practice to women vulnerable to developing PPD (i.e., those with a history of depression) within a health care system may be effective for engaging high-risk women in a preventive intervention to decrease the risk of PPD. The proposed study focuses on preventing PPD and improving generalizability by delivering a virtual prenatal yoga intervention for at-risk, racially diverse women in a health care system.
The proposed study seeks to pilot test the effectiveness of an adapted evidence-based, virtually-delivered 8-session group prenatal yoga pilot preventive intervention for women at high risk of PPD (i.e., history of depression) to assess onset and evaluate factors which influence implementation within a health care system. The intervention incorporates evidence-based integrated yoga with mindfulness and embodiment techniques (i.e., proposed mechanisms). The investigators will also promote the inclusion of individuals of racial/ethnic minority status in yoga interventions by assessing strategies for inclusion of these individuals from patient stakeholders. Pregnant participants with a history of depression will be recruited from Henry Ford Health (HFH), a metropolitan health system that delivers prenatal care for diverse women (29% non-Hispanic Black). The inclusion of patient, provider, and administrative stakeholders will inform recruitment, engagement, and delivery of the intervention, facilitating scalability and sustainability by assessing barriers and facilitators to implementation.
The specific aims are to:
- Optimize a yoga intervention to prevent PPD within a healthcare system.
1.a. Examine facilitators and barriers of implementation. Conduct 3 focus groups with patient (n=6-10 pregnant women in each group with a history of depression) and qualitative interviews administrative (n=10-15 HFH women's health clinicians and administrators) stakeholders to assess logistics, engagement of racially/ethnically diverse women with a history of depression, and sustainability of the intervention. Phenomenological analyses will be used to analyze qualitative findings to increase patient-centeredness.
- b. Optimize delivery. An open trial of pregnant women (n=14) will aid in refining intervention delivery.
- Examine feasibility, acceptability, and satisfaction of the intervention within a health care system. Pregnant women (n=48) with a history of depression will be randomized to the intervention (n=24) or treatment as usual (TAU; n=24). Feasibility will be assessed by measuring enrollment, retention across follow-up time points, and engagement (e.g., attendance at yoga sessions) rates. A post-intervention survey will measure acceptability and satisfaction. The investigators hypothesize that the intervention will be effective for engaging racial/ethnic minorities and that there will be representative enrollment rates of these groups.
- Evaluate effectiveness of the intervention on PPD and proposed mechanisms. Participants will complete measures of depression, embodiment, and mindfulness at baseline, post-intervention, and 1 and 3 months post-delivery. The investigators anticipate that the intervention group will have lower rates of PPD (primary outcome) at each follow-up time point, higher levels of mindfulness and embodiment (i.e., proposed mediators; a path), and that these mediators will be associated with reduced likelihood of PPD (b path).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PRY-D intervention vs treatment as usual (TAU)
| Arm | Type | Receives |
|---|---|---|
| PRY-D intervention | Experimental | Behavioral: Prenatal Yoga to Prevent Postpartum Depression (PRY-D) interventionParticipants in the intervention group will complete 8 prenatal yoga sessions (1x/week) in a virtual group format. The first session will be in person, in which they will meet the instructor, connect with one another through brief introductions, receive their yoga practice materials, practice basic yoga poses, and be given the schedule for the remaining sessions, including virtual access links (e.g., Webex). |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as Usual (TAU)Participants in the the TAU group will receive routine prenatal care, during which time all patients are given information on the importance of physical activity during pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years of age,
- pregnant between 8-28 weeks gestation
- receiving prenatal care at Henry Ford Health
- have a history of depression
- have an internet-enabled device with video capability for the purpose of viewing virtual yoga classes
Key exclusion criteria (2 listed)
- not being fluent in English since this will be required to engage in yoga classes
- physician guidance NOT to participate in exercise
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 |
|---|---|---|
| Prenatal Yoga to Prevent Postpartum Depression (PRY-D) interventionThe PRY-D curriculum is a mindfulness-based prenatal yoga intervention which utilizes techniques to build both embodiment and mindfulness, and has previously been shown to reduce depression in a small sample of pregnant women with clinical depression. | Behavioural | PRY-D intervention |
| Treatment as Usual (TAU)TAU involves routine prenatal care, during which time all patients are given information on the importance of physical activity during pregnancy. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Edinburgh Postnatal Depression Scale
Time frame: 1-month and 3-months postpartum
The Edinburgh Postnatal Depression Scale (EPDS) will be used to measure presence of postpartum depression (yes/no). EPDS scores range from 0 to 30; a score of 10 or above indicates the presence of current depression symptoms.
1 secondary outcome
Edinburgh Postnatal Depression Scale
Time frame: 1-month and 3-months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Derived from this study: PubMed 40738219Loree AM, Santarossa S, Coyne P, Haley EN, Boulay M, Pappas C, Braciszewski JM, Miller-Matero LR, Hicks LM. Virtually-delivered prenatal yoga to prevent postpartum depression (PRYD) in women with a history of depression: Protocol for an exploratory pilot randomized controlled trial. Contemp Clin Trials. 2025 Sep;156:108032. doi: 10.1016/j.cct.2025.108032. Epub 2025 Jul 28.
- Individual participant dataSharing planned: Yes. Quantitative data from this study will be transferred to a de-identified dataset that will be available for noncommercial research use by outside investigators via a data-sharing agreement and under the auspices of the investigators. The study team will be available for support. Information related to errors in the data, future releases, and publication lists will also be shared with users.
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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. This study is not recruiting at the moment.
Amy M Loree, PhD principal investigator
Henry Ford Health
Sara Santarossa, PhD principal investigator
Henry Ford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal Yoga to Prevent Postpartum Depression (PRY-D) intervention and Treatment as Usual (TAU) in people with Postpartum Depression, run by Henry Ford Health System at 1 site 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 3 Aug 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 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Edinburgh Postnatal Depression Scale (time frame: 1-month and 3-months postpartum). 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 NCT06004232, which also lists 1 linked publication.
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 3 Aug 2026.