DepressionBeWellNCT06213701
Behavior, Biology and Well-Being Study
A study testing Healthy Minds Program and Psychoeducation app in people with Depression and Psychological Distress, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The central aim of this pilot study is to compare markers of inflammation and gut microbial diversity with users of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Psychological Distress
- What is being tested?
- Healthy Minds Program and Psychoeducation app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2022to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Elevated PHQ-8 or PHQ-9 ≥ 5 at screening and pre-baseline interview
- Proficient in English
- Able to provide informed consent
- Have access to a smartphone that can download apps from Google Play or the Apple App Store
- For payment purposes, must be a US citizen or a permanent US resident
Who cannot join
- Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
- Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
- Previous use of Healthy Minds Program app
- Current suicidal intent and/or high self-injury risk (determined from the interview)
- Self-reported history of psychosis
- Self-reported history of mania
Show all 10Show fewer
- Current psychopathology that interferes with study participation as assessed by interview
- Living or traveling outside the US during the whole study participation period (trips outside US after the interview phase is not an exclusion)
- Alcohol Use Disorders Identification Test (AUDIT) score ≥ 13 for women and AUDIT score ≥ 15 for men
- Drug Use Disorders Identification Test (DUDIT) score ≥ 8 for women and men
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression: Pilot Study
The central aim of this pilot study is to compare markers of inflammation and gut microbial diversity with users of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. The investigators plan to conduct a randomized controlled trial (RCT) involving 300 participants comparing 4-weeks of the HMP app with an active control (Psychoeducation [HMP without meditation practice]), and a waitlist control in a sample of United States adults with elevated depression symptoms.
Read the detailed description
Depression is highly prevalent and associated with extreme personal and societal costs. Meditation training reduces depression symptoms and psychological distress, but access to in-person programs is limited due to associated cost and lack of available services. Research on neurocognitive and biological mechanisms of mediation training in alleviating depression is at a preliminary stage, and an obstacle limiting research progress is over-reliance on retrospective self-report measures, which are vulnerable to a host of biases. This project will use gold-standard behavioral measures and explore novel measures of relevant neurocognitive and behavioral processes, namely pattern separation, self-referential thought, and video-based assessment of emotional well-being. Furthermore, the project will investigate effects on the gut microbiome (with fecal samples) and inflammation (with dried blood spots), which reflect biological systems hypothesized to be mechanistically related to benefits of meditation and well-being training.
Specific Aims:
- Aim 1. Determine the feasibility and acceptability of assessing inflammatory activity and gut microbiome within the context of a fully remote randomized controlled trial (RCT). Participants with elevated depression symptoms from an RCT (n = 1,100; registered to NCT05183867) comparing the Healthy Minds Program (HMP) app with an active control (HMP with didactic content only) and wait-list will be invited to provide dried blood spots (DBS) for inflammatory protein analysis and fecal samples for gut microbial analysis at baseline and 3-month follow-up. Hypotheses: It will be feasible to recruit 300 participants to provide DBS and fecal samples and 80% will provide samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.
- Aim 2. Characterize the association between self-reports of well-being, inflammatory activity at baseline, and microbiota diversity at baseline. Hypotheses: Well-being will correlate inversely with both protein biomarkers of inflammation (CRP, IL-6) and mRNA-derived indicators of pro-inflammatory transcriptional activity. Well-being will correlate positively with alpha diversity of the gut microbiome. These associations will not be moderated by participant race/ethnicity.
- Aim 3. Evaluate intervention effects on inflammatory activity and microbiota diversity. Hypotheses: Participants randomized to HMP or the active control will show larger reductions in inflammation vs. wait-list at 3-month follow-up and larger increases in alpha diversity of the gut microbiome vs. wait-list at 3-month follow-up. HMP will show larger reductions in inflammation vs. active control at 3-month follow-up and larger increases in alpha diversity vs. active control at 3-month follow-up.
- Conditions
- Depression, Psychological Distress
- Being tested
- Healthy Minds Program, Psychoeducation app
- Keywords
- inflammation, microbiota, alpha diversity
- Medical subject headings
- Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Minds ProgramDevice
Also called HMP
HMP is a 4-week mobile health (mHealth) meditation training program.
Psychoeducation appOther
Psychoeducation app
| Study group | Role | What they receive |
|---|---|---|
| Healthy Minds Program (HMP) app | Experimental | Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice. Receives: Device: Healthy Minds Program |
| Psychoeducation app | Active comparator | Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices. Receives: Other: Psychoeducation app |
| Usual Care | No intervention | Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS
Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.
Measured: Baseline and 3 month follow-up
Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples
Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.
Measured: Baseline and 3 month follow-up
Secondary outcomes (9)
Change in Microbiome Alpha Diversity: Species Richness
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Reported here are the observed (total number of distinct taxa) and calculated (Chao1 = N + S2 / (2 D), where N is the number of observed OTUs (Operational Taxonomic Units), S is the number of singleton OTUs, and D is the number of doublet OTUs) number of species represented in the sample. Chao1 is a species richness calculator that accounts for rare species.
Measured: Baseline and 3 month follow-up
Change in Microbiome Alpha Diversity: Shannon Diversity Index (H')
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Shannon Diversity Index quantifies both the richness and the evenness of a community. It takes into account the number of taxa (richness) and their relative abundances (evenness). A higher Shannon index value indicates greater diversity, with both a high number of taxa and more even distribution of abundances among them. It is often used to assess the balance between species in a community. Typically ranges from 0-5 with higher numbers indicating increasing species diversity.
Measured: Baseline and 3 month follow-up
Change in Microbiome Alpha Diversity: Inverse Simpson (1/D)
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson is the probability that any two microbes are the same species, ranging from 0-1. Inverse Simpson (1 / Simpson) considers both richness and evenness. It places greater weight on the more abundant taxa. A higher inverse Simpson index suggests a more even distribution of taxa, with fewer dominant species. The inverse Simpson index is sensitive to the presence of dominant species and may emphasize diversity loss when one or a few species dominate the community.
Measured: Baseline and 3 month follow-up
Change in Microbiome Alpha Diversity: Pielou Evenness Index (J)
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Pielou Evenness Index measures how evenly the individuals are distributed across the taxa in a sample. It is calculated by dividing the Shannon diversity index by the maximum possible value of the Shannon index (which occurs when all taxa are equally abundant). The Pielou index ranges from 0 (no evenness, where one species dominates) to 1 (perfect evenness, where all species are equally abundant).
Measured: Baseline and 3 month follow-up
Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D)
Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson's Dominance Index measures the probability that two randomly selected individuals from a community belong to the same species (or taxon). It ranges from 0 to 1, where 0 indicates perfect diversity (no dominance of a single species) and values closer to 1 indicate that one or a few species dominate the community. A lower Simpson's dominance score suggests a more diverse community, while a higher score indicates a community dominated by a few taxa.
Measured: Baseline and 3 month follow-up
Change in Inflammatory Biomarkers: C-reactive Protein
Dried blood spot samples will be used to measure inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from ~200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1).
Measured: Baseline and 3 month follow-up
Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10
Dried blood spot samples will be used to measure inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from ~200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1).
Measured: Baseline and 3 month follow-up
Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-24 where higher scores indicate more depressive symptoms.
Measured: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Change in Flourishing Measured by the Flourishing Index Score
The Flourishing Index is a 10-item questionnaire where participants report their general level of flourishing (e.g., well-being, health, etc.). It is scored on a 0 to 10-point scale, with anchors varying across items. The total score ranges from 0 to 100 with higher scores indicating higher flourishing.
Measured: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start16 Jun 2022
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The groups will be randomized to one of three groups in a 2:2:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Hope for Depression Research Foundation, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Simon Goldberg, PhD, Principal investigator, UW-Madison, Center for Healthy Minds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213701
- Sponsor's protocol ID
- 2021-0991: Pilot
- Other IDs
- Protocol Version 6/29/2023, A487400, 1U24AT011289-01
- Acronym
- BeWell
- Status last verified
- Apr 2025
- First submitted
- 9 Jan 2024
- Last updated
- 30 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression: Pilot Study
- ClinicalTrials.gov ID
- NCT06213701
- Acronym / sponsor ID
- BeWell / 2021-0991: Pilot
- Conditions
- Depression, Psychological Distress
- Keywords
- inflammation, microbiota, alpha diversity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Hope for Depression Research Foundation, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Posted 2 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The central aim of this pilot study is to compare markers of inflammation and gut microbial diversity with users of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. The investigators plan to conduct a randomized controlled trial (RCT) involving 300 participants comparing 4-weeks of the HMP app with an active control (Psychoeducation [HMP without meditation practice]), and a waitlist control in a sample of United States adults with elevated depression symptoms.
Detailed description
Depression is highly prevalent and associated with extreme personal and societal costs. Meditation training reduces depression symptoms and psychological distress, but access to in-person programs is limited due to associated cost and lack of available services. Research on neurocognitive and biological mechanisms of mediation training in alleviating depression is at a preliminary stage, and an obstacle limiting research progress is over-reliance on retrospective self-report measures, which are vulnerable to a host of biases. This project will use gold-standard behavioral measures and explore novel measures of relevant neurocognitive and behavioral processes, namely pattern separation, self-referential thought, and video-based assessment of emotional well-being. Furthermore, the project will investigate effects on the gut microbiome (with fecal samples) and inflammation (with dried blood spots), which reflect biological systems hypothesized to be mechanistically related to benefits of meditation and well-being training.
Specific Aims:
- Aim 1. Determine the feasibility and acceptability of assessing inflammatory activity and gut microbiome within the context of a fully remote randomized controlled trial (RCT). Participants with elevated depression symptoms from an RCT (n = 1,100; registered to NCT05183867) comparing the Healthy Minds Program (HMP) app with an active control (HMP with didactic content only) and wait-list will be invited to provide dried blood spots (DBS) for inflammatory protein analysis and fecal samples for gut microbial analysis at baseline and 3-month follow-up. Hypotheses: It will be feasible to recruit 300 participants to provide DBS and fecal samples and 80% will provide samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.
- Aim 2. Characterize the association between self-reports of well-being, inflammatory activity at baseline, and microbiota diversity at baseline. Hypotheses: Well-being will correlate inversely with both protein biomarkers of inflammation (CRP, IL-6) and mRNA-derived indicators of pro-inflammatory transcriptional activity. Well-being will correlate positively with alpha diversity of the gut microbiome. These associations will not be moderated by participant race/ethnicity.
- Aim 3. Evaluate intervention effects on inflammatory activity and microbiota diversity. Hypotheses: Participants randomized to HMP or the active control will show larger reductions in inflammation vs. wait-list at 3-month follow-up and larger increases in alpha diversity of the gut microbiome vs. wait-list at 3-month follow-up. HMP will show larger reductions in inflammation vs. active control at 3-month follow-up and larger increases in alpha diversity vs. active control at 3-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The groups will be randomized to one of three groups in a 2:2:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Healthy Minds Program (HMP) app | Experimental | Device: Healthy Minds ProgramParticipants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice. |
| Psychoeducation app | Active comparator | Other: Psychoeducation appParticipants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices. |
| Usual Care | No intervention | –Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elevated PHQ-8 or PHQ-9 ≥ 5 at screening and pre-baseline interview
- Proficient in English
- Able to provide informed consent
- Have access to a smartphone that can download apps from Google Play or the Apple App Store
- For payment purposes, must be a US citizen or a permanent US resident
Key exclusion criteria (10 listed)
- Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
- Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
- Current suicidal intent and/or high self-injury risk (determined from the interview)
- Self-reported history of psychosis
- Self-reported history of mania
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 |
|---|---|---|
| Healthy Minds ProgramAlso: HMPHMP is a 4-week mobile health (mHealth) meditation training program. | Device | Healthy Minds Program (HMP) app |
| Psychoeducation appPsychoeducation app | Other | Psychoeducation app |
Primary outcome
Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS
Time frame: Baseline and 3 month follow-up
Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.
Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples
Time frame: Baseline and 3 month follow-up
Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.
9 secondary outcomes
Change in Microbiome Alpha Diversity: Species Richness
Time frame: Baseline and 3 month follow-up
Change in Microbiome Alpha Diversity: Shannon Diversity Index (H')
Time frame: Baseline and 3 month follow-up
Change in Microbiome Alpha Diversity: Inverse Simpson (1/D)
Time frame: Baseline and 3 month follow-up
Change in Microbiome Alpha Diversity: Pielou Evenness Index (J)
Time frame: Baseline and 3 month follow-up
Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D)
Time frame: Baseline and 3 month follow-up
Change in Inflammatory Biomarkers: C-reactive Protein
Time frame: Baseline and 3 month follow-up
Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10
Time frame: Baseline and 3 month follow-up
Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Change in Flourishing Measured by the Flourishing Index Score
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FULL Behavior, Biology and Well-Being StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Depression
Not yet recruiting
The Lucida Project
Depression Disorder
Recruiting
SAINT® Therapy for Memory Problems in Older Adults With Treatment-Resistant Depression
Depressive Disorder, Treatment-Resistant, Memory Deficits
RecruitingPhase 2
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
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.
Simon Goldberg, PhD principal investigator
UW-Madison, Center for Healthy Minds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Minds Program and Psychoeducation app in people with Depression and Psychological Distress, run by University of Wisconsin, Madison 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 10 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 30 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 2 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS (time frame: Baseline and 3 month follow-up). The study lists 2 primary outcomes in all. 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 30 Jul 2025.