Suicide, AttemptedNCT06060535
Implementation of Suicide Risk Models in Health Systems
A study testing Suicide Attempt Risk Model Care Pathway in people with Suicide, Attempted and Suicide, Fatal, run by Kaiser Permanente at 3 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate a suicide risk model in patients receiving behavioral health care treatment. The main question it aims to answer is: Does the implementation of the suicide risk model reduce suicide attempts? Researchers will compare the outcomes of patients identified by the model to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide, Attempted, Suicide, Fatal
- What is being tested?
- Suicide Attempt Risk Model Care Pathway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Oct 2022to Jan 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18+ years old
- 1+ visit to a behavioral health clinic at participating sites
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
HealthPartners
Bloomington, Minnesota, 55425
Henry Ford Health System
Detroit, Michigan, 48202
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: Evaluating Effectiveness and Implementation of a Risk Model for Suicide Prevention Across Health Systems
The goal of this clinical trial is to evaluate a suicide risk model in patients receiving behavioral health care treatment. The main question it aims to answer is: Does the implementation of the suicide risk model reduce suicide attempts? Researchers will compare the outcomes of patients identified by the model to those in a usual care group.
Read the detailed description
Suicide is a major public health concern in the United States; nearly 50,000 individuals die by suicide annually and almost 1.5 million attempt suicide. To date, identification of individuals at risk for suicide has relied on suicide risk screening practices, including using a variety of self-reported instruments. However, sensitivity of these measures is only moderate; more precise tools for identifying patients at risk for suicide are needed. Suicide risk models, developed by our team, incorporate health records data and historical self-report screening questionnaire responses to improve accuracy of risk prediction. Our models have outperformed traditional clinical screening and similar risk models for adults receiving care in outpatient mental health specialty settings. However, while statistically accurate, they have not been evaluated in real world care; whether the models actually increase identification or result in patients receiving more suicide prevention services, fewer crisis services, or making fewer suicide attempts is unknown. There is substantial clinical interest in implementing suicide risk models but little scientific evidence about the effectiveness of these models in real-world settings compared to standard screening practices alone. Additionally, there is almost no guidance for their implementation in healthcare. The proposed project leverages the NIMH-funded Mental Health Research Network (MHRN), a collaboration of large health systems with established clinical data infrastructure to support multi-site studies. MHRN members Henry Ford Health, Kaiser Permanente Northwest, and HealthPartners will participate in this project and collectively serve >170,000 behavioral health patients per year. The patient populations are diverse, including thousands of individuals with Medicaid and Medicare. Each of these systems has implemented a suicide prevention care model in their behavioral health departments, including robust suicide risk screening and assessment processes. However, none of these systems has implemented a suicide risk identification model. The proposed project includes a pragmatic trial approach with randomization of behavioral health clinics across the three participating health systems. It is innovative because it seeks to implement an MHRN suicide risk model (intervention) into each system's existing suicide prevention care model (usual care) to increase the reach and effectiveness of the suicide prevention care models. Sites will receive implementation planning support based on stakeholder feedback from preliminary studies and deliverables include an implementation planning tool kit to facilitate spread. This high-impact study has important clinical implications as health systems consider whether it makes sense to enhance their existing suicide prevention care models with a suicide risk model. It is timely because many health systems are advancing toward suicide risk model implementation without evidence to support this innovation.
- Conditions
- Suicide, Attempted, Suicide, Fatal
- Being tested
- Suicide Attempt Risk Model Care Pathway
- Keywords
- Suicide Prevention
- Medical subject headings
- Suicide, Attempted, Suicide, Completed, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicide Attempt Risk Model Care PathwayBehavioural
The suicide attempt risk model uses documented histories of medical and psychiatric diagnoses, medications, and health service utilization to predict risk of a suicide attempt in the 90 days following an outpatient visit in behavioral health clinics.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Usual care suicide prevention pathway Receives: Behavioral: Suicide Attempt Risk Model Care Pathway |
| Intervention | Experimental | Implementation of the suicide risk model Receives: Behavioral: Suicide Attempt Risk Model Care Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide attempt, 90 days post-index encounter
The number and proportion of visits followed by any suicide attempt (ICD-10 diagnosis codes) occurring within 90 days of an index visit.
Measured: 90 days post-index encounter
Secondary outcomes (4)
Identification
The number and proportion of visits identified by PHQ9 item 9 or the risk model or both, stratified by race/ethnicity, where the denominator is the number of visits in the study period.
Measured: Through study completion, an average of 18 months
Recognition
The number and proportion of visits with a completed risk assessment (C-SSRS), stratified by race/ethnicity, where the denominator is the number of visits in the study period.
Measured: Through study completion, an average of 18 months
Evidence-based suicide care
The number and proportion of visits with a documented safety plan, lethal means counseling, or caring contacts subsequent to the index encounter, where the denominator is the number of visits in the study period.
Measured: Through study completion, an average of 18 months
Any 14-day follow-up care in behavioral health
The number and proportion of visits with any contact with behavioral health within 14 days of the index encounter, where the denominator is the number of visits in the study period.
Measured: 14 days post-index encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start4 Oct 2022
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Clinics are the unit of randomization, all behavioral health clinics will be randomized, over the course of three waves, to cross over from usual care to intervention (implementation of the suicide risk model).
- Masking
- None (open label)
- Enrolment
- 394,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Ford Health System, HealthPartners Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Bobbi Jo Yarborough, PsyD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060535
- Sponsor's protocol ID
- R01MH130548
- Other IDs
- 1R01MH130548-01
- Status last verified
- Oct 2025
- First submitted
- 13 Aug 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make our documentation, research methods and protocol, data collection tools, and a de-identified dataset of data that underlie results in publications freely available, upon request, to interested researchers beginning 6 months after publication of the main analyses. Materials will be shared through the MHRN website or a secure file transfer. Creation of a deidentified dataset for sharing may include redaction of some information to prevent re-identification or because the data is proprietary. The de-identified dataset will be available for non-commercial research use to external investigators via a data-sharing agreement and under the auspices of the Site-PIs. Users must agree to the conditions of use governing access to the data. 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
Ahmedani BK, Simon GE, Stewart C, Beck A, Waitzfelder BE, Rossom R, Lynch F, Owen-Smith A, Hunkeler EM, Whiteside U, Operskalski BH, Coffey MJ, Solberg LI. Health care contacts in the year before suicide death. J Gen Intern Med. 2014 Jun;29(6):870-7. doi: 10.1007/s11606-014-2767-3. Epub 2014 Feb 25.
PubMed 24567199Simon GE, Johnson E, Lawrence JM, Rossom RC, Ahmedani B, Lynch FL, Beck A, Waitzfelder B, Ziebell R, Penfold RB, Shortreed SM. Predicting Suicide Attempts and Suicide Deaths Following Outpatient Visits Using Electronic Health Records. Am J Psychiatry. 2018 Oct 1;175(10):951-960. doi: 10.1176/appi.ajp.2018.17101167. Epub 2018 May 24.
PubMed 29792051Hedegaard H, Curtin SC, Warner M. Increase in Suicide Mortality in the United States, 1999-2018. NCHS Data Brief. 2020 Apr;(362):1-8.
PubMed 32487287Yarborough BJH, Ahmedani BK, Boggs JM, Beck A, Coleman KJ, Sterling S, Schoenbaum M, Goldstein-Grumet J, Simon GE. Challenges of Population-based Measurement of Suicide Prevention Activities Across Multiple Health Systems. EGEMS (Wash DC). 2019 Apr 12;7(1):13. doi: 10.5334/egems.277.
PubMed 30993146Rossom RC, Richards JE, Sterling S, Ahmedani B, Boggs JM, Yarborough BJH, Beck A, Lloyd K, Frank C, Liu V, Clinch SB, Patke LD, Simon GE. Connecting Research and Practice: Implementation of Suicide Prevention Strategies in Learning Health Care Systems. Psychiatr Serv. 2022 Feb 1;73(2):219-222. doi: 10.1176/appi.ps.202000596. Epub 2021 Jun 30.
PubMed 34189931Simon GE, Shortreed SM, Johnson E, Rossom RC, Lynch FL, Ziebell R, Penfold ARB. What health records data are required for accurate prediction of suicidal behavior? J Am Med Inform Assoc. 2019 Dec 1;26(12):1458-1465. doi: 10.1093/jamia/ocz136.
PubMed 31529095Simon GE, Rutter CM, Peterson D, Oliver M, Whiteside U, Operskalski B, Ludman EJ. Does response on the PHQ-9 Depression Questionnaire predict subsequent suicide attempt or suicide death? Psychiatr Serv. 2013 Dec 1;64(12):1195-202. doi: 10.1176/appi.ps.201200587.
PubMed 24036589Yarborough BJH, Stumbo SP. Patient perspectives on acceptability of, and implementation preferences for, use of electronic health records and machine learning to identify suicide risk. Gen Hosp Psychiatry. 2021 May-Jun;70:31-37. doi: 10.1016/j.genhosppsych.2021.02.008. Epub 2021 Mar 4.
PubMed 33711562Coleman KJ, Stewart C, Bruschke C, Flores JP, Altschuler A, Beck A, Lynch FL, Smith AO, Richards JE, Rossom R, Simon G, Sterling S, Ahmedani B. Identifying People at Risk for Suicide: Implementation of Screening for the Zero Suicide Initiative in Large Health Systems. Adv Psychiatry Behav Health. 2021 Sep;1(1):67-76. doi: 10.1016/j.ypsc.2021.05.016. Epub 2021 Aug 9. No abstract available.
PubMed 42559352National Action Alliance for Suicide Prevention. A prioritized research agenda for suicide prevention: An action plan to save lives. Rockville, MD. 2014.
Stumbo SP, Hooker SA, Rossom RC, Miley K, Ahmedani BK, Lockhart E, Yeh HH, Yarborough BJH. Study protocol for a stepped-wedge, randomized controlled trial to evaluate implementation of a suicide risk identification model among behavioral health patients in three large health systems. BMC Psychiatry. 2025 Apr 8;25(1):344. doi: 10.1186/s12888-025-06760-0.
PubMed 40200191
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effectiveness and Implementation of a Risk Model for Suicide Prevention Across Health Systems
- ClinicalTrials.gov ID
- NCT06060535
- Acronym / sponsor ID
- R01MH130548
- Conditions
- Suicide, Attempted, Suicide, Fatal
- Keywords
- Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 394,000 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Henry Ford Health System, HealthPartners Institute, National Institute of Mental Health (NIMH)
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 29 Sep 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.
The goal of this clinical trial is to evaluate a suicide risk model in patients receiving behavioral health care treatment. The main question it aims to answer is: Does the implementation of the suicide risk model reduce suicide attempts? Researchers will compare the outcomes of patients identified by the model to those in a usual care group.
Detailed description
Suicide is a major public health concern in the United States; nearly 50,000 individuals die by suicide annually and almost 1.5 million attempt suicide. To date, identification of individuals at risk for suicide has relied on suicide risk screening practices, including using a variety of self-reported instruments. However, sensitivity of these measures is only moderate; more precise tools for identifying patients at risk for suicide are needed. Suicide risk models, developed by our team, incorporate health records data and historical self-report screening questionnaire responses to improve accuracy of risk prediction. Our models have outperformed traditional clinical screening and similar risk models for adults receiving care in outpatient mental health specialty settings. However, while statistically accurate, they have not been evaluated in real world care; whether the models actually increase identification or result in patients receiving more suicide prevention services, fewer crisis services, or making fewer suicide attempts is unknown. There is substantial clinical interest in implementing suicide risk models but little scientific evidence about the effectiveness of these models in real-world settings compared to standard screening practices alone. Additionally, there is almost no guidance for their implementation in healthcare. The proposed project leverages the NIMH-funded Mental Health Research Network (MHRN), a collaboration of large health systems with established clinical data infrastructure to support multi-site studies. MHRN members Henry Ford Health, Kaiser Permanente Northwest, and HealthPartners will participate in this project and collectively serve >170,000 behavioral health patients per year. The patient populations are diverse, including thousands of individuals with Medicaid and Medicare. Each of these systems has implemented a suicide prevention care model in their behavioral health departments, including robust suicide risk screening and assessment processes. However, none of these systems has implemented a suicide risk identification model. The proposed project includes a pragmatic trial approach with randomization of behavioral health clinics across the three participating health systems. It is innovative because it seeks to implement an MHRN suicide risk model (intervention) into each system's existing suicide prevention care model (usual care) to increase the reach and effectiveness of the suicide prevention care models. Sites will receive implementation planning support based on stakeholder feedback from preliminary studies and deliverables include an implementation planning tool kit to facilitate spread. This high-impact study has important clinical implications as health systems consider whether it makes sense to enhance their existing suicide prevention care models with a suicide risk model. It is timely because many health systems are advancing toward suicide risk model implementation without evidence to support this innovation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinics are the unit of randomization, all behavioral health clinics will be randomized, over the course of three waves, to cross over from usual care to intervention (implementation of the suicide risk model).
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Suicide Attempt Risk Model Care PathwayUsual care suicide prevention pathway |
| Intervention | Experimental | Behavioral: Suicide Attempt Risk Model Care PathwayImplementation of the suicide risk model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18+ years old
- 1+ visit to a behavioral health clinic at participating sites
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Suicide Attempt Risk Model Care PathwayThe suicide attempt risk model uses documented histories of medical and psychiatric diagnoses, medications, and health service utilization to predict risk of a suicide attempt in the 90 days following an outpatient visit in behavioral health clinics. | Behavioural | Intervention, Usual Care |
Primary outcome
Suicide attempt, 90 days post-index encounter
Time frame: 90 days post-index encounter
The number and proportion of visits followed by any suicide attempt (ICD-10 diagnosis codes) occurring within 90 days of an index visit.
4 secondary outcomes
Identification
Time frame: Through study completion, an average of 18 months
Recognition
Time frame: Through study completion, an average of 18 months
Evidence-based suicide care
Time frame: Through study completion, an average of 18 months
Any 14-day follow-up care in behavioral health
Time frame: 14 days post-index encounter
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 15 Dec 2025.
- Background: PubMed 24567199Ahmedani BK, Simon GE, Stewart C, Beck A, Waitzfelder BE, Rossom R, Lynch F, Owen-Smith A, Hunkeler EM, Whiteside U, Operskalski BH, Coffey MJ, Solberg LI. Health care contacts in the year before suicide death. J Gen Intern Med. 2014 Jun;29(6):870-7. doi: 10.1007/s11606-014-2767-3. Epub 2014 Feb 25.
- Background: PubMed 29792051Simon GE, Johnson E, Lawrence JM, Rossom RC, Ahmedani B, Lynch FL, Beck A, Waitzfelder B, Ziebell R, Penfold RB, Shortreed SM. Predicting Suicide Attempts and Suicide Deaths Following Outpatient Visits Using Electronic Health Records. Am J Psychiatry. 2018 Oct 1;175(10):951-960. doi: 10.1176/appi.ajp.2018.17101167. Epub 2018 May 24.
- Background: PubMed 32487287Hedegaard H, Curtin SC, Warner M. Increase in Suicide Mortality in the United States, 1999-2018. NCHS Data Brief. 2020 Apr;(362):1-8.
- Background: PubMed 30993146Yarborough BJH, Ahmedani BK, Boggs JM, Beck A, Coleman KJ, Sterling S, Schoenbaum M, Goldstein-Grumet J, Simon GE. Challenges of Population-based Measurement of Suicide Prevention Activities Across Multiple Health Systems. EGEMS (Wash DC). 2019 Apr 12;7(1):13. doi: 10.5334/egems.277.
- Background: PubMed 34189931Rossom RC, Richards JE, Sterling S, Ahmedani B, Boggs JM, Yarborough BJH, Beck A, Lloyd K, Frank C, Liu V, Clinch SB, Patke LD, Simon GE. Connecting Research and Practice: Implementation of Suicide Prevention Strategies in Learning Health Care Systems. Psychiatr Serv. 2022 Feb 1;73(2):219-222. doi: 10.1176/appi.ps.202000596. Epub 2021 Jun 30.
- Background: PubMed 31529095Simon GE, Shortreed SM, Johnson E, Rossom RC, Lynch FL, Ziebell R, Penfold ARB. What health records data are required for accurate prediction of suicidal behavior? J Am Med Inform Assoc. 2019 Dec 1;26(12):1458-1465. doi: 10.1093/jamia/ocz136.
- Background: PubMed 24036589Simon GE, Rutter CM, Peterson D, Oliver M, Whiteside U, Operskalski B, Ludman EJ. Does response on the PHQ-9 Depression Questionnaire predict subsequent suicide attempt or suicide death? Psychiatr Serv. 2013 Dec 1;64(12):1195-202. doi: 10.1176/appi.ps.201200587.
- Background: PubMed 33711562Yarborough BJH, Stumbo SP. Patient perspectives on acceptability of, and implementation preferences for, use of electronic health records and machine learning to identify suicide risk. Gen Hosp Psychiatry. 2021 May-Jun;70:31-37. doi: 10.1016/j.genhosppsych.2021.02.008. Epub 2021 Mar 4.
- Background: PubMed 42559352Coleman KJ, Stewart C, Bruschke C, Flores JP, Altschuler A, Beck A, Lynch FL, Smith AO, Richards JE, Rossom R, Simon G, Sterling S, Ahmedani B. Identifying People at Risk for Suicide: Implementation of Screening for the Zero Suicide Initiative in Large Health Systems. Adv Psychiatry Behav Health. 2021 Sep;1(1):67-76. doi: 10.1016/j.ypsc.2021.05.016. Epub 2021 Aug 9. No abstract available.
- BackgroundNational Action Alliance for Suicide Prevention. A prioritized research agenda for suicide prevention: An action plan to save lives. Rockville, MD. 2014.
- Derived from this study: PubMed 40200191Stumbo SP, Hooker SA, Rossom RC, Miley K, Ahmedani BK, Lockhart E, Yeh HH, Yarborough BJH. Study protocol for a stepped-wedge, randomized controlled trial to evaluate implementation of a suicide risk identification model among behavioral health patients in three large health systems. BMC Psychiatry. 2025 Apr 8;25(1):344. doi: 10.1186/s12888-025-06760-0.
- A Prioritized Research Agenda for Suicide Prevention: An Action Plan to Save LivesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will make our documentation, research methods and protocol, data collection tools, and a de-identified dataset of data that underlie results in publications freely available, upon request, to interested researchers beginning 6 months after publication of the main analyses. Materials will be shared through the MHRN website or a secure file transfer. Creation of a deidentified dataset for sharing may include redaction of some information to prevent re-identification or because the data is proprietary. The de-identified dataset will be available for non-commercial research use to external investigators via a data-sharing agreement and under the auspices of the Site-PIs. Users must agree to the conditions of use governing access to the data. 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.
Bobbi Jo Yarborough, PsyD principal investigator
Kaiser Permanente
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suicide Attempt Risk Model Care Pathway in people with Suicide, Attempted and Suicide, Fatal, run by Kaiser Permanente at 3 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 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide attempt, 90 days post-index encounter (time frame: 90 days post-index encounter). 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 NCT06060535, which also lists 11 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 15 Dec 2025.