PsychosisNCT04247711
On Track Chile For First Episode Psychosis
A study testing OTCH and Usual FEP Services in people with Psychosis, run by University of Chile at 1 site in Chile.
Trial summary
Substantial data support early interventions for people experiencing First Episode Psychosis (FEP) to ameliorate symptoms and minimize disability. FEP programs have been widely and successfully implemented in high-income countries. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Psychosis
- What is being tested?
- OTCH and Usual FEP Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChile
- Study dates
- 25 Mar 2021to 30 Mar 2025
- 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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals who have FEP (First Episode Psychosis)
- Individuals who are receiving services at a participating outpatient mental health clinic.
- Individuals who meet ICT-10 criteria for a diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, delusional disorder, brief psychotic disorder, or psychosis not otherwise specified.
- Individuals who have the capacity to provide fully informed consent. (For those under age 18, capacity to provide assent plus informed consent of parent/guardian.)
- Individuals who are able to participate in research assessments in Spanish
Who cannot join
- Individuals who have a non-psychiatric medical condition that impairs functioning.
- Individuals who have a psychosis due solely to another medical condition.
- Individuals who have a psychosis due to a developmental disability.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
CESAM San Joaquín
Santiago, 8200009
Valerie Villagrán, valerievillagran@cormusanjoaquin.cl
About this study
Substantial data support early interventions for people experiencing First Episode Psychosis (FEP) to ameliorate symptoms and minimize disability. FEP programs have been widely and successfully implemented in high-income countries. With the partial exception of Chile, however, there is not a single low-and-middle-income country (LMIC) that offers universal access to FEP services. Chile is unique among LMICs in having created a platform for the implementation of FEP services, including 1) an FEP policy that mandates identification of FEP individuals at primary care and delivery of community-based FEP treatments at outpatient mental health clinics, and 2) a public health care system within which this mandate can be fulfilled. Nonetheless, previous research has documented that FEP services provided at mental health clinics do not conform to recently established evidence-based approaches. Therefore, the overarching goal of this proposal is to address the shortfall in evidence-based practices for FEP in Chile by first adapting OnTrackChile (OTCH) from OnTrackNY (OTNY), a coordinated specialty care program for FEP currently being implemented across the US, and then implementing OTCH on a wide scale. Like most FEP programs, OTNY is clinically effective, but unlike most others, it also has a well-established training and technical assistance infrastructure, and a proven track record of being scaled up in large urban areas. To achieve this goal, the Dynamic Adaptation Process will be used to first inform the adaptation and implementation of OTCH in the Chilean context. Then, a Hybrid Trial design will be employed to evaluate the implementation of OTCH as well as its effectiveness and cost in a cluster-randomized controlled trial (RCT) (N = 300 from 21 outpatient clinics). The OnTrackChile program will be offered in half of these outpatient clinics; usual care services will continue to be offered at the other clinics. Study participants (ages 15 to 35) attending an outpatient clinic assigned to the intervention arm will receive the OTCH coordinated services provided by an interdisciplinary team, based on the interests, needs, and preferences of each study participant. Study participants attending outpatient clinics assigned to "usual care" will receive the usual services offered to people with a wide range of mental health conditions, not just those experiencing first-episode psychosis. The study will engage participants over the course of two years, with interviews to evaluate their experiences at the beginning of their participation, and again after 12 months and 24 months. Over the course of the study, 4-5 mental health providers will also be interviewed at each of the participating clinics (up to 105 additional interviews at the three timepoints). The data collected in this study will help researchers evaluate the effectiveness and cost of FEP treatments based in outpatient clinics and factors which may help or hinder these outcomes.
- Conditions
- Psychosis
- Being tested
- OTCH, Usual FEP Services
- Keywords
- First-Episode Psychosis, Implementation Science, Coordinated Specialty Care, Global Mental Health
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTCHBehavioural
OTCH is structured in three phrases (i. engagement and initial needs assessment, ii. ongoing intervention and monitoring, and iii. transition to long-term services) and lasts an average of two years. OTCH will maintain the central characteristics of the OnTrack model, as well as its core principles, which include (1) Person-centered care, (2) Shared decision-making, (3) Recovery orientation, and (4) Culturally-competent care.
Usual FEP ServicesBehavioural
These include services such as psychiatric medication, psychotherapy, and psychoeducation for people with FEP and are usually provided at outpatient mental health clinics.
| Study group | Role | What they receive |
|---|---|---|
| OTCH | Experimental | OTCH is based on OTNY, a Coordinated Specialty Care program for people with first-episode psychosis. The program is implemented by a multidisciplinary team, who provide coordinated, evidence-based services based on the interests, needs, and preferences of each participant. Receives: Behavioral: OTCH |
| Usual FEP services | Placebo comparator | This is generally provided in mental health outpatient clinics which serve a population enrolled in the public health care system. Receives: Behavioral: Usual FEP Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adapted version of the OTNY Fidelity Scale
This scale will assess the degree to which the participating clinics deliver OTCH. The scale 24 dimensions rated on a 3-score rating where 0=unmet, 1=partially met, and 2=totally met. Higher scores mean better Fidelity.
Measured: 24 months
Change on Providers' attitudes using the Evidence-Based Practice Attitude Scale
Providers' attitudes to evidence-based practices will be measured by the evidence-based attitude scale (EBPAS). The EBPAS consists of 15 items rated on a five-point scale from 0=Not at all to 4=Very great extent. Higher scores mean better attitudes to evidence-based practices.
Measured: baseline, 12 months, 24 months
Change on Adoption of OTCH among patients using the CollaboRATE
This is a 3-item scale rated on a ten-point scale from 0=No effort was made to 9=Every effort was made. Higher scores mean better Adoption.
Measured: baseline, 12 months, 24 months
Change on Adoption of OTCH among providers using the Shared Decision Making Questionnaire Physician Version
This questionnaire continues with nine items about the steps in the adoption of the shared-decision making approach, one of the key components of OTCH. Each item is rated on a six-point scale from 0=Completely disagree to 5=Completely agree. Higher scores indicate more shared-decision making.
Measured: baseline, 12 months, 24 months
Change on Adoption of OTCH among both patients and providers using the Recovery Self-Assessment scale
This is a 32-item, self-administered rating scale that will measure perceptions about recovery principles and overall quality of services. Each item is rated on a five-point scale from 1=Strongly disagree to 5=Strongly agree. Higher scores indicate greater quality care.
Measured: baseline, 12 months, 24 months
Secondary outcomes (6)
Change on Patient-centeredness
Measured by Youth Services Survey (YSS). Each item is rated on a five-point scale from 1=Strongly disagree to 5=Strongly agree. Higher scores mean more Patient-centeredness.
Measured: baseline, 12 months, 24 months
Change on Medication adherence
Measured by the Brief Adherence Rating Scale (BARS). It consists of 4 items: 3 questions and an overall visual analog rating scale to assess the percentage of antipsychotic medication doses taken by the user in the past month (0%-100%).
Measured: baseline, 12 months, 24 months
Change on Retention
Measured by the Service Utilization and Resources Form (SURF). Time remaining in treatment will be estimated by counting the number of days between randomization to the time of the last mental health service received measured by the SURF. Range: from 0 to 365 days over a 12 month period; from 0 to 730 days over a 24-month period.
Measured: baseline, 12 months, 24 months
Change on Psychotic symptoms
Measured by Positive and Negative Syndrome Scale (PANSS). This scale will be used to assess positive and negative symptoms (only the first 14 items). The level of psychopathology is rated on a seven-point scale from 1=Absent to 7=Extreme. Higher scores mean worse symptomatology.
Measured: baseline, 12 months, 24 months
Change on Social and Occupational Functioning
Measured by the Social and Role Functioning in Psychosis and Schizophrenia (SRFP) scale. This scale asks for social, behavioral, and occupational difficulties associated with mental illness, including psychosis and schizophrenia. Functioning is rated on an eleven-point scale from 0=Extreme role dysfunction to 10=Superior social/interpersonal functioning. Higher scores mean better social and occupational functioning.
Measured: baseline, 12 months, 24 months
Change on Recovery Orientation
Measured by the Questionnaire about the Process of Recovery (QPR). This instrument has 15 items each scored on a four-point scale ranging from 0=Strongly disagree to 4=Strongly agree. A Higher scores indicate greater recovery.
Measured: baseline, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start25 Mar 2021
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
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 PsychosisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The 21 participating clinics will be divided into two groups based on poverty level of catchment area and expected enrollment of individuals with FEP for each clinic. The largest site will be matched with two clinics of similar poverty level and clinic size. The matching will be done based on visual inspection of a scatter plot of expected enrollment by income of each site. The nearest neighbor matching approach will be used to choose pairs. Blocks of size 2, and one block of size 3, will be randomly generated. This procedure will entail 1) generating a random number 0 or 1 ten times, and 2) assigning 0 to the Usual FEP care clinic and 1 to the OTCH clinic in each matched pair. For the block of size 3, two sites will be assigned to either OTCH or Usual FEP care, and the remaining site to either OTCH or Usual FEP care as well. The random allocation will enable us to bring into the study one OTCH and one Usual FEP Care clinic per month (except for the block of size 3, as noted above).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de O'Higgins, Columbia University, Washington University School of Medicine, New York University, Research Foundation for Mental Hygiene, Inc., New York State Psychiatric Institute
- Responsible party
- Principal investigator, Rubén Alvarado, University of Chile
- Investigators
- Ruben Alvarado, MD PhD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247711
- Sponsor's protocol ID
- R01MH115502-02
- Status last verified
- Jun 2023
- First submitted
- 10 Jan 2020
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We aim to produce and share a high-quality, well-documented, and de-identified final dataset with other researchers after publication of results bearing on the specific aims of our proposal. By "high quality," we refer to our commitment to follow the guidelines on rigor and transparency by NIH to ensure strict application of the scientific method and that every effort will be made to collect data that is reliable, valid, and representative of the population studied. By "well-documented," we mean that an accessible code book will define individual variables and any scales derived from those variables, sampling plans and sampling results, procedures for handling missing data, and all other information required to use the data and to report the results with fidelity. By "de-identified," we mean that the data will not allow for the identification of the specific individuals who participated in this research.
Publications
Mascayano F, Bello I, Andrews H, Arancibia D, Arratia T, Burrone MS, Conover S, Fader K, Jorquera MJ, Gomez M, Malverde S, Martinez-Ales G, Ramirez J, Reginatto G, Restrepo-Henao A, Rosencheck RA, Schilling S, Smith TE, Soto-Brandt G, Tapia E, Tapia T, Velasco P, Wall MM, Yang LH, Cabassa LJ, Susser E, Dixon L, Alvarado R. OnTrack Chile for people with early psychosis: a study protocol for a Hybrid Type 1 trial. Trials. 2022 Sep 5;23(1):751. doi: 10.1186/s13063-022-06661-7.
PubMed 36064643
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On Track Chile For First Episode Psychosis
- ClinicalTrials.gov ID
- NCT04247711
- Acronym / sponsor ID
- R01MH115502-02
- Conditions
- Psychosis
- Keywords
- First-Episode Psychosis, Implementation Science, Coordinated Specialty Care, Global Mental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Universidad de O'Higgins, Columbia University, Washington University School of Medicine, New York University, Research Foundation for Mental Hygiene, Inc., New York State Psychiatric Institute
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 30 Jan 2020 (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.
Substantial data support early interventions for people experiencing First Episode Psychosis (FEP) to ameliorate symptoms and minimize disability. FEP programs have been widely and successfully implemented in high-income countries. With the partial exception of Chile, however, there is not a single low-and-middle-income country (LMIC) that offers universal access to FEP services. Chile is unique among LMICs in having created a platform for the implementation of FEP services, including 1) an FEP policy that mandates identification of FEP individuals at primary care and delivery of community-based FEP treatments at outpatient mental health clinics, and 2) a public health care system within which this mandate can be fulfilled. Nonetheless, previous research has documented that FEP services provided at mental health clinics do not conform to recently established evidence-based approaches. Therefore, the overarching goal of this proposal is to address the shortfall in evidence-based practices for FEP in Chile by first adapting OnTrackChile (OTCH) from OnTrackNY (OTNY), a coordinated specialty care program for FEP currently being implemented across the US, and then implementing OTCH on a wide scale. Like most FEP programs, OTNY is clinically effective, but unlike most others, it also has a well-established training and technical assistance infrastructure, and a proven track record of being scaled up in large urban areas. To achieve this goal, the Dynamic Adaptation Process will be used to first inform the adaptation and implementation of OTCH in the Chilean context. Then, a Hybrid Trial design will be employed to evaluate the implementation of OTCH as well as its effectiveness and cost in a cluster-randomized controlled trial (RCT) (N = 300 from 21 outpatient clinics). The OnTrackChile program will be offered in half of these outpatient clinics; usual care services will continue to be offered at the other clinics. Study participants (ages 15 to 35) attending an outpatient clinic assigned to the intervention arm will receive the OTCH coordinated services provided by an interdisciplinary team, based on the interests, needs, and preferences of each study participant. Study participants attending outpatient clinics assigned to "usual care" will receive the usual services offered to people with a wide range of mental health conditions, not just those experiencing first-episode psychosis. The study will engage participants over the course of two years, with interviews to evaluate their experiences at the beginning of their participation, and again after 12 months and 24 months. Over the course of the study, 4-5 mental health providers will also be interviewed at each of the participating clinics (up to 105 additional interviews at the three timepoints). The data collected in this study will help researchers evaluate the effectiveness and cost of FEP treatments based in outpatient clinics and factors which may help or hinder these outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The 21 participating clinics will be divided into two groups based on poverty level of catchment area and expected enrollment of individuals with FEP for each clinic. The largest site will be matched with two clinics of similar poverty level and clinic size. The matching will be done based on visual inspection of a scatter plot of expected enrollment by income of each site. The nearest neighbor matching approach will be used to choose pairs. Blocks of size 2, and one block of size 3, will be randomly generated. This procedure will entail 1) generating a random number 0 or 1 ten times, and 2) assigning 0 to the Usual FEP care clinic and 1 to the OTCH clinic in each matched pair. For the block of size 3, two sites will be assigned to either OTCH or Usual FEP care, and the remaining site to either OTCH or Usual FEP care as well. The random allocation will enable us to bring into the study one OTCH and one Usual FEP Care clinic per month (except for the block of size 3, as noted above).
| Arm | Type | Receives |
|---|---|---|
| OTCH | Experimental | Behavioral: OTCHOTCH is based on OTNY, a Coordinated Specialty Care program for people with first-episode psychosis. The program is implemented by a multidisciplinary team, who provide coordinated, evidence-based services based on the interests, needs, and preferences of each participant. |
| Usual FEP services | Placebo comparator | Behavioral: Usual FEP ServicesThis is generally provided in mental health outpatient clinics which serve a population enrolled in the public health care system. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Individuals who have FEP (First Episode Psychosis)
- Individuals who are receiving services at a participating outpatient mental health clinic.
- Individuals who meet ICT-10 criteria for a diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, delusional disorder, brief psychotic disorder, or psychosis not otherwise specified.
- Individuals who have the capacity to provide fully informed consent. (For those under age 18, capacity to provide assent plus informed consent of parent/guardian.)
- Individuals who are able to participate in research assessments in Spanish
Key exclusion criteria (3 listed)
- Individuals who have a non-psychiatric medical condition that impairs functioning.
- Individuals who have a psychosis due solely to another medical condition.
- Individuals who have a psychosis due to a developmental disability.
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 |
|---|---|---|
| OTCHOTCH is structured in three phrases (i. engagement and initial needs assessment, ii. ongoing intervention and monitoring, and iii. transition to long-term services) and lasts an average of two years. OTCH will maintain the central characteristics of the OnTrack model, as well as its core principles, which include (1) Person-centered care, (2) Shared decision-making, (3) Recovery orientation, and (4) Culturally-competent care. | Behavioural | OTCH |
| Usual FEP ServicesThese include services such as psychiatric medication, psychotherapy, and psychoeducation for people with FEP and are usually provided at outpatient mental health clinics. | Behavioural | Usual FEP services |
Primary outcome
Adapted version of the OTNY Fidelity Scale
Time frame: 24 months
This scale will assess the degree to which the participating clinics deliver OTCH. The scale 24 dimensions rated on a 3-score rating where 0=unmet, 1=partially met, and 2=totally met. Higher scores mean better Fidelity.
Change on Providers' attitudes using the Evidence-Based Practice Attitude Scale
Time frame: baseline, 12 months, 24 months
Providers' attitudes to evidence-based practices will be measured by the evidence-based attitude scale (EBPAS). The EBPAS consists of 15 items rated on a five-point scale from 0=Not at all to 4=Very great extent. Higher scores mean better attitudes to evidence-based practices.
Change on Adoption of OTCH among patients using the CollaboRATE
Time frame: baseline, 12 months, 24 months
This is a 3-item scale rated on a ten-point scale from 0=No effort was made to 9=Every effort was made. Higher scores mean better Adoption.
Change on Adoption of OTCH among providers using the Shared Decision Making Questionnaire Physician Version
Time frame: baseline, 12 months, 24 months
This questionnaire continues with nine items about the steps in the adoption of the shared-decision making approach, one of the key components of OTCH. Each item is rated on a six-point scale from 0=Completely disagree to 5=Completely agree. Higher scores indicate more shared-decision making.
Change on Adoption of OTCH among both patients and providers using the Recovery Self-Assessment scale
Time frame: baseline, 12 months, 24 months
This is a 32-item, self-administered rating scale that will measure perceptions about recovery principles and overall quality of services. Each item is rated on a five-point scale from 1=Strongly disagree to 5=Strongly agree. Higher scores indicate greater quality care.
6 secondary outcomes
Change on Patient-centeredness
Time frame: baseline, 12 months, 24 months
Change on Medication adherence
Time frame: baseline, 12 months, 24 months
Change on Retention
Time frame: baseline, 12 months, 24 months
Change on Psychotic symptoms
Time frame: baseline, 12 months, 24 months
Change on Social and Occupational Functioning
Time frame: baseline, 12 months, 24 months
Change on Recovery Orientation
Time frame: baseline, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 36064643Mascayano F, Bello I, Andrews H, Arancibia D, Arratia T, Burrone MS, Conover S, Fader K, Jorquera MJ, Gomez M, Malverde S, Martinez-Ales G, Ramirez J, Reginatto G, Restrepo-Henao A, Rosencheck RA, Schilling S, Smith TE, Soto-Brandt G, Tapia E, Tapia T, Velasco P, Wall MM, Yang LH, Cabassa LJ, Susser E, Dixon L, Alvarado R. OnTrack Chile for people with early psychosis: a study protocol for a Hybrid Type 1 trial. Trials. 2022 Sep 5;23(1):751. doi: 10.1186/s13063-022-06661-7.
- Individual participant dataSharing planned: Yes. We aim to produce and share a high-quality, well-documented, and de-identified final dataset with other researchers after publication of results bearing on the specific aims of our proposal. By "high quality," we refer to our commitment to follow the guidelines on rigor and transparency by NIH to ensure strict application of the scientific method and that every effort will be made to collect data that is reliable, valid, and representative of the population studied. By "well-documented," we mean that an accessible code book will define individual variables and any scales derived from those variables, sampling plans and sampling results, procedures for handling missing data, and all other information required to use the data and to report the results with fidelity. By "de-identified," we mean that the data will not allow for the identification of the specific individuals who participated in this research.
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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.
Ruben Alvarado, MD PhD principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTCH and Usual FEP Services in people with Psychosis, run by University of Chile at 1 site in Chile.
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 3 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruben Alvarado, MD PhD (562 2 903 0000, ralvarado@med.uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adapted version of the OTNY Fidelity Scale (time frame: 24 months). The study lists 5 primary outcomes in all. 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 NCT04247711, 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 18 Jun 2023.