Mental HealthNCT04902391
A Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Acute Pediatric Mental Health and Addiction Care Bundle
A study testing Health Services in people with Mental Health and Mental Disorders, run by University of Calgary at 8 sites in Canada.
Trial summary
The investigators will determine, in an 8-site, hybrid Type 1 cluster randomized effectiveness implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking emergency department care for mental health and substance use concerns. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Mental Health, Mental Disorders, Pediatrics
- What is being tested?
- Health Services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,800 participants
- Where
- 8 sitesCanada
- Study dates
- 9 Feb 2022to 31 Dec 2025
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8 to 17.99 years
- Chief triage concern of at least one of the following (or comparable) mental health CEDIS triage categories:
- Anxiety/situational crisis and/or hyperventilation
- Bizarre/paranoid behaviour
- Concern for patient's welfare
- Depression/suicidal/deliberate self-harm
Show all 10Show fewer
- Hallucinations/delusions
- Violent/homicidal behaviour
- Insomnia
- Pediatric disruptive behaviour
Who cannot join
- Brought to the ED under provincial mental health legislation
- Exhibiting features of schizophrenia, schizotypal, delusional disorders, or psychosis (e.g., hallucinations/delusions complaint should be reviewed carefully for this exclusion criterion)
- Significant self-harm act (i.e., suicide attempt requiring medical clearance, excluding ideation or minor superficial wounds; e.g., laceration/puncture, overdose ingestion, etc.)
- Other co-morbid medical concerns requiring oversight and/or medical clearance from an emergency physician (e.g., confusion/disorientation, substance withdrawal, other medical complaints, etc.)
- Substance misuse/intoxication or altered level of consciousness
- Exhibiting a behavioural syndrome associated with physiologic disturbances (e.g., anorexia)
- Children/youth will also be excluded based on language barriers:
- Language barrier (i.e., patient and parent/legal guardian must be fluent in either English or French)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
London Health Sciences Centre
London, Ontario, N6A 5W9
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, S7N 0W8
Janeway Children's Hospital
St. John's, Newfoundland and Labrador, A1B 3V6
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
The Children's Hospital of Winnipeg
Winnipeg, Manitoba, R3E 0Z3
About this study
Official title: A Multi-Disciplinary, Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Innovative Acute Pediatric Mental Health and Addiction Care Bundle
The investigators will determine, in an 8-site, hybrid Type 1 cluster randomized effectiveness implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking emergency department care for mental health and substance use concerns.
Read the detailed description
The investigators we co-designed, with parents and youth, an acute mental health care bundle-a set of evidence informed practices collectively used to improve the quality of care. The bundle of care includes:
- Triage-based evaluation of risk for suicide [Ask Suicide-Screening Questions (ASQ) and HEADS-ED, an assessment mnemonic (Home; Education \& Employment; Activities \& Peers; Drugs \& Alcohol; Suicidality; Emotions \& Behaviours; Discharge or Current Resources]
- Focused mental health team psychosocial evaluation to guide decision-making
- Choice And Partnership Approach (CAPA) to care
This bundle of care also strives to remove the ED physician as the gatekeeper to mental health care and will facilitate, ideally, 24-48 hour urgent mental health follow-up (booked before the child/family leave the ED), with up to 96 hours to coordinate follow-up for patients attending the ED on weekends.
Primary Research Objective: To determine, in an 8-site, hybrid Type I cluster randomized effectiveness-implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking ED care for mental health and substance use concerns.
Secondary Research Objectives: (1) To determine if the bundle improves wellbeing, satisfaction with care, family functioning, and health care delivery; (2) To identify modifiable barriers, constraints, and enablers of bundle implementation fidelity and effectiveness; (3) To test if trial intervention effects are moderated by sociodemographic characteristics (sex, gender, ethnicity, culture, education, and socioeconomic status); and (4) To assess the cost-effectiveness of the approach.
- Conditions
- Mental Health, Mental Disorders, Pediatrics, Emergency Psychiatric
- Being tested
- Health Services
- Keywords
- Emergency Psychiatric Services, Healthcare Delivery
- Medical subject headings
- Psychological Well-Being, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health ServicesOther
The Acute Mental Health Care Bundle consists of 3 core elements, including: (1) ED triage, (2) ED assessment and care, and (3) follow-up care.
| Study group | Role | What they receive |
|---|---|---|
| Acute Mental Health Care Bundle | Experimental | We developed an evidence-based bundle of care to address current gaps in care. The bundle: 1) brings together multiple evidence-based assessment tools (ASQ, HEADS-ED) to ensure efficient, high-value ED-based care; 2) removes barriers to assessment and builds connections to care: Assessments are conducted by a mental health care provider and families have access to urgent follow-up care; and 3) prioritizes family engagement: A shared decision-making framework (Choice and Partnership) is used to promote children and youth as stewards of their care and support partnership between EDs and follow-up services with the duration of care determined collaboratively by the patient and their provider. Receives: Other: Health Services |
| Usual ED-Based Mental Health Care | No intervention | Local standards of ED-based mental health care will be delivered at control sites. Site leads have determined that this care does not involve the 3 specific core innovations in the bundle. Local care standards are similar across study sites and include use of CTAS score at triage (but no mental health risk assessment tool), ED physician medical clearance and assessment of consultation need, and no consistent mental health follow-up plan. Sites that are randomized to the control arm will not adopt core bundle elements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Warwick-Edinburgh Mental Wellbeing Scale 30 days after the index ED visit
Measured in survey completed by the participant using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) for patients ≥13 years
Each item is scored on a range from 1 to 5. The total score will be between 14 and 70, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 45. A substantial decrease in wellbeing is a decrease by 5 or more points.
Measured: 30 days after the index emergency department (ED) visit
Stirling Children's Wellbeing Scale 30 days after the index ED visit
Measured in survey completed by the participant using the Stirling Children's Wellbeing Scale (SCWBS) for patients <13 years.
Each item is scored on a range from 1 to 5. The total score will be between 12 and 60, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 30. A substantial decrease in wellbeing is a decrease by 5 or more points.
As these scales used for the primary outcomes measure the same construct, data will be standardized and combined across age groups to derive a single measure of wellbeing.
Measured: 30 days after the index emergency department (ED) visit
Secondary outcomes (9)
Satisfaction with acute mental health care services as measured by the Service Satisfaction Scale 10
Measured in survey completed by the participant using the Service Satisfaction Scale 10 (SSS-10). The scale consists of 12 items (parent version) or 10 items (youth version). Items are scored on a 5-point response scale with a total possible score of 60 (parent) or 50 (youth). Higher scores indicate higher satisfaction.
Measured: 72 hours after the index ED visit
Quality of life as measured by the Beach Center Family Quality of Life Scale
Measured in survey completed by the participant using the Beach Center Family Quality of Life Scale (FQOL). The 25-item scale uses a 5-point rating with a maximum score of 125 indicating highest quality of life.
Measured: 30 days after the index ED visit
Warwick-Edinburgh Mental Wellbeing Scale at 90 days after the index ED visit
Measured in survey completed by the participant using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) for patients ≥13 years.
Each item is scored on a range from 1 to 5. The total score will be between 14 and 70, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 45. A substantial decrease in wellbeing is a decrease by 5 or more points.
Measured: 90 after the index ED visit
Stirling Children's Wellbeing Scale at 90 days after the index ED visit
Measured in survey completed by the participant using the Stirling Children's Wellbeing Scale (SCWBS) for patients <13 years.
Each item is scored on a range from 1 to 5. The total score will be between 12 and 60, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 30. A substantial decrease in wellbeing is a decrease by 5 or more points.
As the WEMWBS and SCWBS measure the same construct, data will be standardized and combined across age groups to derive a single measure of wellbeing.
Measured: 90 after the index ED visit
Warwick-Edinburgh Mental Wellbeing Scale at 180 days after the index ED visit
Measured in survey completed by the participant using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) for patients ≥13 years.
Each item is scored on a range from 1 to 5. The total score will be between 14 and 70, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 45. A substantial decrease in wellbeing is a decrease by 5 or more points.
Measured: 180 days after the index ED visit
Stirling Children's Wellbeing Scale at 180 days after the index ED visit
Measured in survey completed by the participant using the Stirling Children's Wellbeing Scale (SCWBS) for patients <13 years.
Each item is scored on a range from 1 to 5. The total score will be between 12 and 60, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 30. A substantial decrease in wellbeing is a decrease by 5 or more points.
As the WEMWBS and SCWBS measure the same construct, data will be standardized and combined across age groups to derive a single measure of wellbeing.
Measured: 180 days after the index ED visit
Median duration of the index ED visits
Measured using data collected in the patient electronic medical record. ED Length of stay is defined as the time interval between triage and discharge
Measured: Hours spent in the ED, measured at the index ED visit (Day 0)
Proportion of children and youth that revisited the emergency department for a mental health complaint related to their index emergency department visit within 7 and 30 days of the index visit
Measured using data collected in the patient electronic medical record.
Measured: 7 and 30 days after the index ED visit
Proportion of emergency department visits for mental healthcare that concluded in hospital admission
Measured using data collected in the patient electronic medical record.
Measured: Measured based on admissions following the index ED visit (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start9 Feb 2022
- Primary completion30 Jun 2025
- Study completion31 Dec 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 Mental HealthStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, parallel arm cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 6,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, University of Saskatchewan, University of Manitoba, McMaster University, Western University, Canada, University of Toronto, McGill University, Dalhousie University, Memorial University of Newfoundland
- Responsible party
- Sponsor
- Investigators
- Stephen Freedman, MDCM, MSc, Principal investigator, University of CalgaryAmanda Newton, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902391
- Sponsor's protocol ID
- REB20-1825
- Status last verified
- Dec 2024
- First submitted
- 7 Apr 2021
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Rasiah J, Freedman S, Macdonald L, Prisnie K, Eltorki M, Finkelstein Y, Hopkin G, Santana MJ, Thull-Freedman J, Stang A, Prebeg M, Gagnon IJ, Steele M, Mater A, Katz L, Greenfield B, Plotnick L, Monga S, Lipman EL, Wright B, Dimitropoulos G, Porter R, Hurley K, Al Hamarneh YN, Newton A. Evaluation of parent and youth experiences in advisory groups as part of a mental healthcare clinical trial: protocol for a mixed-method study. BMJ Open. 2022 Jun 17;12(6):e059689. doi: 10.1136/bmjopen-2021-059689.
PubMed 35715176
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Disciplinary, Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Innovative Acute Pediatric Mental Health and Addiction Care Bundle
- ClinicalTrials.gov ID
- NCT04902391
- Acronym / sponsor ID
- REB20-1825
- Conditions
- Mental Health, Mental Disorders, Pediatrics, Emergency Psychiatric
- Keywords
- Emergency Psychiatric Services, Healthcare Delivery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,800 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Alberta, University of Saskatchewan, University of Manitoba, McMaster University, Western University, Canada, University of Toronto, McGill University, Dalhousie University, Memorial University of Newfoundland
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 May 2021 (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 investigators will determine, in an 8-site, hybrid Type 1 cluster randomized effectiveness implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking emergency department care for mental health and substance use concerns.
Detailed description
The investigators we co-designed, with parents and youth, an acute mental health care bundle-a set of evidence informed practices collectively used to improve the quality of care. The bundle of care includes:
- Triage-based evaluation of risk for suicide [Ask Suicide-Screening Questions (ASQ) and HEADS-ED, an assessment mnemonic (Home; Education \& Employment; Activities \& Peers; Drugs \& Alcohol; Suicidality; Emotions \& Behaviours; Discharge or Current Resources]
- Focused mental health team psychosocial evaluation to guide decision-making
- Choice And Partnership Approach (CAPA) to care
This bundle of care also strives to remove the ED physician as the gatekeeper to mental health care and will facilitate, ideally, 24-48 hour urgent mental health follow-up (booked before the child/family leave the ED), with up to 96 hours to coordinate follow-up for patients attending the ED on weekends.
Primary Research Objective: To determine, in an 8-site, hybrid Type I cluster randomized effectiveness-implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking ED care for mental health and substance use concerns.
Secondary Research Objectives: (1) To determine if the bundle improves wellbeing, satisfaction with care, family functioning, and health care delivery; (2) To identify modifiable barriers, constraints, and enablers of bundle implementation fidelity and effectiveness; (3) To test if trial intervention effects are moderated by sociodemographic characteristics (sex, gender, ethnicity, culture, education, and socioeconomic status); and (4) To assess the cost-effectiveness of the approach.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic, parallel arm cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Acute Mental Health Care Bundle | Experimental | Other: Health ServicesWe developed an evidence-based bundle of care to address current gaps in care. The bundle: 1) brings together multiple evidence-based assessment tools (ASQ, HEADS-ED) to ensure efficient, high-value ED-based care; 2) removes barriers to assessment and builds connections to care: Assessments are conducted by a mental health care provider and families have access to urgent follow-up care; and 3) prioritizes family engagement: A shared decision-making framework (Choice and Partnership) is used to promote children and youth as stewards of their care and support partnership between EDs and follow-up services with the duration of care determined collaboratively by the patient and their provider. |
| Usual ED-Based Mental Health Care | No intervention | –Local standards of ED-based mental health care will be delivered at control sites. Site leads have determined that this care does not involve the 3 specific core innovations in the bundle. Local care standards are similar across study sites and include use of CTAS score at triage (but no mental health risk assessment tool), ED physician medical clearance and assessment of consultation need, and no consistent mental health follow-up plan. Sites that are randomized to the control arm will not adopt core bundle elements. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age 8 to 17.99 years
- Chief triage concern of at least one of the following (or comparable) mental health CEDIS triage categories:
Key exclusion criteria (8 listed)
- Brought to the ED under provincial mental health legislation
- Exhibiting features of schizophrenia, schizotypal, delusional disorders, or psychosis (e.g., hallucinations/delusions complaint should be reviewed carefully for this exclusion criterion)
- Significant self-harm act (i.e., suicide attempt requiring medical clearance, excluding ideation or minor superficial wounds; e.g., laceration/puncture, overdose ingestion, etc.)
- Other co-morbid medical concerns requiring oversight and/or medical clearance from an emergency physician (e.g., confusion/disorientation, substance withdrawal, other medical complaints, etc.)
- Substance misuse/intoxication or altered level of consciousness
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 |
|---|---|---|
| Health ServicesThe Acute Mental Health Care Bundle consists of 3 core elements, including: (1) ED triage, (2) ED assessment and care, and (3) follow-up care. | Other | Acute Mental Health Care Bundle |
Primary outcome
Warwick-Edinburgh Mental Wellbeing Scale 30 days after the index ED visit
Time frame: 30 days after the index emergency department (ED) visit
Measured in survey completed by the participant using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) for patients ≥13 years Each item is scored on a range from 1 to 5. The total score will be between 14 and 70, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 45. A substantial decrease in wellbeing is a decrease by 5 or more points.
Stirling Children's Wellbeing Scale 30 days after the index ED visit
Time frame: 30 days after the index emergency department (ED) visit
Measured in survey completed by the participant using the Stirling Children's Wellbeing Scale (SCWBS) for patients <13 years. Each item is scored on a range from 1 to 5. The total score will be between 12 and 60, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 30. A substantial decrease in wellbeing is a decrease by 5 or more points. As these scales used for the primary outcomes measure the same construct, data will be standardized and combined across age groups to derive a single measure of wellbeing.
9 secondary outcomes
Satisfaction with acute mental health care services as measured by the Service Satisfaction Scale 10
Time frame: 72 hours after the index ED visit
Quality of life as measured by the Beach Center Family Quality of Life Scale
Time frame: 30 days after the index ED visit
Warwick-Edinburgh Mental Wellbeing Scale at 90 days after the index ED visit
Time frame: 90 after the index ED visit
Stirling Children's Wellbeing Scale at 90 days after the index ED visit
Time frame: 90 after the index ED visit
Warwick-Edinburgh Mental Wellbeing Scale at 180 days after the index ED visit
Time frame: 180 days after the index ED visit
Stirling Children's Wellbeing Scale at 180 days after the index ED visit
Time frame: 180 days after the index ED visit
Median duration of the index ED visits
Time frame: Hours spent in the ED, measured at the index ED visit (Day 0)
Proportion of children and youth that revisited the emergency department for a mental health complaint related to their index emergency department visit within 7 and 30 days of the index visit
Time frame: 7 and 30 days after the index ED visit
Proportion of emergency department visits for mental healthcare that concluded in hospital admission
Time frame: Measured based on admissions following the index ED visit (Day 0)
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 17 Jul 2025.
- Derived from this study: PubMed 35715176Rasiah J, Freedman S, Macdonald L, Prisnie K, Eltorki M, Finkelstein Y, Hopkin G, Santana MJ, Thull-Freedman J, Stang A, Prebeg M, Gagnon IJ, Steele M, Mater A, Katz L, Greenfield B, Plotnick L, Monga S, Lipman EL, Wright B, Dimitropoulos G, Porter R, Hurley K, Al Hamarneh YN, Newton A. Evaluation of parent and youth experiences in advisory groups as part of a mental healthcare clinical trial: protocol for a mixed-method study. BMJ Open. 2022 Jun 17;12(6):e059689. doi: 10.1136/bmjopen-2021-059689.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
Stephen Freedman, MDCM, MSc principal investigator
University of Calgary
Amanda Newton, PhD principal investigator
University of Alberta
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Services in people with Mental Health and Mental Disorders, run by University of Calgary at 8 sites in Canada.
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 10 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 17 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 8 sites in Canada. 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?
Warwick-Edinburgh Mental Wellbeing Scale 30 days after the index ED visit (time frame: 30 days after the index emergency department (ED) visit). 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?
On the ClinicalTrials.gov record for NCT04902391, 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 17 Jul 2025.