Suicide and DepressionNCT05748730
Clinical Trial for Integrated Care to Help At Risk Teens (iCHART) Intervention
A study testing iCHART and Treatment As Usual in people with Suicide and Depression and Adolescent Behavior, run by University of Pittsburgh at 13 sites in United States.
Trial summary
This protocol will test the effectiveness of an intervention, iCHART (integrated Care to Help At-Risk Teens) and facilitate recruitment for other studies in the larger ETUDES Center grant, which are focused on treatment development for target risk factors for suicidal behavior, specifically, sleep, anhedonia, and… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Suicide and Depression, Adolescent Behavior
- What is being tested?
- iCHART and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 765 participants
- Where
- 13 sitesUnited States
- Study dates
- 26 Jan 2023to 30 Apr 2027
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- YOUTH
- Youth will be age 12-18 and speak English.
- Youth will have current depression or suicidal behavior. Suicidal behavior for iCHART (N=900) is defined as past suicidal thoughts in the past two weeks as indicated by clinician interview or report or as indicated by responses to a standardized assessments such as the PHQ-9, PHQ-9M, ASQ, CSSRS, or Behavioral Health Screen, or seeking acute care or clinical contact for mental health crisis/problem in the past year.
- CAREGIVERS/PARENTS
- Parents/caregivers of youth in the study must be at least 18 years old and their child must be willing to participate in the study. Caregivers/parents must be able to speak English. Parents are considered biological/adoptive parents or have court documentation that they can provide consent for research as a legal guardian of a youth. Only 1 parent/caregiver will be engaged in research, but in case 1 parent is unavailable, the other may be engaged (meaning it doesn't have to be the same parent participating in assessments/interviews throughout youth study participation).
Who cannot join
- YOUTH
- Exclusion criteria include conditions that might impair their ability to effectively deploy ETUDES interventions, including:
- current manic or psychotic episode, presence of a life-threatening medical condition requiring immediate treatment, intellectual or developmental disability precluding comprehension of study procedure. The latter will be assessed by parental report of placement in self-contained Special Education classes, EHR review, and during the consent/assent and/or baseline to determine if the participant is not understanding research procedures.
- Participants without access to a phone and/or tablet to interact with components of the intervention that require a phone will be excluded.
- CAREGIVERS/PARENTS
- There are no specific exclusion criteria for caregivers and providers. However, as mentioned in the inclusion criteria, caregivers will be excluded if they are not the biological parent or court-appointed guardian of the youth being interviewed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Gibbsboro
Gibbsboro, New Jersey, 08026
Conemaugh Memorial Medical Center-Family Medicine
Johnstown, Pennsylvania, 15905
CHOP Primary Care, CHOP Campus
Philadelphia, Pennsylvania, 19104
Roxborough
Philadelphia, Pennsylvania, 19128
CHOP Primary Care, Cobbs Creek
Philadelphia, Pennsylvania, 19139
Karabots
Philadelphia, Pennsylvania, 19139
Children's Community Pediatrics (CCP) of Children's Hospital of Pittsburgh UPMC
Pittsburgh, Pennsylvania, 15213
UPMC Center for Adolescent and Young Adult Health
Pittsburgh, Pennsylvania, 15213
UPMC Family Medicine
Pittsburgh, Pennsylvania, 15213
Kids Plus Pediatrics (KPP)
Pittsburgh, Pennsylvania, 15217
Berks Community Health Center
Reading, Pennsylvania, 19604
Springfield
Springfield, Pennsylvania, 19064
CHOP Primary Care, West Chester
West Chester, Pennsylvania, 19380
About this study
Official title: The Center for Enhancing Triage and Utilization for Depression and Emergent Suicidality (ETUDES) in Pediatric Primary Care-iCHART RCT
This protocol will test the effectiveness of an intervention, iCHART (integrated Care to Help At-Risk Teens) and facilitate recruitment for other studies in the larger ETUDES Center grant, which are focused on treatment development for target risk factors for suicidal behavior, specifically, sleep, anhedonia, and stress related to cyber-victimization. This study will recruit 900 adolescents which will be enrolled in a randomized controlled trial to test iCHART and will be randomized to iCHART or treatment as usual (TAU). Based on previous work, the investigators hypothesize that iCHART, compared to TAU, will decrease suicide-related events by 50%. The investigators will use implementation science methods to assess contextual factors (i.e., barriers and facilitators) and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for our predictive algorithm and iCHART to inform future implementation efforts and promote health equity.
Read the detailed description
iCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including the:
- Safety planning app for suicidal youth which enables a primary care provider to streamline the gold standard of care for those with current suicidality symptoms through an app (instead of a paper based version);
- Mental Health Screener questionnaire that gathers additional mental health symptoms, treatment preferences, and family's readiness for treatment engagement;
- Text Messages which aims to provide texts for 2-3 weeks to motivate youth to engage with the safety plan.
Aim 1. Test the effectiveness of iCHART in reducing suicide-related events at 6 months, the primary outcome, and examine mediators and moderators of treatment response. The investigators hypothesize: 1) iCHART will reduce suicide-related events; 2) Individual-, family-, and neighborhood-level risk and protective factors will moderate response; and 3) Examine a predictive algorithm to examine heterogeneity of treatment response.
Aim 2. Examine barriers, facilitators, and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for iCHART to inform future implementation efforts and promote health equity. Barriers and facilitators that span multiple levels of context (e.g., aspects of clinic workflows, provider beliefs and knowledge) are expected to be uncovered. Further, incorporating iCHART in pediatric primary care will be viewed as feasible, acceptable, and appropriate by youth and caregivers across different racial and ethnic groups.
- Conditions
- Suicide and Depression, Adolescent Behavior
- Being tested
- iCHART, Treatment As Usual
- Medical subject headings
- Suicide, Depression, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCHARTBehavioural
The Safety Planning App will guide clinicians in the use of an emotion regulation and safety planning app (BRITE) to be loaded on the phone of depressed and suicidal adolescents in order to improve depression and reduce the likelihood of a suicide attempt.
The Mental Health Screener is a decision support tool to guide clinicians to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.
The Text Messages is a personalized text messaging intervention for patients and parents that targets engagement with the safety plan to increase the likelihood that a depressed or suicidal patient will maintain or initiate recommended services.
Participants will receive psychoeducation and referral to a mental health treatment provider, if needed.
Treatment As UsualBehavioural
Participants in this group will receive usual care from their clinician which may include development of a paper safety plan.
| Study group | Role | What they receive |
|---|---|---|
| iCHART | Experimental | iCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including a:
1. Safety Planning App for suicidal youth which enables a clinician to streamline the gold standard of care for those with current suicidality symptoms through an app (instead of a paper based version);
2. Mental Health Screener questionnaire that gathers additional mental health symptoms, treatment preferences, and family's readiness for treatment engagement to help clinicians make a personalized, tailored treatment plan a suicidal youth is more likely to adhere to;
3. Text Messages which aims to provide texts for 2-3 weeks to motivate you to engage with the safety plan and recommended treatment following the patient visit.
Participants will receive psychoeducation and referral to a mental health treatment provider, if needed. Receives: Behavioral: iCHART |
| Treatment As Usual (TAU) | Active comparator | Participants in this group will receive usual care from their clinician which may will include development of a paper safety plan. Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide related event
Suicidal Event definition: combination of items on CSSRS + CASA: actual attempt=yes; interrupted attempt=yes; aborted attempt=yes; preparatory acts=yes; emergency referral=yes in CSSRS and include emergency referral items in CASA that are suicide related (receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center). Note this is a composite score.
Measured: Cumulative through 6-month follow up
Secondary outcomes (18)
Suicide related event
Suicidal Event definition: combination of items on CSSRS + CASA: actual attempt=yes; interrupted attempt=yes; aborted attempt=yes; preparatory acts=yes; emergency referral=yes in CSSRS and include emergency referral items in CASA that are suicide related (receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center). Note this is a composite score.
Measured: Cumulative through 12-month follow up
Depression Severity
Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity.
Measured: Cumulative 6-month follow up
Time from randomization to first suicide related event
Time of onset to suicide related to event. Dates are collected on CSSRS and CASA when suicidal behavior events occur (CSSRS) and referrals are made to medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center.
Measured: Cumulative through 6-month follow up
Time from randomization to first suicide related event
Time of onset to suicide related to event. Dates are collected on CSSRS and CASA when suicidal behavior events occur (CSSRS) and referrals are made to medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center.
Measured: Cumulative through 12-month follow up
Frequency of suicide-related events
Number of suicide related events across sample collected from CSSRS and CASA.
Measured: Cumulative through 6-month follow up
Frequency of suicide-related events
Number of suicide related events across sample collected from CSSRS and CASA.
Measured: Cumulative through 12-month follow up
Aborted Attempts
Behavior section, aborted (self-interrupted) attempt endorsed for interval covered on CSSRS.
Measured: Cumulative through 6-month follow up
Aborted Attempts
Behavior section, aborted (self-interrupted) attempt endorsed for interval covered on CSSRS.
Measured: Cumulative through 12-month follow up
Interrupted Attempts
Behavior section, interrupted attempt endorsed for interval covered on CSSRS.
Measured: Cumulative through 6-month follow up
Interrupted Attempts
Behavior section, interrupted attempt endorsed for interval covered on CSSRS.
Measured: Cumulative through 12-month follow up
Actual attempt (non-fatal)
Behavior section, actual attempt endorsed for the interval covered on CSSRS.
Measured: Cumulative through 6-month follow up
Actual attempt (non-fatal)
Behavior section, actual attempt endorsed for the interval covered on CSSRS.
Measured: Cumulative through 12-month follow up
Preparatory acts taken for a suicide attempt
Suicidal behavior indicator endorsed for preparatory acts or behavior toward imminent suicidal behavior endorsed for the interval covered on CSSRS.
Measured: Cumulative through 6-month follow up
Preparatory acts taken for a suicide attempt
Suicidal behavior indicator endorsed for preparatory acts or behavior toward imminent suicidal behavior endorsed for the interval covered on CSSRS.
Measured: Cumulative through 12-month follow up
Emergency referral for increased suicidal ideation
Study emergency referral recorded in connection with increased suicidal ideation.
Measured: Cumulative through 6-month follow up
Emergency referral for increased suicidal ideation
Study emergency referral recorded in connection with increased suicidal ideation.
Measured: Cumulative through 12-month follow up
Emergency referral for increased suicidal ideation
Designated CASA emergency referral items where the referral is suicide related (on items related to receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center).
Measured: Cumulative through 6-month follow up
Emergency referral for increased suicidal ideation
Designated CASA emergency referral items where the referral is suicide related (on items related to receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center).
Measured: Cumulative through 12-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 posted1 Mar 2023
- Study start26 Jan 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide and DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- This study uses an effectiveness-implementation hybrid type 1 randomized clinical trial (RCT) design. A qualitative, descriptive design will be used to analyze qualitative aims of this study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 765 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, University of Oregon, Columbia University, Kaiser Permanente, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Stephanie Stepp, University of Pittsburgh
- Investigators
- Stephanie Stepp, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748730
- Sponsor's protocol ID
- STUDY22020069
- Other IDs
- P50MH115838
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All requests for study data will follow NIMH's data sharing and data use policies. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Center for Enhancing Triage and Utilization for Depression and Emergent Suicidality (ETUDES) in Pediatric Primary Care-iCHART RCT
- ClinicalTrials.gov ID
- NCT05748730
- Acronym / sponsor ID
- STUDY22020069
- Conditions
- Suicide and Depression, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 765 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, University of Oregon, Columbia University, Kaiser Permanente, National Institute of Mental Health (NIMH)
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 1 Mar 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.
This protocol will test the effectiveness of an intervention, iCHART (integrated Care to Help At-Risk Teens) and facilitate recruitment for other studies in the larger ETUDES Center grant, which are focused on treatment development for target risk factors for suicidal behavior, specifically, sleep, anhedonia, and stress related to cyber-victimization. This study will recruit 900 adolescents which will be enrolled in a randomized controlled trial to test iCHART and will be randomized to iCHART or treatment as usual (TAU). Based on previous work, the investigators hypothesize that iCHART, compared to TAU, will decrease suicide-related events by 50%. The investigators will use implementation science methods to assess contextual factors (i.e., barriers and facilitators) and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for our predictive algorithm and iCHART to inform future implementation efforts and promote health equity.
Detailed description
iCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including the:
- Safety planning app for suicidal youth which enables a primary care provider to streamline the gold standard of care for those with current suicidality symptoms through an app (instead of a paper based version);
- Mental Health Screener questionnaire that gathers additional mental health symptoms, treatment preferences, and family's readiness for treatment engagement;
- Text Messages which aims to provide texts for 2-3 weeks to motivate youth to engage with the safety plan.
Aim 1. Test the effectiveness of iCHART in reducing suicide-related events at 6 months, the primary outcome, and examine mediators and moderators of treatment response. The investigators hypothesize: 1) iCHART will reduce suicide-related events; 2) Individual-, family-, and neighborhood-level risk and protective factors will moderate response; and 3) Examine a predictive algorithm to examine heterogeneity of treatment response.
Aim 2. Examine barriers, facilitators, and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for iCHART to inform future implementation efforts and promote health equity. Barriers and facilitators that span multiple levels of context (e.g., aspects of clinic workflows, provider beliefs and knowledge) are expected to be uncovered. Further, incorporating iCHART in pediatric primary care will be viewed as feasible, acceptable, and appropriate by youth and caregivers across different racial and ethnic groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses an effectiveness-implementation hybrid type 1 randomized clinical trial (RCT) design. A qualitative, descriptive design will be used to analyze qualitative aims of this study.
| Arm | Type | Receives |
|---|---|---|
| iCHART | Experimental | Behavioral: iCHARTiCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including a: 1. Safety Planning App for suicidal youth which enables a clinician to streamline the gold standard of care for those with current suicidality symptoms through an app (instead of a paper based version); 2. Mental Health Screener questionnaire that gathers additional mental health symptoms, treatment preferences, and family's readiness for treatment engagement to help clinicians make a personalized, tailored treatment plan a suicidal youth is more likely to adhere to; 3. Text Messages which aims to provide texts for 2-3 weeks to motivate you to engage with the safety plan and recommended treatment following the patient visit. Participants will receive psychoeducation and referral to a mental health treatment provider, if needed. |
| Treatment As Usual (TAU) | Active comparator | Behavioral: Treatment As UsualParticipants in this group will receive usual care from their clinician which may will include development of a paper safety plan. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- YOUTH
- CAREGIVERS/PARENTS
Key exclusion criteria (6 listed)
- YOUTH
- CAREGIVERS/PARENTS
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 |
|---|---|---|
| iCHARTThe Safety Planning App will guide clinicians in the use of an emotion regulation and safety planning app (BRITE) to be loaded on the phone of depressed and suicidal adolescents in order to improve depression and reduce the likelihood of a suicide attempt. The Mental Health Screener is a decision support tool to guide clinicians to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. The Text Messages is a personalized text messaging intervention for patients and parents that targets engagement with the safety plan to increase the likelihood that a depressed or suicidal patient will maintain or initiate recommended services. Participants will receive psychoeducation and referral to a mental health treatment provider, if needed. | Behavioural | iCHART |
| Treatment As UsualParticipants in this group will receive usual care from their clinician which may include development of a paper safety plan. | Behavioural | Treatment As Usual (TAU) |
Primary outcome
Suicide related event
Time frame: Cumulative through 6-month follow up
Suicidal Event definition: combination of items on CSSRS + CASA: actual attempt=yes; interrupted attempt=yes; aborted attempt=yes; preparatory acts=yes; emergency referral=yes in CSSRS and include emergency referral items in CASA that are suicide related (receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center). Note this is a composite score.
18 secondary outcomes
Suicide related event
Time frame: Cumulative through 12-month follow up
Depression Severity
Time frame: Cumulative 6-month follow up
Time from randomization to first suicide related event
Time frame: Cumulative through 6-month follow up
Time from randomization to first suicide related event
Time frame: Cumulative through 12-month follow up
Frequency of suicide-related events
Time frame: Cumulative through 6-month follow up
Frequency of suicide-related events
Time frame: Cumulative through 12-month follow up
Aborted Attempts
Time frame: Cumulative through 6-month follow up
Aborted Attempts
Time frame: Cumulative through 12-month follow up
Interrupted Attempts
Time frame: Cumulative through 6-month follow up
Interrupted Attempts
Time frame: Cumulative through 12-month follow up
Actual attempt (non-fatal)
Time frame: Cumulative through 6-month follow up
Actual attempt (non-fatal)
Time frame: Cumulative through 12-month follow up
Preparatory acts taken for a suicide attempt
Time frame: Cumulative through 6-month follow up
Preparatory acts taken for a suicide attempt
Time frame: Cumulative through 12-month follow up
Emergency referral for increased suicidal ideation
Time frame: Cumulative through 6-month follow up
Emergency referral for increased suicidal ideation
Time frame: Cumulative through 12-month follow up
Emergency referral for increased suicidal ideation
Time frame: Cumulative through 6-month follow up
Emergency referral for increased suicidal ideation
Time frame: Cumulative through 12-month follow up
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. All requests for study data will follow NIMH's data sharing and data use policies. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.
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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.
Stephanie Stepp, PhD principal investigator
University of Pittsburgh
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCHART and Treatment As Usual in people with Suicide and Depression and Adolescent Behavior, run by University of Pittsburgh at 13 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 5 inclusion and 6 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 related event (time frame: Cumulative through 6-month follow up). 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 3 Nov 2026.