SuicideISTTNCT05613972
Integrated Suicide & Trauma Therapy for Suicide Risk
A study testing Integrated Suicide and Trauma Therapy in people with Suicide and Trauma, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The investigators have developed a novel suicide intervention, Integrated Suicide and Trauma Therapy (ISTT). ISTT combines Brief-Skills for Safer Living (Brief-SfSL)-a promising method to enhance coping skills and reduce suicidality-with a trauma therapy component to alleviate the specific impacts of childhood trauma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Trauma, Major Depressive Disorder
- What is being tested?
- Integrated Suicide and Trauma Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 8 Dec 2025to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Beck Scale for Suicidal Ideation > 10
- Presence of childhood trauma defined by a minimum moderate score on any of the Childhood Trauma Questionnaire subscales (emotional abuse, physical, abuse, sexual abuse, emotional neglect, and physical neglect
- any psychiatric diagnosis as long as there are no impairments that limit consent or understanding of ISTT (e.g. active psychosis)
- Ability to provide informed consent
- Not receiving other psychotherapy concurrently
- Ability to undergo psychotherapy in English
Who cannot join
- The presence of cognitive impairment and/or active psychosis that would limit consent or understanding of ISTT
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1M8
Molly Hyde, MSc, PhD (cand.), 416-864-6060 ext. 7844, traumatherapy@asrlife.ca
Sakina Rizvi, PhD, RP
About this study
Official title: Using Integrated Suicide and Trauma Therapy to Reduce Suicide Risk Among Adults With a History of Childhood Trauma
The investigators have developed a novel suicide intervention, Integrated Suicide and Trauma Therapy (ISTT). ISTT combines Brief-Skills for Safer Living (Brief-SfSL)-a promising method to enhance coping skills and reduce suicidality-with a trauma therapy component to alleviate the specific impacts of childhood trauma on suicide risk. The aim of this pilot is to test 12-weeks of ISTT to alleviate suicide risk among individuals with a history of childhood trauma and current suicidality.
Read the detailed description
In the last 10 years, despite available treatments, suicide rates have not significantly decreased, and individuals who have experienced any type of childhood maltreatment are at increased odds for suicide attempt. Effective suicide prevention requires learning skills to cope with suicidality in addition to addressing the antecedent factors that contribute to suicide risk. In the context of those with childhood trauma and suicidality, addressing antecedent factors may require treatments that target symptoms associated with developmental trauma. Thus, the investigators have developed an integrated suicide intervention, Integrated Suicide and Trauma Therapy (ISTT). ISTT combines Brief-Skills for Safer Living (Brief-SfSL)-a promising method to enhance coping skills and reduce suicidality-with a trauma therapy component to alleviate the specific impacts of childhood trauma on suicide risk. The aim of this pilot is to test 12-weeks of BSTT to alleviate suicide risk among individuals with a history of childhood trauma and current suicidality.
- Conditions
- Suicide, Trauma, Major Depressive Disorder
- Being tested
- Integrated Suicide and Trauma Therapy
- Keywords
- Childhood trauma, Early life adversity, Adverse childhood experiences, Suicide intervention, Psychotherapy
- Medical subject headings
- Suicide, Wounds and Injuries, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Suicide and Trauma TherapyOther
12-week trauma therapy for suicide risk
| Study group | Role | What they receive |
|---|---|---|
| Integrated Suicide and Trauma Therapy (BSTT) | Experimental | This novel suicide intervention integrates Brief Skills for Safer Learning (B-SfSL) with trauma therapy. ISTT incorporates the guiding principles of taking a non-pathologizing approach to treatment, emphasizing safety, attending to the therapeutic relationship, empowering clients, and incorporating solution-focused concepts. Receives: Other: Integrated Suicide and Trauma Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck Scale for Suicide Ideation (BSS) score
Beck Scale for Suicide Ideation is a 21-item self-report scale that quantifies suicidal ideation. Items are scored 0 to 2 and yield a total score ranging from 0 to 38. Higher scores reflect greater severity of suicidal ideation.
Measured: From baseline to 1 week post-therapy
Feasibility and acceptability of ISTT
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM), in addition to a feedback survey and interview created in-house with questions designed to collect quantitative and qualitative feedback from participants with respect to the feasibility and acceptability of the BSTT intervention.
Measured: From baseline to 1 week post-therapy
Secondary outcomes (3)
Change in Generalized Anxiety Disorder 7-item scale (GAD-7) score
The GAD-7 is a brief 7-item self-report scale measuring anxiety symptoms. Total scores range from 0 to 21, with higher scores reflecting more severe anxiety.
Measured: From baseline to 1-week post therapy
Change in Quick Inventory of Depressive Symptoms 16-item scale (QIDS) score
The QIDS is a 16-item validated depression scale. Total scores range from 0-27, with higher scores reflecting more severe depression.
Measured: From baseline to 1 week post-therapy
Change in Difficulties in Emotion Regulation Scale 36-item scale (DERS) score
The DERS is a 36-item validated scale measuring six aspects of emotion regulation. The DERS is comprised of 6 subscales, where higher scores are reflective of greater difficulties in emotion regulation. The DERS is often analyzed by percentile.
Measured: From baseline to 1 week post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start8 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sakina Rizvi, PhD,MACP,RP, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613972
- Sponsor's protocol ID
- ISTT-01
- Acronym
- ISTT
- Status last verified
- Dec 2025
- First submitted
- 28 Oct 2022
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alloy LB, Abramson LY, Smith JM, Gibb BE, Neeren AM. Role of parenting and maltreatment histories in unipolar and bipolar mood disorders: mediation by cognitive vulnerability to depression. Clin Child Fam Psychol Rev. 2006 Mar;9(1):23-64. doi: 10.1007/s10567-006-0002-4.
PubMed 16718583Angelakis I, Gillespie EL, Panagioti M. Childhood maltreatment and adult suicidality: a comprehensive systematic review with meta-analysis. Psychol Med. 2019 May;49(7):1057-1078. doi: 10.1017/S0033291718003823. Epub 2019 Jan 4.
PubMed 30608046Bergmans Y, Links PS. Reducing potential risk factors for suicide-related behavior with a group intervention for clients with recurrent suicide-related behavior. Ann Clin Psychiatry. 2009 Jan-Mar;21(1):17-25.
PubMed 19239829Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.
PubMed 12615092Berube A, Turgeon J, Blais C, Fiset D. Emotion Recognition in Adults With a History of Childhood Maltreatment: A Systematic Review. Trauma Violence Abuse. 2023 Jan;24(1):278-294. doi: 10.1177/15248380211029403. Epub 2021 Jul 9.
PubMed 34238064Bremness A, Polzin W. Commentary: Developmental Trauma Disorder: A Missed Opportunity in DSM V. J Can Acad Child Adolesc Psychiatry. 2014 May;23(2):142-5. No abstract available.
PubMed 24872830Briggs S, Netuveli G, Gould N, Gkaravella A, Gluckman NS, Kangogyere P, Farr R, Goldblatt MJ, Lindner R. The effectiveness of psychoanalytic/psychodynamic psychotherapy for reducing suicide attempts and self-harm: systematic review and meta-analysis. Br J Psychiatry. 2019 Jun;214(6):320-328. doi: 10.1192/bjp.2019.33. Epub 2019 Feb 28.
PubMed 30816079Brom D, Stokar Y, Lawi C, Nuriel-Porat V, Ziv Y, Lerner K, Ross G. Somatic Experiencing for Posttraumatic Stress Disorder: A Randomized Controlled Outcome Study. J Trauma Stress. 2017 Jun;30(3):304-312. doi: 10.1002/jts.22189. Epub 2017 Jun 6.
PubMed 28585761Bryan CJ, Clemans TA, Hernandez AM, Mintz J, Peterson AL, Yarvis JS, Resick PA; STRONG STAR Consortium. EVALUATING POTENTIAL IATROGENIC SUICIDE RISK IN TRAUMA-FOCUSED GROUP COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF PTSD IN ACTIVE DUTY MILITARY PERSONNEL. Depress Anxiety. 2016 Jun;33(6):549-57. doi: 10.1002/da.22456. Epub 2015 Dec 4.
PubMed 26636426Cao H, Ma R, Li X, Liang Y, Wu Q, Chi P, Li JB, Zhou N. Childhood Emotional Maltreatment and Adulthood Romantic Relationship Well-Being: A Multilevel, Meta-Analytic Review. Trauma Violence Abuse. 2022 Jul;23(3):778-794. doi: 10.1177/1524838020975895. Epub 2020 Dec 3.
PubMed 33267741Cloitre M, Courtois CA, Charuvastra A, Carapezza R, Stolbach BC, Green BL. Treatment of complex PTSD: results of the ISTSS expert clinician survey on best practices. J Trauma Stress. 2011 Dec;24(6):615-27. doi: 10.1002/jts.20697. Epub 2011 Dec 6.
PubMed 22147449Copeland WE, Shanahan L, Hinesley J, Chan RF, Aberg KA, Fairbank JA, van den Oord EJCG, Costello EJ. Association of Childhood Trauma Exposure With Adult Psychiatric Disorders and Functional Outcomes. JAMA Netw Open. 2018 Nov 2;1(7):e184493. doi: 10.1001/jamanetworkopen.2018.4493.
PubMed 30646356Coventry PA, Meader N, Melton H, Temple M, Dale H, Wright K, Cloitre M, Karatzias T, Bisson J, Roberts NP, Brown JVE, Barbui C, Churchill R, Lovell K, McMillan D, Gilbody S. Psychological and pharmacological interventions for posttraumatic stress disorder and comorbid mental health problems following complex traumatic events: Systematic review and component network meta-analysis. PLoS Med. 2020 Aug 19;17(8):e1003262. doi: 10.1371/journal.pmed.1003262. eCollection 2020 Aug.
PubMed 32813696Cruz D, Lichten M, Berg K, George P. Developmental trauma: Conceptual framework, associated risks and comorbidities, and evaluation and treatment. Front Psychiatry. 2022 Jul 22;13:800687. doi: 10.3389/fpsyt.2022.800687. eCollection 2022.
PubMed 35935425Doyle C, Cicchetti D. From the Cradle to the Grave: The Effect of Adverse Caregiving Environments on Attachment and Relationships Throughout the Lifespan. Clin Psychol (New York). 2017 Jun;24(2):203-217. doi: 10.1111/cpsp.12192. Epub 2017 Apr 11.
PubMed 28924334
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Integrated Suicide and Trauma Therapy to Reduce Suicide Risk Among Adults With a History of Childhood Trauma
- ClinicalTrials.gov ID
- NCT05613972
- Acronym / sponsor ID
- ISTT / ISTT-01
- Conditions
- Suicide, Trauma, Major Depressive Disorder
- Keywords
- Childhood trauma, Early life adversity, Adverse childhood experiences, Suicide intervention, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 Nov 2022 (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 have developed a novel suicide intervention, Integrated Suicide and Trauma Therapy (ISTT). ISTT combines Brief-Skills for Safer Living (Brief-SfSL)-a promising method to enhance coping skills and reduce suicidality-with a trauma therapy component to alleviate the specific impacts of childhood trauma on suicide risk. The aim of this pilot is to test 12-weeks of ISTT to alleviate suicide risk among individuals with a history of childhood trauma and current suicidality.
Detailed description
In the last 10 years, despite available treatments, suicide rates have not significantly decreased, and individuals who have experienced any type of childhood maltreatment are at increased odds for suicide attempt. Effective suicide prevention requires learning skills to cope with suicidality in addition to addressing the antecedent factors that contribute to suicide risk. In the context of those with childhood trauma and suicidality, addressing antecedent factors may require treatments that target symptoms associated with developmental trauma. Thus, the investigators have developed an integrated suicide intervention, Integrated Suicide and Trauma Therapy (ISTT). ISTT combines Brief-Skills for Safer Living (Brief-SfSL)-a promising method to enhance coping skills and reduce suicidality-with a trauma therapy component to alleviate the specific impacts of childhood trauma on suicide risk. The aim of this pilot is to test 12-weeks of BSTT to alleviate suicide risk among individuals with a history of childhood trauma and current suicidality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated Suicide and Trauma Therapy (BSTT) | Experimental | Other: Integrated Suicide and Trauma TherapyThis novel suicide intervention integrates Brief Skills for Safer Learning (B-SfSL) with trauma therapy. ISTT incorporates the guiding principles of taking a non-pathologizing approach to treatment, emphasizing safety, attending to the therapeutic relationship, empowering clients, and incorporating solution-focused concepts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Beck Scale for Suicidal Ideation > 10
- Presence of childhood trauma defined by a minimum moderate score on any of the Childhood Trauma Questionnaire subscales (emotional abuse, physical, abuse, sexual abuse, emotional neglect, and physical neglect
- any psychiatric diagnosis as long as there are no impairments that limit consent or understanding of ISTT (e.g. active psychosis)
- Ability to provide informed consent
- Not receiving other psychotherapy concurrently
Key exclusion criteria (2 listed)
- The presence of cognitive impairment and/or active psychosis that would limit consent or understanding of ISTT
- Unwilling or unable to provide informed consent
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 |
|---|---|---|
| Integrated Suicide and Trauma Therapy12-week trauma therapy for suicide risk | Other | Integrated Suicide and Trauma Therapy (BSTT) |
Primary outcome
Change in Beck Scale for Suicide Ideation (BSS) score
Time frame: From baseline to 1 week post-therapy
Beck Scale for Suicide Ideation is a 21-item self-report scale that quantifies suicidal ideation. Items are scored 0 to 2 and yield a total score ranging from 0 to 38. Higher scores reflect greater severity of suicidal ideation.
Feasibility and acceptability of ISTT
Time frame: From baseline to 1 week post-therapy
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM), in addition to a feedback survey and interview created in-house with questions designed to collect quantitative and qualitative feedback from participants with respect to the feasibility and acceptability of the BSTT intervention.
3 secondary outcomes
Change in Generalized Anxiety Disorder 7-item scale (GAD-7) score
Time frame: From baseline to 1-week post therapy
Change in Quick Inventory of Depressive Symptoms 16-item scale (QIDS) score
Time frame: From baseline to 1 week post-therapy
Change in Difficulties in Emotion Regulation Scale 36-item scale (DERS) score
Time frame: From baseline to 1 week post-therapy
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 Aug 2026.
- Background: PubMed 16718583Alloy LB, Abramson LY, Smith JM, Gibb BE, Neeren AM. Role of parenting and maltreatment histories in unipolar and bipolar mood disorders: mediation by cognitive vulnerability to depression. Clin Child Fam Psychol Rev. 2006 Mar;9(1):23-64. doi: 10.1007/s10567-006-0002-4.
- Background: PubMed 30608046Angelakis I, Gillespie EL, Panagioti M. Childhood maltreatment and adult suicidality: a comprehensive systematic review with meta-analysis. Psychol Med. 2019 May;49(7):1057-1078. doi: 10.1017/S0033291718003823. Epub 2019 Jan 4.
- Background: PubMed 19239829Bergmans Y, Links PS. Reducing potential risk factors for suicide-related behavior with a group intervention for clients with recurrent suicide-related behavior. Ann Clin Psychiatry. 2009 Jan-Mar;21(1):17-25.
- Background: PubMed 12615092Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.
- Background: PubMed 34238064Berube A, Turgeon J, Blais C, Fiset D. Emotion Recognition in Adults With a History of Childhood Maltreatment: A Systematic Review. Trauma Violence Abuse. 2023 Jan;24(1):278-294. doi: 10.1177/15248380211029403. Epub 2021 Jul 9.
- Background: PubMed 24872830Bremness A, Polzin W. Commentary: Developmental Trauma Disorder: A Missed Opportunity in DSM V. J Can Acad Child Adolesc Psychiatry. 2014 May;23(2):142-5. No abstract available.
- Background: PubMed 30816079Briggs S, Netuveli G, Gould N, Gkaravella A, Gluckman NS, Kangogyere P, Farr R, Goldblatt MJ, Lindner R. The effectiveness of psychoanalytic/psychodynamic psychotherapy for reducing suicide attempts and self-harm: systematic review and meta-analysis. Br J Psychiatry. 2019 Jun;214(6):320-328. doi: 10.1192/bjp.2019.33. Epub 2019 Feb 28.
- Background: PubMed 28585761Brom D, Stokar Y, Lawi C, Nuriel-Porat V, Ziv Y, Lerner K, Ross G. Somatic Experiencing for Posttraumatic Stress Disorder: A Randomized Controlled Outcome Study. J Trauma Stress. 2017 Jun;30(3):304-312. doi: 10.1002/jts.22189. Epub 2017 Jun 6.
- Background: PubMed 26636426Bryan CJ, Clemans TA, Hernandez AM, Mintz J, Peterson AL, Yarvis JS, Resick PA; STRONG STAR Consortium. EVALUATING POTENTIAL IATROGENIC SUICIDE RISK IN TRAUMA-FOCUSED GROUP COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF PTSD IN ACTIVE DUTY MILITARY PERSONNEL. Depress Anxiety. 2016 Jun;33(6):549-57. doi: 10.1002/da.22456. Epub 2015 Dec 4.
- Background: PubMed 33267741Cao H, Ma R, Li X, Liang Y, Wu Q, Chi P, Li JB, Zhou N. Childhood Emotional Maltreatment and Adulthood Romantic Relationship Well-Being: A Multilevel, Meta-Analytic Review. Trauma Violence Abuse. 2022 Jul;23(3):778-794. doi: 10.1177/1524838020975895. Epub 2020 Dec 3.
- Background: PubMed 22147449Cloitre M, Courtois CA, Charuvastra A, Carapezza R, Stolbach BC, Green BL. Treatment of complex PTSD: results of the ISTSS expert clinician survey on best practices. J Trauma Stress. 2011 Dec;24(6):615-27. doi: 10.1002/jts.20697. Epub 2011 Dec 6.
- Background: PubMed 30646356Copeland WE, Shanahan L, Hinesley J, Chan RF, Aberg KA, Fairbank JA, van den Oord EJCG, Costello EJ. Association of Childhood Trauma Exposure With Adult Psychiatric Disorders and Functional Outcomes. JAMA Netw Open. 2018 Nov 2;1(7):e184493. doi: 10.1001/jamanetworkopen.2018.4493.
- Individual participant dataSharing planned: No
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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.
Sakina Rizvi, PhD,MACP,RP principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Suicide and Trauma Therapy in people with Suicide and Trauma, run by Unity Health Toronto at 1 site 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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 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?
Contact Sakina Rizvi, PhD,MACP,RP (416-864-6060 ext. 6489, rizvisa@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Beck Scale for Suicide Ideation (BSS) score (time frame: From baseline to 1 week post-therapy). 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 NCT05613972, which also lists 48 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 17 Aug 2026.