Postpartum DepressionNCT05753176
Online 1-Day CBT-Based Workshops for Preventing Postpartum Depression
A study testing Online 1-Day Cognitive Behavioural Therapy-Based Workshop in people with Postpartum Depression and Postpartum Anxiety, run by McMaster University at 1 site in Canada.
Trial summary
To conduct a randomized controlled trial (N=408) examining the impact of an online cognitive behavioural therapy (CBT)-based workshop on rates of postpartum depression (i.e., EPDS scores at 2-months postpartum) when added to treatment as usual (TAU) compared to TAU alone. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Postpartum Anxiety
- What is being tested?
- Online 1-Day Cognitive Behavioural Therapy-Based Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteCanada
- Study dates
- 10 Nov 2022to 12 Dec 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Currently residing in Ontario, Canada
- Currently in 3rd trimester of pregnancy (28-36 weeks gestation)
- EPDS score >6
- Past history of major depressive disorder (determined using the Mini International Neuropsychiatric Interview (MINI)
Who cannot join
- positive score on the MINI for a current major depressive episode
- positive score on the MINI subsections of bipolar, psychotic, or borderline personality disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online 1-Day CBT-Based Workshops for Preventing Postpartum Depression: A Randomized Controlled Trial
To conduct a randomized controlled trial (N=408) examining the impact of an online cognitive behavioural therapy (CBT)-based workshop on rates of postpartum depression (i.e., EPDS scores at 2-months postpartum) when added to treatment as usual (TAU) compared to TAU alone.
Read the detailed description
Postpartum depression affects up to 1 in 5 mothers, however just 15% receive evidence-based treatment. It is associated with negative consequences for women and their families with enormous costs to the healthcare system. Postpartum depression is an ideal candidate for prevention because it is common, the window of opportunity to intervene is clear (pregnancy), and its risk factors are well-established and easily identifiable. Furthermore, women are in frequent contact with the healthcare system during pregnancy and are more motivated to improve their health during this time than at any other time in their lives. Given the high rate of PPD and its adverse effects on mothers and their families, and the relative lack of efficient, effective psychotherapeutic interventions for preventing PPD, safe, novel, and efficient preventive interventions are needed. Since large 1-day workshops appear to successfully treat depression, given the widespread interest and investment of public health units across Canada in maternal and child health, Online 1-Day CBT-Based Workshops for Preventing PPD should be developed and tested for their ability to prevent PPD in Canadian women.
Based on longstanding clinical work with women at high risk for PPD, the development of a successful 1-Day CBT-Based Treatment Workshop for PPD and its delivery in-person and online, and an extensive review of the PPD prevention literature, the investigators developed the content for our prevention workshop as well as an accompanying script and intervention manual for participants in a previous pilot study. This pilot study also assessed feasibility by recruiting 32 women who took part in an online CBT-based workshop and provided feedback on its content, delivery and assessment procedures. The workshop, manual, and study protocol were subsequently refined and our experience recruiting participants in community settings into CBT treatment studies for PPD will be utilized in the current randomized controlled trial (N=408), which is aimed as assessing the effectiveness of these workshops at reducing the likelihood of developing PPD in women at risk.
Objectives of the proposed randomized controlled trial are as follows:
Primary: To determine if Online 1-Day CBT-Based Workshops delivered to pregnant persons with a past history of major depressive disorder (MDD) and added to TAU reduces EPDS scores at 2-months postpartum more than TAU alone and to determine if these workshops reduce the risk of developing PPD (EPDS score ≥13 at 2 months postpartum).
Secondary: To determine if 1-Day CBT-based workshops lead to differences in the common comorbidities of PPD (maternal anxiety, problems with the mother-infant relationship, infant temperament, maternal social support, and maternal perceived stress) between the experimental and control groups.
Tertiary: To determine if 1-Day CBT-based workshops alter trajectories of PPD and its comorbidities from birth to three months postpartum and whether they are cost- effective.
Additional Analyses: A subgroup analysis will be conducted in those participants deemed as being of low socioeconomic status. The investigators will also conduct subgroup analyses to determine whether there are any differences in the magnitude of the treatment effect in participants that are single marital status, have a past history of abuse or have poor social support. Additional subgroup analyses will be conducted in those participants who are first time mothers, those who have generalized anxiety disorder, and those receiving treatment for past depression at baseline.
A prospective randomized controlled trial design will be used to address these objectives. The study will be advertised through our public health and community partners (i.e., midwifery associations) in Ontario, as well as on Facebook and Instagram. Participants will be allocated in a 1:1 ratio to experimental (1-Day CBT Workshop in addition to TAU) or control (TAU alone) groups. Both experimental and control groups will complete data collection at baseline (before completing the 1-Day CBT workshop for experimental group participants), and at 1, 2 and 3 months postpartum.
- Conditions
- Postpartum Depression, Postpartum Anxiety
- Being tested
- Online 1-Day Cognitive Behavioural Therapy-Based Workshop
- Keywords
- cognitive behavioral therapy, CBT, postpartum depression, PPD, randomized controlled trial, RCT
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online 1-Day Cognitive Behavioural Therapy-Based WorkshopBehavioural
The Online Workshop is a day-long intervention delivered by two trained facilitators (i.e., psychotherapists, social workers, nurses, and/or a psychiatrist) consisting of 6 hours of instruction delivered in 4 modules. The 1st contains information on PPD etiology with a focus on modifiable cognitive risk factors (e.g., negative thoughts, maladaptive core beliefs). The 2nd module focuses on cognitive skills including cognitive restructuring. The 3rd builds behavioural skills such as problem solving, behavioural activation, assertiveness, sleep strategies, and using supports. The final module provides an opportunity for goal setting/action planning. Teaching methods include didactic sections, group exercises, and role-plays. Regular breaks are incorporated. Each participant is given a professionally designed manual to facilitate learning. Participants are also given a list of region-specific PPD resources and a copy of the Canadian Practice Guidelines for the treatment of PPD.
| Study group | Role | What they receive |
|---|---|---|
| Online 1-Day CBT-Based Workshop | Experimental | Participants assigned to the treatment arm will attend a day long CBT-based workshop delivered online by two trained facilitators in addition to receiving usual care. Receives: Behavioral: Online 1-Day Cognitive Behavioural Therapy-Based Workshop |
| Treatment as Usual | No intervention | Participants assigned to the control arm will continue to receive standard prenatal care from their healthcare providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPDS score as a continuous outcome (Total EPDS) and an EPDS score of 13 or more at 2-months postpartum (T3) will serve as co-primary outcomes.
Edinburgh Postnatal Depression Scale (EPDS): the gold standard measure of PPD symptoms in clinical practice and research. The EPDS is a self-report 10-item scale scored out of 30 points that measures the severity of depressive symptoms in the past 7 days. Scores are between 0 and 30, with higher scores indicating the presence of more depressive symptoms. Scores of 13 and above indicate depressive illness, or a high risk of developing a depressive disorder. A reduction of four points in the EPDS is recognized as a clinically significant improvement.
Measured: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
Secondary outcomes (5)
Maternal Anxiety (Generalized Anxiety Disorder 7-Item Scale (GAD-7))
The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a validated 7-item self-report scale that identifies probable cases of generalized anxiety disorder (GAD) and severity of anxiety symptoms, the most common PPD comorbidity that is known to be responsive to CBT. Respondents rate how often they have been bothered by various symptoms by providing a score on a 4-point Likert scale ranging from 'not at all' to 'nearly every day'. A higher score on this scale indicates greater severity of anxiety.
Measured: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
Maternal Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support (MSPSS)MSPSS is a 12-item measure of perceived adequacy of social support from three sources: friends, family and significant other. It is scored using a 5-point Likert scale (0=strongly disagree, 5=strongly agree). Higher scores indicated higher perceived adequacy of social support.
Measured: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
Maternal Perceived Stress (Perceived Stress Scale (PSS))
The Perceived Stress Scale (PSS) is one of the most widely used psychological instruments for measuring the perception of stress. The PSS measures the degree to which situations are appraised as stressful and items tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The questions in this scale ask about feelings and thoughts experienced during the last month, and respondents are asked to indicate how often they felt or thought a certain way on a 5-point Likert scale ranging from 0=never to 4=very often. Scores range from 0 to 40 with scores between 0-13 considered low stress, 14-26 considered moderate stress, and 27-40 considered high perceived stress.
Measured: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
Problems with the Mother-Infant Relationship (Postpartum Bonding Questionnaire (PBQ))
The Postpartum Bonding Questionnaire (PBQ) is a 25-item maternal-report measure that assesses four aspects of maternal-infant relations: (1) bonding, (2) rejection and anger towards the infant, (3) infant-focused anxiety and (4) incipient abuse. Subscales 1-3 will be explored as a continuous outcome using subscale total score. Each item is scored on a scale of 0-5, with higher scores suggestive of more problems. Mother-infant bonding will be measured as a continuous and dichotomous outcome, using cut-off scores for each subscale indicating bonding disorders. Cutoff values of 12 for the bonding subscale, 17 for rejection and anger, and 10 for infant-focused anxiety have been proposed to define bonding disorders in each category.
Measured: 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
Infant Temperament (Infant Behaviour Questionnaire-Revised (IBQ-R))
The IBQ-R is a 91-item self-report, gold-standard measure of infant temperament. This measure is completed by mothers who report on their infant's behaviour and temperament. How often a mother observes each behaviour in a week is measured on 7-point scale from 1 (never) to 7 (always). This scale assesses temperament on 14 subscales: Activity Level, Distress to Limitations, Approach, Fear, Duration of Orienting, Smiling and Laughter, Vocal Reactivity, Sadness, Perceptual Sensitivity, High Intensity Pleasure, Low Intensity Pleasure, Cuddliness, Soothability, and Falling Reactivity/Rate of Recovery from Distress. Respondents indicate how often the infant did each behaviour during the past seven days by choosing a number between 1 (never) to 7 (always).
Measured: 3-months postpartum (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start10 Nov 2022
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
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 Postpartum DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel-group Ontario-wide RCT with experimental (workshop) and TAU (control) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan J Van Lieshout, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753176
- Sponsor's protocol ID
- RCT1-day CBT to prevent PPD
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boland Z, Lloyd N, Drage J, Serrano-Lomelin J, Bieling P, Streiner D, Van Lieshout RJ. One-Day Online Cognitive Behavioral Therapy-Based Workshops for the Prevention of Postpartum Depression: A Randomized Controlled Trial. J Clin Psychiatry. 2025 Apr 16;86(2):24m15674. doi: 10.4088/JCP.24m15674.
PubMed 40257965
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online 1-Day CBT-Based Workshops for Preventing Postpartum Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05753176
- Acronym / sponsor ID
- RCT1-day CBT to prevent PPD
- Conditions
- Postpartum Depression, Postpartum Anxiety
- Keywords
- cognitive behavioral therapy, CBT, postpartum depression, PPD, randomized controlled trial, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 3 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.
To conduct a randomized controlled trial (N=408) examining the impact of an online cognitive behavioural therapy (CBT)-based workshop on rates of postpartum depression (i.e., EPDS scores at 2-months postpartum) when added to treatment as usual (TAU) compared to TAU alone.
Detailed description
Postpartum depression affects up to 1 in 5 mothers, however just 15% receive evidence-based treatment. It is associated with negative consequences for women and their families with enormous costs to the healthcare system. Postpartum depression is an ideal candidate for prevention because it is common, the window of opportunity to intervene is clear (pregnancy), and its risk factors are well-established and easily identifiable. Furthermore, women are in frequent contact with the healthcare system during pregnancy and are more motivated to improve their health during this time than at any other time in their lives. Given the high rate of PPD and its adverse effects on mothers and their families, and the relative lack of efficient, effective psychotherapeutic interventions for preventing PPD, safe, novel, and efficient preventive interventions are needed. Since large 1-day workshops appear to successfully treat depression, given the widespread interest and investment of public health units across Canada in maternal and child health, Online 1-Day CBT-Based Workshops for Preventing PPD should be developed and tested for their ability to prevent PPD in Canadian women.
Based on longstanding clinical work with women at high risk for PPD, the development of a successful 1-Day CBT-Based Treatment Workshop for PPD and its delivery in-person and online, and an extensive review of the PPD prevention literature, the investigators developed the content for our prevention workshop as well as an accompanying script and intervention manual for participants in a previous pilot study. This pilot study also assessed feasibility by recruiting 32 women who took part in an online CBT-based workshop and provided feedback on its content, delivery and assessment procedures. The workshop, manual, and study protocol were subsequently refined and our experience recruiting participants in community settings into CBT treatment studies for PPD will be utilized in the current randomized controlled trial (N=408), which is aimed as assessing the effectiveness of these workshops at reducing the likelihood of developing PPD in women at risk.
Objectives of the proposed randomized controlled trial are as follows:
Primary: To determine if Online 1-Day CBT-Based Workshops delivered to pregnant persons with a past history of major depressive disorder (MDD) and added to TAU reduces EPDS scores at 2-months postpartum more than TAU alone and to determine if these workshops reduce the risk of developing PPD (EPDS score ≥13 at 2 months postpartum).
Secondary: To determine if 1-Day CBT-based workshops lead to differences in the common comorbidities of PPD (maternal anxiety, problems with the mother-infant relationship, infant temperament, maternal social support, and maternal perceived stress) between the experimental and control groups.
Tertiary: To determine if 1-Day CBT-based workshops alter trajectories of PPD and its comorbidities from birth to three months postpartum and whether they are cost- effective.
Additional Analyses: A subgroup analysis will be conducted in those participants deemed as being of low socioeconomic status. The investigators will also conduct subgroup analyses to determine whether there are any differences in the magnitude of the treatment effect in participants that are single marital status, have a past history of abuse or have poor social support. Additional subgroup analyses will be conducted in those participants who are first time mothers, those who have generalized anxiety disorder, and those receiving treatment for past depression at baseline.
A prospective randomized controlled trial design will be used to address these objectives. The study will be advertised through our public health and community partners (i.e., midwifery associations) in Ontario, as well as on Facebook and Instagram. Participants will be allocated in a 1:1 ratio to experimental (1-Day CBT Workshop in addition to TAU) or control (TAU alone) groups. Both experimental and control groups will complete data collection at baseline (before completing the 1-Day CBT workshop for experimental group participants), and at 1, 2 and 3 months postpartum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel-group Ontario-wide RCT with experimental (workshop) and TAU (control) groups will address our objectives. Participants will be randomly assigned in a 1:1 ratio to the treatment or control group.
| Arm | Type | Receives |
|---|---|---|
| Online 1-Day CBT-Based Workshop | Experimental | Behavioral: Online 1-Day Cognitive Behavioural Therapy-Based WorkshopParticipants assigned to the treatment arm will attend a day long CBT-based workshop delivered online by two trained facilitators in addition to receiving usual care. |
| Treatment as Usual | No intervention | –Participants assigned to the control arm will continue to receive standard prenatal care from their healthcare providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Currently residing in Ontario, Canada
- Currently in 3rd trimester of pregnancy (28-36 weeks gestation)
- EPDS score >6
- Past history of major depressive disorder (determined using the Mini International Neuropsychiatric Interview (MINI)
Key exclusion criteria (2 listed)
- positive score on the MINI for a current major depressive episode
- positive score on the MINI subsections of bipolar, psychotic, or borderline personality disorder
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 |
|---|---|---|
| Online 1-Day Cognitive Behavioural Therapy-Based WorkshopThe Online Workshop is a day-long intervention delivered by two trained facilitators (i.e., psychotherapists, social workers, nurses, and/or a psychiatrist) consisting of 6 hours of instruction delivered in 4 modules. The 1st contains information on PPD etiology with a focus on modifiable cognitive risk factors (e.g., negative thoughts, maladaptive core beliefs). The 2nd module focuses on cognitive skills including cognitive restructuring. The 3rd builds behavioural skills such as problem solving, behavioural activation, assertiveness, sleep strategies, and using supports. The final module provides an opportunity for goal setting/action planning. Teaching methods include didactic sections, group exercises, and role-plays. Regular breaks are incorporated. Each participant is given a professionally designed manual to facilitate learning. Participants are also given a list of region-specific PPD resources and a copy of the Canadian Practice Guidelines for the treatment of PPD. | Behavioural | Online 1-Day CBT-Based Workshop |
Primary outcome
EPDS score as a continuous outcome (Total EPDS) and an EPDS score of 13 or more at 2-months postpartum (T3) will serve as co-primary outcomes.
Time frame: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
Edinburgh Postnatal Depression Scale (EPDS): the gold standard measure of PPD symptoms in clinical practice and research. The EPDS is a self-report 10-item scale scored out of 30 points that measures the severity of depressive symptoms in the past 7 days. Scores are between 0 and 30, with higher scores indicating the presence of more depressive symptoms. Scores of 13 and above indicate depressive illness, or a high risk of developing a depressive disorder. A reduction of four points in the EPDS is recognized as a clinically significant improvement.
5 secondary outcomes
Maternal Anxiety (Generalized Anxiety Disorder 7-Item Scale (GAD-7))
Time frame: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
Maternal Social Support (MSPSS)
Time frame: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
Maternal Perceived Stress (Perceived Stress Scale (PSS))
Time frame: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
Problems with the Mother-Infant Relationship (Postpartum Bonding Questionnaire (PBQ))
Time frame: 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
Infant Temperament (Infant Behaviour Questionnaire-Revised (IBQ-R))
Time frame: 3-months postpartum (T4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 40257965Boland Z, Lloyd N, Drage J, Serrano-Lomelin J, Bieling P, Streiner D, Van Lieshout RJ. One-Day Online Cognitive Behavioral Therapy-Based Workshops for the Prevention of Postpartum Depression: A Randomized Controlled Trial. J Clin Psychiatry. 2025 Apr 16;86(2):24m15674. doi: 10.4088/JCP.24m15674.
- 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. This study is not recruiting at the moment.
Ryan J Van Lieshout, MD, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online 1-Day Cognitive Behavioural Therapy-Based Workshop in people with Postpartum Depression and Postpartum Anxiety, run by McMaster University 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 5 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: finished, as of the sponsor's last update on 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EPDS score as a continuous outcome (Total EPDS) and an EPDS score of 13 or more at 2-months postpartum (T3) will serve as co-primary outcomes. (time frame: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)). 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 NCT05753176, 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 14 Aug 2026.