Depression, PostpartumNCT05110456
To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk
A study testing Telephone support in people with Depression, Postpartum, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Women's perinatal mental health problems can create a cascade of short- and long-term negative influences for the mother, child, and the family as a whole. To prevent these impacts, preventive online and telephone interventions exist, but need to be tested and improved to develop this type of support to women in… Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- Telephone support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteCanada
- Study dates
- 9 Nov 2021to 30 Sep 2024
- 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 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women (12-25 weeks' gestation)
- subclinical and clinical levels of depression (Edinburgh Postnatal Depression Scale (EPDS) scores 8-16)
- ability to read and understand French.
Who cannot join
- EPDS score in the clinical range (≥ 17) or no symptoms (EPDS < 8)
- Positive screening of psychotic symptoms using the Psychosis Screening Questionnaire (PSQ)
- self-reported substance abuse problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Starting Before Birth to Prevent Maternal Mental Health Problems: "Parents and Babies" Program (Programme "Toi, Moi, Bébé")
Women's perinatal mental health problems can create a cascade of short- and long-term negative influences for the mother, child, and the family as a whole. To prevent these impacts, preventive online and telephone interventions exist, but need to be tested and improved to develop this type of support to women in Quebec. The Parents \& Babies program, which is a distance learning course, followed during pregnancy and accompanied by telephone follow-up, aims to improve the mental health of future parents.The investigators seek to evaluate the effect of the intervention of the Parents \& Babies program offered with telephone support compared to the course offered without telephone follow-up.
Read the detailed description
The Parents \& Babies intervention to be evaluated is an adaptation of the existing, evidence-based Mothers \& Babies program which has shown efficacy in four clinical trials for the prevention of postpartum depression through in-person (group or individual) counseling
The Parents \& Babies program was adapted to be virtual and include: 1) specific modules for the mother-partner dyad; 2) third-wave cognitive behavioral therapy (CBT) strategies targeting well-being, relaxation, mindfulness, self-compassion, and gratitude; 3) confinement and social distancing related material. Participants follow the program online or with a paper workbook and are called weekly by a member of the intervention team.
Participants will fill out three questionnaires (online or by telephone) at 12-25 weeks' gestation, 3 months' postpartum and 6-months postpartum to assess baseline values and trial outcomes, respectively.
- Conditions
- Depression, Postpartum
- Being tested
- Telephone support
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone supportBehavioural
Participants will receive 10 telephone counseling calls by trained coaches: 9 during pregnancy (one call/week) and 1 at 6 weeks postpartum. We have included individual telephone calls by a trained coaches aimed to :
- encourage the use of online material;
- identify strategies for overcoming obstacles;
- help apply content to real-life settings; and
- underscore the participants' success in using effective coping strategies
| Study group | Role | What they receive |
|---|---|---|
| Access to an online cognitive behavioural intervention without telephone support | No intervention | The control group will receive a fully automated version of the virtual intervention without telephone support |
| Cognitive-Behavioral Therapy (CBT) and interpersonal counseling with telephone support. | Experimental | The experimental group will receive an online cognitive behavioural intervention with weekly telephone support Receives: Behavioral: Telephone support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at 3 month postpartum depressive symptoms: The Edinburgh Perinatal/Postnatal Depression Scale (EPDS)
The Edinburgh Perinatal/Postnatal Depression Scale (EPDS) assesses a score between 0 and 30. A score less than 8 means depression is unlikely. A score from 9 to 11 means depression is possible. A score from 12 to 13 means high possibility of depression. A score of 14 and higher means probable depression.
Measured: baseline (between gestational weeks 12-25) , 3 months postpartum
Secondary outcomes (17)
Depressive symptoms: The Edinburgh Postnatal Depression Scale (EPDS)
The Edinburgh Perinatal/Postnatal Depression Scale (EPDS) assesses a score between 0 and 30. A score less than 8 means depression is unlikely. A score from 9 to 11 means depression is possible. A score from 12 to 13 means high possibility of depression. A score of 14 and higher means probable depression.
Measured: 6 months postpartum
Change from baseline in Generalized Anxiety Disorder questionnaire (GAD-7) score
Brief questionnaire about problems felt during the last 2 weeks, derived from the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptom criteria for GAD for a total score ranging from 0-21. Minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21) severity ranges have been identified, with a clinical cutoff score of 8 indicating probable diagnosis of GAD
Measured: baseline (between gestational weeks 12-25) , 3 and 6 months postpartum
Anxiety related to pregnancy: Pregnancy-specific anxiety scale (PRAQ-R2)
The 10-item Pregnancy-specific anxiety scale revisited-2 (PRAQ-R2) by Van den Bergh to assess and identify pregnancy-specific anxiety in nulliparous women. Scores on each item are ranged from 1 (definitely not true) to 5 (definitely true). The items are divided into three subscales. The 1st subscale - Fear of giving birth, consists of three items. The 2nd subscale - Worries about bearing a physically or mentally handicapped child, consists of 4 items. The 3rd subscale -Concern about own appearance, consists of 3 items.
Measured: baseline (between gestational weeks 12-25)
Stress: Perceived Stress Scale (PSS)
The Perceived Stress Scale is a 14-items questionnaire to measure the degree to which respondents find their lives unpredictable, uncontrollable and overloading. Individual scores on the PSS can range from 0 to 40, with higher scores indicating higher perceived stress.
Measured: 6 months postpartum
Well-being: WHO-5 (World Health Organization) index
The 5-item WHO-5 well-being index is used to assess subjective psychological well-being.
Measured: 3 months postpartum
Self-efficacy: General Self-Efficacy scale (GSE)
The 10-items General Self-Efficacy scale was created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events.The minimum score is ten points and the maximum score is forty points for this scale.
Measured: 3 months postpartum
Self-compassion: Self-Compassion Scale (SCS)
We used the corresponding items from the short SCS in the 26-item French questionnaire, to use a 10-item French questionnaire. For each item (e.g.; I'm kind to myself when I'm experiencing suffering), respondents are asked to indicate how often they behave in the stated manner. Each statement is rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always).
Measured: 3 months postpartum
Sleep: Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI), a 19-items self-report questionnaire measuring sleep quality over a one-month interval.
Measured: 3 months postpartum
Social Adjustment: Social Adjustment Scale - Self-report (SAS-SR)
The Screener version of the Social Adjustment Scale (SAS-SR) is a self-reported 14-item questionnaire derived from the Social Adjustment Scale interview. The questions measure expressive and instrumental performance over the past 2 weeks in six roles areas: work (paid or unpaid), social and leisure activities, relationships with extended family, role as marital partner, role as parent, and role within the family unit. Each area covers four expressive and instrumental categories: performance at expected tasks; the amount of friction with people; finer aspects of interpersonal relations; and feelings and satisfactions. Questions are rated on a five-point scale from which role area means and an overall mean can be obtained, with higher scores meaning greater impairment. The investigators used only the work subscale for this study
Measured: 3 months postpartum
Marital satisfaction: Short Form of the Dyadic Adjustment Scale (DAS-7)
The 7-item Dyadic Adjustment Scale (DAS-7) is a shortened version of the original 32-item scale was created to assess multidimensional subjective satisfaction of marriage or similar dyads (93). In the shortened version, six items are rated on a six-point Likert-type scales (from "always agree" to "always disagree" or "all the time" to "never") and the seventh is rated on a seven-point scale (from "extremely unhappy" to "perfectly happy"). A 16-item version of the scale was translated in French and validated. We extracted the 7 items corresponding to DAS-7 from the 16-item French questionnaire.
Measured: 3 months postpartum
Co-parenting: Co-parenting Relationship Scale (CRS)
The Co-parenting Relationship Scale multi-domain measure of the co-parenting relationship in dual parent families. The self-reported questionnaire contains 35 items and 7 subscales: Co-parenting Agreement, Co-parenting Closeness, Exposure, Conflict, Co-parenting Support, Co-parenting Undermining, Endorse Partner Parenting, and Division of Labor. Answers have a 7-point response scale ranging from "not true of us" to "very true of us"
Measured: 3 months postpartum
Social support: Social Provisions
The initial 10-items Social Provisions Scale (SPS) was developed based on Weiss's model of social provisions. The model focus on five social need that can be fulfilled through relationships: guidance, reliable alliance, reassurance of worth, attachment and social integration. Each of the 5 subscales are represented by 2 positively worded statements and rated on a 4-point Likert scale from "1=strongly disagree" to "4=strongly agree"
Measured: 6 months postpartum
Parenting practices: Parenting Cognitions and Behaviors Scale
The Parenting Cognitions and Behaviors Scale assesses parents' cognitions and behavioral tendencies that reflect the quality of their parental involvement with the infant. The scale has 32 items, measured on a Likert scale with scores ranging from 0 ("Not at all") to 10 ("Exactly"). The instrument has 6 dimensions: sense of parental efficacy, perceived impact of parenting, tendency to coerce, tendency to overprotect, parental affection, and parent's perception of the child's general qualities.
Measured: 6 months postpartum
Change from 3 months post-partum at 6 month post partum child social, emotional and cognitive development: Ages and stages questionnaire 3rd edition (ASQ-3)
The Ages and Stages Questionnaire is a parent-reported scale designed to screen for developmental delays in children. The scale comprises 21 age-specific questionnaires, covering 1 through 66 months of age, each with six items in each of five developmental domains: communication, problem-solving, personal-social, gross motor, and fine motor skills. Answers to each item are "yes," "sometimes," or "not yet", corresponding to scores of 10,5 and 0.
Measured: 3 and 6 months postpartum
Child's temperament: Difficult Temperament Scale
The 7 items of the difficult temperament scale are taken from the Infant Characteristics Questionnaire (ICQ) of Bates, Freeland and Lounsbury, which is designed to measure the degree of difficulty a child presents to his or her parents. Parents are asked to indicate on a scale of 1 (easy) to 7 (difficult) how they perceive their baby's behavior when compared with that of an "average" or "typical" baby.
Measured: 6 months postpartum
Personality disorders symptoms: Personality Inventory for DSM-5 Brief Form (PID-5 BF)
The brief form of the Personality Inventory for DSM-5 is a 25-item self-report questionnaire that measures the severity of the DSM-5-proposed personality pathology constructs of negative affectivity, detachment, antagonism, disinhibition, and psychoticism.
Measured: baseline (between gestational weeks 12-25)
Gender roles: Bem Sex Role Inventory (BSRI)
The BEM Sex Role Inventory (BSRI) is a 30-items self-reported scale designed to evaluate gender. The items in the masculine subscale measure socially desirable masculine characteristics, with the central characteristic being "cognitive focus on getting the job done". The items in the feminine subscale are intended to measure socially desirable feminine characteristics, with the central characteristic being "affective concern for the welfare of others
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start9 Nov 2021
- Primary completion30 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depression, PostpartumStudies 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
- Masking
- None (open label)
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hewitt Foundation
- Responsible party
- Principal investigator, Sylvana M Côté, St. Justine's Hospital
- Investigators
- Sylvana Côté, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110456
- Sponsor's protocol ID
- 2021-3210
- Status last verified
- Feb 2026
- First submitted
- 13 Oct 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Restrictions apply to the availability of these data. All data used in the current study will be shared upon reasonable request to the corresponding author, with permission of the Research Group on Psychosocial Inadaptation in Children (GRIP), and pending ethics approval. Individual denominated data will be made available (including data dictionaries). The study protocol with statistical analysis plan is available online (trial registry). The data will be available after publication, for up to one (1) year starting from the date of data sharing to the querent. Researchers can submit a request to access the data for either exploratory or planned analyses with the intention to publish (https://grip-info.ca/acces-aux-donnees/).
Publications
Dessy T, Montreuil TC, St-Andre M, Herba CM, MacKinnon AL, Clement M, Boucoiran I, Dinello-Goupil C, Beland J, Samson V, Tchouangue-Dinkou GD, Berard A, Morin L, Amirali L, Dennis CL, Masse B, Cote SM. Effectiveness of a web-based preventive postpartum depression programme in pregnancy, with/without telephone support: a randomised control trial. BMJ Open. 2026 Mar 11;16(3):e100835. doi: 10.1136/bmjopen-2025-100835.
PubMed 41813052Montreuil T, Skinner J, Humez L, Gratton C, Herba CM, Cote SM. From mother to child: a protocol paper on the longitudinal effects of a perinatal intervention on maternal self-efficacy and emotion regulation and child outcomes. BMJ Open. 2026 Mar 3;16(3):e110580. doi: 10.1136/bmjopen-2025-110580.
PubMed 41775471
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starting Before Birth to Prevent Maternal Mental Health Problems: "Parents and Babies" Program (Programme "Toi, Moi, Bébé")
- ClinicalTrials.gov ID
- NCT05110456
- Acronym / sponsor ID
- 2021-3210
- Conditions
- Depression, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Hewitt Foundation
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 8 Nov 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.
Women's perinatal mental health problems can create a cascade of short- and long-term negative influences for the mother, child, and the family as a whole. To prevent these impacts, preventive online and telephone interventions exist, but need to be tested and improved to develop this type of support to women in Quebec. The Parents \& Babies program, which is a distance learning course, followed during pregnancy and accompanied by telephone follow-up, aims to improve the mental health of future parents.The investigators seek to evaluate the effect of the intervention of the Parents \& Babies program offered with telephone support compared to the course offered without telephone follow-up.
Detailed description
The Parents \& Babies intervention to be evaluated is an adaptation of the existing, evidence-based Mothers \& Babies program which has shown efficacy in four clinical trials for the prevention of postpartum depression through in-person (group or individual) counseling
The Parents \& Babies program was adapted to be virtual and include: 1) specific modules for the mother-partner dyad; 2) third-wave cognitive behavioral therapy (CBT) strategies targeting well-being, relaxation, mindfulness, self-compassion, and gratitude; 3) confinement and social distancing related material. Participants follow the program online or with a paper workbook and are called weekly by a member of the intervention team.
Participants will fill out three questionnaires (online or by telephone) at 12-25 weeks' gestation, 3 months' postpartum and 6-months postpartum to assess baseline values and trial outcomes, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access to an online cognitive behavioural intervention without telephone support | No intervention | –The control group will receive a fully automated version of the virtual intervention without telephone support |
| Cognitive-Behavioral Therapy (CBT) and interpersonal counseling with telephone support. | Experimental | Behavioral: Telephone supportThe experimental group will receive an online cognitive behavioural intervention with weekly telephone support |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women (12-25 weeks' gestation)
- subclinical and clinical levels of depression (Edinburgh Postnatal Depression Scale (EPDS) scores 8-16)
- ability to read and understand French.
Key exclusion criteria (3 listed)
- EPDS score in the clinical range (≥ 17) or no symptoms (EPDS < 8)
- Positive screening of psychotic symptoms using the Psychosis Screening Questionnaire (PSQ)
- self-reported substance abuse problems.
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 |
|---|---|---|
| Telephone supportParticipants will receive 10 telephone counseling calls by trained coaches: 9 during pregnancy (one call/week) and 1 at 6 weeks postpartum. We have included individual telephone calls by a trained coaches aimed to : 1. encourage the use of online material; 2. identify strategies for overcoming obstacles; 3. help apply content to real-life settings; and 4. underscore the participants' success in using effective coping strategies | Behavioural | Cognitive-Behavioral Therapy (CBT) and interpersonal counseling with telephone support. |
Primary outcome
Change from baseline at 3 month postpartum depressive symptoms: The Edinburgh Perinatal/Postnatal Depression Scale (EPDS)
Time frame: baseline (between gestational weeks 12-25) , 3 months postpartum
The Edinburgh Perinatal/Postnatal Depression Scale (EPDS) assesses a score between 0 and 30. A score less than 8 means depression is unlikely. A score from 9 to 11 means depression is possible. A score from 12 to 13 means high possibility of depression. A score of 14 and higher means probable depression.
17 secondary outcomes
Depressive symptoms: The Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 6 months postpartum
Change from baseline in Generalized Anxiety Disorder questionnaire (GAD-7) score
Time frame: baseline (between gestational weeks 12-25) , 3 and 6 months postpartum
Anxiety related to pregnancy: Pregnancy-specific anxiety scale (PRAQ-R2)
Time frame: baseline (between gestational weeks 12-25)
Stress: Perceived Stress Scale (PSS)
Time frame: 6 months postpartum
Well-being: WHO-5 (World Health Organization) index
Time frame: 3 months postpartum
Self-efficacy: General Self-Efficacy scale (GSE)
Time frame: 3 months postpartum
Self-compassion: Self-Compassion Scale (SCS)
Time frame: 3 months postpartum
Sleep: Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 months postpartum
Social Adjustment: Social Adjustment Scale - Self-report (SAS-SR)
Time frame: 3 months postpartum
Marital satisfaction: Short Form of the Dyadic Adjustment Scale (DAS-7)
Time frame: 3 months postpartum
Co-parenting: Co-parenting Relationship Scale (CRS)
Time frame: 3 months postpartum
Social support: Social Provisions
Time frame: 6 months postpartum
Parenting practices: Parenting Cognitions and Behaviors Scale
Time frame: 6 months postpartum
Change from 3 months post-partum at 6 month post partum child social, emotional and cognitive development: Ages and stages questionnaire 3rd edition (ASQ-3)
Time frame: 3 and 6 months postpartum
Child's temperament: Difficult Temperament Scale
Time frame: 6 months postpartum
Personality disorders symptoms: Personality Inventory for DSM-5 Brief Form (PID-5 BF)
Time frame: baseline (between gestational weeks 12-25)
Gender roles: Bem Sex Role Inventory (BSRI)
Time frame: 6 months postpartum
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 17 Feb 2026.
- Derived from this study: PubMed 41813052Dessy T, Montreuil TC, St-Andre M, Herba CM, MacKinnon AL, Clement M, Boucoiran I, Dinello-Goupil C, Beland J, Samson V, Tchouangue-Dinkou GD, Berard A, Morin L, Amirali L, Dennis CL, Masse B, Cote SM. Effectiveness of a web-based preventive postpartum depression programme in pregnancy, with/without telephone support: a randomised control trial. BMJ Open. 2026 Mar 11;16(3):e100835. doi: 10.1136/bmjopen-2025-100835.
- Derived from this study: PubMed 41775471Montreuil T, Skinner J, Humez L, Gratton C, Herba CM, Cote SM. From mother to child: a protocol paper on the longitudinal effects of a perinatal intervention on maternal self-efficacy and emotion regulation and child outcomes. BMJ Open. 2026 Mar 3;16(3):e110580. doi: 10.1136/bmjopen-2025-110580.
- Individual participant dataSharing planned: Yes. Restrictions apply to the availability of these data. All data used in the current study will be shared upon reasonable request to the corresponding author, with permission of the Research Group on Psychosocial Inadaptation in Children (GRIP), and pending ethics approval. Individual denominated data will be made available (including data dictionaries). The study protocol with statistical analysis plan is available online (trial registry). The data will be available after publication, for up to one (1) year starting from the date of data sharing to the querent. Researchers can submit a request to access the data for either exploratory or planned analyses with the intention to publish (https://grip-info.ca/acces-aux-donnees/).
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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.
Sylvana Côté principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone support in people with Depression, Postpartum, run by St. Justine's Hospital 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 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 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?
Change from baseline at 3 month postpartum depressive symptoms: The Edinburgh Perinatal/Postnatal Depression Scale (EPDS) (time frame: baseline (between gestational weeks 12-25) , 3 months postpartum). 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 NCT05110456, which also lists 2 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 Feb 2026.