Mental DisorderLIGHTHOUSENCT06315114
A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders
A study testing Lighthouse MBT Parenting Program (LPP) and Care as usual (CAU) in people with Mental Disorder and Behavior Disorders, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 2 sites in Denmark.
Trial summary
The aim of this randomised clinical trial is to evaluate the short and longterm effects of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) compared to care as usal (CAU) for parents with a mental disorder in adult mental health service. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorder, Behavior Disorders, Diagnosis, Psychiatric
- What is being tested?
- Lighthouse MBT Parenting Program (LPP) and Care as usual (CAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesDenmark
- Study dates
- 11 Mar 2024to 1 Apr 2028
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Seeking treatment for one of the following non-psychotic disorders according to ICD-10: obsessive-compulsive disorder and anxiety disorders (F40-42), posttraumatic stress disorder (DF43), personality disorders (F60-61), or one of the previous disorders and a drug-or alcohol related disorder (F10-19) (i.e. 'dual diagnosis disorder')
- Parent of at least one child aged 0-17 years of age at baseline
- Fluent i.e., sufficient Danish language skills
- Parent is living with child or is in regular contact (min. 5 days monthly)
- Written informed consent
Who cannot join
- Possibility of a learning disability (IQ<75)
- A diagnosis of schizotypal personality disorder or antisocial personality disorder
- Presence of a comorbid psychiatric disorder that requires specialist treatment elsewhere
- Concurrent psychotherapeutic treatment outside the clinic
- Acute suicidal risk or state of crises
- Lack of informed consent
- Acute child endangerment
- Participation in another parenting focused intervention simultaniously
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sebastian Simonsen, Doctor contact
Denmark2 sites, 2 recruiting
- Recruiting
Psychotherapeutic Centre Stolpegaard
Gentofte Municipality, Capital Region, 2820
Emilie Hestbaek, +4528302849, emilie.hestbaek.jacobsen@regionh.dk
- Recruiting
Psychotherapeutic Centre Stolpegård
Gentofte Municipality, 2820
Emilie Hestbaek, Msc in Psyc, +4528302849, emilie.hestbaek.jacobsen@regionh.dk
Sebastian Simonsen, Doctor, sebastian.simonsen@regionh.dk
About this study
Official title: A Transdiagnostic Mentalization-based Intervention (LIGHTHOUSE Parenting Program) Versus Care as Usual for Parents With Mental Disorders in Adult Mental Health Service: a Randomised Clinical Trial
The aim of this randomised clinical trial is to evaluate the short and longterm effects of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) compared to care as usal (CAU) for parents with a mental disorder in adult mental health service.
Read the detailed description
According to the World Health Organization (WHO), 970 million people worldwide suffer from mental disorders, many of whom are parents. Cross-sectional studies indicate that between 15-55% of the patients attending adult mental health service (AMHS) are parents. In Denmark, about 430.000 children have at least one parent with a mental disorder.
Parental mental health problems have a detrimental impact on parenting, leading to long-term negative consequences for their children. Robust evidence shows that children of parents with mental disorders have an elevated risk of various adverse outcomes and events, such as developing a mental disorder themselves and exposure to child maltreatment, compared to children of healthy unaffected parents, suggesting an intergenerational transmission of adversity from parent to child. Mental disorders in parents thus leaves deep traces throughout their children's' lives and entails major socio-economic consequences. Given the high prevalence and substantial burden of parental mental disorders, there is an urgent need for evidence-based interventions targeting the specific needs of this population to prevent the adverse impact on their children. Despite this, the existing services in AMHS for parents with mental disorders are insufficient, and not evidence based. The present trial seeks to fill in this gap.
This is an investigator-initiated single-center, two-arm, parallel group randomized clinical trial testing for superiority of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) versus care as usual in 170 parents with various mental disorders. The experimental intervention and active control group intervention are delivered as an add-on to the participants' outpatient treatment.
Participants will be recruited from the outpatient clinics at Psychotherapy Centre Stolpegaard (PCS), Capital Region of Denmark. Participants will be included if they comply with the eligibility criteria. Participants will be assessed at baseline, and at 6, 12, and 24 months follow-up after randomization.
- Conditions
- Mental Disorder, Behavior Disorders, Diagnosis, Psychiatric, Diagnosis Dual, Severe Mental Disorder, Mental Illness
- Being tested
- Lighthouse MBT Parenting Program (LPP), Care as usual (CAU)
- Keywords
- Mental disorder, Parent, Child, Preventive intervention, Prevention, Intergenerational transmission
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lighthouse MBT Parenting Program (LPP)Behavioural
The experimental group is a manualized transdiagnostic mentalization-based parenting intervention (Lighthouse MBT Parenting Program). This is a 12-week parenting group intervention (weekly session of 2 hours) with one preperatory initial individual session (1 hour) before the group commence.
Care as usual (CAU)Behavioural
1-2 next of kin sessions (called 'Familiesamtale') is considered the care as usual offered to parents in adult mental health service in the Capital Region of Denmark.
Parents are offered the possibility of bringing their spouse or offspring to one of the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Lighthouse MBT Parenting Program (LPP) | Experimental | The experimental group is a manualized transdiagnostic mentalization-based parenting intervention (Lighthouse MBT Parenting Program). This is a 12-week parenting group intervention (weekly session of 2 hours) with one preperatory initial individual session (1 hour) before the group commence. Receives: Behavioral: Lighthouse MBT Parenting Program (LPP) |
| Care as usual (CAU) | Active comparator | 1-2 next of kin sessions (called 'Familiesamtale') is considered the care as usual offered to parents in adult mental health service in the Capital Region of Denmark. Receives: Behavioral: Care as usual (CAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF)
PSI-4-SF is a 36-item questionnaire assessing self-reported levels of parenting stress. The PSI-4-SF consists of three subscales: Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC). A total stress score indicates the overall level of parenting stress as experienced by the parent. Parents rate the degree to which they agree with each statement (SA: Strongly agree, A: Agree, NS: Not sure; D: Disagree, SD: Strongly Disagree). Range: 36-180 with higher scores indicating higher levels of parenting stress.
Measured: Baseline, and at 6, 12, and 24 months post randomization
Secondary outcomes (7)
Psychological adjustment in children assessed with the Strenght and Difficulties Questionnaire - Extended version (SDQ)
SDQ is a 25-item questionnaire assessing parent-reported child emotional and behavioural problems. The SDQ has five scales (scored 0-10); emotional problems, conduct problems, hyperactivity, peer problems and pro-social scale. The scales are combined (excluding the pro-social scale) into a 'total difficulties' score (Range: 0-40, with higher scores indicating more problems). The items on the overall distress and impairment can be summed to generate an impact score (Range: 0-10), indicating the need for assessment and possible intervention. Parents rate the degree to which they agree with each statement (NT: Not true, ST: Somewhat true, CT: Certainly true). Higher scores indicate more problems or more functional impairment.
Measured: Baseline, and at 6, 12, and 24 months post randomization
Quality of life in parents assessed with the World Health Organization Questionnaire of Life - BREF (WHOQL-BREF)
WHOQL-BREF is a 26-item questionnaire assessing self-reported quality of life. The instrument measures an individual's overall quality of life and general health and four health dimensions: Physical health, psychological, social relationships, and environment. The domain scores are scaled in a positive direction with higher scores indicating a higher quality of life. The two domains assessing psychological health (6 items) and social relationsships (3-items) and the measure of the overall quality of life and general health (2 items) will be used.
Measured: Baseline, and at 6, 12, and 24 months post randomization
Family functioning assessed with the McMaster Family Assessment Device - General Functioning Scale (FAD-GF).
The FAD is a questionnaire assessing self-reported perceptions of the parent's current family relationships. It consists of five subscales: problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, and general functioning. Parents rate each statement on a 4-point scale (SA: Strongly agree, A: Agree, D: Disagree, SD: Strongly Disagree). Only the general functioning (6-items) subscale will be used.Range: 6-24, with higher scores indicating more functional impairment.
Measured: Baseline, and at 6, 12, and 24 months post randomization
Childhood adversity in children assessed with the Adverse Child Experciences Questionnaire (ACE) extended version developed by the Center for Youth Wellness (CYW)
ACE CYW is questionnaire assessing parent-reported childhood adversity in children and adolescents. The instrument is comprised of two sections: Section 1 consists of the traditional ten ACEs covering exposure to childhood psychological, physical, and sexual abuse as well as household dysfunction, including domestic violence, substance use, and incarceration. Section 2 includes seven (CYW ACE-Q Child) or nine (CYW ACE-Q Teen) items assessing for exposure to additional early life stressors, including involvement in the Foster Care system, bullying, loss of parent or guardian due to death, deportation or migration, medical trauma, exposure to community violence, and discrimination. Parents are asked to how many categories apply to their child (i.e. they do not specificy which categories applies). Parents tally the number for each section, and report the total number, thus resulting in two total scores. Higher scores indicates exposure to more adverse events.
Measured: Baseline, and at 6, 12, and 24 months post randomization
Parenting competence assessed with the Parenting Sense of Competence (PSOC)
PSOC is a 16-item questionnaire assessing self-reported parenting competence It consists of 2 subscales: Parental satisfaction and parental self-efficacy. Parents rate each item on a 6-point scale.ossible scores range from 10 to 60 for Efficacy and 6 to 36 for Satisfaction. Lower scores may indicate a parent's uncertainty about whether they have the knowledge or skills required to be an effective parent.
Measured: Baseline, and at 6, 12, and 24 months post randomization
Psychiatric symptom severity in parents assessed with the Brief Symptom Inventory (BSI)
BSI is a 53-item questionnaire assessing self-reported severity of psychiatric symptoms adapted from the Symptom Checlist Revised (SCL-90-R). it covers 9 symptom dimensions: Somatization, Obsession-Compulsion, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation and Psychoticism; and three global indices of distress: Global Severity Index, Positive Symptom Distress Index, and Positive Symptom Total. The global indices measure current or past level of symptomatology, intensity of symptoms, and number of reported symptoms, respectively. Parents rate each statement on a 5-point scale ranging from 0 (not at all ) to 4 (extremely). Range: 0-212, with higher scores indicating higher symptom severity
Measured: Baseline, and at 6, 12, and 24 months post randomization
Health related quality of life and functioning in parents assessed with the European Quality of life - 5 Dimensions (EQ-5D)
EQ-5D is a 5-item questionnaire assessing health related quality of life and level of functioning. Parents select one out of three statements within each of five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Higher scores indicates better quality of life. The statements are complemented by a visual analog scale in which parents are asked to rate the health ranging form 0 (worst imaginable health) to 100 (best imaginale health)
Measured: Baseline, and at 6, 12, and 24 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start11 Mar 2024
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Sebastian Simonsen, Doctor, Study director, Mental Health Service, Capital Region, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315114
- Sponsor's protocol ID
- p-2023-15049
- Other IDs
- H-23064491
- Acronym
- LIGHTHOUSE
- Status last verified
- May 2025
- First submitted
- 5 Mar 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No plan yet
Publications
Hestbaek E, Vaever MS, Juul S, Sorensen P, Sleed M, Simonsen S. A transdiagnostic mentalization-based parenting intervention versus care as usual for parents with mental disorders in adult mental health services in Denmark: protocol for a randomized clinical trial. Trials. 2026 Mar 10;27(1):305. doi: 10.1186/s13063-026-09587-6.
PubMed 41808113
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Transdiagnostic Mentalization-based Intervention (LIGHTHOUSE Parenting Program) Versus Care as Usual for Parents With Mental Disorders in Adult Mental Health Service: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06315114
- Acronym / sponsor ID
- LIGHTHOUSE / p-2023-15049
- Conditions
- Mental Disorder, Behavior Disorders, Diagnosis, Psychiatric, Diagnosis Dual, Severe Mental Disorder, Mental Illness
- Keywords
- Mental disorder, Parent, Child, Preventive intervention, Prevention, Intergenerational transmission
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 18 Mar 2024 (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 aim of this randomised clinical trial is to evaluate the short and longterm effects of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) compared to care as usal (CAU) for parents with a mental disorder in adult mental health service.
Detailed description
According to the World Health Organization (WHO), 970 million people worldwide suffer from mental disorders, many of whom are parents. Cross-sectional studies indicate that between 15-55% of the patients attending adult mental health service (AMHS) are parents. In Denmark, about 430.000 children have at least one parent with a mental disorder.
Parental mental health problems have a detrimental impact on parenting, leading to long-term negative consequences for their children. Robust evidence shows that children of parents with mental disorders have an elevated risk of various adverse outcomes and events, such as developing a mental disorder themselves and exposure to child maltreatment, compared to children of healthy unaffected parents, suggesting an intergenerational transmission of adversity from parent to child. Mental disorders in parents thus leaves deep traces throughout their children's' lives and entails major socio-economic consequences. Given the high prevalence and substantial burden of parental mental disorders, there is an urgent need for evidence-based interventions targeting the specific needs of this population to prevent the adverse impact on their children. Despite this, the existing services in AMHS for parents with mental disorders are insufficient, and not evidence based. The present trial seeks to fill in this gap.
This is an investigator-initiated single-center, two-arm, parallel group randomized clinical trial testing for superiority of a transdiagnostic mentalization-based intervention (Lighthouse MBT Parenting Program) versus care as usual in 170 parents with various mental disorders. The experimental intervention and active control group intervention are delivered as an add-on to the participants' outpatient treatment.
Participants will be recruited from the outpatient clinics at Psychotherapy Centre Stolpegaard (PCS), Capital Region of Denmark. Participants will be included if they comply with the eligibility criteria. Participants will be assessed at baseline, and at 6, 12, and 24 months follow-up after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lighthouse MBT Parenting Program (LPP) | Experimental | Behavioral: Lighthouse MBT Parenting Program (LPP)The experimental group is a manualized transdiagnostic mentalization-based parenting intervention (Lighthouse MBT Parenting Program). This is a 12-week parenting group intervention (weekly session of 2 hours) with one preperatory initial individual session (1 hour) before the group commence. |
| Care as usual (CAU) | Active comparator | Behavioral: Care as usual (CAU)1-2 next of kin sessions (called 'Familiesamtale') is considered the care as usual offered to parents in adult mental health service in the Capital Region of Denmark. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years
- Seeking treatment for one of the following non-psychotic disorders according to ICD-10: obsessive-compulsive disorder and anxiety disorders (F40-42), posttraumatic stress disorder (DF43), personality disorders (F60-61), or one of the previous disorders and a drug-or alcohol related disorder (F10-19) (i.e. 'dual diagnosis disorder')
- Parent of at least one child aged 0-17 years of age at baseline
- Fluent i.e., sufficient Danish language skills
- Parent is living with child or is in regular contact (min. 5 days monthly)
Key exclusion criteria (8 listed)
- Possibility of a learning disability (IQ<75)
- A diagnosis of schizotypal personality disorder or antisocial personality disorder
- Presence of a comorbid psychiatric disorder that requires specialist treatment elsewhere
- Concurrent psychotherapeutic treatment outside the clinic
- Acute suicidal risk or state of crises
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 |
|---|---|---|
| Lighthouse MBT Parenting Program (LPP)The experimental group is a manualized transdiagnostic mentalization-based parenting intervention (Lighthouse MBT Parenting Program). This is a 12-week parenting group intervention (weekly session of 2 hours) with one preperatory initial individual session (1 hour) before the group commence. | Behavioural | Lighthouse MBT Parenting Program (LPP) |
| Care as usual (CAU)1-2 next of kin sessions (called 'Familiesamtale') is considered the care as usual offered to parents in adult mental health service in the Capital Region of Denmark. Parents are offered the possibility of bringing their spouse or offspring to one of the sessions. | Behavioural | Care as usual (CAU) |
Primary outcome
Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF)
Time frame: Baseline, and at 6, 12, and 24 months post randomization
PSI-4-SF is a 36-item questionnaire assessing self-reported levels of parenting stress. The PSI-4-SF consists of three subscales: Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC). A total stress score indicates the overall level of parenting stress as experienced by the parent. Parents rate the degree to which they agree with each statement (SA: Strongly agree, A: Agree, NS: Not sure; D: Disagree, SD: Strongly Disagree). Range: 36-180 with higher scores indicating higher levels of parenting stress.
7 secondary outcomes
Psychological adjustment in children assessed with the Strenght and Difficulties Questionnaire - Extended version (SDQ)
Time frame: Baseline, and at 6, 12, and 24 months post randomization
Quality of life in parents assessed with the World Health Organization Questionnaire of Life - BREF (WHOQL-BREF)
Time frame: Baseline, and at 6, 12, and 24 months post randomization
Family functioning assessed with the McMaster Family Assessment Device - General Functioning Scale (FAD-GF).
Time frame: Baseline, and at 6, 12, and 24 months post randomization
Childhood adversity in children assessed with the Adverse Child Experciences Questionnaire (ACE) extended version developed by the Center for Youth Wellness (CYW)
Time frame: Baseline, and at 6, 12, and 24 months post randomization
Parenting competence assessed with the Parenting Sense of Competence (PSOC)
Time frame: Baseline, and at 6, 12, and 24 months post randomization
Psychiatric symptom severity in parents assessed with the Brief Symptom Inventory (BSI)
Time frame: Baseline, and at 6, 12, and 24 months post randomization
Health related quality of life and functioning in parents assessed with the European Quality of life - 5 Dimensions (EQ-5D)
Time frame: Baseline, and at 6, 12, and 24 months post randomization
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 14 May 2025.
- Derived from this study: PubMed 41808113Hestbaek E, Vaever MS, Juul S, Sorensen P, Sleed M, Simonsen S. A transdiagnostic mentalization-based parenting intervention versus care as usual for parents with mental disorders in adult mental health services in Denmark: protocol for a randomized clinical trial. Trials. 2026 Mar 10;27(1):305. doi: 10.1186/s13063-026-09587-6.
- Description of trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. No plan yet
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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.
Sebastian Simonsen, Doctor contact
Sebastian Simonsen, Doctor study director
Mental Health Service, Capital Region, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lighthouse MBT Parenting Program (LPP) and Care as usual (CAU) in people with Mental Disorder and Behavior Disorders, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 2 sites in Denmark.
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 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 Emilie Hestbaek, Msc in Psyc. (+4528302849, emilie.hestbaek.jacobsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting stress assessed with Parenting Stress Index - Short Form (PSI-4-SF) (time frame: Baseline, and at 6, 12, and 24 months post randomization). 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 NCT06315114, 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 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.