PsychosisMBT-PsychosisNCT07093671
Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P)
A study testing MBT + NBCI in people with Psychosis, run by Marco Armando at 1 site in Switzerland.
Trial summary
The primary objective of this study is to evaluate the efficacy of Mentalization-Based Treatment (MBT) combined with Need-Based Clinical Interventions (NBCI) compared to NBCI alone, on CHR-P diagnostic statuses and symptom expression (Hypothesis 1). Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Psychosis
- What is being tested?
- MBT + NBCI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2025to 31 Aug 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 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 14-30 years with a CHR-P condition, as defined by the SIPS criteria
- Patients who provide informed consent
Who cannot join
- Patients with a prior diagnosis of a psychotic disorder
- Intellectual disability (IQ < 70).
- Patients whose psychotic symptoms are primarily induced by substance misuse.
- Patients with significant language barriers
- Parents/legal authority who do not provide informed consent (only minors)
- Adult patient under guardianship
- Note: Comorbidities with other psychiatric disorders (e.g., Autism Spectrum Disorder, Personality Disorders) will not constitute an exclusion criterion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne, 1011
Marco Armando, Pr, +41 079 556 49 46, marco.armando@chuv.ch
Marco Armando, PR
About this study
Official title: Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P): a Randomized Controlled Trial
The primary objective of this study is to evaluate the efficacy of Mentalization-Based Treatment (MBT) combined with Need-Based Clinical Interventions (NBCI) compared to NBCI alone, on CHR-P diagnostic statuses and symptom expression (Hypothesis 1). Specifically, the investigator will assess diagnostic outcomes using a 3-level variable: transition to psychosis, CHR-P status quo, and remission out of CHR-P, as well as CHR-P symptom expression. The investigator hypothesize that: (1a) the experimental treatment (MBT + NBCI) will have a significant effect on diagnostic status (i.e. transition to psychosis) at the end of treatment and follow-up; (1b) the experimental treatment (MBT + NBCI) will significantly reduce the severity of psychotic symptoms at the end of treatment and follow-up.
Read the detailed description
Schizophrenia incidence peaks between 20 and 24 years, yet approximately one-third of cases manifest before age 18 as Early Onset Psychosis (EOP), which is associated with poorer outcomes compared to adult-onset cases, as reported in most of the literature. Psychoses are among the most severe disorders in children and adolescents (CAD), representing the second leading cause of years lost due to disability worldwide. Evidence suggests that early intervention in psychosis may improve outcomes, and there is increasing consensus among clinicians to initiate treatment as soon as sustained positive psychotic symptoms emerge. Within this early intervention framework, there is a strong hypothesis that intervening during the clinical high risk for psychosis (CHR-P) phase may mitigate, delay, or even prevent the onset of a full psychotic disorder. Reflecting these specific needs, the EPA guidelines recommend psychotherapeutic interventions as the first-line treatment for CHR-P conditions. Despite progress in early identification of psychosis risk states, advancements in psychotherapeutic interventions targeting the so-called "psychosis prodrome" remain limited. Importantly, existing interventions often fall short in addressing predictors of functional outcomes in the long term. Recent psychological, clinical, and neuroscientific studies underscore that socio-emotional difficulties are critical determinants of clinical and functional outcomes in CHR-P individuals. Furthermore, research in social cognition has highlighted that mentalization abilities, which continue to develop through adolescence and into adulthood, depend on complex cerebral connectivity to support functions such as mentalizing, perspective-taking, and moral judgment. These mentalizing processes are fundamental to adult social adaptation and have been shown to play a crucial role in maintaining good mental health. Mentalization-Based Treatment (MBT), a highly effective psychotherapeutic model for addressing socio-emotional difficulties, has been recently adapted for youth at clinical high risk for psychosis.
- Conditions
- Psychosis
- Being tested
- MBT + NBCI
- Keywords
- Psychosis, MBT, Mentalization-Based Treatment
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBT + NBCIOther
The MBT for CHR-P intervention consists of 24 weekly individual psychotherapy sessions, supplemented by monthly mentalization-based family therapy sessions. Both patient and family sessions will last 50 minutes. These psychotherapeutic sessions will complement those received though NBCI by strengthening mentalizing abilities aiming to reduce or prevent detrimental outcomes, by prohibiting or restricting some usual techniques in NBCI treatment (e.g., interpretation, cognitive challenge and Socratic dialogue) and by emphasizing certain techniques (e.g., empathic validation, active management of emotional arousal) which are only sporadically and irregularly used during NBCI treatment. Overall, the program is designed to improve patients' capacity to understand their own and others' mental states and, within interpersonal settings, how these patterns contribute to conflict and psychological distress.
| Study group | Role | What they receive |
|---|---|---|
| NBCI | No intervention | Control intervention will consist of Need-Based Clinical Intervention (NBCI). NBCI reflects routine, community-based mental health services as delivered in real-world clinical settings. NBCI are not protocol-driven or manualized. Instead, following a structured baseline assessment of risk and clinical needs, treatment recommendations are formulated in accordance with internationally recognized clinical guidelines. A referral mental health professional, not involved in this study, is expected to conduct an initial assessment of each patient's personal needs. These interventions will be tailored according to these needs which will determine the type of treatments and theirs frequencies. These interventions include a large range of treatments such as pharmacological treatment, psychotherapeutic sessions (including psychoeducation), case management, or occupational support, delivered by patient's usual therapists, who are fully qualified mental health professionals. |
| MBT + NBCI | Experimental | Description: The MBT intervention consists of 24 weekly individual psychotherapy sessions, supplemented by monthly mentalization-based family therapy sessions spread across six phases. The individual sessions are manualized into six blocks, each comprising four weekly sessions. Each block typically begins with sessions that heavily incorporate psychoeducation and progressively transitions to a thematically guided session format. Both patient and family sessions will last 50 minutes, and may be audiotaped for quality control and intern supervision. Participants, along with their families or carers, will be informed of this procedure and retain the right to decline recording. Overall, the program is designed to improve patients' capacity to understand their own and others' mental states and, within interpersonal settings, how these patterns contribute to conflict and psychological distress. Receives: Other: MBT + NBCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIPS
All primary outcomes will be assessed at baseline (T0) during routine evaluation, end of treatment (T2; 24 weeks), and at 48 weeks follow-up (T3). The primary outcome of this study is the incidence of transition to psychosis within 6 months post-intervention, as measured by the Structured Interview for Psychosis-Risk Syndromes (SIPS). The SIPS is a well-validated, interview-based tool designed to assess symptoms, functioning, and diagnostic criteria for prodromal or at-risk mental states indicative of psychosis. Transition to psychosis, as well as remission from CHR-P state, will be determined based on predefined criteria within the SIPS framework.
SIPS: Structured Interview for Prodromal Symptoms. Subscales scores (0 to 30). High score = More and/or severe psychotic symptoms
Measured: At Baseline (T0), at both end of treatment T2 : 24 weeks and at T3 : 48 weeks follow up evaluation
Secondary outcomes (7)
MentS
The sub-hypotheses associated with Hypothesis 2 will be assessed using the Mentalization Scale (MentS), which measures three subdomains of mentalizing: self-mentalizing (SM), other-mentalizing (OM), and motivation to mentalize (MM). We will examine both the MentS total score and the three subscale scores independently to test the respective sub-hypotheses.
MentS: Mentalization Scale. Total score (28 to 140). High score = Better mentalization skills
Measured: evaluated at baseline (T0), mid-treatment (T1: 12 weeks), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).
ETMCQ
The sub-hypotheses associated with Hypothesis 3 will be evaluated using the Epistemic Trust, Mistrust, and Credulity Questionnaire (ETMCQ), which includes three subdomains of epistemic trust: trust, mistrust, and credulity. We aim to test the hypotheses using each of the ETMCQ subscale scores separately.
ETMCQ: Epistemic Trust, Mistrust, and Credulity Questionnaire Subscales scores (5 to 35). "High ""Trust"" score = stronger functional stance of trust High ""Mistrust"" score = stronger maladaptive stances of mistrust High ""Credulity"" score = stronger maladaptive stances of credulity"
Measured: evaluated at baseline (T0), mid-treatment (T1: 12 weeks), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).
GAF
The sub-hypotheses associated with Hypothesis 4 will be examined using the Global Assessment of Functioning (GAF) scale. This measure is included as part of the SIPS assessment to provide a single-item measure assessing overall psychosocial impairment due to mental health factors. GAF scale score ranges 0-100. High score = better functionning.
Measured: evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).
GF-R
The sub-hypotheses associated with Hypothesis 4 will be examined using the Global Assessment of Functioning - Role (GF-R) scale. This measure is included as part of the SIPS assessment to provide a single-item measure of role functioning.
GF-R: Global Functioning - Role scale score ranges from 0 to10. High score = better functionning
Measured: evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).
GF-S
The sub-hypotheses associed with Hypothesis 4 will be examined using the Global Assessment of Functioning - Social (GF-S) scale. This measure is included as part of the SIPS assessment to provide a single-item measure of social functioning.
GF-S: Global Functioning - Social scale ranges from 0 to10. High score = better functionning
Measured: evaluated at baseline (T0), end of treatment (T2:24 weeks) and at T3 (48 weeks follow-up)
MADRS
The sub-hypotheses associated with Hypothesis 5 will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) 10 items Sum of each item (0 to 60) High score = more severe depressive symptoms
Measured: evaluated at baseline (T0), mid-treatment (T1: 12 weeks), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).
OASIS
The sub-hypotheses associated with Hypothesis 5 will be assessed using the Overall Anxiety Severity and Impairment Scale (OASIS).
5 item, Sum of each item (0 to 20) High score = more severe anxiety symptoms
Measured: evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Aug 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 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 PsychosisStudies 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
- Model description
- This is a randomized, single-blinded, superiority, two-arm, parallel group-controlled trial. Participants will be randomized in a 1:1 ratio to either control or intervention group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Armando
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marco Armando, Centre Hospitalier Universitaire Vaudois
- Investigators
- Marco Armando, PR, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093671
- Sponsor's protocol ID
- 2024-02579
- Acronym
- MBT-Psychosis
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Debbane M, Nurock M, Abed-Maillard S, Ravey F, Moser M, Decoro V, Drexl K, Conchon C, Abrahamyan Empson L, Alameda L, Fonagy P, Nelson B, Cascone P, Armando M. Mentalisation-Based Treatment (MBT) in youth at Clinical High-Risk for Psychosis (CHR-P): study protocol for a randomised controlled trial (MBT-Psychosis). BMJ Open. 2026 Aug 12;16(8):e119021. doi: 10.1136/bmjopen-2026-119021.
PubMed 42586730
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentalization Based Treatment (MBT) in Help Seeking Youths With a Clinical High-Risk Condition for Psychosis (CHR-P): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07093671
- Acronym / sponsor ID
- MBT-Psychosis / 2024-02579
- Conditions
- Psychosis
- Keywords
- Psychosis, MBT, Mentalization-Based Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Marco ArmandoUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 30 Jul 2025 (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 primary objective of this study is to evaluate the efficacy of Mentalization-Based Treatment (MBT) combined with Need-Based Clinical Interventions (NBCI) compared to NBCI alone, on CHR-P diagnostic statuses and symptom expression (Hypothesis 1). Specifically, the investigator will assess diagnostic outcomes using a 3-level variable: transition to psychosis, CHR-P status quo, and remission out of CHR-P, as well as CHR-P symptom expression. The investigator hypothesize that: (1a) the experimental treatment (MBT + NBCI) will have a significant effect on diagnostic status (i.e. transition to psychosis) at the end of treatment and follow-up; (1b) the experimental treatment (MBT + NBCI) will significantly reduce the severity of psychotic symptoms at the end of treatment and follow-up.
Detailed description
Schizophrenia incidence peaks between 20 and 24 years, yet approximately one-third of cases manifest before age 18 as Early Onset Psychosis (EOP), which is associated with poorer outcomes compared to adult-onset cases, as reported in most of the literature. Psychoses are among the most severe disorders in children and adolescents (CAD), representing the second leading cause of years lost due to disability worldwide. Evidence suggests that early intervention in psychosis may improve outcomes, and there is increasing consensus among clinicians to initiate treatment as soon as sustained positive psychotic symptoms emerge. Within this early intervention framework, there is a strong hypothesis that intervening during the clinical high risk for psychosis (CHR-P) phase may mitigate, delay, or even prevent the onset of a full psychotic disorder. Reflecting these specific needs, the EPA guidelines recommend psychotherapeutic interventions as the first-line treatment for CHR-P conditions. Despite progress in early identification of psychosis risk states, advancements in psychotherapeutic interventions targeting the so-called "psychosis prodrome" remain limited. Importantly, existing interventions often fall short in addressing predictors of functional outcomes in the long term. Recent psychological, clinical, and neuroscientific studies underscore that socio-emotional difficulties are critical determinants of clinical and functional outcomes in CHR-P individuals. Furthermore, research in social cognition has highlighted that mentalization abilities, which continue to develop through adolescence and into adulthood, depend on complex cerebral connectivity to support functions such as mentalizing, perspective-taking, and moral judgment. These mentalizing processes are fundamental to adult social adaptation and have been shown to play a crucial role in maintaining good mental health. Mentalization-Based Treatment (MBT), a highly effective psychotherapeutic model for addressing socio-emotional difficulties, has been recently adapted for youth at clinical high risk for psychosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, single-blinded, superiority, two-arm, parallel group-controlled trial. Participants will be randomized in a 1:1 ratio to either control or intervention group.
| Arm | Type | Receives |
|---|---|---|
| NBCI | No intervention | –Control intervention will consist of Need-Based Clinical Intervention (NBCI). NBCI reflects routine, community-based mental health services as delivered in real-world clinical settings. NBCI are not protocol-driven or manualized. Instead, following a structured baseline assessment of risk and clinical needs, treatment recommendations are formulated in accordance with internationally recognized clinical guidelines. A referral mental health professional, not involved in this study, is expected to conduct an initial assessment of each patient's personal needs. These interventions will be tailored according to these needs which will determine the type of treatments and theirs frequencies. These interventions include a large range of treatments such as pharmacological treatment, psychotherapeutic sessions (including psychoeducation), case management, or occupational support, delivered by patient's usual therapists, who are fully qualified mental health professionals. |
| MBT + NBCI | Experimental | Other: MBT + NBCIDescription: The MBT intervention consists of 24 weekly individual psychotherapy sessions, supplemented by monthly mentalization-based family therapy sessions spread across six phases. The individual sessions are manualized into six blocks, each comprising four weekly sessions. Each block typically begins with sessions that heavily incorporate psychoeducation and progressively transitions to a thematically guided session format. Both patient and family sessions will last 50 minutes, and may be audiotaped for quality control and intern supervision. Participants, along with their families or carers, will be informed of this procedure and retain the right to decline recording. Overall, the program is designed to improve patients' capacity to understand their own and others' mental states and, within interpersonal settings, how these patterns contribute to conflict and psychological distress. |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients aged 14-30 years with a CHR-P condition, as defined by the SIPS criteria
- Patients who provide informed consent
Key exclusion criteria (7 listed)
- Patients with a prior diagnosis of a psychotic disorder
- Intellectual disability (IQ < 70).
- Patients whose psychotic symptoms are primarily induced by substance misuse.
- Patients with significant language barriers
- Parents/legal authority who do not provide informed consent (only minors)
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 |
|---|---|---|
| MBT + NBCIThe MBT for CHR-P intervention consists of 24 weekly individual psychotherapy sessions, supplemented by monthly mentalization-based family therapy sessions. Both patient and family sessions will last 50 minutes. These psychotherapeutic sessions will complement those received though NBCI by strengthening mentalizing abilities aiming to reduce or prevent detrimental outcomes, by prohibiting or restricting some usual techniques in NBCI treatment (e.g., interpretation, cognitive challenge and Socratic dialogue) and by emphasizing certain techniques (e.g., empathic validation, active management of emotional arousal) which are only sporadically and irregularly used during NBCI treatment. Overall, the program is designed to improve patients' capacity to understand their own and others' mental states and, within interpersonal settings, how these patterns contribute to conflict and psychological distress. | Other | MBT + NBCI |
Primary outcome
SIPS
Time frame: At Baseline (T0), at both end of treatment T2 : 24 weeks and at T3 : 48 weeks follow up evaluation
All primary outcomes will be assessed at baseline (T0) during routine evaluation, end of treatment (T2; 24 weeks), and at 48 weeks follow-up (T3). The primary outcome of this study is the incidence of transition to psychosis within 6 months post-intervention, as measured by the Structured Interview for Psychosis-Risk Syndromes (SIPS). The SIPS is a well-validated, interview-based tool designed to assess symptoms, functioning, and diagnostic criteria for prodromal or at-risk mental states indicative of psychosis. Transition to psychosis, as well as remission from CHR-P state, will be determined based on predefined criteria within the SIPS framework. SIPS: Structured Interview for Prodromal Symptoms. Subscales scores (0 to 30). High score = More and/or severe psychotic symptoms
7 secondary outcomes
MentS
Time frame: evaluated at baseline (T0), mid-treatment (T1: 12 weeks), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).
ETMCQ
Time frame: evaluated at baseline (T0), mid-treatment (T1: 12 weeks), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).
GAF
Time frame: evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).
GF-R
Time frame: evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).
GF-S
Time frame: evaluated at baseline (T0), end of treatment (T2:24 weeks) and at T3 (48 weeks follow-up)
MADRS
Time frame: evaluated at baseline (T0), mid-treatment (T1: 12 weeks), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up).
OASIS
Time frame: evaluated at baseline (T0), end of treatment (T2: 24 weeks), and at the T3 (48 weeks follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 42586730Debbane M, Nurock M, Abed-Maillard S, Ravey F, Moser M, Decoro V, Drexl K, Conchon C, Abrahamyan Empson L, Alameda L, Fonagy P, Nelson B, Cascone P, Armando M. Mentalisation-Based Treatment (MBT) in youth at Clinical High-Risk for Psychosis (CHR-P): study protocol for a randomised controlled trial (MBT-Psychosis). BMJ Open. 2026 Aug 12;16(8):e119021. doi: 10.1136/bmjopen-2026-119021.
- 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.
Marco Armando, PR principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBT + NBCI in people with Psychosis, run by Marco Armando at 1 site in Switzerland.
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 2 inclusion and 7 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 8 Jul 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 Switzerland. 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 Marco Armando, Pr (+41 079 556 49 46, marco.armando@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIPS (time frame: At Baseline (T0), at both end of treatment T2 : 24 weeks and at T3 : 48 weeks follow up evaluation). 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 NCT07093671, 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 8 Jul 2026.