Cluster B Personality Disorder (Diagnosis)NCT05014217
Comparing Mentalization-based Treatment And A Dialectical Behavior Therapy-inspired Treatment On The Utilization Of Services And The Dropout Rate In A Clinical Adult Population With A Cluster B Personality Disorder
An observational study of Cluster B Personality Disorder (Diagnosis) and Borderline Personality Disorder, run by Ciusss de L'Est de l'Île de Montréal.
Trial summary
Cluster B personality disorders (borderline, narcissistic, antisocial and/or histrionic) are an important clinical consideration because of their high prevalence and associated morbidity. Although many studies examine borderline personality disorder, few of them explore cluster B personality disorders as a whole. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cluster B Personality Disorder (Diagnosis), Borderline Personality Disorder
- What is being tested?
- Mentalization-based Treatment and Dialectical Behavior Therapy-inspired Treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 4 Aug 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with at least one cluster B personality disorder and admitted to the Service of personality and relational disorders at the Institut universitaire de Santé Mentale de Montréal after being referred to the program and oriented to mentalization-based treatment or dialectical behavior therapy. Patients with comorbid personality disorders are also included to better represent clinical practice.
Who may be able to join
- Meet the general criteria for a personality disorder
- Be diagnosed with at least one cluster B personality disorder
- Be admitted to the Service of personality and relational disorders and referred to mentalization-based treatment or a treatment inspired from dialectical behavior therapy
Who cannot join
- None
About this study
Official title: Comparaison d'Une thérapie basée Sur la Mentalisation et d'un Traitement inspiré de la thérapie Comportementale Dialectique Sur l'Utilisation Des Services et Sur le Taux d'Abandon Dans Une Population Clinique Adulte Atteinte d'un Trouble de la personnalité du Groupe B
Cluster B personality disorders (borderline, narcissistic, antisocial and/or histrionic) are an important clinical consideration because of their high prevalence and associated morbidity. Although many studies examine borderline personality disorder, few of them explore cluster B personality disorders as a whole. In clinical practice, personality disorders are frequently comorbid. Patients who receive services in specialized clinics for these disorders often have a complex diagnosis that include many cluster B personality disorders. Therefore, our study globally examines patients with cluster B personality disorders even though borderline personality disorder is empirically the most studied psychopathology. Previous data suggests that borderline personality disorder has a prevalence of 2% in the general population, of 25% in the clinical psychiatric population and of 15% in all visits to the emergency room. Furthermore, it is associated with social costs estimated from 15,000$ to 50,000$ USD per patient per year. In Quebec, this psychopathology is associated with an increased mortality rate compared to the general population, totaling a loss of nine years for women and 13 years for men of life expectancy. Other studies suggest that borderline personality disorder is often comorbid with other personality disorders, including those in cluster B. The population with comorbid personality disorders have a worse prognosis and a lower chance of reaching symptomatic remission, which is the reason why it is crucial to better understand and study patients with cluster B personality disorders.
The study compares the effectiveness of two psychotherapies for borderline personality disorder, mentalization-based therapy and a modified version of Linehan's dialectical behavior therapy, in a retrospective naturalistic study of patients with at least one cluster B personality disorder who have undergone either treatment. The scarcity of data on cluster B personality disorders and on the comparison between MBT and DBT further highlights the necessity of a naturalistic study like ours to examine both aspects and bring research closer to the clinical setting. Based on clinical observations, the investigators believe that there will be no statistically significant difference between either treatment.
- Being tested
- Mentalization-based Treatment, Dialectical Behavior Therapy-inspired Treatment
- Keywords
- cluster B personality disorder, mentalization-based treatment, dialectical behavior therapy, borderline personality disorder, service utilization, dropout rate, naturalistic study
- Medical subject headings
- Disease, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalization-based TreatmentBehavioural
An empirically-validated intervention for personality disorders based on the attachment theory and on knowledge from developmental psychology and cognitive neuroscience (Bateman and Fonagy, 2004). Patients assist psychoeducative group meetings beforehand, along with a pretreatment of four to six individual meetings (over four to eight weeks), followed by bi-weekly individual follow-ups and weekly group follow-ups. The treatment lasts two years. Patients have an assessment meeting with their individual therapist and one of the group therapists at the end of each session. Psychiatric follow-up appointments are on an as-needed basis and every patient has a treatment contract with specific and measurable treatment objectives.
Dialectical Behavior Therapy-inspired TreatmentBehavioural
A psychotherapy developed by M. Linehan for patients with borderline personality disorder that combines cognitive behavioral therapy techniques (emotional regulation, practical exercises) with Buddhist meditation principles (stress tolerance, acceptance, open-mindedness) (Linehan, M. M. \& Dimeff, L., 2001). As opposed to Linehan's model, individual meetings are bi-weekly, no emergency phone service is offered, the mindful meditation module is reorganized into life habits modules, and every module includes mindfulness exercises. Patients assist psychoeducative group meetings beforehand, along with a pre-treatment of 4-6 individual meetings (over 4-8 weeks), followed by bi-weekly individual follow-ups and weekly group follow-ups. The treatment lasts one year, but can be extended to two years for eligible patients who are interested. Psychiatric follow-up appointments are on an as-needed basis. Every every patient has a treatment contract with specific and measurable treatment objectives.
| Study group | Role | What they receive |
|---|---|---|
| Mentalization-based Treatment | Participants who have been oriented to the mentalization-based treatment among the clinical adult population with a cluster B personality disorder. Receives: Behavioral: Mentalization-based Treatment | |
| Dialectical Behavior Therapy-inspired Treatment | Participants who have been oriented to the dialectical behavior therapy-inspired treatment among the clinical adult population with a cluster B personality disorder. Receives: Behavioral: Dialectical Behavior Therapy-inspired Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Visits To The Emergency Room
A comparison of the difference between a patient's number of visits to the emergency room in the year prior to and the year following the index date for each treatment.
Measured: One year before the index date (first group therapy meeting) to one year after the index date.
Number of Hospitalizations
A comparison of the difference between a patient's number of hospitalizations in the year prior to and the year following the index date for each treatment.
Measured: One year before the index date (first group therapy meeting) to one year after the index date.
Secondary outcomes (1)
Dropout rate
The comparison of the dropout rate between mentalization-based treatment and dialectical behavior therapy.
Measured: From the beginning until the end of the psychotherapy treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Jan 2015
- Primary completion31 Dec 2019
- Study completion4 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Cluster B Personality Disorder (Diagnosis)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Poirier, MD, Principal investigator, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014217
- Sponsor's protocol ID
- STRP1 2020-2193
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients have not consented to have their data be available to researchers outside the institution.
Publications
Ansell EB, Sanislow CA, McGlashan TH, Grilo CM. Psychosocial impairment and treatment utilization by patients with borderline personality disorder, other personality disorders, mood and anxiety disorders, and a healthy comparison group. Compr Psychiatry. 2007 Jul-Aug;48(4):329-36. doi: 10.1016/j.comppsych.2007.02.001. Epub 2007 Apr 6.
PubMed 17560953Barnicot K, Crawford M. Dialectical behaviour therapy v. mentalisation-based therapy for borderline personality disorder. Psychol Med. 2019 Sep;49(12):2060-2068. doi: 10.1017/S0033291718002878. Epub 2018 Oct 10.
PubMed 30303061Bateman, A. & Fonagy, P. (2004). Psychotherapy of Borderline Personality Disorder:mentalisation-based treatment. Oxford, UK: Oxford University Press.
Bender DS, Dolan RT, Skodol AE, Sanislow CA, Dyck IR, McGlashan TH, Shea MT, Zanarini MC, Oldham JM, Gunderson JG. Treatment utilization by patients with personality disorders. Am J Psychiatry. 2001 Feb;158(2):295-302. doi: 10.1176/appi.ajp.158.2.295.
PubMed 11156814Cailhol, L., et al. (2015). Surveillance des troubles de la personnalité au Québec : prévalence, mortalité et profil d'utilisation des services, INSPQ (Institut National de santé publique du Québec).
Cristea IA, Gentili C, Cotet CD, Palomba D, Barbui C, Cuijpers P. Efficacy of Psychotherapies for Borderline Personality Disorder: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2017 Apr 1;74(4):319-328. doi: 10.1001/jamapsychiatry.2016.4287.
PubMed 28249086Duggan, C., Huband, N., Smailagic, N., Ferriter, M., & Adams, C. (2007). The use of psychological treatments for people with personality disorder: A systematic review of randomized controlled trials. Personality and Mental Health, 1, 95-125.
Linehan, M. M. & Dimeff, L. (2001). Dialectical Behavior Therapy in a nutshell [archive], The California Psychologist, 34, 10-13.
Linehan MM, Comtois KA, Murray AM, Brown MZ, Gallop RJ, Heard HL, Korslund KE, Tutek DA, Reynolds SK, Lindenboim N. Two-year randomized controlled trial and follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and borderline personality disorder. Arch Gen Psychiatry. 2006 Jul;63(7):757-66. doi: 10.1001/archpsyc.63.7.757.
PubMed 16818865Links PS, Heslegrave R, van Reekum R. Prospective follow-up study of borderline personality disorder: prognosis, prediction of outcome, and Axis II comorbidity. Can J Psychiatry. 1998 Apr;43(3):265-70. doi: 10.1177/070674379804300305.
PubMed 9561315Luyten P, Leichsenring F, Abbass A, Hilsenroth M, Rabung S, Steinert C. What to conclude from a non-randomized clinical trial comparing dialectical behavior therapy and mentalization-based treatment in patients with borderline personality disorder? Psychol Med. 2019 Dec;49(16):2810-2811. doi: 10.1017/S0033291719001922. Epub 2019 Sep 19. No abstract available.
PubMed 31535604McGlashan TH, Grilo CM, Skodol AE, Gunderson JG, Shea MT, Morey LC, Zanarini MC, Stout RL. The Collaborative Longitudinal Personality Disorders Study: baseline Axis I/II and II/II diagnostic co-occurrence. Acta Psychiatr Scand. 2000 Oct;102(4):256-64. doi: 10.1034/j.1600-0447.2000.102004256.x.
PubMed 11089725McMurran M, Huband N, Overton E. Non-completion of personality disorder treatments: a systematic review of correlates, consequences, and interventions. Clin Psychol Rev. 2010 Apr;30(3):277-87. doi: 10.1016/j.cpr.2009.12.002. Epub 2009 Dec 13.
PubMed 20047783Meuldijk D, McCarthy A, Bourke ME, Grenyer BF. The value of psychological treatment for borderline personality disorder: Systematic review and cost offset analysis of economic evaluations. PLoS One. 2017 Mar 1;12(3):e0171592. doi: 10.1371/journal.pone.0171592. eCollection 2017.
PubMed 28249032Moran P, Rendu A, Jenkins R, Tylee A, Mann A. The impact of personality disorder in UK primary care: a 1-year follow-up of attenders. Psychol Med. 2001 Nov;31(8):1447-54. doi: 10.1017/s003329170105450z.
PubMed 11722159
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison d'Une thérapie basée Sur la Mentalisation et d'un Traitement inspiré de la thérapie Comportementale Dialectique Sur l'Utilisation Des Services et Sur le Taux d'Abandon Dans Une Population Clinique Adulte Atteinte d'un Trouble de la personnalité du Groupe B
- ClinicalTrials.gov ID
- NCT05014217
- Acronym / sponsor ID
- STRP1 2020-2193
- Keywords
- cluster B personality disorder, mentalization-based treatment, dialectical behavior therapy, borderline personality disorder, service utilization, dropout rate, naturalistic study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 20 Aug 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.
Cluster B personality disorders (borderline, narcissistic, antisocial and/or histrionic) are an important clinical consideration because of their high prevalence and associated morbidity. Although many studies examine borderline personality disorder, few of them explore cluster B personality disorders as a whole. In clinical practice, personality disorders are frequently comorbid. Patients who receive services in specialized clinics for these disorders often have a complex diagnosis that include many cluster B personality disorders. Therefore, our study globally examines patients with cluster B personality disorders even though borderline personality disorder is empirically the most studied psychopathology. Previous data suggests that borderline personality disorder has a prevalence of 2% in the general population, of 25% in the clinical psychiatric population and of 15% in all visits to the emergency room. Furthermore, it is associated with social costs estimated from 15,000$ to 50,000$ USD per patient per year. In Quebec, this psychopathology is associated with an increased mortality rate compared to the general population, totaling a loss of nine years for women and 13 years for men of life expectancy. Other studies suggest that borderline personality disorder is often comorbid with other personality disorders, including those in cluster B. The population with comorbid personality disorders have a worse prognosis and a lower chance of reaching symptomatic remission, which is the reason why it is crucial to better understand and study patients with cluster B personality disorders.
The study compares the effectiveness of two psychotherapies for borderline personality disorder, mentalization-based therapy and a modified version of Linehan's dialectical behavior therapy, in a retrospective naturalistic study of patients with at least one cluster B personality disorder who have undergone either treatment. The scarcity of data on cluster B personality disorders and on the comparison between MBT and DBT further highlights the necessity of a naturalistic study like ours to examine both aspects and bring research closer to the clinical setting. Based on clinical observations, the investigators believe that there will be no statistically significant difference between either treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentalization-based Treatment | – | Behavioral: Mentalization-based TreatmentParticipants who have been oriented to the mentalization-based treatment among the clinical adult population with a cluster B personality disorder. |
| Dialectical Behavior Therapy-inspired Treatment | – | Behavioral: Dialectical Behavior Therapy-inspired TreatmentParticipants who have been oriented to the dialectical behavior therapy-inspired treatment among the clinical adult population with a cluster B personality disorder. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with at least one cluster B personality disorder and admitted to the Service of personality and relational disorders at the Institut universitaire de Santé Mentale de Montréal after being referred to the program and oriented to mentalization-based treatment or dialectical behavior therapy. Patients with comorbid personality disorders are also included to better represent clinical practice.
Key inclusion criteria (3 listed)
- Meet the general criteria for a personality disorder
- Be diagnosed with at least one cluster B personality disorder
- Be admitted to the Service of personality and relational disorders and referred to mentalization-based treatment or a treatment inspired from dialectical behavior therapy
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Mentalization-based TreatmentAn empirically-validated intervention for personality disorders based on the attachment theory and on knowledge from developmental psychology and cognitive neuroscience (Bateman and Fonagy, 2004). Patients assist psychoeducative group meetings beforehand, along with a pretreatment of four to six individual meetings (over four to eight weeks), followed by bi-weekly individual follow-ups and weekly group follow-ups. The treatment lasts two years. Patients have an assessment meeting with their individual therapist and one of the group therapists at the end of each session. Psychiatric follow-up appointments are on an as-needed basis and every patient has a treatment contract with specific and measurable treatment objectives. | Behavioural | Mentalization-based Treatment |
| Dialectical Behavior Therapy-inspired TreatmentA psychotherapy developed by M. Linehan for patients with borderline personality disorder that combines cognitive behavioral therapy techniques (emotional regulation, practical exercises) with Buddhist meditation principles (stress tolerance, acceptance, open-mindedness) (Linehan, M. M. \& Dimeff, L., 2001). As opposed to Linehan's model, individual meetings are bi-weekly, no emergency phone service is offered, the mindful meditation module is reorganized into life habits modules, and every module includes mindfulness exercises. Patients assist psychoeducative group meetings beforehand, along with a pre-treatment of 4-6 individual meetings (over 4-8 weeks), followed by bi-weekly individual follow-ups and weekly group follow-ups. The treatment lasts one year, but can be extended to two years for eligible patients who are interested. Psychiatric follow-up appointments are on an as-needed basis. Every every patient has a treatment contract with specific and measurable treatment objectives. | Behavioural | Dialectical Behavior Therapy-inspired Treatment |
Primary outcome
Number of Visits To The Emergency Room
Time frame: One year before the index date (first group therapy meeting) to one year after the index date.
A comparison of the difference between a patient's number of visits to the emergency room in the year prior to and the year following the index date for each treatment.
Number of Hospitalizations
Time frame: One year before the index date (first group therapy meeting) to one year after the index date.
A comparison of the difference between a patient's number of hospitalizations in the year prior to and the year following the index date for each treatment.
1 secondary outcome
Dropout rate
Time frame: From the beginning until the end of the psychotherapy treatment.
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 13 Oct 2021.
- Background: PubMed 17560953Ansell EB, Sanislow CA, McGlashan TH, Grilo CM. Psychosocial impairment and treatment utilization by patients with borderline personality disorder, other personality disorders, mood and anxiety disorders, and a healthy comparison group. Compr Psychiatry. 2007 Jul-Aug;48(4):329-36. doi: 10.1016/j.comppsych.2007.02.001. Epub 2007 Apr 6.
- Background: PubMed 30303061Barnicot K, Crawford M. Dialectical behaviour therapy v. mentalisation-based therapy for borderline personality disorder. Psychol Med. 2019 Sep;49(12):2060-2068. doi: 10.1017/S0033291718002878. Epub 2018 Oct 10.
- BackgroundBateman, A. & Fonagy, P. (2004). Psychotherapy of Borderline Personality Disorder:mentalisation-based treatment. Oxford, UK: Oxford University Press.
- Background: PubMed 11156814Bender DS, Dolan RT, Skodol AE, Sanislow CA, Dyck IR, McGlashan TH, Shea MT, Zanarini MC, Oldham JM, Gunderson JG. Treatment utilization by patients with personality disorders. Am J Psychiatry. 2001 Feb;158(2):295-302. doi: 10.1176/appi.ajp.158.2.295.
- BackgroundCailhol, L., et al. (2015). Surveillance des troubles de la personnalité au Québec : prévalence, mortalité et profil d'utilisation des services, INSPQ (Institut National de santé publique du Québec).
- Background: PubMed 28249086Cristea IA, Gentili C, Cotet CD, Palomba D, Barbui C, Cuijpers P. Efficacy of Psychotherapies for Borderline Personality Disorder: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2017 Apr 1;74(4):319-328. doi: 10.1001/jamapsychiatry.2016.4287.
- BackgroundDuggan, C., Huband, N., Smailagic, N., Ferriter, M., & Adams, C. (2007). The use of psychological treatments for people with personality disorder: A systematic review of randomized controlled trials. Personality and Mental Health, 1, 95-125.
- BackgroundLinehan, M. M. & Dimeff, L. (2001). Dialectical Behavior Therapy in a nutshell [archive], The California Psychologist, 34, 10-13.
- Background: PubMed 16818865Linehan MM, Comtois KA, Murray AM, Brown MZ, Gallop RJ, Heard HL, Korslund KE, Tutek DA, Reynolds SK, Lindenboim N. Two-year randomized controlled trial and follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and borderline personality disorder. Arch Gen Psychiatry. 2006 Jul;63(7):757-66. doi: 10.1001/archpsyc.63.7.757.
- Background: PubMed 9561315Links PS, Heslegrave R, van Reekum R. Prospective follow-up study of borderline personality disorder: prognosis, prediction of outcome, and Axis II comorbidity. Can J Psychiatry. 1998 Apr;43(3):265-70. doi: 10.1177/070674379804300305.
- Background: PubMed 31535604Luyten P, Leichsenring F, Abbass A, Hilsenroth M, Rabung S, Steinert C. What to conclude from a non-randomized clinical trial comparing dialectical behavior therapy and mentalization-based treatment in patients with borderline personality disorder? Psychol Med. 2019 Dec;49(16):2810-2811. doi: 10.1017/S0033291719001922. Epub 2019 Sep 19. No abstract available.
- Background: PubMed 11089725McGlashan TH, Grilo CM, Skodol AE, Gunderson JG, Shea MT, Morey LC, Zanarini MC, Stout RL. The Collaborative Longitudinal Personality Disorders Study: baseline Axis I/II and II/II diagnostic co-occurrence. Acta Psychiatr Scand. 2000 Oct;102(4):256-64. doi: 10.1034/j.1600-0447.2000.102004256.x.
- Individual participant dataSharing planned: No. Patients have not consented to have their data be available to researchers outside the institution.
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.
Simon Poirier, MD principal investigator
Ciusss de L'Est de l'Île de Montréal
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster B Personality Disorder (Diagnosis) and Borderline Personality Disorder, run by Ciusss de L'Est de l'Île de Montréal.
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 1 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 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of Visits To The Emergency Room (time frame: One year before the index date (first group therapy meeting) to one year after the index date.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05014217, which also lists 24 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 13 Oct 2021.