Severe Mental IllnessA2C'estMieuxVENCT07316803
Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness
A study testing À deux, c'est mieux (Better Together) Group Intervention in people with Severe Mental Illness and Schizophrenia, run by Centre hospitalier de Ville-Evrard, France at 2 sites in France.
Trial summary
This study evaluates a group-based intervention designed to improve romantic and social relationship skills in adults living with a severe mental illness (SMI), such as schizophrenia, bipolar disorder, or major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Mental Illness, Schizophrenia, Bipolar Disorder
- What is being tested?
- À deux, c'est mieux (Better Together) Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Nov 2025to 30 Nov 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Diagnosis of a severe mental illness (e.g., schizophrenia, bipolar disorder, or major depressive disorder)
- Currently single
- Motivated to improve romantic and social relationships and to pursue a romantic relationship
- Received mental health care within the past two years
- Able and willing to provide informed consent
Who cannot join
- Inability to speak or read French
- Currently receiving acute or crisis-level psychiatric care
- Unable to comply with study procedures or group rules (e.g., maintaining sobriety during sessions)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
HDJ (Hôpital de Jour)
Épinay-sur-Seine, Île-de-France Region, 93800
Sabrina HAMMAR, Nurse, 00.33.1.55.83.01.80, s.hammar@epsve.fr
Bachra BARBOUCHA, Nurse, 00.33.1.55.83.01.80, b.barboucha@epsve.fr
- Recruiting
L'UNIRRE (Unité Référente de Réhabilitation)
Neuilly-sur-Marne, Île-de-France Region, 93330
Adeline POETE, Specialized Educator, 00.33.1.43.09.31.89, a.poete@epsve.fr
Stéphanie MARTIN, Nurse, 00.33.1.43.09.38.18, s.martin@epsve.fr
About this study
Official title: Study on the Effectiveness of a Group Intervention on Romantic Relationships in Young Adults With Severe Mental Illness
This study evaluates a group-based intervention designed to improve romantic and social relationship skills in adults living with a severe mental illness (SMI), such as schizophrenia, bipolar disorder, or major depressive disorder.
Many adults with SMI experience loneliness, social isolation, and difficulties forming romantic relationships, even though most express a strong desire for intimacy. These challenges may be related to social skill difficulties, stigma, low self-esteem, and limited opportunities to develop healthy relationships.
Read more
The "À deux, c'est mieux" (Better Together) program is a structured 12-session group intervention focused on developing communication skills, emotional regulation, social understanding, and healthy romantic relationship behaviors. Sessions are led by trained mental health professionals and take place in small groups.
Participants will complete assessments before starting the program, at the end of the 12 sessions, and three months later. The study will examine changes in romantic relationship skills, quality of life, loneliness, self-esteem, self-stigma, and recovery.
The purpose of this study is to determine whether this intervention improves romantic and social functioning and overall well-being, and whether it is acceptable and relevant for adults living with severe mental illness.
Read the detailed description
This multicenter, prospective study examines the effects of the "À deux, c'est mieux" group intervention on romantic and social functioning in adults living with a severe mental illness (SMI).
Romantic relationships are an important component of emotional well-being and social integration. However, adults with SMI often face significant barriers to forming and maintaining intimate relationships, including social skill challenges, limited social networks, stigma, low self-esteem, and fear of rejection. Although most express a desire for romantic relationships, many feel unprepared to develop or sustain healthy partnerships.
The "À deux, c'est mieux" program is a manualized group intervention consisting of 12 weekly sessions. The program follows a progressive structure, beginning with topics such as attraction, communication, and relationship initiation, and gradually addressing more sensitive themes including emotional intimacy, attachment-related anxiety, and sexuality. The intervention uses group discussions, experiential exercises, and practical strategies to promote healthy romantic relationship skills, emotional awareness, and social cognition. The program is inclusive of sexual and gender diversity.
The intervention will be delivered in small groups of 4 to 6 participants by trained mental health professionals. Outcomes will be assessed at three time points: before the intervention (baseline), immediately after completion of the 12 sessions, and at a three-month follow-up. The study uses a repeated single-case experimental design in which each participant serves as their own control, allowing for comparison of outcomes over time without the use of an inactive control group.
The primary outcome is improvement in romantic relationship functioning. Secondary outcomes include quality of life, perceived loneliness, self-esteem, internalized stigma, and recovery. Data will be analyzed using repeated-measures statistical methods to evaluate changes across assessment time points.
This study addresses an important gap in mental health care by focusing on romantic relationships and intimacy, areas that are often overlooked but central to recovery and quality of life.
- Being tested
- À deux, c'est mieux (Better Together) Group Intervention
- Keywords
- severe mental illness, omantic relationships, intimate relationships, social functioning; loneliness, self-esteem, self-stigma, recovery, group intervention, psychosocial intervention, social skills training, relationship skills, mental health rehabilitation, adults with mental illness
- Medical subject headings
- Mental Disorders, Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
À deux, c'est mieux (Better Together) Group InterventionBehavioural
Also called Better Together
The "À deux, c'est mieux" intervention is a manualized, group-based psychosocial program consisting of 12 weekly sessions. The program targets the development of romantic relationship skills, including communication, emotional regulation, social cognition, and intimacy-related behaviors. Sessions follow a progressive structure, beginning with relationship initiation and communication skills and gradually addressing more sensitive topics such as emotional intimacy, attachment-related anxiety, and sexuality. The intervention is inclusive of sexual and gender diversity and is delivered by trained mental health professionals in groups of 4 to 6 participants.
| Study group | Role | What they receive |
|---|---|---|
| À deux, c'est mieux Group Intervention | Experimental | Participants receive the "À deux, c'est mieux" group-based psychosocial intervention, a structured program designed to improve romantic and social relationship functioning in adults living with a severe mental illness. The intervention is delivered in small groups over 12 weekly sessions led by trained mental health professionals. Receives: Behavioral: À deux, c'est mieux (Better Together) Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Romantic Relationship Functioning
Romantic relationship functioning will be assessed using the Romantic Relationships Functioning Scale, a self-report questionnaire measuring skills related to initiating, maintaining, and experiencing healthy romantic relationships. Higher scores indicate better romantic relationship functioning.
Measured: Baseline (pre-intervention), end of the 12-session intervention, and 3-month follow-up
Secondary outcomes (5)
Change in Quality of Life
Quality of life will be measured using the Schizophrenia Quality of Life Questionnaire (SQOL-18), a self-report scale assessing psychological well-being, self-esteem, family relationships, and social functioning. Higher scores indicate better quality of life.
Measured: Baseline, end of the 12-session intervention, and 3-month follow-up
Change in Perceived Loneliness
Perceived loneliness will be assessed using the UCLA Loneliness Scale (ULS-8), a self-report measure evaluating subjective feelings of loneliness and social isolation. Higher scores indicate greater loneliness.
Measured: Baseline, end of the 12-session intervention, and 3-month follow-up
Change in Self-Esteem
Self-esteem will be assessed using the Self-Esteem Rating Scale (SERS), a self-report questionnaire measuring positive and negative self-evaluations. Higher scores indicate higher self-esteem.
Measured: Baseline, end of the 12-session intervention, and 3-month follow-up
Change in Internalized Stigma
Internalized stigma will be measured using the Internalized Stigma of Mental Illness Scale (ISMI), a self-report questionnaire assessing self-stigma related to mental illness. Higher scores indicate greater internalized stigma.
Measured: Baseline, end of the 12-session intervention, and 3-month follow-up
Change in Recovery
Recovery will be assessed using the Stages of Recovery Instrument (STORI), a self-report measure evaluating subjective recovery processes in individuals with mental illness.
Measured: Baseline, end of the 12-session intervention, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start3 Nov 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Severe Mental IllnessStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a repeated single-case experimental design in which all participants receive the same group-based intervention. Participants serve as their own control, with outcomes measured before the intervention, immediately after completion of the 12-session program, and at a three-month follow-up.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raluca ROSETTI, Centre hospitalier de Ville-Evrard, France
- Investigators
- Raluca ROSETTI, Principal Investigator, Principal investigator, Psychiatrist, EPS Ville-Evrard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316803
- Sponsor's protocol ID
- CLER 02 - 001_A2 C'estMieux VE
- Acronym
- A2C'estMieuxVE
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
White R, Haddock G, Campodonico C, Haarmans M, Varese F. The influence of romantic relationships on mental wellbeing for people who experience psychosis: A systematic review. Clin Psychol Rev. 2021 Jun;86:102022. doi: 10.1016/j.cpr.2021.102022. Epub 2021 Mar 20.
PubMed 33819779Weissbourd et al. The Talk: How Adults Can Promote Young People's Healthy Relationships and Prevent Misogyny and Sexual Harassment. (Harvard School of Education, 2017)
Pillay R, Lecomte T, Abdel-Baki A. Factors limiting romantic relationship formation for individuals with early psychosis. Early Interv Psychiatry. 2018 Aug;12(4):645-651. doi: 10.1111/eip.12353. Epub 2016 May 17.
PubMed 27186857Macdonald EM, Hayes RL, Baglioni AJ Jr. The quantity and quality of the social networks of young people with early psychosis compared with closely matched controls. Schizophr Res. 2000 Nov 30;46(1):25-30. doi: 10.1016/s0920-9964(00)00024-4.
PubMed 11099882Hache-Labelle C, Abdel-Baki A, Lepage M, Laurin AS, Guillou A, Francoeur A, Bergeron S, Lecomte T. Romantic relationship group intervention for men with early psychosis: A feasibility, acceptability and potential impact pilot study. Early Interv Psychiatry. 2021 Aug;15(4):753-761. doi: 10.1111/eip.13012. Epub 2020 Jun 23.
PubMed 32578401Bonfils KA, Firmin RL, Salyers MP, Wright ER. Sexuality and intimacy among people living with serious mental illnesses: Factors contributing to sexual activity. Psychiatr Rehabil J. 2015 Sep;38(3):249-55. doi: 10.1037/prj0000117. Epub 2015 Feb 9.
PubMed 25664756Cloutier B, Lecomte T, Diotte F, Lamontagne J, Abdel-Baki A, Daneault JG, Gelineau Rabbath ME, de Connor A, Perrine C. Improving Romantic Relationship Functioning Among Young Men With First-Episode Psychosis: Impact of a Novel Group Intervention. Behav Modif. 2023 Sep;47(5):1170-1192. doi: 10.1177/01454455231186586. Epub 2023 Jul 26.
PubMed 37496322Borge L, Martinsen EW, Ruud T, Watne O, Friis S. Quality of life, loneliness, and social contact among long-term psychiatric patients. Psychiatr Serv. 1999 Jan;50(1):81-4. doi: 10.1176/ps.50.1.81.
PubMed 9890584Beyers W, Seiffge-Krenke I. Does Identity Precede Intimacy? Testing Erikson's Theory on Romantic Development in Emerging Adults of the 21st Century. Journal of Adolescent Research. 2010;25(3):387-415.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness of a Group Intervention on Romantic Relationships in Young Adults With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT07316803
- Acronym / sponsor ID
- A2C'estMieuxVE / CLER 02 - 001_A2 C'estMieux VE
- Keywords
- severe mental illness, omantic relationships, intimate relationships, social functioning; loneliness, self-esteem, self-stigma, recovery, group intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 Jan 2026 (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.
This study evaluates a group-based intervention designed to improve romantic and social relationship skills in adults living with a severe mental illness (SMI), such as schizophrenia, bipolar disorder, or major depressive disorder.
Many adults with SMI experience loneliness, social isolation, and difficulties forming romantic relationships, even though most express a strong desire for intimacy. These challenges may be related to social skill difficulties, stigma, low self-esteem, and limited opportunities to develop healthy relationships.
The "À deux, c'est mieux" (Better Together) program is a structured 12-session group intervention focused on developing communication skills, emotional regulation, social understanding, and healthy romantic relationship behaviors. Sessions are led by trained mental health professionals and take place in small groups.
Participants will complete assessments before starting the program, at the end of the 12 sessions, and three months later. The study will examine changes in romantic relationship skills, quality of life, loneliness, self-esteem, self-stigma, and recovery.
The purpose of this study is to determine whether this intervention improves romantic and social functioning and overall well-being, and whether it is acceptable and relevant for adults living with severe mental illness.
Detailed description
This multicenter, prospective study examines the effects of the "À deux, c'est mieux" group intervention on romantic and social functioning in adults living with a severe mental illness (SMI).
Romantic relationships are an important component of emotional well-being and social integration. However, adults with SMI often face significant barriers to forming and maintaining intimate relationships, including social skill challenges, limited social networks, stigma, low self-esteem, and fear of rejection. Although most express a desire for romantic relationships, many feel unprepared to develop or sustain healthy partnerships.
The "À deux, c'est mieux" program is a manualized group intervention consisting of 12 weekly sessions. The program follows a progressive structure, beginning with topics such as attraction, communication, and relationship initiation, and gradually addressing more sensitive themes including emotional intimacy, attachment-related anxiety, and sexuality. The intervention uses group discussions, experiential exercises, and practical strategies to promote healthy romantic relationship skills, emotional awareness, and social cognition. The program is inclusive of sexual and gender diversity.
The intervention will be delivered in small groups of 4 to 6 participants by trained mental health professionals. Outcomes will be assessed at three time points: before the intervention (baseline), immediately after completion of the 12 sessions, and at a three-month follow-up. The study uses a repeated single-case experimental design in which each participant serves as their own control, allowing for comparison of outcomes over time without the use of an inactive control group.
The primary outcome is improvement in romantic relationship functioning. Secondary outcomes include quality of life, perceived loneliness, self-esteem, internalized stigma, and recovery. Data will be analyzed using repeated-measures statistical methods to evaluate changes across assessment time points.
This study addresses an important gap in mental health care by focusing on romantic relationships and intimacy, areas that are often overlooked but central to recovery and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a repeated single-case experimental design in which all participants receive the same group-based intervention. Participants serve as their own control, with outcomes measured before the intervention, immediately after completion of the 12-session program, and at a three-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| À deux, c'est mieux Group Intervention | Experimental | Behavioral: À deux, c'est mieux (Better Together) Group InterventionParticipants receive the "À deux, c'est mieux" group-based psychosocial intervention, a structured program designed to improve romantic and social relationship functioning in adults living with a severe mental illness. The intervention is delivered in small groups over 12 weekly sessions led by trained mental health professionals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years and older
- Diagnosis of a severe mental illness (e.g., schizophrenia, bipolar disorder, or major depressive disorder)
- Currently single
- Motivated to improve romantic and social relationships and to pursue a romantic relationship
- Received mental health care within the past two years
Key exclusion criteria (3 listed)
- Inability to speak or read French
- Currently receiving acute or crisis-level psychiatric care
- Unable to comply with study procedures or group rules (e.g., maintaining sobriety during sessions)
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 |
|---|---|---|
| À deux, c'est mieux (Better Together) Group InterventionAlso: Better TogetherThe "À deux, c'est mieux" intervention is a manualized, group-based psychosocial program consisting of 12 weekly sessions. The program targets the development of romantic relationship skills, including communication, emotional regulation, social cognition, and intimacy-related behaviors. Sessions follow a progressive structure, beginning with relationship initiation and communication skills and gradually addressing more sensitive topics such as emotional intimacy, attachment-related anxiety, and sexuality. The intervention is inclusive of sexual and gender diversity and is delivered by trained mental health professionals in groups of 4 to 6 participants. | Behavioural | À deux, c'est mieux Group Intervention |
Primary outcome
Change in Romantic Relationship Functioning
Time frame: Baseline (pre-intervention), end of the 12-session intervention, and 3-month follow-up
Romantic relationship functioning will be assessed using the Romantic Relationships Functioning Scale, a self-report questionnaire measuring skills related to initiating, maintaining, and experiencing healthy romantic relationships. Higher scores indicate better romantic relationship functioning.
5 secondary outcomes
Change in Quality of Life
Time frame: Baseline, end of the 12-session intervention, and 3-month follow-up
Change in Perceived Loneliness
Time frame: Baseline, end of the 12-session intervention, and 3-month follow-up
Change in Self-Esteem
Time frame: Baseline, end of the 12-session intervention, and 3-month follow-up
Change in Internalized Stigma
Time frame: Baseline, end of the 12-session intervention, and 3-month follow-up
Change in Recovery
Time frame: Baseline, end of the 12-session intervention, and 3-month 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 5 Jan 2026.
- Background: PubMed 33819779White R, Haddock G, Campodonico C, Haarmans M, Varese F. The influence of romantic relationships on mental wellbeing for people who experience psychosis: A systematic review. Clin Psychol Rev. 2021 Jun;86:102022. doi: 10.1016/j.cpr.2021.102022. Epub 2021 Mar 20.
- BackgroundWeissbourd et al. The Talk: How Adults Can Promote Young People's Healthy Relationships and Prevent Misogyny and Sexual Harassment. (Harvard School of Education, 2017)
- Background: PubMed 27186857Pillay R, Lecomte T, Abdel-Baki A. Factors limiting romantic relationship formation for individuals with early psychosis. Early Interv Psychiatry. 2018 Aug;12(4):645-651. doi: 10.1111/eip.12353. Epub 2016 May 17.
- Background: PubMed 11099882Macdonald EM, Hayes RL, Baglioni AJ Jr. The quantity and quality of the social networks of young people with early psychosis compared with closely matched controls. Schizophr Res. 2000 Nov 30;46(1):25-30. doi: 10.1016/s0920-9964(00)00024-4.
- Background: PubMed 32578401Hache-Labelle C, Abdel-Baki A, Lepage M, Laurin AS, Guillou A, Francoeur A, Bergeron S, Lecomte T. Romantic relationship group intervention for men with early psychosis: A feasibility, acceptability and potential impact pilot study. Early Interv Psychiatry. 2021 Aug;15(4):753-761. doi: 10.1111/eip.13012. Epub 2020 Jun 23.
- Background: PubMed 25664756Bonfils KA, Firmin RL, Salyers MP, Wright ER. Sexuality and intimacy among people living with serious mental illnesses: Factors contributing to sexual activity. Psychiatr Rehabil J. 2015 Sep;38(3):249-55. doi: 10.1037/prj0000117. Epub 2015 Feb 9.
- Background: PubMed 37496322Cloutier B, Lecomte T, Diotte F, Lamontagne J, Abdel-Baki A, Daneault JG, Gelineau Rabbath ME, de Connor A, Perrine C. Improving Romantic Relationship Functioning Among Young Men With First-Episode Psychosis: Impact of a Novel Group Intervention. Behav Modif. 2023 Sep;47(5):1170-1192. doi: 10.1177/01454455231186586. Epub 2023 Jul 26.
- Background: PubMed 9890584Borge L, Martinsen EW, Ruud T, Watne O, Friis S. Quality of life, loneliness, and social contact among long-term psychiatric patients. Psychiatr Serv. 1999 Jan;50(1):81-4. doi: 10.1176/ps.50.1.81.
- BackgroundBeyers W, Seiffge-Krenke I. Does Identity Precede Intimacy? Testing Erikson's Theory on Romantic Development in Emerging Adults of the 21st Century. Journal of Adolescent Research. 2010;25(3):387-415.
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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.
Raluca ROSETTI, Principal Investigator principal investigator
Psychiatrist, EPS Ville-Evrard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing À deux, c'est mieux (Better Together) Group Intervention in people with Severe Mental Illness and Schizophrenia, run by Centre hospitalier de Ville-Evrard, France at 2 sites in France.
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 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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. 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 France. 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 Youcef BENCHERIF, Clinical Project Manager (00.33.01.43.09.32.32, y.bencherif@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Romantic Relationship Functioning (time frame: Baseline (pre-intervention), end of the 12-session intervention, and 3-month follow-up). 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 NCT07316803, which also lists 9 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 5 Jan 2026.