Borderline Personality DisorderSHOONCT03994510
SHame prOpensity in bOrderline Personality Disorder
A study testing Clinical and biological assessments - a 5 Years follow-up in people with Borderline Personality Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Borderline Personality Disorder (BPD) is a common psychiatric disorder occurring in 2 to 6% of the population. 70% of patients with BPD do at least one Suicide Attempt (SA) in their lives. It makes BPD the most related to SA condition. Negative interpersonal events are among the main stressor inducing a SA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Clinical and biological assessments - a 5 Years follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2020to Sep 2031
- 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
- To be over 18
- Clinical diagnosis of BPD using the SCID II (Structured Clinical Interview for DSM-IV-Text Reviewed Axis II Personality Disorders)
- Having signed the informed consent
- Able to understand the nature, the purpose and the methodology of the study
- Able to understand and perform the clinical evaluations
Who cannot join
- Deprived of liberty (by judicial or administrative decision)
- Protected by law (guardianship)
- Not affiliated to a social security scheme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Montpellier
Montpellier, Hérault, 34295
Laëtitia LACOURT, (0)467335663, l-lacourt@chu-montpellier.fr
Catherine GENTY, (0)499614575 ext. +33, c-genty@chu-montpellier.fr
About this study
Official title: Study of Shame Propensity as a Prognostic Factor of Suicidal Behaviors in Patients With Borderline Personality Disorder
Borderline Personality Disorder (BPD) is a common psychiatric disorder occurring in 2 to 6% of the population. 70% of patients with BPD do at least one Suicide Attempt (SA) in their lives. It makes BPD the most related to SA condition.
Negative interpersonal events are among the main stressor inducing a SA. Patients with BPD are characterized by emotional dysregulation, impulsivity (repeated parasuicidal and suicidal behaviors), and instability in interpersonal relationships. The feeling of shame related to this psychiatric disorder could be one of the causes of the high SA rate. In this study, patients with BPD will be follow-up during 5 years.
Read more
The main objective is to study the propensity to feel shame as a predictor of SA.
This include:
- Study of shame propensity as a predictive factor of suicidal behavior - Identify homogeneous subgroups of patients with BPD based on SA, and overall functioning.
- Identify biological markers predicting SA
- Identify predictive and protective treatments (pharmacological and psychotherapeutic) for SA
Read the detailed description
This is a 5 years follow-up prospective study recruiting 688 patients.
Schedule of the study :
Inclusion period : 3 years Duration of follow-up of each patient : 5 years Estimated duration of the study : 8.5 years
As part of the research, patients will be summoned annually for 5 years.
The first visit (at baseline) is included in the usual care
The follow-up visits are specifics to the research
During the visits patients will complete self questionary and clinical interview.
The organization of visits is as follows:
- an inclusion visit lasting around 2 hours (clinical evaluation and then self-questionnaires)
- a visit to 1 year, 2 years, 3 years, 4 years and 5 years (+/- 1 month) lasting approximately 1 hour 30 (clinical evaluation and passing of self-questionnaires)
Genetic samples will be taken during the initial visit as well as during the visit to 5 years.
They consist of:
- A genetic collection consisting of a DNA library (3 Ethylene Diamine Triacetic Acid (EDTA) tubes of 6ml - 18 ml).
- An off-genetics collection consisting of serum and plasma samples, (1 6 ml EDTA tube, 1 4 ml heparinized tube, 2 dry tubes of 5 ml each and 2 citrated tubes of 2.7 ml each - 25 , 4 ml).
- Conditions
- Borderline Personality Disorder
- Being tested
- Clinical and biological assessments - a 5 Years follow-up
- Keywords
- Psychiatry, Suicidal Behavior, Borderline Personality Disorder, Follow-Up Study
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and biological assessments - a 5 Years follow-upOther
During each visit, a clinical evaluation will be carried out, as well as the filling of hetero-questionnaires and self-questionnaires. Two biological collections will be made: one during the inclusion visit, and the other during the last visit, 5 years after inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Borderline Personality Disorder | Other | At each visit, these patients will have an interview that will allow for a clinical evaluation, as well as completing the hetero-questionnaires and self-questionnaires Receives: Other: Clinical and biological assessments - a 5 Years follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of shame propensity
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Measured: At enrollment
Level of shame propensity
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Measured: 1 year after enrollment
Level of shame propensity
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Measured: 2 years after enrollment
Level of shame propensity
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Measured: 3 years after enrollment
Level of shame propensity
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Measured: 4 years after enrollment
Level of shame propensity
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Measured: 5 years after enrollment
Number of SA compared to the clinical data obtained in baseline
The number of SA will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
Measured: At enrollment
Number of SA compared to the clinical data obtained in baseline
The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
Measured: 1 year after enrollment
Number of SA compared to the clinical data obtained in baseline
The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
Measured: 2 years after enrollment
Number of SA compared to the clinical data obtained in baseline
The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
Measured: 3 years after enrollment
Number of SA compared to the clinical data obtained in baseline
The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
Measured: 4 years after enrollment
Number of SA compared to the clinical data obtained in baseline
The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
Measured: 5 years after enrollment
Secondary outcomes (54)
Number of SA compared to the biological data obtained in baseline
The number of SA will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the biological data obtained in baseline
Measured: At enrollment
Number of SA compared to the biological data obtained in baseline
The number of SA will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the biological data obtained in baseline
Measured: 1 year after enrollment
Number of SA compared to the biological data obtained in baseline
The number of SA will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the biological data obtained in baseline
Measured: 2 years after enrollment
Number of SA compared to the biological data obtained in baseline
The number of SA will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the biological data obtained in baseline
Measured: 3 years after enrollment
Number of SA compared to the biological data obtained in baseline
The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the biological data obtained in baseline
Measured: 4 years after enrollment
Number of SA compared to the biological data obtained in baseline
The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the biological data obtained in baseline
Measured: 5 years after enrollment
Suicidal Ideation
The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: At enrollment
Suicidal Ideation
The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: 1 year after enrollment
Suicidal Ideation
The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: 2 years after enrollment
Suicidal Ideation
The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: 3 years after enrollment
Suicidal Ideation
The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: 4 years after enrollment
Suicidal Ideation
The number of suicidal ideation will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: 5 years after enrollment
Parasuicidal Behaviours
The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: At enrollment
Parasuicidal Behaviours
The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: 1 year after enrollment
Parasuicidal Behaviours
The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: 2 years after enrollment
Parasuicidal Behaviours
The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: 3 years after enrollment
Parasuicidal Behaviours
The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: 4 years after enrollment
Parasuicidal Behaviours
The number of parasuicidal behaviours will be collected using Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: 5 years after enrollment
Sick leave for a psychiatric condition
The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Measured: At enrollment
Sick leave for a psychiatric condition
The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Measured: 1 year after enrollment
Sick leave for a psychiatric condition
The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Measured: 2 years after enrollment
Sick leave for a psychiatric condition
The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Measured: 3 years after enrollment
Sick leave for a psychiatric condition
The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Measured: 4 years after enrollment
Sick leave for a psychiatric condition
The number of sick leaves, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Measured: 5 years after enrollment
Hospitalization for a psychiatric condition
The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Measured: At enrollment
Hospitalization for a psychiatric condition
The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Measured: 1 year after enrollment
Hospitalization for a psychiatric condition
The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Measured: 2 years after enrollment
Hospitalization for a psychiatric condition
The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Measured: 3 years after enrollment
Hospitalization for a psychiatric condition
The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Measured: 4 years after enrollment
Hospitalization for a psychiatric condition
The number of hospitalization, related to BPD, and their duration will be collected and reported on the case report form (CRF).
Measured: 5 years after enrollment
The need to emergency psychiatric consult
The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).
Measured: At enrollment
The need to emergency psychiatric consult
The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).
Measured: 1 year after enrollment
The need to emergency psychiatric consult
The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).
Measured: 2 years after enrollment
The need to emergency psychiatric consult
The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).
Measured: 3 years after enrollment
The need to emergency psychiatric consult
The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).
Measured: 4 years after enrollment
The need to emergency psychiatric consult
The number of emergency visit related to BPD, will be collected and reported on the case report form (CRF).
Measured: 5 years after enrollment
Major depressive episodes
The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).
Measured: At enrollment
Major depressive episodes
The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).
Measured: 1 year after enrollment
Major depressive episodes
The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).
Measured: 2 years after enrollment
Major depressive episodes
The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).
Measured: 3 years after enrollment
Major depressive episodes
The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).
Measured: 4 years after enrollment
Major depressive episodes
The number of major depressives episodes and the measure of the depression intensity will be collected using the Inventory of Depressive Symptomatology (IDS-C30).
Measured: 5 years after enrollment
Global functioning
The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
Measured: At enrollment
Global functioning
The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
Measured: 1 year after enrollment
Global functioning
The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
Measured: 2 years after enrollment
Global functioning
The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
Measured: 3 years after enrollment
Global functioning
The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
Measured: 4 years after enrollment
Global functioning
The Global functioning will be measured using the Functioning Assessment Short Test (FAST).
Measured: 5 years after enrollment
Life Quality
The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
Measured: At enrollment
Life Quality
The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
Measured: 1 year after enrollment
Life Quality
The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
Measured: 2 years after enrollment
Life Quality
The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
Measured: 3 years after enrollment
Life Quality
The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
Measured: 4 years after enrollment
Life Quality
The Life Quality will be measured using the Satisfaction With Life Scale (SWLS).
Measured: 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start18 Sep 2020
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- During each visit, a clinical evaluation will be carried out, as well as the filling of hetero-questionnaires and self-questionnaires. Two biological collections will be made: one during the inclusion visit, and the other during the last visit, 5 years after inclusion. First visit (Baseline) only: Sociodemographic data, Clinical evaluation, family history At Baseline and 5 years after baseline only: * Blood sample * BPD diagnosis (using the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM) Disorders (SCID II))
- Masking
- None (open label)
- Enrolment
- 688 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994510
- Sponsor's protocol ID
- RECHMPL18_0286
- Acronym
- SHOO
- Status last verified
- Jan 2025
- First submitted
- 20 Jun 2019
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Shame Propensity as a Prognostic Factor of Suicidal Behaviors in Patients With Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT03994510
- Acronym / sponsor ID
- SHOO / RECHMPL18_0286
- Conditions
- Borderline Personality Disorder
- Keywords
- Psychiatry, Suicidal Behavior, Borderline Personality Disorder, Follow-Up Study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 688 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 21 Jun 2019 (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.
Borderline Personality Disorder (BPD) is a common psychiatric disorder occurring in 2 to 6% of the population. 70% of patients with BPD do at least one Suicide Attempt (SA) in their lives. It makes BPD the most related to SA condition.
Negative interpersonal events are among the main stressor inducing a SA. Patients with BPD are characterized by emotional dysregulation, impulsivity (repeated parasuicidal and suicidal behaviors), and instability in interpersonal relationships. The feeling of shame related to this psychiatric disorder could be one of the causes of the high SA rate. In this study, patients with BPD will be follow-up during 5 years.
The main objective is to study the propensity to feel shame as a predictor of SA.
This include:
- Study of shame propensity as a predictive factor of suicidal behavior - Identify homogeneous subgroups of patients with BPD based on SA, and overall functioning.
- Identify biological markers predicting SA
- Identify predictive and protective treatments (pharmacological and psychotherapeutic) for SA
Detailed description
This is a 5 years follow-up prospective study recruiting 688 patients.
Schedule of the study :
Inclusion period : 3 years Duration of follow-up of each patient : 5 years Estimated duration of the study : 8.5 years
As part of the research, patients will be summoned annually for 5 years.
The first visit (at baseline) is included in the usual care
The follow-up visits are specifics to the research
During the visits patients will complete self questionary and clinical interview.
The organization of visits is as follows:
- an inclusion visit lasting around 2 hours (clinical evaluation and then self-questionnaires)
- a visit to 1 year, 2 years, 3 years, 4 years and 5 years (+/- 1 month) lasting approximately 1 hour 30 (clinical evaluation and passing of self-questionnaires)
Genetic samples will be taken during the initial visit as well as during the visit to 5 years.
They consist of:
- A genetic collection consisting of a DNA library (3 Ethylene Diamine Triacetic Acid (EDTA) tubes of 6ml - 18 ml).
- An off-genetics collection consisting of serum and plasma samples, (1 6 ml EDTA tube, 1 4 ml heparinized tube, 2 dry tubes of 5 ml each and 2 citrated tubes of 2.7 ml each - 25 , 4 ml).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- During each visit, a clinical evaluation will be carried out, as well as the filling of hetero-questionnaires and self-questionnaires. Two biological collections will be made: one during the inclusion visit, and the other during the last visit, 5 years after inclusion. First visit (Baseline) only: Sociodemographic data, Clinical evaluation, family history At Baseline and 5 years after baseline only: * Blood sample * BPD diagnosis (using the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM) Disorders (SCID II))
| Arm | Type | Receives |
|---|---|---|
| Patients with Borderline Personality Disorder | Other | Other: Clinical and biological assessments - a 5 Years follow-upAt each visit, these patients will have an interview that will allow for a clinical evaluation, as well as completing the hetero-questionnaires and self-questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be over 18
- Clinical diagnosis of BPD using the SCID II (Structured Clinical Interview for DSM-IV-Text Reviewed Axis II Personality Disorders)
- Having signed the informed consent
- Able to understand the nature, the purpose and the methodology of the study
- Able to understand and perform the clinical evaluations
Key exclusion criteria (3 listed)
- Deprived of liberty (by judicial or administrative decision)
- Protected by law (guardianship)
- Not affiliated to a social security scheme
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 |
|---|---|---|
| Clinical and biological assessments - a 5 Years follow-upDuring each visit, a clinical evaluation will be carried out, as well as the filling of hetero-questionnaires and self-questionnaires. Two biological collections will be made: one during the inclusion visit, and the other during the last visit, 5 years after inclusion. | Other | Patients with Borderline Personality Disorder |
Primary outcome
Level of shame propensity
Time frame: At enrollment
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Level of shame propensity
Time frame: 1 year after enrollment
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Level of shame propensity
Time frame: 2 years after enrollment
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Level of shame propensity
Time frame: 3 years after enrollment
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Level of shame propensity
Time frame: 4 years after enrollment
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Level of shame propensity
Time frame: 5 years after enrollment
Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
Number of SA compared to the clinical data obtained in baseline
Time frame: At enrollment
The number of SA will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
Number of SA compared to the clinical data obtained in baseline
Time frame: 1 year after enrollment
The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
Number of SA compared to the clinical data obtained in baseline
Time frame: 2 years after enrollment
The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
Number of SA compared to the clinical data obtained in baseline
Time frame: 3 years after enrollment
The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
Number of SA compared to the clinical data obtained in baseline
Time frame: 4 years after enrollment
The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
Number of SA compared to the clinical data obtained in baseline
Time frame: 5 years after enrollment
The number of SA within the year will be collected using Columbia Suicide Severity Rating Scale (C-SSRS) and compared to the clinical data obtained in baseline
54 secondary outcomes
Number of SA compared to the biological data obtained in baseline
Time frame: At enrollment
Number of SA compared to the biological data obtained in baseline
Time frame: 1 year after enrollment
Number of SA compared to the biological data obtained in baseline
Time frame: 2 years after enrollment
Number of SA compared to the biological data obtained in baseline
Time frame: 3 years after enrollment
Number of SA compared to the biological data obtained in baseline
Time frame: 4 years after enrollment
Number of SA compared to the biological data obtained in baseline
Time frame: 5 years after enrollment
Suicidal Ideation
Time frame: At enrollment
Suicidal Ideation
Time frame: 1 year after enrollment
Suicidal Ideation
Time frame: 2 years after enrollment
Suicidal Ideation
Time frame: 3 years after enrollment
Suicidal Ideation
Time frame: 4 years after enrollment
Suicidal Ideation
Time frame: 5 years after enrollment
Parasuicidal Behaviours
Time frame: At enrollment
Parasuicidal Behaviours
Time frame: 1 year after enrollment
Parasuicidal Behaviours
Time frame: 2 years after enrollment
Parasuicidal Behaviours
Time frame: 3 years after enrollment
Parasuicidal Behaviours
Time frame: 4 years after enrollment
Parasuicidal Behaviours
Time frame: 5 years after enrollment
Sick leave for a psychiatric condition
Time frame: At enrollment
Sick leave for a psychiatric condition
Time frame: 1 year after enrollment
Sick leave for a psychiatric condition
Time frame: 2 years after enrollment
Sick leave for a psychiatric condition
Time frame: 3 years after enrollment
Sick leave for a psychiatric condition
Time frame: 4 years after enrollment
Sick leave for a psychiatric condition
Time frame: 5 years after enrollment
Hospitalization for a psychiatric condition
Time frame: At enrollment
Hospitalization for a psychiatric condition
Time frame: 1 year after enrollment
Hospitalization for a psychiatric condition
Time frame: 2 years after enrollment
Hospitalization for a psychiatric condition
Time frame: 3 years after enrollment
Hospitalization for a psychiatric condition
Time frame: 4 years after enrollment
Hospitalization for a psychiatric condition
Time frame: 5 years after enrollment
The need to emergency psychiatric consult
Time frame: At enrollment
The need to emergency psychiatric consult
Time frame: 1 year after enrollment
The need to emergency psychiatric consult
Time frame: 2 years after enrollment
The need to emergency psychiatric consult
Time frame: 3 years after enrollment
The need to emergency psychiatric consult
Time frame: 4 years after enrollment
The need to emergency psychiatric consult
Time frame: 5 years after enrollment
Major depressive episodes
Time frame: At enrollment
Major depressive episodes
Time frame: 1 year after enrollment
Major depressive episodes
Time frame: 2 years after enrollment
Major depressive episodes
Time frame: 3 years after enrollment
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 30 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and biological assessments - a 5 Years follow-up in people with Borderline Personality Disorder, run by University Hospital, Montpellier at 1 site 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 5 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 30 Sep 2025. 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 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 Déborah DUCASSE, MD, PhD ((0)467338581 ext. +33, d-ducasse@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of shame propensity (time frame: At enrollment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2025.