Clinical trial NCT03994510: SHame PrOpensity in BOrderline Personality Disorder
Official title: Study of Shame Propensity As a Prognostic Factor of Suicidal Behaviors in Patients with Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Psychiatry
Suicidal Behavior
Borderline Personality Disorder
Follow-Up Study
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
First posted: 2019-06-21
Enrollment: 688
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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))
Primary purpose: OTHER

Brief 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. 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).

Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* Deprived of liberty (by judicial or administrative decision)
* Protected by law (guardianship)
* Exclusion period in relation to another protocol
* Not affiliated to a social security scheme

Primary outcomes:
measure: Level of shame propensity
timeFrame: At enrollment
measure: Level of shame propensity
timeFrame: 1 year after enrollment
measure: Level of shame propensity
timeFrame: 2 years after enrollment
measure: Level of shame propensity
timeFrame: 3 years after enrollment
measure: Level of shame propensity
timeFrame: 4 years after enrollment
measure: Level of shame propensity
timeFrame: 5 years after enrollment
measure: Number of SA compared to the clinical data obtained in baseline
timeFrame: At enrollment
measure: Number of SA compared to the clinical data obtained in baseline
timeFrame: 1 year after enrollment
measure: Number of SA compared to the clinical data obtained in baseline
timeFrame: 2 years after enrollment
measure: Number of SA compared to the clinical data obtained in baseline
timeFrame: 3 years after enrollment
measure: Number of SA compared to the clinical data obtained in baseline
timeFrame: 4 years after enrollment
measure: Number of SA compared to the clinical data obtained in baseline
timeFrame: 5 years after enrollment
Secondary outcomes:
measure: Number of SA compared to the biological data obtained in baseline
timeFrame: At enrollment
measure: Number of SA compared to the biological data obtained in baseline
timeFrame: 1 year after enrollment
measure: Number of SA compared to the biological data obtained in baseline
timeFrame: 2 years after enrollment
measure: Number of SA compared to the biological data obtained in baseline
timeFrame: 3 years after enrollment
measure: Number of SA compared to the biological data obtained in baseline
timeFrame: 4 years after enrollment
measure: Number of SA compared to the biological data obtained in baseline
timeFrame: 5 years after enrollment
measure: Suicidal Ideation
timeFrame: At enrollment
measure: Suicidal Ideation
timeFrame: 1 year after enrollment
measure: Suicidal Ideation
timeFrame: 2 years after enrollment
measure: Suicidal Ideation
timeFrame: 3 years after enrollment
measure: Suicidal Ideation
timeFrame: 4 years after enrollment
measure: Suicidal Ideation
timeFrame: 5 years after enrollment
measure: Parasuicidal Behaviours
timeFrame: At enrollment
measure: Parasuicidal Behaviours
timeFrame: 1 year after enrollment
measure: Parasuicidal Behaviours
timeFrame: 2 years after enrollment
measure: Parasuicidal Behaviours
timeFrame: 3 years after enrollment
measure: Parasuicidal Behaviours
timeFrame: 4 years after enrollment
measure: Parasuicidal Behaviours
timeFrame: 5 years after enrollment
measure: Sick leave for a psychiatric condition
timeFrame: At enrollment
measure: Sick leave for a psychiatric condition
timeFrame: 1 year after enrollment
measure: Sick leave for a psychiatric condition
timeFrame: 2 years after enrollment
measure: Sick leave for a psychiatric condition
timeFrame: 3 years after enrollment
measure: Sick leave for a psychiatric condition
timeFrame: 4 years after enrollment
measure: Sick leave for a psychiatric condition
timeFrame: 5 years after enrollment
measure: Hospitalization for a psychiatric condition
timeFrame: At enrollment
measure: Hospitalization for a psychiatric condition
timeFrame: 1 year after enrollment
measure: Hospitalization for a psychiatric condition
timeFrame: 2 years after enrollment
measure: Hospitalization for a psychiatric condition
timeFrame: 3 years after enrollment
measure: Hospitalization for a psychiatric condition
timeFrame: 4 years after enrollment
measure: Hospitalization for a psychiatric condition
timeFrame: 5 years after enrollment
measure: The need to emergency psychiatric consult
timeFrame: At enrollment
measure: The need to emergency psychiatric consult
timeFrame: 1 year after enrollment
measure: The need to emergency psychiatric consult
timeFrame: 2 years after enrollment
measure: The need to emergency psychiatric consult
timeFrame: 3 years after enrollment
measure: The need to emergency psychiatric consult
timeFrame: 4 years after enrollment
measure: The need to emergency psychiatric consult
timeFrame: 5 years after enrollment
measure: Major depressive episodes
timeFrame: At enrollment
measure: Major depressive episodes
timeFrame: 1 year after enrollment
measure: Major depressive episodes
timeFrame: 2 years after enrollment
measure: Major depressive episodes
timeFrame: 3 years after enrollment
measure: Major depressive episodes
timeFrame: 4 years after enrollment
measure: Major depressive episodes
timeFrame: 5 years after enrollment
measure: Global functioning
timeFrame: At enrollment
measure: Global functioning
timeFrame: 1 year after enrollment
measure: Global functioning
timeFrame: 2 years after enrollment
measure: Global functioning
timeFrame: 3 years after enrollment
measure: Global functioning
timeFrame: 4 years after enrollment
measure: Global functioning
timeFrame: 5 years after enrollment
measure: Life Quality
timeFrame: At enrollment
measure: Life Quality
timeFrame: 1 year after enrollment
measure: Life Quality
timeFrame: 2 years after enrollment
measure: Life Quality
timeFrame: 3 years after enrollment
measure: Life Quality
timeFrame: 4 years after enrollment
measure: Life Quality
timeFrame: 5 years after enrollment
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
state: Hérault
Study officials:
References: