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Recruiting Not applicable

SHame prOpensity in bOrderline Personality Disorder

NCT03994510 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-09-18
Last updated
2025-09-30

Condition(s) studied

Borderline Personality Disorder

Investigational drug(s) / intervention(s)

Clinical and biological assessments - a 5 Years follow-up

Clinical and biological assessments - a 5 Years follow-up: 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 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Level of shame propensity — At enrollment
    Evaluation of the level of shame propensity will be measured using the Test of Self Conscious Affect (TOSCA)
  • Level of shame propensity — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Montpellier Montpellier Hérault Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03994510 on ClinicalTrials.gov ↗ ← All trials in France