SHame prOpensity in bOrderline Personality Disorder

NCT ID: NCT03994510

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 688 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-18
• Study Completion Date: 2031-09-30

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).

Conditions

Borderline Personality Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with Borderline Personality Disorder

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

Group Type: OTHER

Clinical and biological assessments - a 5 Years follow-up

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier

UNKNOWN

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Montpellier

Montpellier, Hérault, France

Site Status: RECRUITING

Countries

France

Central Contacts

Déborah DUCASSE, MD, PhD

Role: CONTACT

d-ducasse@chu-montpellier.fr

(0)467338581 ext. +33

Facility Contacts

Laëtitia LACOURT

Role: primary

l-lacourt@chu-montpellier.fr

(0)467335663

Catherine GENTY

Role: backup

c-genty@chu-montpellier.fr

(0)499614575 ext. +33

Other Identifiers

RECHMPL18_0286

Identifier Type: -

Identifier Source: org_study_id